BUPRENORPHINE- buprenorphine patch, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUPRENORPHINE (UNII: 40D3SCR4GZ) (BUPRENORPHINE - UNII:40D3SCR4GZ)

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

BUPRENORPHINE

Composition:

BUPRENORPHINE 5 ug in 1 h

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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).

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

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

Summary of Product characteristics

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