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TARO-BUPRENORPHINE/NALOXONE is a brand name for Buprenorphine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TARO-BUPRENORPHINE / NALOXONE (buprenorphine and naloxone) is indicated for: • substitution treatment in adults with problematic opioid drug dependence. 1.1 Pediatrics Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of buprenorphine and naloxone in…
Verbatim from this product's HC label. Tap a section to expand.
). Appropriate security measures should be taken to safeguard stocks of TARO- BUPRENORPHINE/NALOXONE against diversion. • Addiction, Abuse, and Misuse Abuse and diversion of buprenorphine and naloxone have been reported. All patients should be monitored regularly for the development of these behaviours or conditions (see7 WARNINGS AND PRECAUTIONS, Addiction, Abuse, and Misuse).
• Life-threatening Respiratory Depression: OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of TARO- BUPRENORPHINE / NALOXONE. Infants exposed in-utero or through breast milk are at risk of life-threatening respiratory depression upon delivery or when nursed.
• Interaction with Alcohol The co-ingestion of alcohol with TARO-BUPRENORPHINE / NALOXONE should be avoided as it may result in dangerous additive effects, causing serious injury or death (see 7 WARNINGS AND PRECAUTIONS, Neurologic, and 9 DRUG INTERACTIONS).
• Interaction with other Central Nervous System Depressants Risks from 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 (see 7 WARNINGS AND PRECAUTIONS, Neurologic and 9 DRUG INTERACTIONS).
- Reserve concomitant prescribing of TARO-BUPRENORPHINE / NALOXONE and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. - Consider dose reduction of CNS depressants, TARO-BUPRENORPHINE / NALOXONE, or - both in situations of concomitant prescribing.
- Follow patients for signs and symptoms of respiratory depression and sedation. • Accidental Exposure Accidental ingestion of even one dose of TARO-BUPRENORPHINE / NALOXONE by individuals not physically dependent on opioids, especially children, can result in a fatal overdose of buprenorphine (see 4 DOSAGE AND ADMINISTRATION).
Taro-Buprenorphine / Naloxone (buprenorphine / naloxone) Page 6 of 61 • Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of TARO-BUPRENORPHINE / NALOXONE during pregnancy can result in a neonatal opioid withdrawal syndrome, which may be life -threatening (see 7 WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal Syndrome ).
• Risk of Overdose in Opioid-Naïve Patients TARO-BUPRENORPHINE / NALOXONE is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2 mg sublingual dose. • Interchangeability of Dosage Forms Due to the greater bioavailability of buprenorphine-naloxone film compared to buprenorphine-naloxone tablet at certain dosage strengths, patients switching from a film formulation to a tablet should be monitored for opioid withdrawal and other symptoms of under-dosing.
TARO-BUPRENORPHINE / NALOXONE should be placed under the tongue until completely dissolved, and patients should not swallow or consume food or drink until the tablet is completely dissolved. Altering TARO-BUPRENORPHINE / NALOXONE to take it by routes other than the indicated sublingual route can lead to serious adverse events including death.
Do not cut, break, crush or chew TARO- BUPRENORPHINE/NALOXONE (see 7 WARNINGS AND PRECAUTIONS, Addiction, Abuse, and Misuse). 1 Dosing Considerations • Altering the tablet to take it by routes other than the indicated routes can lead to serious adverse events including death.
Do not cut, break, crush, swallow or chew TARO - BUPRENORPHINE/NALOXONE. Appropriate security measures should be taken to safeguard stocks of TARO- BUPRENORPHINE/NALOXONE against diversion. TARO-BUPRENORPHINE / NALOXONE must be dispensed on a daily basis under the supervision of a healthcare professional until the patient has sufficient clinical stability and is able to safely store TARO-BUPRENORPHINE / NALOXONE take-home doses.
• TARO-BUPRENORPHINE / NALOXONE is indicated for substitution treatment in adults with problematic opioid drug dependence. Naloxone is an antagonist at mu -opioid receptors. The intention of the naloxone component is to deter injection and intranasal misuse and abuse in individuals physically dependent on mu -opioid full agonists.
Opioid drug dependence is a chronic relapsing disease; length of treatment must be tailored for each patient depending on his/her condition. • Patients prescribed TARO-BUPRENORPHINE / NALOXONE should be carefully monitored within a framework of medical, social, and psychological support as part of a comprehensive opioid- Taro-Buprenorphine / Naloxone (buprenorphine / naloxone) Page 7 of 61 dependence treatment program.
• TARO-BUPRENORPHINE / NALOXONE should only be prescribed by physicians who meet the following requirements: 1. Experience in substitution treatment in opioid drug dependence, and 2. Completion of a recognized TARO-BUPRENORPHINE / NALOXONE Training Program.
The TARO-BUPRENORPHINE / NALOXONE Training Program is a risk management program founded on the following four core components that provide for the safe and effective use of the drug within a framework of medical, social and psychological support: o training of the prescribing physicians in the use of TARO-BUPRENORPHINE / NALOXONE; o maintenance of a list of TARO-BUPRENORPHINE / NALOXONE Training Program trained physicians; o daily dosing supervised by a healthcare professional, progressing to unsupervised administration as the patient’s clinical stability permits; o take-home doses once the patient has sufficient clinical stability and is able to safely store TARO-BUPRENORPHINE / NALOXONE.
Take-home doses should be assessed and reviewed on a regular basis. • Physicians may obtain more information about the TARO-BUPRENORPHINE / NALOXONE Training Program by calling the following toll -free phone number: 1-800-268-1975. ca.
