ER/LA opioid REMS supplement
DOI:
https://doi.org/10.5055/jom.2014.0233Keywords:
Long-Acting, Extended-Release, and Sustained-Release Opioids, Chronic Nonmalignant PainAbstract
Extended-Release and Long-Acting Opioids for Chronic Pain Management
General Pharmacology of Long-Acting, Extended-Release, and Sustained-Release Opioids for the Treatment of Chronic Nonmalignant Pain
Specific Pharmacology of Long-Acting, Extended-Release, and Sustained-Release Opioids for the Treatment of Chronic Nonmalignant Pain
Case Studies of Long-Acting, Extended-Release, and Sustained-Release Opioids for the Treatment of Chronic Nonmalignant Pain
References
Article 1 references:
Sloan PA: Buprenorphine for chronic pain management. J Supp Oncol. 2012; 10: 220-221.
Sloan PA: Oxymorphone in the management of pain. Ther Clin Risk Manage. 2008; 4: 777-787.
Substance Abuse and Mental Health Services Administration: Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings. NSDUH Series H-41 2011. HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2011.
Substance Abuse and Mental Health Services Administration: National estimates of drug-related emergency department visits. 2011. Available at www.samhsa.gov/data/2k11.htm. Accessed October 1, 2014.
Warner M, Chen LH, Makuc DM, et al.: U.S. Department of Health and Human Services, National Center for Health Statistics: Drug-poisoning deaths involving opioid analgesics: United States, 1999-2011. Available at www.cdc.gov/nchs/data/databriefs/db166.htm. Accessed October 1, 2014.
IMS Health: U.S. Prescription drug sales grow slowly; hydrocodone most prescribed. 2009. Available at www.seekingalpha.com/article/128003-u-s-prescription-drug-sales-grow-slowly-hydrocodone-mostprescribed. Accessed October 1, 2014.
Chou R, Deyo R, Devine B, et al.: The effectiveness and risks of long-term opioid treatment of chronic pain. Evidence Report/Technology Assessment No. 218. September 2014. AHRQ Publication No. 14-E005-EF. Rockville, MD: Agency for Healthcare Research and Quality. Available at www.effective healthcare.ahrq.gov/reports/final.cfm. Accessed October 1, 2014.
FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. August 2014. Available at www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/UCM277916.pdf. Accessed October 1, 2014.
Chou R, Cruciani RA, Fiellin DA, et al.: Methadone safety: A clinical practice guideline from the American Pain Society and College on Problems of Drug Dependence, in collaboration with the Heart Rhythm Society. J Pain. 2014; 15(4): 321-337.
Reisfield GM, Sloan PA: Rethinking methadone for the management of chronic pain. J Opioid Manage. 2012; 8: 271-272. DOI: https://doi.org/10.5055/jom.2012.0126
Hirsch A, Proescholdbell SK, Bronson W, et al.: Prescription histories and dose strengths associated with overdose deaths. Pain Med. 2014; 15(7): 1187-1195. DOI: https://doi.org/10.1111/pme.12391
Denlinger CS, Ligibel JA, Are M, et al.: Survivorship: Pain Version 1.2014: Clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2014; 12: 488-500. DOI: https://doi.org/10.6004/jnccn.2014.0001
Webster LR, Webster RM: Predicting aberrant behaviors in opioid-treated patients: Preliminary validation of the Opioid Risk Tool. Pain Med. 2005; 6(6): 432-442. DOI: https://doi.org/10.1111/j.1526-4637.2005.00072.x
Butler SF, Fernandez K, Benoit C, et al.: Validation of the Revised Screener and Opioid Assessment for Patients in Pain (SOAPP-R). J Pain. 2008; 9: 360-372. DOI: https://doi.org/10.1016/j.jpain.2007.11.014
Sloan PA, Babul J: Extended-release opioids for the management of chronic non-malignant pain. Exp Opin Drug Deliv. 2006; 3: 489-497.
Lee M, Silverman SM, Hansen H, et al.: A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011; 14(2): 145-161. DOI: https://doi.org/10.36076/ppj.2011/14/145
Hawkins EJ, Malte CA, Grossbard J, et al.: Comparative safety of benzodiazepines and opioids among Veterans Affairs patients with posttraumatic stress disorder. J Addict Med. 2013; 7(5): 354-362. DOI: https://doi.org/10.1097/ADM.0b013e31829e3957
Benyamin R, Trescot AM, Datta S, et al.: Opioid complications and side effects. Pain Physician. 2008; 11(2 suppl): S105-S120. DOI: https://doi.org/10.36076/ppj.2008/11/S105
Noble M, Tregear SJ, Treadwell JR, et al.: Long-term opioid therapy for chronic noncancer pain: A systematic review and meta-analysis of efficacy and safety. J Pain Symptom Manage. 2008; 35(2): 214-218. DOI: https://doi.org/10.1016/j.jpainsymman.2007.03.015
Manchikanti L, Abdi S, Atluri S, et al.: American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2—Guidance. Pain Physician. 2012; 15(3 suppl): S67-S116. DOI: https://doi.org/10.36076/ppj.2012/15/S67
Knotkova H, Fine PG, Portenoy RK: Opioid rotation: The science and the limitations of the equianalgesic table. J Pain Symptom Manage. 2009; 38(3): 426-439.
Vissers KC, Besse K, Hans G, et al.: Opioid rotation in the management of chronic pain: Where is the evidence? Pain Pract. 2010; 10(2): 85-93. DOI: https://doi.org/10.1111/j.1533-2500.2009.00335.x
Webster LR, Fine PG: Review and critique of opioid rotation practices and associated risks of toxicity. Pain Med. 2012; 13(4): 562-570.
Chou R, Fanciullo GJ, Fine PG, et al.: Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009; 10(2): 113-130. DOI: https://doi.org/10.1016/j.jpain.2008.10.008
Reisfield GM, Sloan PA: Physician identification of opioid diversion: A difficult diagnosis. J Opioid Manage. 2012; 8: 5-6. DOI: https://doi.org/10.5055/jom.2012.0090
Passik SD, Portenoy RK, Ricketts PL: Substance abuse issues in cancer patients. Part 1: Prevalence and diagnosis. Oncology. 1998; 12(4): 517-521.
Fitzgibbon DR, Rathmell JP, Michna E, et al.: Malpractice claims associated with medication management for chronic pain. Anesthesiology. 2010; 112(4): 948-956. DOI: https://doi.org/10.1097/ALN.0b013e3181cdef98
Wakim JH: Alleviating symptoms of withdrawal from an opioid. Pain Ther. 2012; 1(1): 4. DOI: https://doi.org/10.1007/s40122-012-0004-5
Nilsen HK, Stiles TC, Landro NI, et al.: Patients with problematic opioid use can be weaned from codeine without pain escalation. Acta Anaesthesiol Scand. 2010; 54(5): 571-579. DOI: https://doi.org/10.1111/j.1399-6576.2009.02164.x
Stamer UM, Stuber F, Muders T, et al.: Respiratory depression with tramadol in a patient with renal impairment and CYP2D6 gene duplication. Anesth Analg. 2008; 107(3): 926-929. DOI: https://doi.org/10.1213/ane.0b013e31817b796e
Hariharan J, Lamb GC, Neuner JM: Long-term opioid contract use for chronic pain management in primary care practice. A five year experience. J Gen Intern Med. 2007; 22(4): 485-490. DOI: https://doi.org/10.1007/s11606-006-0084-1
Savage S: The patient-centered opioid agreement. Am J Bioeth. 2010; 10(11): 18-19. DOI: https://doi.org/10.1080/15265161.2010.519426
Penki J, Mattson J, Miaskowski C, et al.: Do patients know they are on pain medication agreements? Results from a sample of high-risk patients on chronic opioid therapy. Pain Med. 2012; 13(9): 1174-1180. DOI: https://doi.org/10.1111/j.1526-4637.2012.01430.x
Collen M: Opioid contracts and random drug testing for people with chronic pain—Think twice. J Law Med Ethics. 2009; 37(4): 841-845. DOI: https://doi.org/10.1111/j.1748-720X.2009.00455.x
FDA Patient Counseling Document on Extended-Release/Long-Acting Opioid Analgesics. Available at www.er-la-opioidremscom/lwgUl/rems/pdf/patient_counseling_document.pdf. Accessed October 1, 2014.
The American Academy of Pain Medicine Eight Opioid Safety Principles for Patients and Caregivers. Available at www.painmed.org/files/eight-opioid-safety-practices-for-patients-and-caregivers.pdf. Accessed October 1, 2014.
The FDA Safety Information and Adverse Event Reporting Program. Available at www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/UCM163919.pdf. Accessed October 1, 2014.
Article 2 references:
Rauck RL: What is the case for prescribing long-acting opioids over short-acting opioids for patients with chronic pain? A critical review. Pain Pract. 2009; 9(6): 468-479. DOI: https://doi.org/10.1111/j.1533-2500.2009.00320.x
Davies AN: Breakthrough cancer pain. Curr Pain Headache Rep. 2014; 18(6): 420. DOI: https://doi.org/10.1007/s11916-014-0420-9
Davies AN, Dickman A, Reid C, et al.: The management of cancer-related breakthrough pain: Recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain. 2009; 13(4): 331-338. DOI: https://doi.org/10.1016/j.ejpain.2008.06.014
McCarberg BH, Barkin RL: Long-acting opioids for chronic pain: Pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther. 2001; 8(3): 181-186. DOI: https://doi.org/10.1097/00045391-200105000-00006
Gourlay GK: Sustained relief of chronic pain. Pharmacokinetics of sustained release morphine. Clin Pharmacokinet. 1998; 35(3): 173-190.
Hill HF, Chapman CR, Saeger LS, et al.: Steady-state infusions of opioids in human. II. Concentration-effect relationships and therapeutic margins. Pain. 1990; 43(1): 69-79. DOI: https://doi.org/10.1016/0304-3959(90)90051-E
Hill HF, Saeger L, Bjurstrom R, et al.: Steady-state infusions of opioids in human volunteers. I. Pharmacokinetic tailoring. Pain. 1990; 43(1): 57-67. DOI: https://doi.org/10.1016/0304-3959(90)90050-N
Ferrell B, Wisdom C, Wenzl C, et al.: Effects of controlled-released morphine on quality of life for cancer pain. Oncol Nurs Forum. 1989; 16(4): 521-526.
Chary S, Goughnour BR, Moulin DE, et al.: The dose-response relationship of controlled-release codeine (Codeine Contin) in chronic cancer pain. J Pain Symptom Manage. 1994; 9(6): 363-371. DOI: https://doi.org/10.1016/0885-3924(94)90173-2
Arkinstall WW, Goughnour BR, White JA, et al.: Control of severe pain with sustained-release morphine tablets v. oral morphine solution. CMAJ. 1989; 140(6): 653-657, 661. DOI: https://doi.org/10.1097/00132586-198912000-00039
Caldwell JR, Hale ME, Boyd RE, et al.: Treatment of osteoarthritis pain with controlled release oxycodone or fixed combination oxycodone plus acetaminophen added to nonsteroidal anti-inflammatory drugs: A double blind, randomized, multicenter, placebo controlled trial. J Rheumatol. 1999; 26(4): 862-869.
Klepstad P, Dale O, Kaasa S, et al.: Influences on serum concentrations of morphine, M6G and M3G during routine clinical drug monitoring: A prospective survey in 300 adult cancer patients. Acta Anaesthesiol Scand. 2003; 47(6): 725-731. DOI: https://doi.org/10.1034/j.1399-6576.2003.00138.x
Amabile CM, Bowman BJ: Overview of oral modified-release opioid products for the management of chronic pain. Ann Pharmacother. 2006; 40(7-8): 1327-1335. DOI: https://doi.org/10.1345/aph.1G259
Fine PG, Mahajan G, McPherson ML: Long-acting opioids and short-acting opioids: Appropriate use in chronic pain management. Pain Med. 2009; 10(suppl 2): S79-S88. DOI: https://doi.org/10.1111/j.1526-4637.2009.00666.x
Chou R, Clark E, Helfand M: Comparative efficacy and safety of long-acting oral opioids for chronic non-cancer pain: A systematic review. J Pain Symptom Manage. 2003; 26(5): 1026-1048. DOI: https://doi.org/10.1016/j.jpainsymman.2003.03.003
Carson S, Thakurta S, Low A, et al.: Drug Class Review: Long-Acting Opioid Analgesics: Final Update 6 Report. Portland (OR): Oregon Health & Science University, 2011.
Chou R, Carson S: Drug Class Review on Long-Acting Opioid Analgesics: Final Report Update 5. Portland (OR): Oregon Health & Science University, 2008.
Nuckols TK, Anderson L, Popescu I, et al.: Opioid prescribing: A systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014; 160(1): 38-47.
Pedersen L, Borchgrevink PC, Riphagen, II, et al.: Long- or short-acting opioids for chronic non-malignant pain? A qualitative systematic review. Acta Anaesthesiol Scand. 2014; 58(4): 390-401. DOI: https://doi.org/10.1111/aas.12279
Kalso E, Allan L, Dellemijn PL, et al.: Recommendations for using opioids in chronic non-cancer pain. Eur J Pain. 2003; 7(5): 381-386. DOI: https://doi.org/10.1016/S1090-3801(02)00143-X
Webster LR, Bath B, Medve RA, et al.: Randomized, double-blind, placebo-controlled study of the abuse potential of different formulations of oral oxycodone. Pain Med. 2012; 13(6): 790-801. DOI: https://doi.org/10.1111/j.1526-4637.2012.01380.x
Jonsson T, Christrup LL, Hojsted J, et al.: Symptoms and side effects in chronic non-cancer pain: Patient report vs. systematic assessment. Acta Anaesthesiol Scand. 2011; 55(1): 69-74. DOI: https://doi.org/10.1111/j.1399-6576.2010.02329.x
Ioannidis JP, Evans SJ, Gotzsche PC, et al.: Better reporting of harms in randomized trials: An extension of the CONSORT statement. Ann Intern Med. 2004; 141(10): 781-788. DOI: https://doi.org/10.7326/0003-4819-141-10-200411160-00009
Klepstad P, Kaasa S, Jystad A, et al.: Immediate- or sustained-release morphine for dose finding during start of morphine to cancer patients: A randomized, double-blind trial. Pain. 2003; 101(1-2): 193-198. DOI: https://doi.org/10.1016/S0304-3959(02)00328-7
Salzman RT, Roberts MS, Wild J, et al.: Can a controlled-release oral dose form of oxycodone be used as readily as an immediate-release form for the purpose of titrating to stable pain control? J Pain Symptom Manage. 1999; 18(4): 271-279. DOI: https://doi.org/10.1016/S0885-3924(99)00079-2
Weimer MB, Chou R: Research gaps on methadone harms and comparative harms: Findings from a review of the evidence for an American Pain Society and College on Problems of Drug Dependence clinical practice guideline. J Pain. 2014; 15(4): 366-376. DOI: https://doi.org/10.1016/j.jpain.2014.01.496
Chou R, Weimer MB, Dana T: Methadone overdose and cardiac arrhythmia potential: Findings from a review of the evidence for an American Pain Society and College on Problems of Drug Dependence clinical practice guideline. J Pain. 2014; 15(4): 338-365. DOI: https://doi.org/10.1016/j.jpain.2014.01.495
Chou R, Cruciani RA, Fiellin DA, et al.: Methadone safety: A clinical practice guideline from the American Pain Society and College on Problems of Drug Dependence, in collaboration with the Heart Rhythm Society. J Pain. 2014; 15(4): 321-337.
