Buprenorphine (Buprenorphine)

Trade Name : Buprenorphine

Teva Pharmaceuticals USA, Inc.

PATCH, EXTENDED RELEASE

Strength 5 ug/h

BUPRENORPHINE Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Buprenorphine (Buprenorphine) which is also known as Buprenorphine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 5 ug/h per ml. Read more

Buprenorphine (Buprenorphine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

About GNH

No data

Arrayn- Addiction, Abuse, and Misuse
Buprenorphine transdermal systemu00a0n- exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing buprenorphine transdermal system, and monitor all patients regularly for the development of these behaviors and conditions n
Arrayn- Array
Arrayn- Array
Serious, life-threatening, or fatal respiratory depression may occur with use of buprenorphine transdermal system. Monitor for respiratory depression, especially during initiation of buprenorphine transdermal system or following a dose increaseMisuse or abuse of buprenorphine transdermal system 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 n
u00a0
Arrayn- Accidental Exposure
Accidental exposure to even one dose of buprenorphine transdermal system, especially in children, can result in a fatal overdose of buprenorphine .
u00a0
Arrayn- Neonatal Opioid Withdrawal Syndrome
Pn- rolonged use of buprenorphine transdermal system 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 .
u00a0
Arrayn- Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
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 n
WARNING: ADDICTION, ABUSE, and MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); 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 patientu2019s risk before prescribing, and monitor for these behaviors and conditions. (, )
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. ()
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. ()
Accidental exposure to buprenorphine transdermal system, especially in children, can result in fatal overdose of buprenorphine. ()
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. ()
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 patients for signs and symptoms of respiratory depression and sedation. (, )

u00a0
Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 09/2018
Dosage and Administration (2.4)u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 10/2019
Warnings and Precautions (5.3, 5.14)u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 10/2019

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.
Ln- imitations of Use
Buprenorphine transdermal system is a partial opioid agonist 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. ()

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, 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. ()

No data

To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain. ()
Buprenorphine transdermal system doses of 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour are only for use in patients who are opioid experienced and in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid- experienced are those receiving, for one week or longer, daily opioid doses up to 80 mg/day of oral morphine or an equianalgesic dose of another opioid. ()
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ().
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ()
For opioid-nau00efve patients, initiate treatment with a 5 mcg/hour patch. ()
Instruct patients to wear buprenorphine transdermal system for 7 days and to wait a minimum of 3 weeks before applying to the same site. ()
Do not abruptly discontinue buprenorphine transdermal system in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ()

Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Buprenorphine transdermal system is available in four strengths:
Transdermal system: 5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour. ()n

Buprenorphine transdermal system is contraindicated in patients with:

Significant respiratory depression ()
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ()
Known or suspected gastrointestinal obstruction, including paralytic ileus ()
Hypersensitivity to buprenorphine ()

No data

Ln- in- fn- e Threatening Respiratory Depression in Patients with Chronicu00a0n- Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
An- dn- rn- en- nan- l Insufficiency
Rin- sn- k of Prolonged QTc Interval
5.8n- 12.2
Sn- en- vn- en- rn- e Hypotension
Rin- sn- kn- s of Use in Patients with Increased Intracranial Cranial Pressure, Brainu00a0n- Tumors, Head Injury, or Impaired Consciousness

The following serious adverse reactions are described elsewhere in the labeling:
Most common adverse reactions (greater than or equal to 5%) include: nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash. ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Table 5 includes clinically significant drug interactions with buprenorphine transdermal system.

Bn- en- nn- zn- on- dian- zen- pn- in- nn- en- s
Cn- YPn- 3n- An- 4 Inhibitors/Inducers
Sn- en- ron- tn- on- nn- en- rn- gn- in- c Drugs
Min- xn- en- d Agonist/Antagonist Analgesics

No data

Pregnancy
Lactation
Severe Hepatic Impairment

No data

Cn- linical Presentation
Acute overdosage with buprenorphine transdermal system is manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations .
Treatment of Overdose
In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
Naloxone may not be effective in reversing any respiratory depression produced by buprenorphine. High doses of naloxone, 10 mg to 35 mg/70 kg, may be of limited value in the management of buprenorphine overdose. The onset of naloxone effect may be delayed by 30 minutes or more. Doxapram hydrochloride (a respiratory stimulant) has also been used.
Remove buprenorphine transdermal system immediately. u00a0Because the duration of reversal would be expected to be less than the duration of action of buprenorphine from buprenorphine transdermal system, carefully monitor the patient until spontaneous respiration is reliably re-established. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects as buprenorphine continues to be absorbed from the skin. After removal of buprenorphine transdermal system, the mean buprenorphine concentrations decrease approximately 50% in 12 hours (range 10 to 24 hours) with an apparent terminal half-life of approximately 26 hours. Due to this long apparent terminal half-life, patients may require monitoring and treatment for at least 24 hours.
In an individual physically dependent on opioids, administration of an opioid receptor antagonist may precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

