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:

Amneal Pharmaceuticals NY LLC

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use - Because of the risks of addiction, abuse and misuse with opioids, which can occur at any dosage or duration, and because of the greater risk of overdose and death with extended-release/long-acting 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 absence of resuscitative equipment [see Warnings and Precautions (5.10)] -   Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.15)] -   Hypersensitivity (e.g., anaphylaxis) to buprenorphine [see Warnings and Precautions (5.18), Adverse Reactions (6)] Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. Available data with buprenorphine transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, buprenorphine caused an increase in the number of stillborn offspring, reduced litter size, and reduced offspring growth in rats at maternal exposure levels that were approximately 10 times that of human subjects who received one buprenorphine transdermal system 20 mcg/hour, the maximum recommended human dose (MRHD) [see Data]. Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/neonatal adverse reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4)]. Labor and Delivery Opioids cross the placenta and may produce respiratory depression in neonates. An opioid antagonist such as naloxone must be available for reversal of opioid-induced respiratory depression in the neonate. Buprenorphine transdermal system is not recommended for use in women immediately prior to labor, when shorter acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including buprenorphine transdermal system, can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Animal Data Studies in rats and rabbits demonstrated no evidence of teratogenicity following buprenorphine transdermal system  or subcutaneous (SC) administration of buprenorphine during the period of organogenesis. Rats were administered up to one buprenorphine transdermal system 20 mcg/hour every 3 days (Gestation Days 6, 9, 12, & 15) or received daily SC buprenorphine up to 5 mg/kg (Gestation Days 6 to 17). Rabbits were administered four buprenorphine transdermal systems 20 mcg/hour every 3 days (Gestation Days 6, 9, 12, 15, 18, and 19) or received daily SC buprenorphine up to 5 mg/kg (Gestation Days 6 to 19). No teratogenicity was observed at any dose. AUC values for buprenorphine with buprenorphine transdermal system application and SC injection were approximately 110 and 140 times, respectively, that of human subjects who received the MRHD of one buprenorphine transdermal system 20 mcg/hour. In a pre- and post-natal study conducted in pregnant and lactating rats, administration of buprenorphine either as buprenorphine transdermal system or SC buprenorphine was associated with toxicity to offspring. Buprenorphine was present in maternal milk. Pregnant rats were administered 1/4 of one buprenorphine transdermal system 5 mcg/hour every 3 days or received daily SC buprenorphine at doses of 0.05, 0.5, or 5 mg/kg from Gestation Day 6 to Lactation Day 21 (weaning). Administration of buprenorphine transdermal system or SC buprenorphine at 0.5 or 5 mg/kg caused maternal toxicity and an increase in the number of stillborns, reduced litter size, and reduced offspring growth at maternal exposure levels that were approximately 10 times that of human subjects who received the MRHD of one buprenorphine transdermal system 20 mcg/hour. Maternal toxicity was also observed at the no observed adverse effect level (NOAEL) for offspring. Risk Summary Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with buprenorphine transdermal system. Clinical Considerations Monitor infants exposed to buprenorphine transdermal system through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of buprenorphine is stopped or when breast-feeding is stopped. Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2), Preclinical Pharmacology (12.2), Nonclinical Toxicology (13.1)] . The safety and efficacy of buprenorphine transdermal system in patients under 18 years of age has not been established. Buprenorphine transdermal system has been evaluated in an open-label clinical trial in pediatric patients. However, definitive conclusions are not possible because of the small sample size. Of the total number of subjects in the clinical trials (5,415), buprenorphine transdermal system was administered to 1,377 patients aged 65 years and older. Of those, 457 patients were 75 years of age and older. In the clinical program, the incidences of selected buprenorphine transdermal system-related AEs were higher in older subjects. The incidences of application site AEs were slightly higher among subjects < 65 years of age than those ≥ 65 years of age for both buprenorphine transdermal system and placebo treatment groups. In a single-dose study of healthy elderly and healthy young subjects treated with buprenorphine transdermal system 10 mcg/hour, the pharmacokinetics were similar. In a separate dose-escalation safety study, the pharmacokinetics in the healthy elderly and hypertensive elderly subjects taking thiazide diuretics were similar to those in the healthy young adults. In the elderly groups evaluated, adverse event rates were similar to or lower than rates in healthy young adult subjects, except for constipation and urinary retention, which were more common in the elderly. Although specific dose adjustments on the basis of advanced