Mercadante S, Villari P, Ferrera P, et al.: Safety and effectiveness of intravenous morphine for episodic breakthrough pain in patients receiving transdermal buprenorphine. J Pain Symptom Manage. 2006; 32(2): 175-179. DOI: https://doi.org/10.1016/j.jpainsymman.2006.01.013
Dasgupta N, Kramer ED, Zalman MA, et al.: Association between non-medical and prescriptive usage of opioids. Drug Alcohol Depend. 2006; 82(2): 135-142. DOI: https://doi.org/10.1016/j.drugalcdep.2005.08.019
Edlund MJ, Martin BC, Russo JE, et al.: The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: The role of opioid prescription. Clin J Pain. 2014; 30(7): 557-564. DOI: https://doi.org/10.1097/AJP.0000000000000021
Martell BA, O’Connor PG, Kerns RD, et al.: Systematic review: Opioid treatment for chronic back pain: Prevalence, efficacy, and association with addiction. Ann Intern Med. 2007; 146(2): 116-127. DOI: https://doi.org/10.7326/0003-4819-146-2-200701160-00006
Banta-Green CJ, Merrill JO, Doyle SR, et al.: Measurement of opioid problems among chronic pain patients in a general medical population. Drug Alcohol Depend. 2009; 104(1-2): 43-49. DOI: https://doi.org/10.1016/j.drugalcdep.2009.03.022
Boscarino JA, Rukstalis M, Hoffman SN, et al.: Risk factors for drug dependence among out-patients on opioid therapy in a large US healthcare system. Addiction. 2010; 105(10): 1776-1782. DOI: https://doi.org/10.1111/j.1360-0443.2010.03052.x
Compton PA, Wu SM, Schieffer B, et al.: Introduction of a self-report version of the Prescription Drug Use Questionnaire and relationship to medication agreement noncompliance. J Pain Symptom Manage. 2008; 36(4): 383-395. DOI: https://doi.org/10.1016/j.jpainsymman.2007.11.006
Saffier K, Colombo C, Brown D, et al.: Addiction Severity Index in a chronic pain sample receiving opioid therapy. J Subst Abuse Treat. 2007; 33(3): 303-311. DOI: https://doi.org/10.1016/j.jsat.2006.12.011
Cowan DT, Wilson-Barnett J, Griffiths P, et al.: A survey of chronic noncancer pain patients prescribed opioid analgesics. Pain Med. 2003; 4(4): 340-351. DOI: https://doi.org/10.1111/j.1526-4637.2003.03038.x
Hojsted J, Nielsen PR, Guldstrand SK, et al.: Classification and identification of opioid addiction in chronic pain patients. Eur J Pain. 2010; 14(10): 1014-1020. DOI: https://doi.org/10.1016/j.ejpain.2010.04.006
Fleming MF, Balousek SL, Klessig CL, et al.: Substance use disorders in a primary care sample receiving daily opioid therapy. J Pain. 2007; 8(7): 573-582. DOI: https://doi.org/10.1016/j.jpain.2007.02.432
Mistry CJ, Bawor M, Desai D, et al.: Genetics of opioid dependence: A review of the genetic contribution to opioid dependence. Curr Psychiatry Rev. 2014; 10(2): 156-167. DOI: https://doi.org/10.2174/1573400510666140320000928
Starrels JL, Becker WC, Alford DP, et al.: Systematic review: Treatment agreements and urine drug testing to reduce opioid misuse in patients with chronic pain. Ann Intern Med. 2010; 152(11): 712-720. DOI: https://doi.org/10.7326/0003-4819-152-11-201006010-00004
Turk DC, Swanson KS, Gatchel RJ: Predicting opioid misuse by chronic pain patients: A systematic review and literature synthesis. Clin J Pain. 2008; 24(6): 497-508. DOI: https://doi.org/10.1097/AJP.0b013e31816b1070
Dunn KM, Saunders KW, Rutter CM, et al.: Opioid prescriptions for chronic pain and overdose: A cohort study. Ann Intern Med. 2010; 152(2): 85-92. DOI: https://doi.org/10.7326/0003-4819-152-2-201001190-00006
Gomes T, Mamdani MM, Dhalla IA, et al.: Opioid dose and drugrelated mortality in patients with nonmalignant pain. Arch Intern Med. 2011; 171(7): 686-691. DOI: https://doi.org/10.1001/archinternmed.2011.117
Bohnert AS, Ilgen MA, Ignacio RV, et al.: Risk of death from accidental overdose associated with psychiatric and substance use disorders. Am J Psychiatry. 2012; 169(1): 64-70. DOI: https://doi.org/10.1176/appi.ajp.2011.10101476
Webster LR, Cochella S, Dasgupta N, et al.: An analysis of the root causes for opioid-related overdose deaths in the United States. Pain Med. 2011;12(suppl 2): S26-S35. DOI: https://doi.org/10.1111/j.1526-4637.2011.01134.x
Siegler A, Tuazon E, Bradley O’Brien D, et al.: Unintentional opioid overdose deaths in New York City, 2005-2010: A place-based approach to reduce risk. Int J Drug Policy. 2014; 25(3): 569-574. DOI: https://doi.org/10.1016/j.drugpo.2013.10.015
Hasegawa K, Brown DF, Tsugawa Y, et al.: Epidemiology of emergency department visits for opioid overdose: A population-based study. Mayo Clinic Proc. 2014; 89(4): 462-471. DOI: https://doi.org/10.1016/j.mayocp.2013.12.008
Kuehn BM: Methadone overdose deaths rise with increased prescribing for pain. JAMA. 2012; 308(8): 749-750. DOI: https://doi.org/10.1001/jama.2012.9289
Mercado-Crespo MC, Sumner SA, Spelke MB, et al.: Notes from the field: Increase in fentanyl-related overdose deaths—Rhode Island, November 2013-March 2014. MMWR Morb Mortal Wkly Rep. 2014; 63(24): 531.
Sessler NE, Downing JM, Kale H, et al.: Reductions in reported deaths following the introduction of extended-release oxycodone (OxyContin) with an abuse-deterrent formulation. Pharmacoepidemiol Drug Saf. 2014 (in press). DOI: https://doi.org/10.1002/pds.3658
Walley AY, Xuan Z, Hackman HH, et al.: Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: Interrupted time series analysis. BMJ. 2013; 346: f174. DOI: https://doi.org/10.1136/bmj.f174
Walley AY, Doe-Simkins M, Quinn E, et al.: Opioid overdose prevention with intranasal naloxone among people who take methadone. J Subst Abuse Treat. 2013; 44(2): 241-247. DOI: https://doi.org/10.1016/j.jsat.2012.07.004
Dahan A, Overdyk F, Smith T, et al.: Pharmacovigilance: A review of opioid-induced respiratory depression in chronic pain patients. Pain Physician. 2013; 16(2): E85-E94.
Jann M, Kennedy WK, Lopez G: Benzodiazepines: A major component in unintentional prescription drug overdoses with opioid analgesics. J Pharm Pract. 2014; 27(1): 5-16. DOI: https://doi.org/10.1177/0897190013515001
Panagiotou I, Mystakidou K: Non-analgesic effects of opioids: Opioids’ effects on sleep (including sleep apnea). Curr Pharm Des. 2012; 18(37): 6025-6033. DOI: https://doi.org/10.2174/138161212803582450
Rose AR, Catcheside PG, McEvoy RD, et al.: Sleep disordered breathing and chronic respiratory failure in patients with chronic pain on long term opioid therapy. J Clin Sleep Med. 2014; 10(8): 847-852. DOI: https://doi.org/10.5664/jcsm.3950
Walker JM, Farney RJ, Rhondeau SM, et al.: Chronic opioid use is a risk factor for the development of central sleep apnea and ataxic breathing. J Clin Sleep Med. 2007; 3(5): 455-461. DOI: https://doi.org/10.5664/jcsm.26908
Weil JV, McCullough RE, Kline JS, et al.: Diminished ventilatory response to hypoxia and hypercapnia after morphine in normal man. N Engl J Med. 1975; 292(21): 1103-1106. DOI: https://doi.org/10.1056/NEJM197505222922106
Bouillon T, Bruhn J, Radu-Radulescu L, et al.: A model of the ventilator depressant potency of remifentanil in the non-steady state. Anesthesiology. 2003; 99(4): 779-787. DOI: https://doi.org/10.1097/00000542-200310000-00007
Santiago TV, Edelman NH: Opioids and breathing. J Appl Physiol. 1985; 59(6): 1675-1685. DOI: https://doi.org/10.1152/jappl.1985.59.6.1675
Kuo A, Wyse BD, Meutermans W, et al.: In vivo profiling of seven common opioids for antinociception, constipation and respiratory depression: No two opioids have the same profile. Br J Pharmacol. 2014 (in press). DOI: https://doi.org/10.1111/bph.12696
Robinson RW, Zwillich CW, Bixler EO, et al.: Effects of oral narcotics on sleep-disordered breathing in healthy adults. Chest. 1987; 91(2): 197-203. DOI: https://doi.org/10.1378/chest.91.2.197
Chidambaran V, Mavi J, Esslinger H, et al.: Association of OPRM1 A118G variant with risk of morphine-induced respiratory depression following spine fusion in adolescents. Pharmacogenomics J. 2014 (in press). DOI: https://doi.org/10.1038/tpj.2014.59
Wheatley RG, Somerville ID, Sapsford DJ, et al.: Postoperative hypoxaemia: Comparison of extradural, i.m. and patient-controlled opioid analgesia. Br J Anaesth. 1990; 64(3): 267-275. DOI: https://doi.org/10.1093/bja/64.3.267
Madej TH, Wheatley RG, Jackson IJ, et al.: Hypoxaemia and pain relief after lower abdominal surgery: Comparison of extradural and patient-controlled analgesia. Br J Anaesth. 1992; 69(6): 554-557. DOI: https://doi.org/10.1093/bja/69.6.554
Barbour SJ, Vandebeek CA, Ansermino JM: Increased tidal volume variability in children is a better marker of opioid-induced respiratory depression than decreased respiratory rate. J Clin Monit Comput. 2004; 18(3): 171-178. DOI: https://doi.org/10.1023/B:JOCM.0000042922.63647.b9
Bouillon T, Bruhn J, Roepcke H, et al.: Opioid-induced respiratory depression is associated with increased tidal volume variability. Eur J Anaesthesiol. 2003; 20(2): 127-133. DOI: https://doi.org/10.1097/00003643-200302000-00009
Boland J, Boland E, Brooks D: Importance of the correct diagnosis of opioid-induced respiratory depression in adult cancer patients and titration of naloxone. Clin Med. 2013; 13(2): 149-151. DOI: https://doi.org/10.7861/clinmedicine.13-2-149
Martin WR: Naloxone. Ann Intern Med. 1976; 85(6): 765-768. DOI: https://doi.org/10.7326/0003-4819-85-6-765
Ngai SH, Berkowitz BA, Yang JC, et al.: Pharmacokinetics of naloxone in rats and in man: Basis for its potency and short duration of action. Anesthesiology. 1976; 44(5): 398-401. DOI: https://doi.org/10.1097/00000542-197605000-00008
Vizi ES, Foldes FF, Rich J, et al.: The structure-action relationship and kinetics of some naloxone and naltrexone derivatives. Pharma - cology. 1976; 14(1): 76-85. DOI: https://doi.org/10.1159/000136582
Berkowitz BA: The relationship of pharmacokinetics to pharmacological activity: Morphine, methadone and naloxone. Clin Pharma - cokinet. 1976; 1(3): 219-230. DOI: https://doi.org/10.2165/00003088-197601030-00004
Olofsen E, van Dorp E, Teppema L, et al.: Naloxone reversal of morphine-and morphine-6-glucuronide-induced respiratory depression in healthy volunteers: A mechanism-based pharmacokinetic-pharmacodynamic modeling study. Anesthesiology. 2010; 112(6): 1417-1427. DOI: https://doi.org/10.1097/ALN.0b013e3181d5e29d
van Dorp E, Yassen A, Sarton E, et al.: Naloxone reversal of buprenorphine-induced respiratory depression. Anesthesiology. 2006; 105(1): 51-57. DOI: https://doi.org/10.1097/00000542-200607000-00012
Yassen A, Olofsen E, van Dorp E, et al.: Mechanism-based pharmacokinetic-pharmacodynamic modelling of the reversal of buprenorphine-induced respiratory depression by naloxone: A study in healthy volunteers. Clin Pharmacokinet. 2007; 46(11): 965-980. DOI: https://doi.org/10.2165/00003088-200746110-00004
Goldfrank L, Weisman RS, Errick JK, et al.: A dosing nomogram for continuous infusion intravenous naloxone. Ann Emerg Med. 1986; 15(5): 566-570. DOI: https://doi.org/10.1016/S0196-0644(86)80994-5
Sabzghabaee AM, Eizadi-Mood N, Yaraghi A, et al.: Naloxone therapy in opioid overdose patients: Intranasal or intravenous? A randomized clinical trial. Arch Med Sci. 2014; 10(2): 309-314. DOI: https://doi.org/10.5114/aoms.2014.42584
De Schepper HU, Cremonini F, Park MI, et al.: Opioids and the gut: Pharmacology and current clinical experience. Neurogastroenterol Motil. 2004; 16(4): 383-394. DOI: https://doi.org/10.1111/j.1365-2982.2004.00513.x
Mori T, Shibasaki Y, Matsumoto K, et al.: Mechanisms that underlie mu-opioid receptor agonist-induced constipation: Differential involvement of mu-opioid receptor sites and responsible regions. J Pharmacol Exp Ther. 2013; 347(1): 91-99. DOI: https://doi.org/10.1124/jpet.113.204313
Szigethy E, Schwartz M, Drossman D: Narcotic bowel syndrome and opioid-induced constipation. Curr Gastroenterol Rep. 2014; 16(10): 410. DOI: https://doi.org/10.1007/s11894-014-0410-4
Drossman D, Szigethy E: The narcotic bowel syndrome: A recent update. Am J Gastroenterol. 2014; 2(1): 22-30. DOI: https://doi.org/10.1038/ajgsup.2014.6
Davis MP: The opioid bowel syndrome: A review of pathophysiology and treatment. J Opioid Manag. 2005; 1(3): 153-161. DOI: https://doi.org/10.5055/jom.2005.0035
Kurlander JE, Drossman DA: Diagnosis and treatment of narcotic bowel syndrome. Nat Rev Gastroenterol Hepatol. 2014; 11(7): 410-418. DOI: https://doi.org/10.1038/nrgastro.2014.53
Tuteja AK, Biskupiak J, Stoddard GJ, et al.: Opioid-induced bowel disorders and narcotic bowel syndrome in patients with chronic noncancer pain. Neurogastroenterol Motil. 2010; 22(4): 424-430, e496. DOI: https://doi.org/10.1111/j.1365-2982.2009.01458.x
Farmer AD, Ferdinand E, Aziz Q: Opioids and the gastrointestinal tract—A case of narcotic bowel syndrome and literature review. J Neurogastroenterol Motil. 2013; 19(1): 94-98. DOI: https://doi.org/10.5056/jnm.2013.19.1.94
Grover CA, Wiele ED, Close RJ: Narcotic bowel syndrome. J Emerg Med. 2012; 43(6): 992-995. DOI: https://doi.org/10.1016/j.jemermed.2011.05.025
Wirz S, Nadstawek J, Elsen C, et al.: Laxative management in ambulatory cancer patients on opioid therapy: A prospective, open-label investigation of polyethylene glycol, sodium picosulphate and lactulose. Eur J Cancer Care. 2012; 21(1): 131-140. DOI: https://doi.org/10.1111/j.1365-2354.2011.01286.x
Bouvy ML, Buurma H, Egberts TC: Laxative prescribing in relation to opioid use and the influence of pharmacy-based intervention. J Clin Pharm Ther. 2002; 27(2): 107-110. DOI: https://doi.org/10.1046/j.1365-2710.2002.00385.x
Sykes N: Emerging evidence on docusate: Commentary on Tarumi et al. J Pain Symptom Manage. 2013; 45(1): 1. DOI: https://doi.org/10.1016/j.jpainsymman.2012.11.001
Twycross R, Sykes N, Mihalyo M, et al.: Stimulant laxatives and opioid-induced constipation. J Pain Symptom Manage. 2012; 43(2): 306-313. DOI: https://doi.org/10.1016/j.jpainsymman.2011.12.002
Larkin PJ, Sykes NP, Centeno C, et al.: The management of constipation in palliative care: Clinical practice recommendations. Palliat Med. 2008; 22(7): 796-807. DOI: https://doi.org/10.1177/0269216308096908
Cass LJ, Frederik WS: A clinical comparison of bulk and stimulant laxatives. J Lancet. 1955; 75(3): 105-108.