2 Recommended Dose and Dosage Adjustment Health […]
, Addiction, Abuse, and Misuse). • Life-threatening Respiratory Depression: OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of TARO- BUPRENORPHINE / NALOXONE. Infants exposed in-utero or through breast milk are at risk of life-threatening respiratory depression upon delivery or when nursed.
• Interaction with Alcohol The co-ingestion of alcohol with TARO-BUPRENORPHINE / NALOXONE should be avoided as it may result in dangerous additive effects, causing serious injury or death (see 7 WARNINGS AND PRECAUTIONS, Neurologic, and 9 DRUG INTERACTIONS).
• Interaction with other Central Nervous System Depressants Risks from 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 (see 7 WARNINGS AND PRECAUTIONS, Neurologic and 9 DRUG INTERACTIONS).
- Reserve concomitant prescribing of TARO-BUPRENORPHINE / NALOXONE and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. - Consider dose reduction of CNS depressants, TARO-BUPRENORPHINE / NALOXONE, or - both in situations of concomitant prescribing.
- Follow patients for signs and symptoms of respiratory depression and sedation. • Accidental Exposure Accidental ingestion of even one dose of TARO-BUPRENORPHINE / NALOXONE by individuals not physically dependent on opioids, especially children, can result in a fatal overdose of buprenorphine (see 4 DOSAGE AND ADMINISTRATION).
Taro-Buprenorphine / Naloxone (buprenorphine / naloxone) Page 6 of 61 • Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of TARO-BUPRENORPHINE / NALOXONE during pregnancy can result in a neonatal opioid withdrawal syndrome, which may be life -threatening (see 7 WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal Syndrome ).
• Risk of Overdose in Opioid-Naïve Patients TARO-BUPRENORPHINE / NALOXONE is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2 mg sublingual dose. • Interchangeability of Dosage Forms Due to the greater bioavailability of buprenorphine-naloxone film compared to buprenorphine-naloxone tablet at certain dosage strengths, patients switching from a film formulation to a tablet should be monitored for opioid withdrawal and other symptoms of under-dosing.
TARO-BUPRENORPHINE / NALOXONE should be placed under the tongue until completely dissolved, and patients should not swallow or consume food or drink until the tablet is completely dissolved. Altering TARO-BUPRENORPHINE / NALOXONE to take it by routes other than the indicated sublingual route can lead to serious adverse events including death.
Do not cut, break, crush or chew TARO- BUPRENORPHINE/NALOXONE (see 7 WARNINGS AND PRECAUTIONS, Addiction, Abuse, and Misuse). 1 Dosing Considerations • Altering the tablet to take it by routes other than the indicated routes can lead to serious adverse events including death.
Do not cut, break, crush, swallow or chew TARO - BUPRENORPHINE/NALOXONE. Appropriate security measures should be taken to safeguard stocks of TARO- BUPRENORPHINE/NALOXONE against diversion. TARO-BUPRENORPHINE / NALOXONE must be dispensed on a daily basis under the supervision of a healthcare professional until the patient has sufficient clinical stability and is able to safely store TARO-BUPRENORPHINE / NALOXONE take-home doses.
• TARO-BUPRENORPHINE / NALOXONE is indicated for substitution treatment in adults with problematic opioid drug dependence. Naloxone is an antagonist at mu -opioid receptors. The intention of the naloxone component is to deter injection and intranasal misuse and abuse in individuals physically dependent on mu -opioid full agonists.
Opioid drug dependence is a chronic relapsing disease; length of treatment must be tailored for each patient depending on his/her condition. • Patients prescribed TARO-BUPRENORPHINE / NALOXONE should be carefully monitored within a framework of medical, social, and psychological support as part of a comprehensive opioid- Taro-Buprenorphine / Naloxone (buprenorphine / naloxone) Page 7 of 61 dependence treatment program.
• TARO-BUPRENORPHINE / NALOXONE should only be prescribed by physicians who meet the following requirements: 1. Experience in substitution treatment in opioid drug dependence, and 2. Completion of a recognized TARO-BUPRENORPHINE / NALOXONE Training Program.
The TARO-BUPRENORPHINE / NALOXONE Training Program is a risk management program founded on the following four core components that provide for the safe and effective use of the drug within a framework of medical, social and psychological support: o training of the prescribing physicians in the use of TARO-BUPRENORPHINE / NALOXONE; o maintenance of a list of TARO-BUPRENORPHINE / NALOXONE Training Program trained physicians; o daily dosing supervised by a healthcare professional, progressing to unsupervised administration as the patient’s clinical stability permits; o take-home doses once the patient has sufficient clinical stability and is able to safely store TARO-BUPRENORPHINE / NALOXONE.
Take-home doses should be assessed and reviewed on a regular basis. • Physicians may obtain more information about the TARO-BUPRENORPHINE / NALOXONE Training Program by calling the following toll -free phone number: 1-800-268-1975. ca.
1 Pediatrics) Induction • Precautions to be taken before induction Baseline liver function tests and documentation of viral hepatitis status are recommended prior to commencing therapy. Regular monitoring of liver function is recommended.
Prior to induction, consideration should be […]
• Patients who are hypersensitive to buprenorphine, naloxone, or to any ingredient in the formulation (For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • Opioid naïve patients. , acute or severe bronchial asthma, chronic obstructive airway, status asthmaticus, acute respiratory depression, and/or corpulmonale.
• Patients with severe hepatic impairment. • Patients with acute alcoholism or delirium tremens. , ileus of any type). , acute appendicitis or pancreatitis). • Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury.
• Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy). • Patients with convulsive or seizure disorders. Taro-Buprenorphine / Naloxone (buprenorphine / naloxone) Page 5 of 61
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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