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Butrans (Buprenorphine) - Summary

 
 



WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORYDEPRESSION; ACCIDENTAL EXPOSURE; and NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse
BUTRANS® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BUTRANS, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions and Overdosage].

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of BUTRANS. Monitor for respiratory depression, especially during initiation of BUTRANS or following a dose increase. Misuse or abuse of BUTRANS by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions ].

Accidental Exposure
Accidental exposure to even one dose of BUTRANS, especially by children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of BUTRANS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions].

 

BUTRANS SUMMARY

BUTRANS is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days.

BUTRANS is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.


Limitations of Use

  • Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risk of overdose and death with extended-release opioid formulations, reserve BUTRANS for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • BUTRANS is not indicated as an as-needed (prn) analgesic

See all Butrans indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Butrans (Buprenorphine)

Neonatal outcomes and their relationship to maternal buprenorphine dose during pregnancy. [2014]
neonatal clinical outcomes... CONCLUSIONS: (1) Findings failed to support the existence of a dose-response

A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusers. [2013]
IMPORTANCE: Although abuse of prescription opioids (POs) is a significant public health problem, few experimental studies have investigated the treatment needs of this growing population. OBJECTIVE: To evaluate, following brief stabilization with a combination of buprenorphine hydrochloride and naloxone hydrochloride dihydrate, the relative efficacy of 1-, 2-, and 4-week buprenorphine tapering regimens and subsequent naltrexone hydrochloride therapy in PO-dependent outpatients...

A randomised controlled trial of sublingual buprenorphine-naloxone film versus tablets in the management of opioid dependence. [2013]
(substance use, psychosocial function)... CONCLUSIONS: The study demonstrated dose equivalence and comparable clinical

Cocaine use reduction with buprenorphine (CURB): rationale, design, and methodology. [2013]
study... CONCLUSIONS: This research using 2 medications will demonstrate whether BUP,

Analgesia after feline ovariohysterectomy under midazolam-medetomidine-ketamine anaesthesia with buprenorphine or butorphanol, and carprofen or meloxicam: a prospective, randomised clinical trial. [2012]
One hundred female cats undergoing routine ovariohysterectomy under midazolam-medetomidine-ketamine anaesthesia were included in a blinded, randomised, prospective clinical study to compare postoperative analgesia produced by four analgesic drug combinations given preoperatively (n = 25 per group)...

more studies >>

Clinical Trials Related to Butrans (Buprenorphine)

Butrans for Treatment of Restless Legs Syndrome [Withdrawn]
The primary objective of the study is to determine whether Butrans Transdermal System (BTDS) reduces RLS symptom severity in patients with moderate to severe idiopathic RLS who are nave to opiate treatment. The secondary objective of the study is to investigate the effects of BTDS on mood, sleep, and quality of life. The study will consist of nine visits. Depending on the need for medication titration, there may also be two scheduled telephone contacts. Visit 1: This is a screening visit to determine study eligibility. Eligible subjects who choose to participate must undergo medication washout as described in the detailed protocol between visits 1 and 2.

Treatment period #1 (Visits 2 - 5; day 0 - 28): Baseline measures will be recorded and

subjects randomized to treatment order at visit 2 (day 0). Study medication as well as rescue medication (l-dopa, a non-blinded active treatment to be used within a limited dose range as described in the detailed protocol) will be dispensed. Subjects will begin treatment period #1 immediately after this. The study medication will be titrated within the allowed range according to subject's reported symptoms during visit 3 (day 7), visit 4 (day 14), telephone contact (day 21). Visit 5 will occur on day 28 and will include assessment of outcome measures for the first treatment period. Visit 5 will also mark the beginning of the second treatment period.

Treatment period #2 (Visits 6 - 8; day 28 - 56): Procedures will be similar to those

described above during treatment period #1. Visit 8 will mark the end of the second treatment period during which outcome measures will be ascertained. Follow up visit (Visit 9; day 70): This will be a safety follow-up visit approximately two weeks after visit 8 for review of adverse events.

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome [Completed]
Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").

Preference for Subutex� (Buprenorphine) Versus Suboxone� (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex� (Study P05094)(COMPLETED) [Completed]
This study is designed to determine if opioid dependent subjects who are already receiving Subutex prefer the Suboxone tablet over the Subutex tablet after switching from Subutex to Suboxone. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.

A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction [Completed]
Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.

Disposition Effects of Cyclosporin on Buprenorphine [Recruiting]
The purpose of this study is to see how healthy volunteers bodies handle buprenorphine.

more trials >>

Reports of Suspected Butrans (Buprenorphine) Side Effects

Death (27)Vomiting (22)Nausea (22)Pain (21)Dyspnoea (20)Headache (19)Inadequate Analgesia (18)Dizziness (16)Drug Ineffective (14)Somnolence (14)more >>


Page last updated: 2014-11-30

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