Connolly P, Hughes IW, Ryan G: Comparison of “Duphalac” and “irritant” laxatives during and after treatment of chronic constipation: A preliminary study. Curr Med Res Opin. 1974; 2(10): 620-625. DOI: https://doi.org/10.1185/03007997409111873
Dettmar PW, Sykes J: A multi-centre, general practice comparison of ispaghula husk with lactulose and other laxatives in the treatment of simple constipation. Curr Med Res Opin. 1998; 14(4): 227-233. DOI: https://doi.org/10.1185/03007999809113363
Simpson K, Leyendecker P, Hopp M, et al.: Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin. 2008; 24(12): 3503-3512.
Sykes NP: Oral naloxone in opioid-associated constipation. Lancet. 1991; 337(8755): 1475. DOI: https://doi.org/10.1016/0140-6736(91)93162-3
Hellwig TR, Pottebaum AA: The role of methylnaltrexone in opioid-induced constipation. S D Med. 2013; 66(10): 425, 427.
Rauck RL: Treatment of opioid-induced constipation: Focus on the peripheral mu-opioid receptor antagonist methylnaltrexone. Drugs. 2013; 73(12): 1297-1306. DOI: https://doi.org/10.1007/s40265-013-0084-5
Bader S, Durk T, Becker G: Methylnaltrexone for the treatment of opioid-induced constipation. Expert Rev Gastroenterol Hepatol. 2013; 7(1): 13-26. DOI: https://doi.org/10.1586/egh.12.63
Cryer B, Katz S, Vallejo R, et al.: A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain. Pain Med. 2014 (in press). DOI: https://doi.org/10.1111/pme.12437
Lubiprostone (Amitiza) for opioid-induced constipation. Med Lett Drugs Ther. 2013; 55(1418): 47-48.
Wong BS, Camilleri M: Lubiprostone for the treatment of opioidinduced bowel dysfunction. Expert Opin Pharmacother. 2011; 12(6): 983-990. DOI: https://doi.org/10.1517/14656566.2011.566559
Sharma A, Jamal MM: Opioid induced bowel disease: A twenty-first century physicians’ dilemma. Considering pathophysiology and treatment strategies. Curr Gastroenterol Rep. 2013; 15(7): 334. DOI: https://doi.org/10.1007/s11894-013-0334-4
Azizi Z, Javid Anbardan S, Ebrahimi Daryani N: A review of the clinical manifestations, pathophysiology and management of opioid bowel dysfunction and narcotic bowel syndrome. Middle East J Dig Dis. 2014; 6(1): 5-12.
Sandgren JE, McPhee MS, Greenberger NJ: Narcotic bowel syndrome treated with clonidine. Resolution of abdominal pain and intestinal pseudo-obstruction. Ann Intern Med. 1984; 101(3): 331-334. DOI: https://doi.org/10.7326/0003-4819-101-3-331
Bruera E, Brenneis C, Michaud M, et al.: Continuous Sc infusion of metoclopramide for treatment of narcotic bowel syndrome. Cancer Treat Rep. 1987; 71(11): 1121-1122.
Wong V, Sobala G, Losowsky M: A case of narcotic bowel syndrome successfully treated with clonidine. Postgrad Med J. 1994; 70(820): 138-140. DOI: https://doi.org/10.1136/pgmj.70.820.138
Pergolizzi JV Jr, Ma L, Foster DR, et al.: The prevalence of opioid-related major potential drug-drug interactions and their impact on health care costs in chronic pain patients. J Manag Care Pharm. 2014; 20(5): 467-476. DOI: https://doi.org/10.18553/jmcp.2014.20.5.467
Chen LH, Hedegaard H, Warner M: Drug-poisoning deaths involving opioid analgesics: United States, 1999-2011. NCHS Data Brief. 2014; (166): 1-8.
Leung SY: Benzodiazepines, opioids and driving: An overview of the experimental research. Drug Alcohol Rev. 2011; 30(3): 281-286. DOI: https://doi.org/10.1111/j.1465-3362.2011.00311.x
Zacny JP, Paice JA, Coalson DW: Separate and combined psychopharmacological effects of alprazolam and oxycodone in healthy volunteers. Drug Alcohol Depend. 2012; 124(3): 274-282. DOI: https://doi.org/10.1016/j.drugalcdep.2012.01.023
Gudin JA, Mogali S, Jones JD, et al.: Risks, management, and monitoring of combination opioid, benzodiazepines, and/or alcohol use. Postgrad Med. 2013; 125(4): 115-130. DOI: https://doi.org/10.3810/pgm.2013.07.2684
Jobski K, Schmid U, Behr S, et al.: 3-Year prevalence of alcoholrelated disorders in German patients treated with high-potency opioids. Pharmacoepidemiol Drug Saf. 2012; 21(10): 1125-1129. DOI: https://doi.org/10.1002/pds.3268
Krajacic A, Tucker IG: Matrix formation in sustained release tablets: Possible mechanism of dose dumping. Int J Pharm. 2003; 251(1-2): 67- 78. DOI: https://doi.org/10.1016/S0378-5173(02)00584-7
Fiske WD, Jobes J, Xiang Q, et al.: The effects of ethanol on the bioavailability of oxymorphone extended-release tablets and oxymorphone crush-resistant extended-release tablets. J Pain. 2012; 13(1): 90-99. DOI: https://doi.org/10.1016/j.jpain.2011.10.011
Lennernas H: Ethanol-drug absorption interaction: Potential for a significant effect on the plasma pharmacokinetics of ethanol vulnerable formulations. Mol Pharm. 2009; 6(5): 1429-1440. DOI: https://doi.org/10.1021/mp9000876
Sathyan G, Sivakumar K, Thipphawong J: Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence of alcohol. Curr Med Res Opin. 2008; 24(1): 297-305. DOI: https://doi.org/10.1185/030079908X253861
Browne B, Linter S: Monoamine oxidase inhibitors and narcotic analgesics. A critical review of the implications for treatment. Br J Psychiatry. 1987; 151: 210-212. DOI: https://doi.org/10.1192/bjp.151.2.210
Gillman PK: Monoamine oxidase inhibitors, opioid analgesics and serotonin toxicity. Br J Anaesth. 2005; 95(4): 434-441. DOI: https://doi.org/10.1093/bja/aei210
Park SH, Wackernah RC, Stimmel GL: Serotonin syndrome: Is it a reason to avoid the use of tramadol with antidepressants? J Pharm Pract. 2014; 27(1): 71-78. DOI: https://doi.org/10.1177/0897190013504957
Van Vugt DA, Meites J: Influence of endogenous opiates on anterior pituitary function. Fed Proc. 1980; 39(8): 2533-2538.
Iakobishvili Z, Cohen E, Garty M, et al.: Use of intravenous morphine for acute decompensated heart failure in patients with and without acute coronary syndromes. Acute Card Care. 2011; 13(2): 76-80. DOI: https://doi.org/10.3109/17482941.2011.575165
Gray A, Goodacre S, Seah M, et al.: Diuretic, opiate and nitrate use in severe acidotic acute cardiogenic pulmonary oedema: Analysis from the 3CPO trial. QJM. 2010; 103(8): 573-581. DOI: https://doi.org/10.1093/qjmed/hcq077
Korinek AM, Languille M, Bonnet F, et al.: Effect of postoperative extradural morphine on ADH secretion. Br J Anaesth. 1985; 57(4): 407-411. DOI: https://doi.org/10.1093/bja/57.4.407
Graham CA, Cattermole GN: Morphine should be abandoned as a treatment for acute cardiogenic pulmonary oedema. Emerg Med Australas. 2009; 21(2): 160. DOI: https://doi.org/10.1111/j.1742-6723.2009.01173.x
Kao D, Bucher Bartelson B, Khatri V, et al.: Trends in reporting methadone-associated cardiac arrhythmia, 1997-2011: An analysis of registry data. Ann Intern Med. 2013; 158(10): 735-740. DOI: https://doi.org/10.7326/0003-4819-158-10-201305210-00008
Farsi D, Mirafzal A, Hassanian-Moghaddam H, et al.: The correlation between prolonged corrected QT interval with the frequency of respiratory arrest, endotracheal intubation, and mortality in acute methadone overdose. Cardiovasc Toxicol. 2014; 14(4): 358-367. DOI: https://doi.org/10.1007/s12012-014-9259-x
Wolbrette D: Gender differences in the proarrhythmic potential of QT-prolonging drugs. Curr Womens Health Rep. 2002; 2(2): 105-109.
Byrne A, Stimmel B: Methadone and QTc prolongation. Lancet. 2007; 369(9559): 366; author reply 366-367. DOI: https://doi.org/10.1016/S0140-6736(07)60182-2
Abramson DW, Quinn DK, Stern TA: Methadone-associated QTc prolongation: A case report and review of the literature. Primary Care Companion J Clin Psychiatry. 2008; 10(6): 470-476. DOI: https://doi.org/10.4088/PCC.v10n0609
Krantz MJ, Martin J, Stimmel B, et al.: QTc interval screening in methadone treatment. Ann Intern Med. 2009; 150(6): 387-395. DOI: https://doi.org/10.7326/0003-4819-150-6-200903170-00103
Chang KC, Huang CL, Liang HY, et al.: Gender-specific differences in susceptibility to low-dose methadone-associated QTc prolongation in patients with heroin dependence. J Cardiovasc Electrophysiol. 2012; 23(5): 527-533. DOI: https://doi.org/10.1111/j.1540-8167.2011.02231.x
Mujtaba S, Romero J, Taub CC: Methadone, QTc prolongation and torsades de pointes: Current concepts, management and a hidden twist in the tale? J Cardiovasc Dis Res. 2013; 4(4): 229-235. DOI: https://doi.org/10.1016/j.jcdr.2013.10.001
Wang SC, Ho IK, Tsou HH, et al.: Functional genetic polymorphisms in CYP2C19 gene in relation to cardiac side effects and treatment dose in a methadone maintenance cohort. OMICS. 2013; 17(10): 519-526. DOI: https://doi.org/10.1089/omi.2012.0068
Anchersen K, Hansteen V, Gossop M, et al.: Opioid maintenance patients with QTc prolongation: Congenital long QT syndrome mutation may be a contributing risk factor. Drug Alcohol Depend. 2010; 112(3): 216-219. DOI: https://doi.org/10.1016/j.drugalcdep.2010.06.015
Katchman AN, McGroary KA, Kilborn MJ, et al.: Influence of opioid agonists on cardiac human ether-a-go-go-related gene K(+) currents. J Pharmacol Exp Ther. 2002; 303(2): 688-694. DOI: https://doi.org/10.1124/jpet.102.038240
Wedam EF, Bigelow GE, Johnson RE, et al.: QT-interval effects of methadone, levomethadyl, and buprenorphine in a randomized trial. Arch Intern Med. 2007; 167(22): 2469-2475. DOI: https://doi.org/10.1001/archinte.167.22.2469
Fareed A, Patil D, Scheinberg K, et al.: Comparison of QTc interval prolongation for patients in methadone versus buprenorphine maintenance treatment: A 5-year follow-up. J Addict Dis. 2013; 32(3): 244-251. DOI: https://doi.org/10.1080/10550887.2013.824333
Krantz MJ, Garcia JA, Mehler PS: Effects of buprenorphine on cardiac repolarization in a patient with methadone-related torsade de pointes. Pharmacotherapy. 2005; 25(4): 611-614. DOI: https://doi.org/10.1592/phco.25.4.611.61020
Esses JL, Rosman J, Do LT, et al.: Successful transition to buprenorphine in a patient with methadone-induced torsades de pointes. J Interv Card Electrophysiol. 2008; 23(2): 117-119. DOI: https://doi.org/10.1007/s10840-008-9280-8
Baker JR, Best AM, Pade PA, et al.: Effect of buprenorphine and antiretroviral agents on the QT interval in opioid-dependent patients. Ann Pharmacother. 2006; 40(3): 392-396. DOI: https://doi.org/10.1345/aph.1G524
Zhou SF: Polymorphism of human cytochrome P450 2D6 and its clinical significance: Part I. Clin Pharmacokinet. 2009; 48(11): 689-723. DOI: https://doi.org/10.2165/11318030-000000000-00000
Zhou SF: Polymorphism of human cytochrome P450 2D6 and its clinical significance: Part II. Clin Pharmacokinet. 2009; 48(12): 761-804. DOI: https://doi.org/10.2165/11318070-000000000-00000
Zahari Z, Ismail R: Influence of cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6) polymorphisms on pain sensitivity and clinical response to weak opioid analgesics. Drug Metab Pharmacokinet. 2014; 29(1): 29-43. DOI: https://doi.org/10.2133/dmpk.DMPK-13-RV-032
Kirchheiner J, Schmidt H, Tzvetkov M, et al.: Pharmacokinetics of codeine and its metabolite morphine in ultra-rapid metabolizers due to CYP2D6 duplication. Pharmacogenomics J. 2007; 7(4): 257-265. DOI: https://doi.org/10.1038/sj.tpj.6500406
Crews KR, Gaedigk A, Dunnenberger HM, et al.: Clinical Pharmacogenetics Implementation Consortium guidelines for cytochrome P450 2D6 genotype and codeine therapy: 2014 update. Clin Pharmacol Ther. 2014; 95(4): 376-382. DOI: https://doi.org/10.1038/clpt.2013.254
Stamer UM, Zhang L, Book M, et al.: CYP2D6 genotype dependent oxycodone metabolism in postoperative patients. PLoS One. 2013; 8(3): e60239. DOI: https://doi.org/10.1371/journal.pone.0060239
Kummer O, Hammann F, Moser C, et al.: Effect of the inhibition of CYP3A4 or CYP2D6 on the pharmacokinetics and pharmacodynamics of oxycodone. Eur J Clin Pharmacol. 2011; 67(1): 63-71.
Samer CF, Daali Y, Wagner M, et al.: Genetic polymorphisms and drug interactions modulating CYP2D6 and CYP3A activities have a major effect on oxycodone analgesic efficacy and safety. Br J Pharmacol. 2010; 160(4): 919-930. DOI: https://doi.org/10.1111/j.1476-5381.2010.00709.x
Susce MT, Murray-Carmichael E, de Leon J: Response to hydrocodone, codeine and oxycodone in a CYP2D6 poor metabolizer. Prog Neuropsychopharmacol Biol Psychiatry. 2006; 30(7): 1356-1358. DOI: https://doi.org/10.1016/j.pnpbp.2006.03.018
Lurcott G: The effects of the genetic absence and inhibition of CYP2D6 on the metabolism of codeine and its derivatives, hydrocodone and oxycodone. Anesth Prog. 1998; 45(4): 154-156.
Samer CF, Daali Y, Wagner M, et al.: The effects of CYP2D6 and CYP3A activities on the pharmacokinetics of immediate release oxycodone. Br J Pharmacol. 2010; 160(4): 907-918. DOI: https://doi.org/10.1111/j.1476-5381.2010.00673.x
Hutchinson MR, Menelaou A, Foster DJ, et al.: CYP2D6 and CYP3A4 involvement in the primary oxidative metabolism of hydrocodone by human liver microsomes. Br J Clin Pharmacol. 2004; 57(3): 287-297. DOI: https://doi.org/10.1046/j.1365-2125.2003.02002.x
Soderberg Lofdal KC, Andersson ML, Gustafsson LL: Cytochrome P450-mediated changes in oxycodone pharmacokinetics/pharmacodynamics and their clinical implications. Drugs. 2013; 73(6): 533-543. DOI: https://doi.org/10.1007/s40265-013-0036-0
Solassol I, Caumette L, Bressolle F, et al.: Inter- and intra-individual variability in transdermal fentanyl absorption in cancer pain patients. Oncol Rep. 2005; 14(4): 1029-1036. DOI: https://doi.org/10.3892/or.14.4.1029
Solassol I, Bressolle F, Caumette L, et al.: Inter- and intraindividual variabilities in pharmacokinetics of fentanyl after repeated 72-hour transdermal applications in cancer pain patients. Ther Drug Monit. 2005; 27(4): 491-498. DOI: https://doi.org/10.1097/01.ftd.0000160717.50704.42
Feierman DE, Lasker JM: Metabolism of fentanyl, a synthetic opioid analgesic, by human liver microsomes. Role of CYP3A4. Drug Metab Dispos. 1996; 24(9): 932-939.