age are not required for pharmacokinetic reasons, use caution in the elderly population to ensure safe use [see Clinical Pharmacology (12.3)] . Respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of buprenorphine transdermal system slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.10)] . In a study utilizing intravenous buprenorphine, peak plasma levels (Cmax ) and exposure (AUC) of buprenorphine in patients with mild and moderate hepatic impairment did not increase as compared to those observed in subjects with normal hepatic function. Buprenorphine transdermal system has not been evaluated in patients with severe hepatic impairment. As buprenorphine transdermal system is intended for 7-day dosing, consider the use of alternate analgesic therapy in patients with severe hepatic impairment [see Dosage and Administration (2.6)   and Clinical Pharmacology (12.3)]. Buprenorphine transdermal system contains buprenorphine, a Schedule III controlled substance. Buprenorphine transdermal system contains buprenorphine, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see Warnings and Precautions (5.1)] . Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of buprenorphine transdermal system increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of buprenorphine transdermal system with alcohol and/or other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of buprenorphine transdermal system abuse include those with a history of prolonged use of any opioid, including products containing buprenorphine, those with a history of drug or alcohol abuse, or those who use buprenorphine transdermal system in combination with other abused drugs. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare providers(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. Buprenorphine transdermal system, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of Buprenorphine Transdermal System Abuse of buprenorphine transdermal system poses a risk of overdose and death. This risk is increased with the concurrent use of buprenorphine transdermal system with alcohol and/or other substances including other opioids and benzodiazepines [see Warnings and Precautions (5.1, 5.3), Drug Interactions (7)] . Buprenorphine transdermal system is approved for transdermal use only. Intentional compromise of the transdermal delivery system will result in the uncontrolled delivery of buprenorphine and pose a significant risk to the abuser that could result in overdose and death [see Warnings and Precautions (5.1)]. Abuse may occur by applying the transdermal system in the absence of legitimate purpose, or by chewing, swallowing, snorting, or injecting buprenorphine extracted from the transdermal system. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during use of opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. Do not abruptly discontinue buprenorphine transdermal system in a patient physically dependent on opioids. Rapid tapering of buprenorphine transdermal system in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing buprenorphine transdermal system, gradually taper the dosage using a patient-specific plan that considers the following: the dose of buprenorphine transdermal system the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see Dosage and Administration (2.1), Warnings and Precautions (5.19)] . Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)]. Buprenorphine (bue" pre nor' feen) Transdermal System, CIII   Be sure that you read, understand, and follow these Instructions for Use before you use buprenorphine transdermal system. Talk to your healthcare provider or pharmacist if you have any questions. Before applying buprenorphine transdermal system: - Do not use soap, alcohol, lotions, oils, or other products to remove any leftover adhesive from a patch because this may cause more buprenorphine transdermal system to pass through the skin. - Each patch is sealed in its own protective pouch. Do not remove a patch from the pouch until you are ready to use it. - Do not use a patch if the seal on the protective pouch is broken or if the patch is cut, damaged or changed in any way. - Buprenorphine transdermal system patches are available in different strengths and patch sizes. Make sure you have the right strength patch that has been prescribed for you. Where to apply buprenorphine transdermal system: - Buprenorphine transdermal system should be applied to the upper outer arm, upper chest, upper back, or the side of the chest (See Figure A ). These 4 sites (located on both sides of the body) provide 8 possible buprenorphine transdermal system application sites. Figure A - Do not apply more than 1 patch at the same time unless your healthcare provider tells you to. However, if your healthcare provider tells you to do so, you may use 2 patches as prescribed, applied at the same site (See Figure A for application sites) right next to each other (See Figure B for an example of patch position when applying 2 patches). Always apply and remove the two patches together at the same time. Figure B   - You should change the skin site where you apply buprenorphine transdermal system each week, making sure that at least 3 weeks (21 days) pass before you re-use the same skin site. - Apply buprenorphine transdermal system to a hairless or nearly hairless skin site . If needed, you can clip the hair at the skin site (See Figure C ). Do not shave the area. The skin site should not be irritated. Use only water to clean the