Buprenorphine is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-u03b1-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-u03b1-methyl-, [5u03b1, 7u03b1, (S)]. The structural formula is:
The molecular weight of buprenorphine is 467.6; the molecular formula is CHNO. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217u00b0C.
Arrayn- System Components and Structure
Four different strengths of buprenorphine transdermal system are available: 5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the four strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream.
Buprenorphine transdermal system is a square, tan-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a tan-colored web backing layer; (2) a separating layer over the buprenorphine-containing adhesive matrix; (3) the buprenorphine-containing adhesive matrix; and (4) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded.
Figure 1: Cross-Section Diagram of Buprenorphine Transdermal Systemu00a0n- (not to scale).
The active ingredient in buprenorphine transdermal system is buprenorphine. The inactive ingredients in each system are: levulinic acid, citric acid, and acrylate copolymer adhesive.

No data

C
arc
inogenesis
Buprenorphine administered daily by skin painting to Sprague Dawley rats for 100 weeks at dosages (20 mg/kg, 60 mg/kg, or 200 mg/kg) produced systemic exposures (based on AUC) that ranged from approximately 130 to 350 times that of human subjects administered the maximum recommended human dose (MRHD) of buprenorphine transdermal system 20 mcg/hour. An increased incidence of benign testicular interstitial cell tumors, considered buprenorphine treatment-related, was observed in male rats compared with concurrent controls. The tumor incidence was also above the highest incidence in the historical control database of the testing facility. These tumors were noted at 60 mg/kg/day and higher at approximately 220 times the proposed MRHD based on AUC. The no observed effect level (NOEL) was 20 mg/kg/day (approximately 140 times the proposed MRHD based on AUC). The mechanism leading to the tumor findings and the relevance to humans is unknown.
Buprenorphine was administered by skin painting to hemizygous Tg.AC mice over a 6-month study period.u00a0 At the dosages administered daily (18.75 mg/kg/day, 37.5 mg/kg/day, 150 mg/kg/day, or 600 mg/kg/day), buprenorphine was not carcinogenic or tumorigenic at systemic exposure to buprenorphine, based on AUC, of up to approximately 1000 times that of human subjects administered buprenorphine transdermal system 20 mcg/hour, the MRHD.
Mutagenesis
Buprenorphine was not genotoxic in three genetic toxicology studies (bacterial mutagenicity test, mouse lymphoma assay, chromosomal aberration assay in human peripheral blood lymphocytes), and in one mouse micronucleus test.
I
mpairment of Fertility
Buprenorphine transdermal system (1/4 of a buprenorphine transdermal system 5 mcg/hour, one buprenorphine transdermal system 5 mcg/hour, or one buprenorphine transdermal system 20 mcg/hour every 3 days in males for 4 weeks prior to mating for a total of 10 weeks and in females for 2 weeks prior to mating through Gestation Day 7) had no effect on fertility or general reproductive performance of rats at AUC-based exposure levels as high as approximately 65 times (females) and 100 times (males) that for human subjects who received buprenorphine transdermal system 20 mcg/hour, the MRHD.