Kokubun H, Ebinuma K, Matoba M, et al.: Population pharmacokinetics of transdermal fentanyl in patients with cancer-related pain. J Pain Palliat Care Pharmacother. 2012; 26(2): 98-104. DOI: https://doi.org/10.3109/15360288.2012.679725
Kapur BM, Hutson JR, Chibber T, et al.: Methadone: A review of drug-drug and pathophysiological interactions. Crit Rev Clin Lab Sci. 2011; 48(4): 171-195. DOI: https://doi.org/10.3109/10408363.2011.620601
Campbell SD, Crafford A, Williamson BL, et al.: Mechanism of autoinduction of methadone N-demethylation in human hepatocytes. Anesth Anal. 2013; 117(1): 52-60. DOI: https://doi.org/10.1213/ANE.0b013e3182918252
Dickmann LJ, Isoherranen N: Quantitative prediction of CYP2B6 induction by estradiol during pregnancy: Potential explanation for increased methadone clearance during pregnancy. Drug Metab Dispos. 2013; 41(2): 270-274. DOI: https://doi.org/10.1124/dmd.112.047118
Bendayan R, Lee G, Bendayan M: Functional expression and localization of P-glycoprotein at the blood brain barrier. Microsc Res Tech. 2002; 57(5): 365-380. DOI: https://doi.org/10.1002/jemt.10090
Mercer SL, Coop A: Opioid analgesics and P-glycoprotein efflux transporters: A potential systems-level contribution to analgesic tolerance. Curr Top Med Chem. 2011; 11(9): 1157-1164. DOI: https://doi.org/10.2174/156802611795371288
Takashina Y, Naito T, Mino Y, et al.: Impact of CYP3A5 and ABCB1 gene polymorphisms on fentanyl pharmacokinetics and clinical responses in cancer patients undergoing conversion to a transdermal system. Drug Metab Pharmacokinet. 2012; 27(4): 414-421. DOI: https://doi.org/10.2133/dmpk.DMPK-11-RG-134
Hamabe W, Maeda T, Kiguchi N, et al.: Negative relationship between morphine analgesia and P-glycoprotein expression levels in the brain. J Pharmacol Sci. 2007; 105(4): 353-360.
Hassan HE, Mercer SL, Cunningham CW, et al.: Evaluation of the Pglycoprotein (Abcb1) affinity status of a series of morphine analogs: Comparative study with meperidine analogs to identify opioids with minimal P-glycoprotein interactions. Int J Pharm. 2009; 375(1-2): 48-54. DOI: https://doi.org/10.1016/j.ijpharm.2009.03.037
Mercer SL, Cunningham CW, Eddington ND, et al.: Opioids and efflux transporters. Part 3: P-glycoprotein substrate activity of 3-hydroxyladdition to meperidine analogs. Bioorg Med Chem Lett. 2008; 18(12): 3638-3640. DOI: https://doi.org/10.1016/j.bmcl.2008.04.046
Cunningham CW, Mercer SL, Hassan HE, et al.: Opioids and efflux transporters. Part 2: P-glycoprotein substrate activity of 3- and 6-substituted morphine analogs. J Med Chem. 2008; 51(7): 2316-2320.
Kalvass JC, Olson ER, Cassidy MP, et al.: Pharmacokinetics and pharmacodynamics of seven opioids in P-glycoprotein-competent mice: Assessment of unbound brain EC50,u and correlation of in vitro, preclinical, and clinical data. J Pharmacol Exp Ther. 2007; 323(1): 346-355. DOI: https://doi.org/10.1124/jpet.107.119560
Yousif S, Saubamea B, Cisternino S, et al.: Effect of chronic exposure to morphine on the rat blood-brain barrier: Focus on the P-glycoprotein. J Neurochem. 2008; 107(3): 647-657. DOI: https://doi.org/10.1111/j.1471-4159.2008.05647.x
Letrent SP, Polli JW, Humphreys JE, et al.: P-glycoprotein-mediated transport of morphine in brain capillary endothelial cells. Biochem Pharmacol. 1999; 58(6): 951-957. DOI: https://doi.org/10.1016/S0006-2952(99)00180-X
Letrent SP, Pollack GM, Brouwer KR, et al.: Effects of a potent and specific P-glycoprotein inhibitor on the blood-brain barrier distribution and antinociceptive effect of morphine in the rat. Drug Metab Dispos. 1999; 27(7): 827-834.
Henthorn TK, Liu Y, Mahapatro M, et al.: Active transport of fentanyl by the blood-brain barrier. J Pharmacol Exp Ther. 1999; 289(2): 1084-1089.
Fudin J, Fontenelle DV, Payne A: Rifampin reduces oral morphine absorption: A case of transdermal buprenorphine selection based on morphine pharmacokinetics. J Pain Palliat Care Pharmacother. 2012; 26(4): 362-367. DOI: https://doi.org/10.3109/15360288.2012.734903
Richarz U, Jacobs A, Spina E: How frequently are contraindicated or warned against combinations of drugs prescribed to patients receiving long-term opioid therapy for chronic pain? Pharmacoepidemiol Drug Saf. 2012; 21(5): 453-462. DOI: https://doi.org/10.1002/pds.2250
Ashburn MA, Ogden LL, Zhang J, et al.: The pharmacokinetics of transdermal fentanyl delivered with and without controlled heat. J Pain. 2003; 4(6): 291-297. DOI: https://doi.org/10.1016/S1526-5900(03)00618-7
Knotkova H, Fine PG, Portenoy RK: Opioid rotation: The science and the limitations of the equianalgesic dose table. J Pain Symptom Manage. 2009; 38(3): 426-439.
Article 3 references:
Caldwell JR: Avinza—24-h sustained-release oral morphine therapy. Expert Opin Pharmacother. 2004; 5(2): 469-472. DOI: https://doi.org/10.1517/14656566.5.2.469
Portenoy RK, Sciberras A, Eliot L, et al.: Steady-state pharmacokinetic comparison of a new, extended-release, once-daily morphine formulation, Avinza, and a twice-daily controlled-release morphine formulation in patients with chronic moderate-to-severe pain. J Pain Symptom Manage. 2002; 23(4): 292-300. DOI: https://doi.org/10.1016/S0885-3924(02)00382-2
Adams EH, Chwiecko P, Ace-Wagoner Y, et al.: A study of AVINZA (morphine sulfate extended-release capsules) for chronic moderate-tosevere noncancer pain conducted under real-world treatment conditions—The ACCPT Study. Pain Pract. 2006; 6(4): 254-264. DOI: https://doi.org/10.1111/j.1533-2500.2006.00094.x
Rauck RL, Bookbinder SA, Bunker TR, et al.: A randomized, open-label study of once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled- release tablets) for chronic low back pain: The extension phase of the ACTION trial. J Opioid Manag. 2006; 2(6): 325-328, 331-323. DOI: https://doi.org/10.5055/jom.2006.0048
Rauck RL, Bookbinder SA, Bunker TR, et al.: The ACTION study: A randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin) for the treatment of chronic, moderate to severe low back pain. J Opioid Manag. 2006; 2(3): 155-166. DOI: https://doi.org/10.5055/jom.2006.0025
Panjabi SS, Panjabi RS, Shepherd MD, et al.: Extended-release, once-daily morphine (Avinza) for the treatment of chronic nonmalignant pain: Effect on pain, depressive symptoms, and cognition. Pain Med. 2008; 9(8): 985-993. DOI: https://doi.org/10.1111/j.1526-4637.2008.00483.x
Caldwell JR, Rapoport RJ, Davis JC, et al.: Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: Results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002; 23(4): 278-291. DOI: https://doi.org/10.1016/S0885-3924(02)00383-4
King CR, Khabazian A: Avinza (morphine sulfate extended-release capsules). Clin J Oncol Nurs. 2003; 7(4): 458-460, 478. DOI: https://doi.org/10.1188/03.CJON.458-460
Semenchuk MR: Avinza Elan. Curr Opin Investig Drugs. 2002; 3(9): 1369-1372.
Heiskanen T, Backman JT, Neuvonen M, et al.: Itraconazole, a potent inhibitor of P-glycoprotein, moderately increases plasma concentrations of oral morphine. Acta Anaesthesiol Scand. 2008; 52(10): 1319-1326. DOI: https://doi.org/10.1111/j.1399-6576.2008.01739.x
Su W, Pasternak GW: The role of multidrug resistance-associated protein in the blood-brain barrier and opioid analgesia. Synapse. 2013; 67(9): 609-619. DOI: https://doi.org/10.1002/syn.21667
Cunningham CW, Mercer SL, Hassan HE, et al.: Opioids and efflux transporters. Part 2: P-glycoprotein substrate activity of 3- and 6-substituted morphine analogs. J Med Chem. 2008; 51(7): 2316-2320. DOI: https://doi.org/10.1021/jm701457j
Groenendaal D, Freijer J, de Mik D, et al.: Population pharmacokinetic modelling of non-linear brain distribution of morphine: Influence of active saturable influx and P-glycoprotein mediated efflux. Br J Pharmacol. 2007; 151(5): 701-712. DOI: https://doi.org/10.1038/sj.bjp.0707257
Skarke C, Jarrar M, Erb K, et al.: Respiratory and miotic effects of morphine in healthy volunteers when P-glycoprotein is blocked by quinidine. Clin Pharmacol Ther. 2003; 74(4): 303-311. DOI: https://doi.org/10.1016/S0009-9236(03)00220-0
Wandel C, Kim R, Wood M, et al.: Interaction of morphine, fentanyl, sufentanil, alfentanil, and loperamide with the efflux drug transporter Pglycoprotein. Anesthesiology. 2002; 96(4): 913-920. DOI: https://doi.org/10.1097/00000542-200204000-00019
Drewe J, Ball HA, Beglinger C, et al.: Effect of P-glycoprotein modulation on the clinical pharmacokinetics and adverse effects of morphine. Br J Clin Pharmacol. 2000; 50(3): 237-246. DOI: https://doi.org/10.1046/j.1365-2125.2000.00226.x
Heiskanen T, Kalso E: Non-analgesic effects of opioids: Interactions between opioids and other drugs. Curr Pharm Des. 2012; 18(37): 6079- 6089. DOI: https://doi.org/10.2174/138161212803582423
Transdermal buprenorphine (Butrans) for chronic pain. Med Lett Drugs Ther. 2011; 53(1362): 31-32.
Plosker GL, Lyseng-Williamson KA: Buprenorphine 5, 10 and 20 mug/h transdermal patch: A guide to its use in chronic non-malignant pain. CNS Drugs. 2012; 26(4): 367-373. DOI: https://doi.org/10.2165/11208360-000000000-00000
Plosker GL: Buprenorphine 5, 10 and 20 mug/h transdermal patch: A review of its use in the management of chronic non-malignant pain. Drugs. 2011; 71(18): 2491-2509. DOI: https://doi.org/10.2165/11208250-000000000-00000
Pergolizzi JV Jr, Ben-Joseph R, Chang CL, et al.: US practitioner prescribing practices and patient characteristics of those newly treated with a buprenorphine transdermal patch system. Curr Med Res Opin. 2014; 30(8): 1579-1587. DOI: https://doi.org/10.1185/03007995.2014.901941
Park I, Kim D, Song J, et al.: Buprederm, a new transdermal delivery system of buprenorphine: Pharmacokinetic, efficacy and skin irritancy studies. Pharm Res. 2008; 25(5): 1052-1062. DOI: https://doi.org/10.1007/s11095-007-9470-6
Brown SM, Holtzman M, Kim T, et al.: Buprenorphine metabolites, buprenorphine-3-glucuronide and norbuprenorphine-3-glucuronide, are biologically active. Anesthesiology. 2011; 115(6): 1251-1260. DOI: https://doi.org/10.1097/ALN.0b013e318238fea0
Ohtani M, Kotaki H, Sawada Y, et al.: Comparative analysis of buprenorphine- and norbuprenorphine-induced analgesic effects based on pharmacokinetic-pharmacodynamic modeling. J Pharmacol Exp Ther. 1995; 272(2): 505-510.
Kress HG: Clinical update on the pharmacology, efficacy and safety of transdermal buprenorphine. Eur J Pain. 2009; 13(3): 219-230. DOI: https://doi.org/10.1016/j.ejpain.2008.04.011
Chang Y, Moody DE: Glucuronidation of buprenorphine and norbuprenorphine by human liver microsomes and UDP-glucuronosyltransferases. Drug Metab Lett. 2009; 3(2): 101-107. DOI: https://doi.org/10.2174/187231209788654117
Huang W, Moody DE, McCance-Katz EF: The in vivo glucuronidation of buprenorphine and norbuprenorphine determined by liquid chromatography-electrospray ionization-tandem mass spectrometry. Ther Drug Monit. 2006; 28(2): 245-251. DOI: https://doi.org/10.1097/01.ftd.0000197094.92559.b4
Mistry M, Houston JB: Glucuronidation in vitro and in vivo. Comparison of intestinal and hepatic conjugation of morphine, naloxone, and buprenorphine. Drug Metab Dispos. 1987; 15(5): 710-717.
Kapil RP, Cipriano A, Michels GH, et al.: Effect of ketoconazole on the pharmacokinetic profile of buprenorphine following administration of a once-weekly buprenorphine transdermal system. Clin Drug Investig. 2012; 32(9): 583-592. DOI: https://doi.org/10.1007/BF03261913
Dilmaghanian S, Gerber JG, Filler SG, et al.: Enantioselectivity of inhibition of cytochrome P450 3A4 (CYP3A4) by ketoconazole: Testosterone and methadone as substrates. Chirality. 2004; 16(2): 79- 85. DOI: https://doi.org/10.1002/chir.10294
McCance-Katz EF, Moody DE, Morse GD, et al.: Interaction between buprenorphine and atazanavir or atazanavir/ritonavir. Drug Alcohol Depend. 2007; 91(2-3): 269-278. DOI: https://doi.org/10.1016/j.drugalcdep.2007.06.007
Bruce RD, Altice FL: Three case reports of a clinical pharmacokinetic interaction with buprenorphine and atazanavir plus ritonavir. AIDS. 2006; 20(5): 783-784. DOI: https://doi.org/10.1097/01.aids.0000216384.22432.9a
Ohtani M, Kotaki H, Nishitateno K, et al.: Kinetics of respiratory depression in rats induced by buprenorphine and its metabolite, norbuprenorphine. J Pharmacol Exp Ther. 1997; 281(1): 428-433.