application site. You should not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before you apply the patch. Figure C - The skin site should be free of cuts and irritation (rashes, swelling, redness, or other skin problems). When to apply a new patch: When to apply a new patch: - When you apply a new patch, write down the date and time that the patch is applied. Use this to remember when the patch should be removed. - Change the patch at the same time of day, one week (exactly 7 days) after you apply it. - After removing and disposing of the patch, write down the time it was removed and how it was disposed. How to apply buprenorphine transdermal system: - If you are wearing a patch, remember to remove it before applying a new one. - Each patch is sealed in its own protective pouch. - If you are using two patches, remember to apply them at the same site right next to each other. Always apply and remove the two patches together at the same time. - Use scissors to cut open the pouch along the dotted line (See Figure D ) and remove the patch. Do not remove the patch from the pouch until you are ready to use it. Do not use patches that have been cut or damaged in any way. Figure D   - Hold the patch with the protective liner facing you. - Gently bend the patch (See Figures E and F ) along the faint line and slowly peel the larger portion of the liner, which covers the sticky surface of the patch. Figure E   Figure F - Do not touch the sticky side of the patch with your fingers. - Using the smaller portion of the protective liner as a handle (See Figure G ), apply the sticky side of the patch to one of the 8 body locations described above (See “Where to apply buprenorphine transdermal system” ). Figure G   - While still holding the sticky side down, gently fold back the smaller portion of the patch. Grasp an edge of the remaining protective liner and slowly peel it off (See Figure H ). Figure H - Press the entire patch firmly into place with the palm (See Figure I ) of your hand over the patch, for about 15 seconds. Do not rub the patch. Figure I   - Make sure that the patch firmly sticks to the skin. - Go over the edges with your fingers to assure good contact around the patch. - If you are using two patches, follow the steps in this section to apply them right next to each other. - Always wash your hands after applying or handling a patch. - After the patch is applied, write down the date and time that the patch is applied. Use this to remember when the patch should be removed. If the patch falls off right away after applying, throw it away and put a new one on at a different skin site (See “Disposing of Buprenorphine Transdermal System Patch” ). If a patch falls off, do not touch the sticky side of the patch with your fingers. A new patch should be applied to a different site. Patches that fall off should not be re-applied. They must be thrown away correctly. Short-term exposure of the buprenorphine transdermal system patch to water, such as when bathing or showering, is permitted. If the edges of the buprenorphine transdermal system patch start to loosen: - Apply first aid tape only to the edges of the patch. - If problems with the patch not sticking continue, cover the patch with special see-through adhesive dressings (for example Bioclusive or Tegaderm). - Remove the backing from the transparent adhesive dressing and place it carefully and completely over the buprenorphine transdermal system patch, smoothing it over the patch and your skin. - Never cover a buprenorphine transdermal system patch with any other bandage or tape. It should only be covered with a special see-through adhesive dressing. Talk to your healthcare provider or pharmacist about the kinds of dressing that should be used. If your patch falls off later, but before 1 week (7 days) of use, throw it away properly (See “Disposing of Buprenorphine Transdermal System Patch” ) and apply a new patch at a different skin site. Be sure to let your healthcare provider know that this has happened. Do not replace the new patch until 1 week (7 days) after you put it on (or as directed by your healthcare provider). Disposing of Buprenorphine Transdermal System Patch:   Buprenorphine transdermal system patches should be disposed of by using the Patch-Disposal Unit. Alternatively, the patches can be flushed down the toilet if a drug take-back option is not readily available.   To dispose of buprenorphine transdermal system patches in household trash using the Patch-Disposal Unit: Remove your patch and follow the directions printed on the Patch-Disposal Unit (See Figure J ) or see complete instructions below. Use one Patch-Disposal Unit for each patch. Figure J   1. Fold used patch in half with sticky sides together (See Figure K ). Figure K   2. On flat surface, lay back cover of disposal unit and center folded patch on inside cover (See Figure L ). Figure L   3. Remove the white instruction sheet to expose the sticky side of the disposal unit (See Figure M ). Figure M   4. Close disposal unit containing used patch by firmly pressing together to seal (See Figure N ). Figure N 5. Discard in trash receptacle (See Figure O ). Figure O     Do not put expired, unwanted or unused patches in household trash without first sealing them in the Patch-Disposal Unit. Always remove the leftover patches from their protective pouch and remove the protective liner. The pouch and liner can be disposed of separately in the trash and should not be sealed in the Patch-Disposal