The efficacy of buprenorphine transdermal system has been evaluated in four 12-week double-blind, controlled clinical trials in opioid-nau00efve and opioid-experienced patients with moderate to severe chronic low back pain or osteoarthritis using pain scores as the primary efficacy variable. Two of these studies, described below, demonstrated efficacy in patients with low back pain. u00a0One study in low back pain and one study in osteoarthritis did not show a statistically significant pain reduction for either buprenorphine transdermal system or the respective active comparators.
12-Week Study in Opioid-Nau00efve Patients with Chronic Low Back Pain
A total of 1,024 patients with chronic low back pain who were suboptimally responsive to their non-opioid therapy entered an open-label, dose-titration period for up to four weeks. Patients initiated therapy with three days of treatment with buprenorphine transdermal system 5 mcg/hour. After three days, if adverse events were tolerated, the dose was increased to buprenorphine transdermal system 10 mcg/hour. If adverse effects were tolerated but adequate analgesia was not reached, the dose was increased to buprenorphine transdermal system 20 mcg/hour for an additional 10 to 12 days. Patients who achieved adequate analgesia and tolerable adverse effects on buprenorphine transdermal system 10 or 20 mcg/hour were then randomized to remain on their titrated dose of buprenorphine transdermal system or matching placebo. Fifty-three percent of the patients who entered the open-label titration period were able to titrate to a tolerable and effective dose and were randomized into a 12-week, double-blind treatment period. Twenty-three percent of patients discontinued due to an adverse event from the open-label titration period and 14% discontinued due to lack of a therapeutic effect. The remaining 10% of patients were dropped due to various administrative reasons.
During the first seven days of double-blind treatment patients were allowed up to two tablets per day of immediate-release oxycodone 5 mg as supplemental analgesia to minimize opioid withdrawal symptoms in patients randomized to placebo. Thereafter, the supplemental analgesia was limited to either acetaminophen 500 mg or ibuprofen 200 mg at a maximum of four tablets per day. Sixty-six percent of the patients treated with buprenorphine transdermal system completed the 12-week treatment compared to 70% of the patients treated with placebo. Of the 256 patients randomized to buprenorphine transdermal system, 9% discontinued due to lack of efficacy and 16% due to adverse events. Of the 283 patients randomized to placebo, 13% discontinued due to lack of efficacy and 7% due to adverse events.
Of the patients who were randomized, the mean pain (SE) NRS scores were 7.2 (0.08) and 7.2 (0.07) at screening and 2.6 (0.08) and 2.6 (0.07) at pre-randomization (beginning of double-blind phase) for the buprenorphine transdermal system and placebo groups, respectively.
The score for average pain over the last 24 hours at the end of the study (Week 12/Early Termination) was statistically significantly lower for patients treated with buprenorphine transdermal system compared with patients treated with placebo. The proportion of patients with various degrees of improvement, from screening to study endpoint, is shown in Figure 3 below.
Fn- igure 3: Percent Reduction in Pain Intensity
12-Week Study in Opioid-Experienced Patients with Chronic Low Back Pain
One thousand one hundred and sixty (1,160) patients on chronic opioid therapy (total daily dose 30 mg to 80 mg morphine equivalent) entered an open-label, dose-titration period with buprenorphine transdermal system for up to 3 weeks, following taper of prior opioids. Patients initiated therapy with buprenorphine transdermal system 10 mcg/hour for three days. After three days, if the patient tolerated the adverse effects, the dose was increased to buprenorphine transdermal system 20 mcg/hour for up to 18 days. Patients with adequate analgesia and tolerable adverse effects on buprenorphine transdermal system 20 mcg/hour were randomized to remain on buprenorphine transdermal system 20 mcg/hour or were switched to a low-dose control (buprenorphine transdermal system 5 mcg/hour) or an active control. Fifty-seven percent of the patients who entered the open-label titration period were able to titrate to and tolerate the adverse effects of buprenorphine transdermal system 20 mcg/hour and were randomized into a 12-week double-blind treatment phase. Twelve percent of patients discontinued due to an adverse event and 21% discontinued due to lack of a therapeutic effect during the open-label titration period.
During the double-blind period, patients were permitted to take ibuprofen (200 mg tablets) or acetaminophen (500 mg tablets) every 4 hours as needed for supplemental analgesia (up to 3200 mg of ibuprofen and 4 grams of acetaminophen daily). Sixty-seven percent of patients treated with buprenorphine transdermal system 20 mcg/hour and 58% of patients treated with buprenorphine transdermal system 5 mcg/hour completed the 12-week treatment. Of the 219 patients randomized to buprenorphine transdermal system 20 mcg/hour, 11% discontinued due to lack of efficacy and 13% due to adverse events. Of the 221 patients randomized to buprenorphine transdermal system 5 mcg/hour, 24% discontinued due to lack of efficacy and 6% due to adverse events.
Of the patients who were able to be randomized in the double-blind period, the mean pain (SE) NRS scores were 6.4 (0.08) and 6.5 (0.08) at screening and were 2.8 (0.08) and 2.9 (0.08) at pre-randomization (beginning of Double-Blind Period) for the buprenorphine transdermal system 5 mcg/hour and buprenorphine transdermal system 20 mcg/hour, respectively.
The score for average pain over the last 24 hours at Week 12 was statistically significantly lower for subjects treated with buprenorphine transdermal system 20 mcg/hour compared to subjects treated with buprenorphine transdermal system 5 mcg/hour. A higher proportion of buprenorphine transdermal system 20 mcg/hour patients (49%) had at least a 30% reduction in pain score from screening to study endpoint when compared to buprenorphine transdermal system 5 mcg/hour patients (33%). The proportion of patients with various degrees of improvement from screening to study endpoint is shown in Figure 4 below.
Figure 4: Percent Reduction in Pain Intensity