Megarbane B, Hreiche R, Pirnay S, et al.: Does high-dose buprenorphine cause respiratory depression?: Possible mechanisms and therapeutic consequences. Toxicol Rev. 2006; 25(2): 79-85. DOI: https://doi.org/10.2165/00139709-200625020-00002
Suzuki T, Zaima C, Moriki Y, et al.: P-glycoprotein mediates brainto-blood efflux transport of buprenorphine across the blood-brain barrier. J Drug Target. 2007; 15(1): 67-74. DOI: https://doi.org/10.1080/10611860601141606
Alhaddad H, Cisternino S, Decleves X, et al.: Respiratory toxicity of buprenorphine results from the blockage of P-glycoprotein-mediated efflux of norbuprenorphine at the blood-brain barrier in mice. Crit Care Med. 2012; 40(12): 3215-3223. DOI: https://doi.org/10.1097/CCM.0b013e318265680a
Hassan HE, Myers AL, Coop A, et al.: Differential involvement of Pglycoprotein (ABCB1) in permeability, tissue distribution, and antinociceptive activity of methadone, buprenorphine, and diprenorphine: In vitro and in vivo evaluation. J Pharm Sci. 2009; 98(12): 4928-4940. DOI: https://doi.org/10.1002/jps.21770
Megarbane B, Alhaddad H: P-glycoprotein should be considered as an additional factor contributing to opioid-induced respiratory depression in paediatrics: The buprenorphine example. Br J Anaesth. 2013; 110(5): 842. DOI: https://doi.org/10.1093/bja/aet082
Wang J, Cai B, Huang DX, et al.: Decreased analgesic effect of morphine, but not buprenorphine, in patients with advanced P-glycoprotein(+) cancers. Pharmacol Rep. 2012; 64(4): 870-877. DOI: https://doi.org/10.1016/S1734-1140(12)70881-2
Al-Tawil N, Odar-Cederlof I, Berggren AC, et al.: Pharmacokinetics of transdermal buprenorphine patch in the elderly. Eur J Clin Pharmacol. 2013; 69(2): 143-149. DOI: https://doi.org/10.1007/s00228-012-1320-8
Boger RH: Renal impairment: A challenge for opioid treatment? The role of buprenorphine. Palliat Med. 2006; 20(suppl 1): s17-s23. DOI: https://doi.org/10.1191/0269216306pm1127oa
Simon N, Simon R: Adaptive enrichment designs for clinical trials. Biostatistics. 2013; 14(4): 613-625. DOI: https://doi.org/10.1093/biostatistics/kxt010
Miller K, Yarlas A, Wen W, et al.: Buprenorphine transdermal system and quality of life in opioid-experienced patients with chronic low back pain. Expert Opin Pharmacother. 2013; 14(3): 269-277. DOI: https://doi.org/10.1517/14656566.2013.767331
Gordon A, Callaghan D, Spink D, et al.: Buprenorphine transdermal system in adults with chronic low back pain: A randomized, doubleblind, placebo-controlled crossover study, followed by an open-label extension phase. Clin Ther. 2010; 32(5): 844-860. DOI: https://doi.org/10.1016/j.clinthera.2010.04.018
Steiner DJ, Sitar S, Wen W, et al.: Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naive patients with moderate to severe chronic low back pain: An enriched, randomized, double-blind, placebo-controlled study. J Pain Symptom Manage. 2011; 42(6): 903-917. DOI: https://doi.org/10.1016/j.jpainsymman.2011.04.006
Landau CJ, Carr WD, Razzetti AJ, et al.: Buprenorphine transdermal delivery system in adults with persistent noncancer-related pain syndromes who require opioid therapy: A multicenter, 5-week run-in and randomized, double-blind maintenance-of-analgesia study. Clin Ther. 2007; 29(10): 2179-2193. DOI: https://doi.org/10.1016/j.clinthera.2007.10.010
Uberall MA, Muller-Schwefe GH: Long-term treatment of chronic pain with low-dose 7-day buprenorphine transdermal patch. Observational data from elderly patients of pain relief and quality of life. MMW Fortschr Med. 2013; 155(suppl 3): 87-96.
Uberall MA, Muller-Schwefe GH: Low-dose 7-day transdermal buprenorphine in daily clinical practice—Perceptions of elderly patients with moderate non-malignant chronic pain. Curr Med Res Opin. 2012; 28(10): 1585-1595. DOI: https://doi.org/10.1185/03007995.2012.731387
Karlsson J, Soderstrom A, Augustini BG, et al.: Is buprenorphine transdermal patch equally safe and effective in younger and elderly patients with osteoarthritis-related pain? Results of an age-group controlled study. Curr Med Res Opin. 2014; 30(4): 575-587. DOI: https://doi.org/10.1185/03007995.2013.873714
Karlsson M, Berggren AC: Efficacy and safety of low-dose transdermal buprenorphine patches (5, 10, and 20 microg/h) versus prolonged-release tramadol tablets (75, 100, 150, and 200 mg) in patients with chronic osteoarthritis pain: A 12-week, randomized, open-label, controlled, parallel-group noninferiority study. Clin Ther. 2009; 31(3): 503-513. DOI: https://doi.org/10.1016/j.clinthera.2009.03.001
Schutter U, Ritzdorf I, Heckes B: The transdermal 7-day buprenorphine patch—An effective and safe treatment option, if tramadol or tilidate/naloxone is insufficient. Results of a non-interventional study. MMW Fortschr Med. 2010; 152(suppl 2): 62-69.
Gallagher AM, Leighton-Scott J, van Staa TP: Utilization characteristics and treatment persistence in patients prescribed low-dose buprenorphine patches in primary care in the United Kingdom: A retrospective cohort study. Clin Ther. 2009; 31(8): 1707-1715. DOI: https://doi.org/10.1016/j.clinthera.2009.08.022
James IG, O’Brien CM, McDonald CJ: A randomized, double-blind, double-dummy comparison of the efficacy and tolerability of low-dose transdermal buprenorphine (BuTrans seven-day patches) with buprenorphine sublingual tablets (Temgesic) in patients with osteoarthritis pain. J Pain Symptom Manage. 2010; 40(2): 266-278. DOI: https://doi.org/10.1016/j.jpainsymman.2010.01.013
Wolff RF, Aune D, Truyers C, et al.: Systematic review of efficacy and safety of buprenorphine versus fentanyl or morphine in patients with chronic moderate to severe pain. Curr Med Res Opin. 2012; 28(5): 833-845. DOI: https://doi.org/10.1185/03007995.2012.678938
Ripa SR, McCarberg BH, Munera C, et al.: A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 mug/h or 20 mug/h in patients with osteoarthritis pain. Expert Opin Pharmacother. 2012; 13(9): 1229-1241. DOI: https://doi.org/10.1517/14656566.2012.667073
Wolff RF, Reid K, di Nisio M, et al.: Systematic review of adverse events of buprenorphine patch versus fentanyl patch in patients with chronic moderate-to-severe pain. Pain Manag. 2012; 2(4): 351-362. DOI: https://doi.org/10.2217/pmt.12.22
Holdsworth MT, Forman WB, Killilea TA, et al.: Transdermal fentanyl disposition in elderly subjects. Gerontology. 1994; 40(1): 32-37. DOI: https://doi.org/10.1159/000213572
Canneti A, Luzi M, Di Marco P, et al.: Safety and efficacy of transdermal buprenorphine and transdermal fentanyl in the treatment of neuropathic pain in AIDS patients. Minerva Anestesiol. 2013; 79(8): 871-883.
Mercadante S, Porzio G, Ferrera P, et al.: Low doses of transdermal buprenorphine in opioid-naive patients with cancer pain: A 4-week, nonrandomized, open-label, uncontrolled observational study. Clin Ther. 2009; 31(10): 2134-2138. DOI: https://doi.org/10.1016/j.clinthera.2009.10.013
Wen W, Lynch SY, Munera C, et al.: Application site adverse events associated with the buprenorphine transdermal system: A pooled analysis. Expert Opin Drug Saf. 2013; 12(3): 309-319. DOI: https://doi.org/10.1517/14740338.2013.780025
Durand C, Alhammad A, Willett KC: Practical considerations for optimal transdermal drug delivery. Am J Health Syst Pharm. 2012; 69(2): 116-124. DOI: https://doi.org/10.2146/ajhp110158
Katz N, Sun S, Johnson F, et al.: ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules in the treatment of chronic pain of osteoarthritis of the hip or knee: Pharmacokinetics, efficacy, and safety. J Pain. 2010; 11(4): 303-311. DOI: https://doi.org/10.1016/j.jpain.2009.07.017
Johnson FK, Ciric S, Boudriau S, et al.: The relative bioavailability of morphine sulfate and naltrexone hydrochloride extended release capsules (EMBEDA(R)) and an extended release morphine sulfate capsule formulation (KADIAN(R)) in healthy adults under fasting conditions. Am J Ther. 2011; 18(1): 2-8. DOI: https://doi.org/10.1097/MJT.0b013e3181f05957
Johnson FK, Stark JG, Bieberdorf FA, et al.: Relative oral bioavailability of morphine and naltrexone derived from crushed morphine sulfate and naltrexone hydrochloride extended-release capsules versus intact product and versus naltrexone solution: A single-dose, randomized- sequence, open-label, three-way crossover trial in healthy volunteers. Clin Ther. 2010; 32(6): 1149-1164. DOI: https://doi.org/10.1016/j.clinthera.2010.05.011
Johnson F, Ciric S, Boudriau S, et al.: Food effects on the pharmacokinetics of morphine sulfate and naltrexone hydrochloride extended release capsules. Adv Ther. 2010; 27(11): 846-858. DOI: https://doi.org/10.1007/s12325-010-0074-x
Stauffer J, Setnik B, Sokolowska M, et al.: Subjective effects and safety of whole and tampered morphine sulfate and naltrexone hydrochloride (ALO-01) extended-release capsules versus morphine solution and placebo in experienced non-dependent opioid users: A randomized, double-blind, placebo-controlled, crossover study. Clin Drug Investig. 2009; 29(12): 777-790. DOI: https://doi.org/10.2165/11530800-000000000-00000
Smith HS: Morphine sulfate and naltrexone hydrochloride extended release capsules for the management of chronic, moderate-to-severe pain, while reducing morphine-induced subjective effects upon tampering by crushing. Expert Opin Pharmacother. 2011; 12(7): 1111-1125. DOI: https://doi.org/10.1517/14656566.2011.571205
Setnik B, Sommerville K, Goli V, et al.: Assessment of pharmacodynamics effects following oral administration of crushed morphine sulfate and naltrexone hydrochloride extended-release capsules compared with crushed morphine sulfate controlled-release tablets and placebo in nondependent recreational opioid users. Pain Med. 2013; 14(8): 1173-1186. DOI: https://doi.org/10.1111/pme.12148
Katz N, Hale M, Morris D, et al.: Morphine sulfate and naltrexone hydrochloride extended release capsules in patients with chronic osteoarthritis pain. Postgrad Med. 2010; 122(4): 112-128. DOI: https://doi.org/10.3810/pgm.2010.07.2179
Webster LR, Brewer R, Wang C, et al.: Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride extended release capsules, a novel formulation containing morphine and sequestered naltrexone, in patients with chronic, moderate to severe pain. J Pain Symptom Manage. 2010; 40(5): 734-746. DOI: https://doi.org/10.1016/j.jpainsymman.2010.05.004
Ruan X, Chen T, Gudin J, et al.: Acute opioid withdrawal precipitated by ingestion of crushed embeda (morphine extended release with sequestered naltrexone): Case report and the focused review of the literature. J Opioid Manag. 2010; 6(4): 300-303. DOI: https://doi.org/10.5055/jom.2010.0028
Jang DH, Rohe JC, Hoffman RS, et al.: Severe opioid withdrawal due to misuse of new combined morphine and naltrexone product (Embeda). Ann Emerg Med. 2010; 55(3): 303-304. DOI: https://doi.org/10.1016/j.annemergmed.2009.10.013
Schaeffer T: Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J Med Toxicol. 2012; 8(4): 400-407. DOI: https://doi.org/10.1007/s13181-012-0270-y
Hamabe W, Maeda T, Kiguchi N, et al.: Negative relationship between morphine analgesia and P-glycoprotein expression levels in the brain. J Pharmacol Sci. 2007; 105(4): 353-360. DOI: https://doi.org/10.1254/jphs.FP0071287
Kharasch ED, Hoffer C, Whittington D, et al.: Role of P-glycoprotein in the intestinal absorption and clinical effects of morphine. Clin Pharmacol Ther. 2003; 74(6): 543-554. DOI: https://doi.org/10.1016/j.clpt.2003.08.011
Aquilante CL, Letrent SP, Pollack GM, et al.: Increased brain P-glycoprotein in morphine tolerant rats. Life Sci. 2000; 66(4): PL47-PL51. DOI: https://doi.org/10.1016/S0024-3205(99)00599-8
Huwyler J, Drewe J, Gutmann H, et al.: Modulation of morphine-6- glucuronide penetration into the brain by P-glycoprotein. Int J Clin Pharmacol Ther. 1998; 36(2): 69-70.
Qi X, Evans AM, Wang J, et al.: Inhibition of morphine metabolism by ketamine. Drug Metab Dispos. 2010; 38(5): 728-731. DOI: https://doi.org/10.1124/dmd.109.030957
Fujita K, Ando Y, Yamamoto W, et al.: Association of UGT2B7 and ABCB1 genotypes with morphine-induced adverse drug reactions in Japanese patients with cancer. Cancer Chemother Pharmacol. 2010; 65(2): 251-258. DOI: https://doi.org/10.1007/s00280-009-1029-2
Darbari DS, van Schaik RH, Capparelli EV, et al.: UGT2B7 promoter variant -840G>A contributes to the variability in hepatic clearance of morphine in patients with sickle cell disease. Am J Hematol. 2008; 83(3): 200-202. DOI: https://doi.org/10.1002/ajh.21051
Coffman BL, Rios GR, King CD, et al.: Human UGT2B7 catalyzes morphine glucuronidation. Drug Metab Dispos. 1997; 25(1): 1-4.
Nicholson B, Ross E, Weil A, et al.: Treatment of chronic moderate-to-severe non-malignant pain with polymer-coated extended-release morphine sulfate capsules. Curr Med Res Opin. 2006; 22(3): 539-550. DOI: https://doi.org/10.1185/030079906X89784
Ross EL, Hahn K: KADIAN (morphine sulfate extended-release) capsules for treatment of chronic, moderate-to-severe, nonmalignant pain. Int J Clin Pract. 2008; 62(3): 471-479. DOI: https://doi.org/10.1111/j.1742-1241.2007.01688.x
Nicholson B: Morphine sulfate extended-release capsules for the treatment of chronic, moderate-to-severe pain. Expert Opin Pharmacother. 2008; 9(9): 1585-1594. DOI: https://doi.org/10.1517/14656566.9.9.1585
Broomhead A, Kerr R, Tester W, et al.: Comparison of a once-aday sustained-release morphine formulation with standard oral morphine treatment for cancer pain. J Pain Symptom Manage. 1997; 14(2): 63-73. DOI: https://doi.org/10.1016/S0885-3924(97)00012-2
Chen ML, Shah V, Patnaik R, et al.: Bioavailability and bioequivalence: An FDA regulatory overview. Pharm Res. 2001; 18(12): 1645-1650. DOI: https://doi.org/10.1023/A:1013319408893
Williams RL, Patnaik RN, Chen ML: The basis for individual bioequivalence. FDA Population and Individual Bioequivalence Working Group. Eur J Drug Metab Pharmacokinet. 2000; 25(1): 13-17. DOI: https://doi.org/10.1007/BF03190050
Bioavailability and bioequivalence requirements; abbreviated applications; proposed revisions—FDA. Proposed rule. Fed Regist. 1998; 63(223): 64222-64228.
Patnaik RN, Lesko LJ, Chen ML, et al.: Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics. FDA Individual Bioequivalence Working Group. Clin Pharmacokinet. 1997; 33(1): 1-6. DOI: https://doi.org/10.2165/00003088-199733010-00001
Hagen NA, Thirlwell M, Eisenhoffer J, et al.: Efficacy, safety, and steady-state pharmacokinetics of once-a-day controlled-release morphine (MS Contin XL) in cancer pain. J Pain Symptom Manage. 2005; 29(1): 80-90. DOI: https://doi.org/10.1016/j.jpainsymman.2004.04.015
Johnson F, Wagner G, Sun S, et al.: Effect of concomitant ingestion of alcohol on the in vivo pharmacokinetics of KADIAN (morphine sulfate extended-release) capsules. J Pain. 2008; 9(4): 330-336. DOI: https://doi.org/10.1016/j.jpain.2007.11.009
Sasaki J, Weil AJ, Ross EL, et al.: Effectiveness of polymer-coated extended-release morphine sulfate capsules in older patients with persistent moderate-to-severe pain: A subgroup analysis of a large, open-label, community-based trial. Curr Ther Res Clin Exp. 2007; 68(3): 137-150. DOI: https://doi.org/10.1016/j.curtheres.2007.05.002
Villesen HH, Banning AM, Petersen RH, et al.: Pharmacokinetics of morphine and oxycodone following intravenous administration in elderly patients. Ther Clin Risk Manag. 2007; 3(5): 961-967.