Unit. To flush your buprenorphine transdermal system patches down the toilet: Remove your buprenorphine transdermal system patch, fold the sticky sides of a used patch together and flush it down the toilet right away (See Figure P ). Figure P When disposing of unused buprenorphine transdermal system patches you no longer need, remove the leftover patches from their protective pouch and remove the protective liner. Fold the patches in half with the sticky sides together, and flush the patches down the toilet. Do not flush the pouch or the protective liner down the toilet. These items can be thrown away in the trash. If you prefer not to flush the used patch down the toilet , and if there is not a drug take-back option readily available, you must use the Patch-Disposal Unit provided to you to discard the patch. Never put used buprenorphine transdermal system patches in the trash without first sealing them in the Patch-Disposal Unit. This “Instructions for Use” has been approved by the U.S. Food and Drug Administration. Manufactured by: Amneal Pharmaceuticals LLC Piscataway, NJ 08854 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 03-2020-02

Product summary:

Buprenorphine Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units. Buprenorphine Transdermal Systems, 5 mcg/hour , are square, beige-colored adhesive patches measuring 20.6 cm2 . Each system is printed in blue with “Buprenorphine CIII Transdermal System 5 mcg/hr” and are supplied in a 4-count carton (NDC 69238-1202-2 ). Buprenorphine Transdermal Systems, 7.5 mcg/hour , are rectangular, beige-colored adhesive patches measuring 25.8 cm2 . Each system is printed in blue with “Buprenorphine CIII Transdermal System 7.5 mcg/hr” and are supplied in a 4-count carton (NDC 69238-1505-2 ). Buprenorphine Transdermal Systems, 10 mcg/hour , are rectangular, beige-colored adhesive patches measuring 31.5 cm2 . Each system is printed in blue with “Buprenorphine CIII Transdermal System 10 mcg/hr” and are supplied in a 4-count carton (NDC 69238-1203-2 ). Buprenorphine Transdermal Systems, 15 mcg/hour , are rectangular, beige-colored adhesive patches measuring 40.3 cm2 . Each system is printed in blue with “Buprenorphine CIII Transdermal System 15 mcg/hr” and are supplied in a 4-count carton (NDC 69238-1204-2 ). Buprenorphine Transdermal Systems, 20 mcg/hour , are square, beige-colored adhesive patches measuring 49.5 cm2 . Each system is printed in blue with “Buprenorphine CIII Transdermal System 20 mcg/hr” and are supplied in a 4-count carton (NDC 69238-1205-2 ). Store buprenorphine transdermal systems securely and dispose of properly [see Patient Counseling Information (17)] . Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals NY LLC
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MEDICATION GUIDE
Buprenorphine (bue” pre nor’ feen) transdermal system, CIII
Buprenorphine transdermal system is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
severe and persistent pain that requires an extended treatment period
with a daily opioid pain
medicine, when other pain 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 to be taken on an “as needed” basis.
Important information about buprenorphine transdermal system:
•
Get emergency help or call 911 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. Talk to your healthcare
provider about naloxone, a
medicine for the emergency treatment of an opioid overdose.
•
Taking buprenorphine transdermal system with other opioid medicines,
benzodiazepines, and
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, decreased awareness, breathing problems, coma, and death.
•
Never give anyone else your buprenorphine transdermal system. They
could die from taking it.
Selling or giving away buprenorphine transdermal system is against the
law.
•
Store buprenorphine transdermal system securely, out of sight and
reach of children, and in a
location not accessible by others, including visitors to the home.
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 tra

Summary of Product characteristics

BUPRENORPHINE- BUPRENORPHINE PATCH, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS NY LLC
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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, CIII
INITIAL U.S. APPROVAL: 1981
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUPRENORPHINE
TRANSDERMAL SYSTEM
_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 REASSESS REGULARLY FOR THESE BEHAVIORS AND CONDITIONS.
(5.1, 10)
SERIOUS, LIFE-THREATENING OR FATAL RESPIRATORY DEPRESSION MAY OCCUR,
ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSAGE INCREASE. TO REDUCE THE RISK OF
RESPIRATORY
DEPRESSION, PROPER DOSING AND TITRATION OF BUPRENORPHINE TRANSDERMAL
SYSTEM ARE
ESSENTIAL. INSTRUCT PATIENTS ON PROPER ADMINISTRATION OF BUPRENORPHINE
TRANSDERMAL
SYSTEM TO REDUCE THE RISK. (2.1, 5.2)
ACCIDENTAL EXPOSURE TO BUPRENORPHINE TRANSDERMAL SYSTEM, ESPECIALLY IN
CHILDREN,
CAN RESULT IN FATAL OVERDOSE OF BUPRENORPHINE. (5.2)
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. (5.3, 7)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN,
ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME,
WHICH MAY
BE LIFE THREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT
MANAGEMENT BY
NEONATOLOGY EXPERTS WILL BE AVAILABLE AT DELIVERY. (5.4) HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO COMPLETE A
REMS-COMPLIANT
EDUCATION PROGRAM AND TO COUNSEL PATIENTS AND CAREGIVERS ON SERIOUS
RISKS, SAFE
USE, AND THE