Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
BUPRENORPHINE (UNII: 40D3SCR4GZ) (BUPRENORPHINE - UNII:40D3SCR4GZ)
Teva Pharmaceuticals USA, Inc.
BUPRENORPHINE
BUPRENORPHINE 5 ug in 1 h
TRANSDERMAL
PRESCRIPTION DRUG
Buprenorphine transdermal system 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 [see Warnings and Precautions (5.1)] , reserve buprenorphine transdermal system 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. - Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic Buprenorphine transdermal system is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.2)] - Acute or severe bronchial asthma in an unmonitored setting or in the
Buprenorphine Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units. Buprenorphine transdermal system 5 mcg/hour are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with “Buprenorphine Transdermal System” and “5 mcg/hour” and are supplied in a 4-count carton (NDC 0093-3600-40 ). Buprenorphine transdermal system 10 mcg/hour are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with “Buprenorphine Transdermal System” and “10 mcg/hour” and are supplied in a 4-count carton (NDC 0093-3601-40 ). Buprenorphine transdermal system 15 mcg/hour are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm. Each system is printed in blue with “Buprenorphine Transdermal System” and “15 mcg/hour” and are supplied in a 4-count carton (NDC 0093-3602-40 ). Buprenorphine transdermal system 20 mcg/hour are square, beige-colored adhesive patches measuring 72 mm by 72 mm. Each system is printed in blue with “Buprenorphine Transdermal System” and “20 mcg/hour” and are supplied in a 4-count carton (NDC 0093-3603-40 ). Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).
New Drug Application Authorized Generic
BUPRENORPHINE- BUPRENORPHINE PATCH, EXTENDED RELEASE Teva Pharmaceuticals USA, Inc. ---------- MEDICATION GUIDE Buprenorphine (byü-prə-ˈnȯr-ˌfēn) Transdermal System, CIII Buprenorphine transdermal system is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. • Not for use to treat pain that is not around-the-clock Important information about buprenorphine transdermal system: • Get emergency help right away if you take too much buprenorphine transdermal system (overdose). When you first start taking buprenorphine transdermal system, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. • Never give anyone else your buprenorphine transdermal system. They could die from taking it. Store buprenorphine transdermal system away from children and in a safe place to prevent stealing or abuse. Selling or giving away buprenorphine transdermal system is against the law. • Taking buprenorphine transdermal system with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Do not use buprenorphine transdermal system if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. Before applying buprenorphine transdermal system, tell your healthcare provider if you have Přečtěte si celý dokument
BUPRENORPHINE- BUPRENORPHINE PATCH, EXTENDED RELEASE TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUPRENORPHINE TRANSDERMAL SYSTEM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPRENORPHINE TRANSDERMAL SYSTEM. BUPRENORPHINE TRANSDERMAL SYSTEM FOR TRANSDERMAL ADMINISTRATION CIII INITIAL U.S. APPROVAL: 1981 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ BUPRENORPHINE TRANSDERMAL SYSTEM EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCRIBING, AND MONITOR FOR THESE BEHAVIORS AND CONDITIONS. (5.1, 10) SERIOUS, LIFE-THREATENING OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS ON PROPER ADMINISTRATION OF BUPRENORPHINE TRANSDERMAL SYSTEM TO REDUCE THE RISK. (5.2) ACCIDENTAL EXPOSURE TO BUPRENORPHINE TRANSDERMAL SYSTEM, ESPECIALLY IN CHILDREN, CAN RESULT IN FATAL OVERDOSE OF BUPRENORPHINE. (5.2) PROLONGED USE OF BUPRENORPHINE TRANSDERMAL SYSTEM DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. IF PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE. (5.3) CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE; LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED; AND FOLLOW PAT Přečtěte si celý dokument