Sear JW, Hand CW, Moore RA: Studies on morphine disposition: Plasma concentrations of morphine and its metabolites in anesthetized middle-aged and elderly surgical patients. J Clin Anesth. 1989; 1(3): 164-169. DOI: https://doi.org/10.1016/0952-8180(89)90036-6
Weil AJ, Nicholson B, Sasaki J: Factors affecting dosing regimens of morphine sulfate extended-release (KADIAN) capsules. J Opioid Manag. 2009; 5(1): 39-45. DOI: https://doi.org/10.5055/jom.2009.0005
Nicholson B, Ross E, Sasaki J, et al.: Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain. Curr Med Res Opin. 2006; 22(8): 1503-1514. DOI: https://doi.org/10.1185/030079906X115603
Armstrong SC, Cozza KL: Pharmacokinetic drug interactions of morphine, codeine, and their derivatives: Theory and clinical reality, Part II. Psychosomatics. 2003; 44(6): 515-520. DOI: https://doi.org/10.1176/appi.psy.44.6.515
Armstrong SC, Cozza KL: Pharmacokinetic drug interactions of morphine, codeine, and their derivatives: Theory and clinical reality, Part I. Psychosomatics. 2003; 44(2): 167-171. DOI: https://doi.org/10.1176/appi.psy.44.2.167
Uchaipichat V, Raungrut P, Chau N, et al.: Effects of ketamine on human UDP-glucuronosyltransferases in vitro predict potential drug-drug interactions arising from ketamine inhibition of codeine and morphine glucuronidation. Drug Metab Dispos. 2011; 39(8): 1324-1328. DOI: https://doi.org/10.1124/dmd.111.039727
Nelsen JL, Marraffa JM, Jones L, et al.: Management considerations following overdoses of modified-release morphine preparations. World J Emerg Med. 2010; 1(1): 75-76.
Finn JW, Walsh TD, MacDonald N, et al.: Placebo-blinded study of morphine sulfate sustained-release tablets and immediate-release morphine sulfate solution in outpatients with chronic pain due to advanced cancer. J Clin Oncol. 1993; 11(5): 967-972. DOI: https://doi.org/10.1200/JCO.1993.11.5.967
Thirlwell MP, Sloan PA, Maroun JA, et al.: Pharmacokinetics and clinical efficacy of oral morphine solution and controlled-release morphine tablets in cancer patients. Cancer. 1989; 63(11 suppl): 2275-2283. DOI: https://doi.org/10.1002/1097-0142(19890601)63:11<2275::AID-CNCR2820631136>3.0.CO;2-4
Kaiko RF, Grandy RP, Oshlack B, et al.: The United States experience with oral controlled-release morphine (MS Contin tablets). Parts I and II. Review of nine dose titration studies and clinical pharmacology of 15-mg, 30-mg, 60-mg, and 100-mg tablet strengths in normal subjects. Cancer. 1989; 63(11 suppl): 2348-2354. DOI: https://doi.org/10.1002/1097-0142(19890601)63:11<2348::AID-CNCR2820631146>3.0.CO;2-V
Eliot L, Butler J, Devane J, et al.: Pharmacokinetic evaluation of a sprinkle-dose regimen of a once-daily, extended-release morphine formulation. Clin Ther. 2002; 24(2): 260-268. DOI: https://doi.org/10.1016/S0149-2918(02)85022-6
Allan L, Richarz U, Simpson K, et al.: Transdermal fentanyl versus sustained release oral morphine in strong-opioid naive patients with chronic low back pain. Spine. 2005; 30(22): 2484-2490. DOI: https://doi.org/10.1097/01.brs.0000186860.23078.a8
Clark AJ, Ahmedzai SH, Allan LG, et al.: Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic non-cancer pain. Curr Med Res Opin. 2004; 20(9): 1419-1428. DOI: https://doi.org/10.1185/030079904X2114
van Seventer R, Smit JM, Schipper RM, et al.: Comparison of TTSfentanyl with sustained-release oral morphine in the treatment of patients not using opioids for mild-to-moderate pain. Curr Med Res Opin. 2003; 19(6): 457-469. DOI: https://doi.org/10.1185/030079903125002045
Allan L, Hays H, Jensen NH, et al.: Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. BMJ. 2001; 322(7295): 1154-1158. DOI: https://doi.org/10.1136/bmj.322.7295.1154
Ahmedzai S, Brooks D: Transdermal fentanyl versus sustained-release oral morphine in cancer pain: Preference, efficacy, and quality of life. The TTS-Fentanyl Comparative Trial Group. J Pain Symptom Manage. 1997; 13(5): 254-261. DOI: https://doi.org/10.1016/S0885-3924(97)00082-1
Tassain V, Attal N, Fletcher D, et al.: Long term effects of oral sustained release morphine on neuropsychological performance in patients with chronic non-cancer pain. Pain. 2003; 104(1-2): 389-400. DOI: https://doi.org/10.1016/S0304-3959(03)00047-2
Gourlay GK: Sustained relief of chronic pain. Pharmacokinetics of sustained release morphine. Clin Pharmacokinet. 1998; 35(3): 173-190. DOI: https://doi.org/10.2165/00003088-199835030-00002
Wilkinson TJ, Robinson BA, Begg EJ, et al.: Pharmacokinetics and efficacy of rectal versus oral sustained-release morphine in cancer patients. Cancer Chemother Pharmacol. 1992; 31(3): 251-254. DOI: https://doi.org/10.1007/BF00685556
Beer B, Rabl W, Libiseller K, et al.: Impact of slow-release oral morphine on drug abusing habits in Austria. Neuropsychiatr. 2010; 24(2): 108-117.
Lamb D, Roberts G: Starch and talc emboli in drug addicts’ lungs. J Clin Pathol. 1972; 25(10): 876-881. DOI: https://doi.org/10.1136/jcp.25.10.876
Rubinstein AL, Carpenter DM, Minkoff JR: Hypogonadism in men with chronic pain linked to the use of long-acting rather than short-acting opioids. Clin J Pain. 2013; 29(10): 840-845. DOI: https://doi.org/10.1097/AJP.0b013e31827c7b5d
Cicero TJ: Effects of exogenous and endogenous opiates on the hypothalamic-pituitary-gonadal axis in the male. Fed Proc. 1980; 39(8): 2551-2554.
Vuong C, Van Uum SH, O’Dell LE, et al.: The effects of opioids and opioid analogs on animal and human endocrine systems. Endocr Rev. 2010; 31(1): 98-132. DOI: https://doi.org/10.1210/er.2009-0009
Ceccarelli I, De Padova AM, Fiorenzani P, et al.: Single opioid administration modifies gonadal steroids in both the CNS and plasma of male rats. Neuroscience. 2006; 140(3): 929-937. DOI: https://doi.org/10.1016/j.neuroscience.2006.02.044
Khanal A, Peterson GM, Castelino RL, et al.: Renal drug dosing recommendations: Evaluation of product information for brands of the same drug. Intern Med J. 2014; 44(6): 591-596. DOI: https://doi.org/10.1111/imj.12446
Perrino PJ, Colucci SV, Apseloff G, et al.: Pharmacokinetics, tolerability, and safety of intranasal administration of reformulated OxyContin((R)) tablets compared with original OxyContin ((R)) tablets
in healthy adults. Clin Drug Investig. 2013; 33(6): 441-449. DOI: https://doi.org/10.1007/s40261-013-0085-x
Cicero TJ, Ellis MS, Surratt HL: Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 2012; 367(2): 187-189. DOI: https://doi.org/10.1056/NEJMc1204141
Carise D, Dugosh KL, McLellan AT, et al.: Prescription OxyContin abuse among patients entering addiction treatment. Am J Psychiatry. 2007; 164(11): 1750-1756. DOI: https://doi.org/10.1176/appi.ajp.2007.07050252
Cicero TJ, Inciardi JA, Munoz A: Trends in abuse of Oxycontin and other opioid analgesics in the United States: 2002-2004. J Pain. 2005; 6(10): 662-672. DOI: https://doi.org/10.1016/j.jpain.2005.05.004
Mandema JW, Kaiko RF, Oshlack B, et al.: Characterization and validation of a pharmacokinetic model for controlled-release oxycodone. Br J Clin Pharmacol. 1996; 42(6): 747-756. DOI: https://doi.org/10.1046/j.1365-2125.1996.00481.x
Benziger DP, Miotto J, Grandy RP, et al.: A pharmacokinetic/pharmacodynamics study of controlled-release oxycodone. J Pain Symptom Manage. 1997; 13(2): 75-82. DOI: https://doi.org/10.1016/S0885-3924(96)00300-4
Benziger DP, Kaiko RF, Miotto JB, et al.: Differential effects of food on the bioavailability of controlled-release oxycodone tablets and immediate- release oxycodone solution. J Pharm Sci. 1996; 85(4): 407-410. DOI: https://doi.org/10.1021/js950403a
Reder RF, Oshlack B, Miotto JB, et al. Steady-state bioavailability of controlled-release oxycodone in normal subjects. Clin Ther. 1996; 18(1): 95-105. DOI: https://doi.org/10.1016/S0149-2918(96)80182-2
Stambaugh JE, Reder RF, Stambaugh MD, et al. Double-blind, randomized comparison of the analgesic and pharmacokinetic profiles of controlled- and immediate-release oral oxycodone in cancer pain patients. J Clin Pharmacol. 2001; 41(5): 500-506. DOI: https://doi.org/10.1177/00912700122010375
Colucci RD, Swanton RE, Thomas GB, et al.: Relative variability in bioavailability of oral controlled-release formulations of oxycodone and morphine. Am J Ther. 2001; 8(4): 231-236. DOI: https://doi.org/10.1097/00045391-200107000-00004
Binsfeld H, Szczepanski L, Waechter S, et al.: A randomized study to demonstrate noninferiority of once-daily OROS® hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010; 10(5): 404-415. DOI: https://doi.org/10.1111/j.1533-2500.2009.00342.x
Kampe S, Wolter K, Warm M, et al.: Clinical equivalence of controlled-release oxycodone 20 mg and controlled-release tramadol 200 mg after surgery for breast cancer. Pharmacology. 2009; 84(5): 276-281. DOI: https://doi.org/10.1159/000242998
Afilalo M, Etropolski MS, Kuperwasser B, et al.: Efficacy and safety of tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: A randomized, double-blind, placebo- and active-controlled phase III study. Clin Drug Investig. 2010; 30(8): 489-505. DOI: https://doi.org/10.2165/11533440-000000000-00000
Gronlund J, Saari TI, Hagelberg NM, et al.: Effect of inhibition of cytochrome P450 enzymes 2D6 and 3A4 on the pharmacokinetics of intravenous oxycodone: A randomized, three-phase, crossover, placebo-controlled study. Clin Drug Investig. 2011; 31(3): 143-153. DOI: https://doi.org/10.2165/11539950-000000000-00000
Gronlund J, Saari TI, Hagelberg NM, et al.: Exposure to oral oxycodone is increased by concomitant inhibition of CYP2D6 and 3A4 pathways, but not by inhibition of CYP2D6 alone. Br J Clin Pharmacol. 2010; 70(1): 78-87. DOI: https://doi.org/10.1111/j.1365-2125.2010.03653.x
Hagelberg NM, Nieminen TH, Saari TI, et al.: Voriconazole drastically increases exposure to oral oxycodone. Eur J Clin Pharmacol. 2009; 65(3): 263-271. DOI: https://doi.org/10.1007/s00228-008-0568-5
Nieminen TH, Hagelberg NM, Saari TI, et al.: Oxycodone concentrations are greatly increased by the concomitant use of ritonavir or lopinavir/ritonavir. Eur J Clin Pharmacol. 2010; 66(10): 977-985. DOI: https://doi.org/10.1007/s00228-010-0879-1
Nieminen TH, Hagelberg NM, Saari TI, et al.: Grapefruit juice enhances the exposure to oral oxycodone. Basic Clin Pharmacol
Toxicol. 2010; 107(4): 782-788. DOI: https://doi.org/10.1111/j.1742-7843.2010.00582.x
Kummer O, Hammann F, Moser C, et al.: Effect of the inhibition of CYP3A4 or CYP2D6 on the pharmacokinetics and pharmacodynamics of oxycodone. Eur J Clin Pharmacol. 2011; 67(1): 63-71. DOI: https://doi.org/10.1007/s00228-010-0893-3
Fudin J, Atkinson TJ: Personalized oxycodone dosing: Using pharmacogenetic testing and clinical pharmacokinetics to reduce toxicity risk and increase effectiveness. Pain Med. 2014; 15(5): 723-725. DOI: https://doi.org/10.1111/pme.12417
Okura T, Hattori A, Takano Y, et al.: Involvement of the pyrilamine transporter, a putative organic cation transporter, in blood-brain barrier transport of oxycodone. Drug Metab Dispos. 2008; 36(10): 2005-2013. DOI: https://doi.org/10.1124/dmd.108.022087
Bostrom E, Simonsson US, Hammarlund-Udenaes M: In vivo blood-brain barrier transport of oxycodone in the rat: Indications for active influx and implications for pharmacokinetics/pharmacodynamics. Drug Metab Dispos. 2006; 34(9): 1624-1631. DOI: https://doi.org/10.1124/dmd.106.009746
Kokki M, Valitalo P, Kuusisto M, et al.: Central nervous system penetration of oxycodone after intravenous and epidural administration. Br J Anaesth. 2014; 112(1): 133-140. DOI: https://doi.org/10.1093/bja/aet337
Mikus G, Klimas R: Contribution of oxycodone and its metabolites to the analgesic effect. Br J Anaesth. 2014; 112(5): 944-945. DOI: https://doi.org/10.1093/bja/aeu123
Bostrom E, Hammarlund-Udenaes M, Simonsson US: Blood-brain barrier transport helps to explain discrepancies in in vivo potency between oxycodone and morphine. Anesthesiology. 2008; 108(3): 495-505. DOI: https://doi.org/10.1097/ALN.0b013e318164cf9e
Suzuki T, Ohmuro A, Miyata M, et al.: Involvement of an influx transporter in the blood-brain barrier transport of naloxone. Biopharm Drug Dispos. 2010; 31(4): 243-252. DOI: https://doi.org/10.1002/bdd.707
Sadiq MW, Borgs A, Okura T, et al.: Diphenhydramine active uptake at the blood-brain barrier and its interaction with oxycodone in vitro and in vivo. J Pharm Sci. 2011; 100(9): 3912-3923. DOI: https://doi.org/10.1002/jps.22567
Hassan HE, Myers AL, Lee IJ, et al.: Oxycodone induces overexpression of P-glycoprotein (ABCB1) and affects paclitaxel’s tissue distribution in Sprague Dawley rats. J Pharm Sci. 2007; 96(9): 2494-2506. DOI: https://doi.org/10.1002/jps.20893
Bostrom E, Simonsson US, Hammarlund-Udenaes M: Oxycodone pharmacokinetics and pharmacodynamics in the rat in the presence of the P-glycoprotein inhibitor PSC833. J Pharm Sci. 2005; 94(5): 1060-1066. DOI: https://doi.org/10.1002/jps.20327
Nakazawa Y, Okura T, Shimomura K, et al.: Drug-drug interaction between oxycodone and adjuvant analgesics in blood-brain barrier transport and antinociceptive effect. J Pharm Sci. 2010; 99(1): 467-474. DOI: https://doi.org/10.1002/jps.21807
Zwisler ST, Enggaard TP, Noehr-Jensen L, et al.: The antinociceptive effect and adverse drug reactions of oxycodone in human experimental pain in relation to genetic variations in the OPRM1 and ABCB1 genes. Fundam Clin Pharmacol. 2010; 24(4): 517-524. DOI: https://doi.org/10.1111/j.1472-8206.2009.00781.x
Zwisler ST, Enggaard TP, Noehr-Jensen L, et al.: The hypoalgesic effect of oxycodone in human experimental pain models in relation to the CYP2D6 oxidation polymorphism. Basic Clin Pharmacol Toxicol. 2009; 104(4): 335-344. DOI: https://doi.org/10.1111/j.1742-7843.2009.00378.x
Hagelberg NM, Nieminen TH, Saari TI, et al.: Interaction of oxycodone and voriconazole—A case series of patients with cancer pain supports the findings of randomised controlled studies with healthy subjects. Eur J Clin Pharmacol. 2011; 67(8): 863-864. DOI: https://doi.org/10.1007/s00228-010-0969-0
Gronlund J, Saari TI, Hagelberg N, et al.: Miconazole oral gel increases exposure to oral oxycodone by inhibition of CYP2D6 and CYP3A4. Antimicrob Agents Chemother. 2011; 55(3): 1063-1067. DOI: https://doi.org/10.1128/AAC.01242-10
Saari TI, Gronlund J, Hagelberg NM, et al.: Effects of itraconazole on the pharmacokinetics and pharmacodynamics of intravenously and orally administered oxycodone. Eur J Clin Pharmacol. 2010; 66(4): 387-397. DOI: https://doi.org/10.1007/s00228-009-0775-8