Buprenorphine Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.
Buprenorphine 5 mcg/hour Transdermal Systems are square with rounded corners, tan colored adhesive patches measuring 48 mm by 48 mm. Each system is printed with Buprenorphine Transdermal System CIII 5 mcg/hour with TEVA 3656 and is supplied in a 4-count carton ().
Buprenorphine 10 mcg/hour Transdermal Systems are square with rounded corners, tan colored adhesive patches measuring 59 mm by 59 mm. Each system is printed with Buprenorphine Transdermal System CIII 10 mcg/hour with TEVA 3657 and is supplied in a 4-count carton ().
Buprenorphine 15 mcg/hour Transdermal Systems are square with rounded corners, tan colored adhesive patches measuring 65 mm by 65 mm. Each system is printed with Buprenorphine Transdermal System CIII 15 mcg/hour with TEVA 3658 and is supplied in a 4-count carton ().
Buprenorphine 20 mcg/hour Transdermal Systems are square with rounded corners, tan colored adhesive patches measuring 75 mm by 75 mm. Each system is printed with Buprenorphine Transdermal System CIII 20 mcg/hour with TEVA 3659 and is supplied in a 4-count carton ().
Store Buprenorphine Transdermal System securely and dispose of properly .
Store at 25u00b0C (77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Storage and Disposal:
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to 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 ). Inform patients that leaving buprenorphine transdermal system unsecured can pose a deadly risk to others in the home.
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. buprenorphine transdermal system patches can be disposed of by using the Patch- Disposal Unit Alternatively, expired, unwanted, or unused buprenorphine transdermal system should be disposed of by folding the patch in half and flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.n
Addiction, Abuse, and Misuse
Inform patients that the use of buprenorphine transdermal system, even when taken as recommended, can result in addiction, abuse, and misuse, which could lead to overdose and death Instruct patients not to share buprenorphine transdermal system with others and to take steps to protect buprenorphine transdermal system from theft or misuse.
Ln- ife-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting buprenorphine transdermal system or when the dosage is increased, and that it can occur even at recommended doses . Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Exposure
Inform patients that accidental exposure, especially in children, may result in respiratory depression or death . u00a0
In- nteraction with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if buprenorphine transdermal system is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider .
In- nteraction with Benzodiazepines
Warn patients that it is extremely dangerous to self-administer benzodiazepines while taking buprenorphine transdermal system, and warn patients to use benzodiazepines concurrently with buprenorphine transdermal system only as directed by their physician .
Sn- ern- otonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications .
MAOI Interaction
Inform patients to avoid taking buprenorphine transdermal system while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking buprenorphine transdermal system .
Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms .
In- mportant Administration Instructions
Instruct patients how to properly use buprenorphine transdermal system, including the following:
Important Discontinuation Instructions
In order to avoid developing withdrawal symptoms, instruct patients not to discontinue buprenorphine transdermal system without first discussing a tapering plan with the prescriber n
Hn- yn- potension
Inform patients that buprenorphine transdermal system may cause orthostatic hypotension and syncope. u00a0Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) .
Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in buprenorphine transdermal system. Advise patients how to recognize such a reaction and when to seek medical attention n
Pn- ren- gn- nn- an- ncy
Nn- en- onatal Opioid Withdrawal Syndrome
u00a0n- [see Warnings and Precautions ()], Use in Specific Populations ().
Embryofetal Toxicity
Inform female patients of reproductive potential that buprenorphine transdermal system can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy .
Ln- an- cn- tation
Advise patients that breastfeeding is not recommended during treatment with buprenorphine transdermal system n
In- nn- fern- tility
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible n
Driving or Operating Heavy Machinery
Inform patients that buprenorphine transdermal system may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery.u00a0 Advise patients not to perform such tasks until they know how they will react to the medication .
Cn- onstipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention .
Healthcare professionals can contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 for information on this product.n
Manufactured By:n n 19901 Nordhoff Street Northridge, CA 91324 USA
Manufactured For:n North Wales, PA 19454
Rev. A 10/2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0 u00a0 u00a0 Rev. A 10/2019