Gronlund J, Saari T, Hagelberg N, et al.: Effect of telithromycin on the pharmacokinetics and pharmacodynamics of oral oxycodone. J Clin Pharmacol. 2010; 50(1): 101-108. DOI: https://doi.org/10.1177/0091270009336444
Nieminen TH, Hagelberg NM, Saari TI, et al.: Rifampin greatly reduces the plasma concentrations of intravenous and oral oxycodone. Anesthesiology. 2009; 110(6): 1371-1378. DOI: https://doi.org/10.1097/ALN.0b013e31819faa54
Nieminen TH, Hagelberg NM, Saari TI, et al.: St John’s wort greatly reduces the concentrations of oral oxycodone. Eur J Pain. 2010; 14(8): 854-859. DOI: https://doi.org/10.1016/j.ejpain.2009.12.007
Kokki M, Valitalo P, Rasanen I, et al.: Absorption of different oral dosage forms of oxycodone in the elderly: A cross-over clinical trial in patients undergoing cystoscopy. Eur J Clin Pharmacol. 2012; 68(10): 1357-1363. DOI: https://doi.org/10.1007/s00228-012-1267-9
Liukas A, Kuusniemi K, Aantaa R, et al.: Elimination of intravenous oxycodone in the elderly: A pharmacokinetic study in postoperative orthopaedic patients of different age groups. Drugs Aging. 2011; 28(1): 41-50. DOI: https://doi.org/10.2165/11586140-000000000-00000
Liukas A, Kuusniemi K, Aantaa R, et al.: Plasma concentrations of oral oxycodone are greatly increased in the elderly. Clin Pharmacol Ther. 2008; 84(4): 462-467. DOI: https://doi.org/10.1038/clpt.2008.64
Saari TI, Ihmsen H, Neuvonen PJ, et al.: Oxycodone clearance is markedly reduced with advancing age: A population pharmacokinetic study. Br J Anaesth. 2012; 108(3): 491-498. DOI: https://doi.org/10.1093/bja/aer395
Komatsu T, Kokubun H, Suzuki A, et al.: Population pharmacokinetics of oxycodone in patients with cancer-related pain. J Pain Palliat Care Pharmacother. 2012; 26(3): 220-225. DOI: https://doi.org/10.3109/15360288.2012.702200
Naito T, Tashiro M, Ishida T, et al.: Cancer cachexia raises the plasma concentration of oxymorphone through the reduction of CYP3A but not CYP2D6 in oxycodone-treated patients. J Clin Pharmacol. 2013; 53(8): 812-818. DOI: https://doi.org/10.1002/jcph.112
Naito T, Tashiro M, Yamamoto K, et al.: Impact of cachexia on pharmacokinetic disposition of and clinical responses to oxycodone in cancer patients. Eur J Clin Pharmacol. 2012; 68(10): 1411-1418. DOI: https://doi.org/10.1007/s00228-012-1266-x
Lalovic B, Phillips B, Risler LL, et al.: Quantitative contribution of CYP2D6 and CYP3A to oxycodone metabolism in human liver and intestinal microsomes. Drug Metab Dispos. 2004; 32(4): 447-454. DOI: https://doi.org/10.1124/dmd.32.4.447
Tallgren M, Olkkola KT, Seppala T, et al.: Pharmacokinetics and ventilatory effects of oxycodone before and after liver transplantation. Clin Pharmacol Ther. 1997; 61(6): 655-661. DOI: https://doi.org/10.1016/S0009-9236(97)90100-4
Kirvela M, Lindgren L, Seppala T, et al.: The pharmacokinetics of oxycodone in uremic patients undergoing renal transplantation. J Clin Anesth. 1996; 8(1): 13-18. DOI: https://doi.org/10.1016/0952-8180(95)00092-5
Lee MA, Leng ME, Cooper RM: Measurements of plasma oxycodone, noroxycodone and oxymorphone levels in a patient with bilateral nephrectomy who is undergoing haemodialysis. Palliat Med. 2005; 19(3): 259-260. DOI: https://doi.org/10.1191/0269216305pm1004cr
Foral PA, Ineck JR, Nystrom KK: Oxycodone accumulation in a hemodialysis patient. South Med J. 2007; 100(2): 212-214. DOI: https://doi.org/10.1097/01.smj.0000242876.45747.0a
Harris SC, Perrino PJ, Smith I, et al.: Abuse potential, pharmacokinetics, pharmacodynamics, and safety of intranasally administered crushed oxycodone HCl abuse-deterrent controlled-release tablets in recreational opioid users. J Clin Pharmacol. 2014; 54(4): 468-477. DOI: https://doi.org/10.1002/jcph.235
Coplan PM, Kale H, Sandstrom L, et al.: Changes in oxycodone and heroin exposures in the National Poison Data System after introduction of extended-release oxycodone with abuse-deterrent characteristics. Pharmacoepidemiol Drug Saf. 2013; 22(12): 1274-1282. DOI: https://doi.org/10.1002/pds.3522
Havens JR, Leukefeld CG, DeVeaugh-Geiss AM, et al.: The impact of a reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers. Drug Alcohol Depend. 2014; 139: 9-17. DOI: https://doi.org/10.1016/j.drugalcdep.2014.02.018
Rossiter LF, Kirson NY, Shei A, et al.: Medical cost savings associated with an extended-release opioid with abuse-deterrent technology in the US. J Med Econ. 2014; 17(4): 279-287. DOI: https://doi.org/10.3111/13696998.2014.897628
Buer LM, Havens JR, Leukefeld C: Does the new formulation of OxyContin(R) deter misuse? A qualitative analysis. Subst Use Misuse. 2014; 49(6): 770-774. DOI: https://doi.org/10.3109/10826084.2013.866963
Cassidy TA, DasMahapatra P, Black RA, et al.: Changes in prevalence of prescription opioid abuse after introduction of an abuse-deterrent opioid formulation. Pain Med. 2014; 15(3): 440-451. DOI: https://doi.org/10.1111/pme.12295
Anastassopoulos KP, Chow W, Tapia CI, et al.: Economic study on the impact of side effects in patients taking oxycodone controlled-release for noncancer pain. J Manag Care Pharm. 2012; 18(8): 615-626. DOI: https://doi.org/10.18553/jmcp.2012.18.8.615
Nalamachu S: Opioid rotation with extended-release opioids: Where should we begin? Int J Gen Med. 2012; 5: 11-17. DOI: https://doi.org/10.2147/IJGM.S24287
Syrmis W, Good P, Wootton J, et al.: Opioid conversion ratios used in palliative care: Is there an Australian consensus? Intern Med J. 2014; 44(5): 483-489. DOI: https://doi.org/10.1111/imj.12401
Mercadante S, Caraceni A: Conversion ratios for opioid switching in the treatment of cancer pain: A systematic review. Palliat Med. 2011; 25(5): 504-515. DOI: https://doi.org/10.1177/0269216311406577
Webster LR, Fine PG: Review and critique of opioid rotation practices and associated risks of toxicity. Pain Med. 2012; 13(4): 562-570. DOI: https://doi.org/10.1111/j.1526-4637.2012.01357.x
Webster LR, Fine PG: Overdose deaths demand a new paradigm for opioid rotation. Pain Med. 2012; 13(4): 571-574. DOI: https://doi.org/10.1111/j.1526-4637.2012.01356.x
Knotkova H, Fine PG, Portenoy RK: Opioid rotation: The science and the limitations of the equianalgesic dose table. J Pain Symptom Manage. 2009; 38(3): 426-439. DOI: https://doi.org/10.1016/j.jpainsymman.2009.06.001
Fine PG, Portenoy RK, Ad Hoc Expert Panel on Evidence R, Guidelines for Opioid R: Establishing “best practices” for opioid rotation: Conclusions of an expert panel. J Pain Symptom Manage. 2009; 38(3): 418-425. DOI: https://doi.org/10.1016/j.jpainsymman.2009.06.002
Smith K, Hopp M, Mundin G, et al.: Single- and multiple-dose pharmacokinetic evaluation of oxycodone and naloxone in an opioid agonist/ antagonist prolonged-release combination in healthy adult volunteers. Clin Ther. 2008; 30(11): 2051-2068. DOI: https://doi.org/10.1016/j.clinthera.2008.11.008
Meissner W, Leyendecker P, Mueller-Lissner S, et al.: A randomized controlled trial with prolonged-release oral oxycodone and naloxone to prevent and reverse opioid-induced constipation. Eur J Pain. 2009; 13(1): 56-64. DOI: https://doi.org/10.1016/j.ejpain.2008.06.012
Mercadante S, Giarratano A: Combined oral prolonged-release oxycodone and naloxone in chronic pain management. Expert Opin Investig Drugs. 2013; 22(1): 161-166. DOI: https://doi.org/10.1517/13543784.2013.752460
Sykes NP: An investigation of the ability of oral naloxone to correct opioid-related constipation in patients with advanced cancer. Palliat Med. 1996; 10(2): 135-144. DOI: https://doi.org/10.1177/026921639601000208
Meissner W, Schmidt U, Hartmann M, et al.: Oral naloxone reverses opioid-associated constipation. Pain. 2000; 84(1): 105-109. DOI: https://doi.org/10.1016/S0304-3959(99)00185-2
Liu M, Wittbrodt E: Low-dose oral naloxone reverses opioid-induced constipation and analgesia. J Pain Symptom Manage. 2002; 23(1): 48-53. DOI: https://doi.org/10.1016/S0885-3924(01)00369-4
Vondrackova D, Leyendecker P, Meissner W, et al.: Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. J Pain. 2008; 9(12): 1144-1154. DOI: https://doi.org/10.1016/j.jpain.2008.06.014
Smith K, Hopp M, Mundin G, et al.: Naloxone as part of a prolonged release oxycodone/naloxone combination reduces oxycodone-induced slowing of gastrointestinal transit in healthy volunteers. Expert Opin Investig Drugs. 2011; 20(4): 427-439. DOI: https://doi.org/10.1517/13543784.2011.563236
van Dorp E, Yassen A, Dahan A: Naloxone treatment in opioid addiction: The risks and benefits. Expert Opin Drug Saf. 2007; 6(2): 125-132. DOI: https://doi.org/10.1517/14740338.6.2.125
Mundin GE, Smith KJ, Mysicka J, et al.: Validated in vitro/in vivo correlation of prolonged-release oxycodone/naloxone with differing dissolution rates in relation to gastrointestinal transit times. Expert Opin Drug Metab Toxicol. 2012; 8(12): 1495-1503. DOI: https://doi.org/10.1517/17425255.2012.729578
Wahlstrom A, Persson K, Rane A: Metabolic interaction between morphine and naloxone in human liver. A common pathway of glucuronidation? Drug Metab Dispos. 1989; 17(2): 218-220.
Schulteis G, Chiang D, Archer C: Relative potency of the opioid antagonists naloxone and 6-alpha-naloxol to precipitate withdrawal from acute morphine dependence varies with time post-antagonist. Pharmacol Biochem Behav. 2009; 92(1): 157-163. DOI: https://doi.org/10.1016/j.pbb.2008.11.007
Leow KP, Smith MT, Watt JA, et al.: Comparative oxycodone pharmacokinetics in humans after intravenous, oral, and rectal administration. Ther Drug Monit. 1992; 14(6): 479-484. DOI: https://doi.org/10.1097/00007691-199212000-00008
Smith K, Hopp M, Mundin G, et al.: Low absolute bioavailability of oral naloxone in healthy subjects. Int J Clin Pharmacol Ther. 2012; 50(5): 360-367. DOI: https://doi.org/10.5414/CP201646
Simpson K, Leyendecker P, Hopp M, et al.: Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin. 2008; 24(12): 3503-3512. DOI: https://doi.org/10.1185/03007990802584454
Lowenstein O, Leyendecker P, Hopp M, et al.: Combined prolonged-release oxycodone and naloxone improves bowel function in patients receiving opioids for moderate-to-severe non-malignant chronic pain: A randomised controlled trial. Expert Opin Pharmacother. 2009; 10(4): 531-543. DOI: https://doi.org/10.1517/14656560902796798
Koopmans G, Simpson K, De Andres J, et al.: Fixed ratio (2:1) prolonged-release oxycodone/naloxone combination improves bowel function in patients with moderate-to-severe pain and opioid-induced constipation refractory to at least two classes of laxatives. Curr Med Res Opin. 2014: 30(11): 2389-2396. DOI: https://doi.org/10.1185/03007995.2014.971355
Ahmedzai SH, Leppert W, Janecki M, et al.: Long-term safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate-to-severe chronic cancer pain. Support Care Cancer. 2014 (in press). DOI: https://doi.org/10.1007/s00520-014-2435-5
Davis M, Goforth HW, Gamier P: Oxycodone combined with opioid receptor antagonists: Efficacy and safety. Expert Opin Drug Saf. 2013; 12(3): 389-402. DOI: https://doi.org/10.1517/14740338.2013.783564
Ahmedzai SH, Nauck F, Bar-Sela G, et al.: A randomized, doubleblind, active-controlled, double-dummy, parallel-group study to determine the safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate/severe, chronic cancer pain. Palliat Med. 2012; 26(1): 50-60. DOI: https://doi.org/10.1177/0269216311418869
Cuomo A, Russo G, Esposito G, et al.: Efficacy and gastrointestinal tolerability of oral oxycodone/naloxone combination for chronic pain in outpatients with cancer: An observational study. Am J Hosp Palliat Care. 2014 (in press). DOI: https://doi.org/10.1177/1049909113510058
Mercadante S, Ferrera P, Adile C: High doses of oxycodone-naloxone combination may provide poor analgesia. Support Care Cancer. 2011; 19(9): 1471-1472. DOI: https://doi.org/10.1007/s00520-011-1205-x
Holzer P, Ahmedzai SH, Niederle N, et al.: Opioid-induced bowel dysfunction in cancer-related pain: Causes, consequences, and a novel approach for its management. J Opioid Manag. 2009; 5(3): 145-151. DOI: https://doi.org/10.5055/jom.2009.0015
DePriest AZ, Miller K: Oxycodone/naloxone: Role in chronic pain management, opioid-induced constipation, and abuse deterrence. Pain Ther. 2014; 3(1): 1-15. DOI: https://doi.org/10.1007/s40122-014-0026-2
Tompkins DA, Lanier RK, Harrison JA, et al.: Human abuse liability assessment of oxycodone combined with ultra-low-dose naltrexone. Psychopharmacology. 2010; 210(4): 471-480. DOI: https://doi.org/10.1007/s00213-010-1838-3
Severtson SG, Bartelson BB, Davis JM, et al.: Reduced abuse, therapeutic errors, and diversion following reformulation of extendedrelease oxycodone in 2010. J Pain. 2013; 14(10): 1122-1130. DOI: https://doi.org/10.1016/j.jpain.2013.04.011
Pappagallo M, Sokolowska M: The implications of tamper-resistant formulations for opioid rotation. Postgrad Med. 2012; 124(5): 101-109. DOI: https://doi.org/10.3810/pgm.2012.09.2588
Nalamachu SR: Opioid rotation in clinical practice. Adv Ther. 2012; 29(10): 849-863. DOI: https://doi.org/10.1007/s12325-012-0051-7
Fredheim OM, Moksnes K, Borchgrevink PC, et al.: Clinical pharmacology of methadone for pain. Acta Anaesthesiol Scand. 2008; 52(7): 879-889. DOI: https://doi.org/10.1111/j.1399-6576.2008.01597.x
Longshore D, Annon J, Anglin MD, et al.: Levo-alpha-acetylmethadol (LAAM) versus methadone: Treatment retention and opiate use. Addiction. 2005; 100(8): 1131-1139. DOI: https://doi.org/10.1111/j.1360-0443.2005.01122.x
Ferrari A, Coccia CPR, Bertolini A, et al.: Methadone-metabolism, pharmacokinetics and interactions. Pharmacol Res. 2004; 6: 551-559. DOI: https://doi.org/10.1016/j.phrs.2004.05.002
Lynch ME: A review of the use of methadone for the treatment of chronic noncancer pain. Pain Res Manag. 2005; 10(3): 133-144. DOI: https://doi.org/10.1155/2005/286713
Somogyi AA, Barratt DT, Coller JK: Pharmacogenetics of opioids. Clin Pharmacol Ther. 2007; 81(3): 429-444. DOI: https://doi.org/10.1038/sj.clpt.6100095
Brown R, Kraus C, Fleming M, et al.: Methadone: Applied pharmacology and use as adjunctive treatment in chronic pain. Postgrad Med J. 2004; 80(949): 654-659. DOI: https://doi.org/10.1136/pgmj.2004.022988
Chou R, Cruciani RA, Fiellin DA, et al.: Methadone safety: A clinical practice guideline from the American Pain Society and College on Problems of Drug Dependence, in collaboration with the Heart Rhythm Society. J Pain. 2014; 15(4): 321-337.
Modesto-Lowe V, Brooks D, Petry N: Methadone deaths: Risk factors in pain and addicted populations. J Gen Intern Med. 2010; 25(4): 305-309. DOI: https://doi.org/10.1007/s11606-009-1225-0
Andrews CM, Krantz MJ, Wedam EF, et al.: Methadone-induced mortality in the treatment of chronic pain: Role of QT prolongation. Cardiol J. 2009; 16(3): 210-217.
Chan GM, Stajic M, Marker EK, et al.: Testing positive for methadone and either a tricyclic antidepressant or a benzodiazepine is associated with an accidental overdose death: Analysis of medical examiner data. Acad Emerg Med. 2006; 13(5): 543-547. DOI: https://doi.org/10.1197/j.aem.2005.12.011
Chou R, Deyo R, Devine B, et al.: The effectiveness and risks of long-term opioid treatment of chronic pain. Evidence Report/Technology Assessment No. 218. AHRQ Publication No. 14-E005-EF. Rockville, MD: Agency for Healthcare Research and Quality, September 2014. Available at www.effectivehealthcare.ahrq.gov/reports/final.cfm. Accessed October 1, 2014.
Lichtenwalner MR, Mencken T, Tully R, et al.: False-positive immunochemical screen for methadone attributable to metabolites of verapamil. Clin Chem. 1998; 44(5): 1039-1041. DOI: https://doi.org/10.1093/clinchem/44.5.1039
Lotsch J, Walter C, Parnham MJ, et al.: Pharmacokinetics of non-intravenous formulations of fentanyl. Clin Pharmacokinet. 2013; 52(1): 23-36. DOI: https://doi.org/10.1007/s40262-012-0016-7
Sloan PA, Moulin DE, Hays H: A clinical evaluation of transdermal therapeutic system fentanyl for the treatment of cancer pain. J Pain Symptom Mange. 1998; 16(2): 102-111. DOI: https://doi.org/10.1016/S0885-3924(98)00044-X
Grond S, Radbruch L, Lehmann KA: Clinical pharmacokinetics of transdermal opioids: Focus on transdermal fentanyl. Clin
Pharmacokinet. 2000; 38(1): 59-89. DOI: https://doi.org/10.2165/00003088-200038010-00004
Jeal W, Benfield P: Transdermal fentanyl. A review of its pharmacological properties and therapeutic efficacy in pain control. Drugs. 1997; 53(1): 109-138. DOI: https://doi.org/10.2165/00003495-199753010-00011
Sloan PA: Transdermal pain management delivery system in the cancer patient. Home Health Care Consult. 2000; 7: 10-14.
Zernikow B, Michel E, Anderson B: Transdermal fentanyl in childhood and adolescence: A comprehensive literature review. J Pain. 2007; 8(3): 187-207. DOI: https://doi.org/10.1016/j.jpain.2006.11.008
Jenerowicz D, Polanska A, Olek-Hrab K, et al.: Skin hypersensitivity reactions to transdermal therapeutic systems-still an important clinical problem. Ginekol Pol. 2012; 83(1): 46-50.
FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. August 2014. Available at www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/UCM277916.pdf. Accessed October 1, 2014.
Niscola P, Scaramucci L, Vischini G, et al.: The use of major analgesics in patients with renal dysfunction. Curr Drug Targets. 2010; 11(6): 752-758. DOI: https://doi.org/10.2174/138945010791170879
Dahan A, Overdyk F, Smith T, et al.: Pharmacovigilance: A review of opioid-induced respiratory depression in chronic pain patients. Pain Phys. 2013; 16: E85-E94. DOI: https://doi.org/10.36076/ppj.2013/16/E85
Nelson L, Schwaner R: Transdermal fentanyl: Pharmacology and toxicology. J Med Toxicol. 2009; 5(4): 230-241. DOI: https://doi.org/10.1007/BF03178274
Fentanyl patches: Preventable overdose [editorial]. Prescrire Int. 2010; 19(105): 22-25.
Voight I: Fatal overdose due to confusion of an transdermal fentanyl delivery system. Case Rep Crit Care. 2013; 2013: 1-3. DOI: https://doi.org/10.1155/2013/154143
Hawley P: Case report of severe bradycardia due to transdermal fentanyl. Palliat Med. 2013; 27(8): 793-795. DOI: https://doi.org/10.1177/0269216312472383
Vadivelu N, Maria M, Jolly S, et al.: Clinical applications of oxymorphone. J Opioid Manag. 2013; 9(6): 439-452. DOI: https://doi.org/10.5055/jom.2013.0186
Sloan PA, Babul N: Extended-release opioids for the management of chronic non-malignant pain. Exp Opin Drug Deliv. 2006; 3: 489-497.
Chamberlin KW, Cottle M, Neville R, et al.: Oral oxymorphone for pain management. Ann Pharmacother. 2007; 41(7): 1144-1152. DOI: https://doi.org/10.1345/aph.1H451
Guay DR: Use of oral oxymorphone in the elderly. Consult Pharm. 2007; 22(5): 417-430. DOI: https://doi.org/10.4140/TCP.n.2007.417
Sloan PA, Barkin R: Oxymorphone and oxymorphone extended-release: A pharmcotherapeutic review. J Opioid Manag. 2008; 4: 251-254.
Matsumoto AK: Oral extended-release oxymorphone: A new choice for chronic pain relief. Exp Opin Pharmacother. 2007; 8(10): 1515-1527. DOI: https://doi.org/10.1517/14656566.8.10.1515
Prommer E: Oxymorphone: A review. Supp Care Cancer. 2006; 14: 109-115. DOI: https://doi.org/10.1007/s00520-005-0917-1
Sloan PA, Slatkin NE, Ahdieh H: Effectiveness and safety of oral extended-release oxymorphone for the treatment of cancer pain: A pilot study. Supp Care Cancer. 2005; 13: 57-65. DOI: https://doi.org/10.1007/s00520-004-0731-1
Sloan PA: Oxymorphone in the management of pain. Ther Clin Risk Manage. 2008; 4: 777-787. DOI: https://doi.org/10.2147/TCRM.S1784
Pergolizzi JV, Raffa RB, Gould E: Considerations on the use of oxymorphone in geriatric patients. Exp Opin Drug Saf. 2009; 8(5): 603-613. DOI: https://doi.org/10.1517/14740330903153854
Singla A, Sloan PA: Pharmacokinetic evaluation of hydrocodone/acetaminophen for pain management. J Opioid Manag. 2013; 9: 71-80. DOI: https://doi.org/10.5055/jom.2013.0149
U.S. Prescription drug sales grow slowly; hydrocodone most prescribed. Available at www.seekingalpha.com/article/128003-u-s-prescription-drug-sales-grow-slowly-hydrocodone-most-prescribed. Accessed October 10, 2014.
Prommer E: Hydrocodone: Does it have a role in palliative care? J Opioid Manag. 2010; 6(4): 295-299. DOI: https://doi.org/10.5055/jom.2010.0027
Melhem MR, Rubino CM, Farr SJ, et al.: Population pharmacokinetic analysis for hydrocodone following the administration of hydrocodone bitartrate extended-release capsules. Clin Pharmacokinet. 2013; 52: 907-917. DOI: https://doi.org/10.1007/s40262-013-0081-6
Kaplan HL, Busto UE, Baylon GJ, et al.: Inhibition of cytochrome P450 2D6 metabolism of hydrocodone to hydromorphone does not importantly affect abuse liability. J Pharm Exp Ther. 1997; 281(1): 103-108.
Otton SV, Schadel M, Cheung SW, et al.: CYP2D6 phenotype determines the metabolic conversion of hydrocodone to hydromorphone. Clin Pharmacol Ther. 1993; 54(5): 463-472. DOI: https://doi.org/10.1038/clpt.1993.177
Extended-release hydrocodone (Zohydro) for pain. Med Lett Drugs Ther. 2014; 56(1444): 45-46.
Rauck RL, Nalamachu S, Wild JE, et al.: Single-entity hydrocodone extended-release capsules in opioid-tolerant subjects with moderate-tosevere chronic low back pain: A randomized double-blind, placebocontrolled study. Pain Med. 2014; 15: 975-985. DOI: https://doi.org/10.1111/pme.12377
Krashin D, Murinova N, Trescot AM: Extended-release hydrocodone-gift or curse? J Pain Res. 2013; 6: 53-57. DOI: https://doi.org/10.2147/JPR.S33062
Sloan PA: Tapentadol for acute and chronic pain. Exp Opin Pharmacother. 2010; 11: 1783-1785. DOI: https://doi.org/10.1517/14656566.2010.495870
Smith HS, Raffa RB, Pergolizzi JV, et al.: Combining opioid and adrenergic mechanisms for chronic pain. Postgrad Med. 2014; 126(4): 98-114. DOI: https://doi.org/10.3810/pgm.2014.07.2788
Hartrick CT, Rozek RJ: Tapentadol in pain management: A mu-opioid receptor agonist and noradrenaline reuptake inhibitor. CNS Drugs. 2011; 25(5): 359-370. DOI: https://doi.org/10.2165/11589080-000000000-00000
Pierce DM, Shipstone E: Pharmacology update: Tapentadol for neuropathic pain. Am J Hospice Pall Med. 2012; 29(8): 663-666. DOI: https://doi.org/10.1177/1049909111434634
Zannikos PN, Smith JW, Stahlberg HJ, et al.: Pharmacokinetics evaluation of tapentadol extended-release tablets in healthy subjects. J Opioid Manag. 2013; 9(4): 291-300. DOI: https://doi.org/10.5055/jom.2013.0171
Mercadante S, Porzio G, Gebbia V: New opioids. J Clin Oncol. 2014; 32(16): 1671-1676. DOI: https://doi.org/10.1200/JCO.2013.51.8662
Mercadante S, Porzio G, Aielli F, et al.: Opioid switching from and to tapentadol extended-release in cancer patients: Conversion ratio with other opioids. Curr Med Res Opin. 2013; 29(6): 661-666. DOI: https://doi.org/10.1185/03007995.2013.791617
Hoy SM: Tapentadol extended release. Drugs. 2012; 72(3): 375-393. DOI: https://doi.org/10.2165/11208600-000000000-00000
Etropolski M, Lange B, Goldberg J, et al.: A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol
extended release treatment for moderate to severe chronic pain. J Opioid Manag. 2013; 9(5): 343-356. DOI: https://doi.org/10.5055/jom.2013.0177
Afilalo M, Morlion B: Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Phys. 2013; 16(1): 27-40. DOI: https://doi.org/10.36076/ppj.2013/16/27
Taylor R, Pergolizzi JV, Raffa RB: Tapentadol extended release for chronic pain patients. Adv Ther. 2013; 30(1): 14-27. DOI: https://doi.org/10.1007/s12325-013-0002-y
Gregory TB: Hydromorphone: Evolving to meet the challenges of today’s health care environment. Clin Ther. 2013; 35(12): 2007-2027. DOI: https://doi.org/10.1016/j.clinthera.2013.09.027
Bruera E, Sloan PA, Mount B, et al.: A randomized, double-blind, double-dummy, crossover trial comparing the safety and efficacy of oral sustained-release hydromorphone with immediate-release hydromorphone in patients with cancer pain. J Clin Oncol. 1996; 14(5): 1713-1717. DOI: https://doi.org/10.1200/JCO.1996.14.5.1713
Goforth HW: Hydromorphone-OROS formulation. Expert Opin Pharmacother. 2010; 11(7): 1207-1214. DOI: https://doi.org/10.1517/14656566.2010.482099
Conley R, Gupta SK, Sathyan G: Clinical spectrum of the osmotic-controlled release oral delivery system (OROS), an advanced oral delivery form. Curr Med Res Opin. 2006; 22(10): 1879-1892. DOI: https://doi.org/10.1185/030079906X132613
Guay DR: Oral hydromorphone extended-release. Consult Pharm. 2010; 25(12): 816-828. DOI: https://doi.org/10.4140/TCP.n.2010.816
Extended-release hydromorphone (Exalgo) for pain. Med Lett Drugs Ther. 2011; 1370: 62.
Lussier D, Richarz U, Finco G: Use of hydromorphone, with particular reference to the OROS formulation, in the elderly. Drugs Aging. 2010; 27(4): 327-335. DOI: https://doi.org/10.2165/11318320-000000000-00000
Reisfield GM, Wilson GR: The metamorphosis of hydromorphone. J Opioid Manag. 2005; 1(3): 139-145. DOI: https://doi.org/10.5055/jom.2005.0033
Wallace M, Rauck RL, Moulin D, et al.: Once-daily OROS hydromorphone for the management of chronic nonmalignant pain: A dose-conversion and titration study. Int J Clin Pract. 2007; 61(10): 1671-1676. DOI: https://doi.org/10.1111/j.1742-1241.2007.01500.x
Moore KT, St-Fleur D, Marricco NC, et al.: A randomized study of the effects of food on the pharmacokinetics of once-daily extended-release hydromorphone in healthy volunteers. J Clin Pharmacol. 2011; 51(11): 1571-1579. DOI: https://doi.org/10.1177/0091270010383858
Article 4 References:
Sloan PA, Babul J: Extended-release opioids for the management of chronic non-malignant pain. Exp Opin Drug Deliv. 2006; 3: 489-497. DOI: https://doi.org/10.1517/17425247.3.4.489
FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. August 2014. Available at www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/UCM277916.pdf. Accessed October 30, 2014.
Chou R, Deyo R, Devine B, et al.: The effectiveness and risks of long-term opioid treatment of chronic pain. Evidence Report/Technology Assessment No. 218. AHRQ Publication No. 14-E005-EF. Rockville, MD: Agency for Healthcare Research and Quality, September 2014. Available at www.effectivehealthcare.ahrq.gov/reports/final.cfm. Accessed November 1, 2014.
Chou R, Cruciani RA, Fiellin DA, et al.: Methadone safety: A clinical practice guideline from the American Pain Society and College on Problems of Drug Dependence, in collaboration with the Heart Rhythm Society. J Pain. 2014; 15(4): 321-337. DOI: https://doi.org/10.1016/j.jpain.2014.01.494
Kahan M, Mailis-GagnonA, Wilson L, et al.: Canadian guideline for safe and effective use of opioids for chronic noncancer pain: Clinical summary for family physicians: Part 1: General population. Can Fam Physician. 2011; 57(11): 1257-1266.
Nuckols TK, Anderson L, Popescu I, et al.: Opioid prescribing: A systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014; 160(1): 38-47. DOI: https://doi.org/10.7326/0003-4819-160-1-201401070-00732
Sloan PA: Buprenorphine for chronic pain management. J Supp Oncol. 2012; 10: 220-221. DOI: https://doi.org/10.1016/j.suponc.2012.06.002
Moyo J, Rashiq S: Perioperative considerations for “new” kids on the opioid block. Can J Anesth. 2011; 58: 417-422. DOI: https://doi.org/10.1007/s12630-011-9476-8
Published
How to Cite
Issue
Section
License
Copyright 2005-2024, Weston Medical Publishing, LLC
All Rights Reserved