Buprenorphine CIII
(bueu02ba pre noru02b9 feen)
Transdermal System
Bn- e sure that you read, understand, and follow these Instructions for Use before you use n- buprenorphine transdermal systemn- . Talk to your healthcare provider or pharmacist if you have any questions.
Bn- en- fn- ore applying n- buprenorphine transdermal systemn- :
Where to apply n- buprenorphine transdermal systemn- :
If the patch falls off right away after applying, throw it away and put a new one on at a different skin site (n n n .
If a patch falls off, do not touch the sticky side of the patch with your fingers.u00a0 A new patch should be applied to a different site. . 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.
In- f the edges of the n- buprenorphine transdermal system n- patch start to loosen:
If your patch falls off later, but before 1 week (7 days) of use, throw it away properly (n n n n n 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).
Dn- in- sposing of n- buprenorphine transdermal system n- patch:
Buprenorphine transdermal system n- patches should be disposed of by using the Patch-Disposal Unit. Alternatively, the patches can be flushed down the toilet .
Tn- o dispose of n- buprenorphine transdermal system n- patches in household trash using the Patch-Disposal Unit:
Remove your patch and follow the directions printed on the Patch-Disposal Unit () or see complete instructions belown
Arrayn- Array
1.u00a0 u00a0Fold used patch in half with sticky sides together ().
Arrayn- Array
2.u00a0 u00a0On flat surface, lay back cover of disposal unit and remove liner to expose the sticky side of the disposal unit ().
3.u00a0 u00a0Center and place folded patch on the adhesive side of the disposal unit. ().
Arrayn- Array
4.u00a0 u00a0Close disposal unit containing used patch by firmly pressing to seal ().
5.u00a0 u00a0Discard in trash receptacle ().
Dn- o not put expired, unwanted oru00a0 patches in household trash without first sealing them in the Patch-Disposal Unit.
Aln- wn- ays remove the leftover patches from their protective pouch and remove the protective liner.
Tn- o flush your n- buprenorphine transdermal system n- 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 ().
When disposing of unused n- buprenorphine transdermal system n- patches you no longer need,
Do not flush the pouch or the protective liner down the toilet. These items can be thrown away in the trash.
In- f you prefer not to flush the used patch down the toilet,
Nn- ever put used n- buprenorphine transdermal system pn- atches in the trash without first sealing them in the Patch-Disposal Unit.
Tn- his u201cInstructions for Useu201d has been approved by the U.S. Food and Drug Administration.
Brands listed are the trademarks of their respective owners.
Manufactured By:n n 19901 Nordhoff Street Northridge, CA 91324 USA
Manufactured For:n North Wales, PA 19454
Rev. A 10/2019

NDCn- 3656
Buprenorphine CIIIn- Transdermal Systemn- 5 mcg/hour
Systemic delivery of 5 mcg per hour of buprenorphine for seven days.
Because serious or life-threatening breathing problems could result,DO NOT USE BUPRENORPHINE TRANSDERMAL SYSTEM for:n n- Array
Rx only
Contains:4 Transdermal Systems4 Disposal Units
ATTENTION DISPENSER:The enclosed MedicationGuide MUST be provided tothe patient upon dispensing.
Arrayn- Array
u00a0

NDCn- 3657
Buprenorphine CIIIn- Transdermal Systemn- 10 mcg/hour
Systemic delivery of 10 mcg per hour ofbuprenorphine for seven days.
Because serious or life-threatening breathing problems could result, DO NOT USE BUPRENORPHINE TRANSDERMAL SYSTEM for:n n- Array
Arrayn- ATTENTION DISPENSER:The enclosed MedicationGuide MUST be provided tothe patient upon dispensing.
Rx only
Contains:4 Transdermal Systems4 Disposal Units
For Use InOpioid-ExperiencedPatients Only

NDCn- 3658
Buprenorphine CIIIn- Transdermal Systemn- 10 mcg/hour
Systemic delivery of 15 mcg per hour ofbuprenorphine for seven days.
Because serious or life-threatening breathingu00a0problems could result, DO NOT USEu00a0BUPRENORPHINE TRANSDERMAL SYSTEM for:n n- Array
ATTENTION DISPENSER:The enclosed MedicationGuide MUST be provided tothe patient upon dispensing.
Rx only
Contains:4 Transdermal Systems4 Disposal Units
For Use InOpioid-ExperiencedPatients Only
Arrayn- Array

NDCn- 3659
Buprenorphine CIIIn- Transdermal Systemn- 20 mcg/hour
Systemic delivery of 20 mcg per hour ofbuprenorphine for seven days.
Because serious or life-threatening breathingu00a0problems could result, DO NOT USEu00a0BUPRENORPHINE TRANSDERMAL SYSTEM for:n n- Array
ATTENTION DISPENSER:The enclosed MedicationGuide MUST be provided tothe patient upon dispensing.
Rx only
Contains:4 Transdermal Systems4 Disposal Units
For Use InOpioid-ExperiencedPatients Only

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Get Price

Buprenorphine (Buprenorphine)

Trade Name : Buprenorphine

PATCH, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what
you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Buprenorphine (Buprenorphine)

Trade Name : Buprenorphine

PATCH, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?