Loading…
SUBOXONE 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: SUBOXONE® (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 SUBOXONE in pediatric patients has not been…
Verbatim from this product's HC label. Tap a section to expand.
). Appropriate security measures should be taken to safeguard stocks of SUBOXONE against diversion. • Addiction, Abuse, and Misuse Abuse and diversion of SUBOXONE have been reported. All patients should be monitored regularly for the development of these behaviours or conditions (see 7 WARNING AND PRECAUTIONS, Addition, Abuse, and Misuse).
• Life-threatening Respiratory Depression: OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of SUBOXONE. 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 SUBOXONE should be avoided as it may result in dangerous additive effects, causing serious injury or death (see 7 WARNING 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 WARNING AND PRECAUTIONS, Neurologic, and 9 DRUG INTERACTIONS).
- Reserve concomitant prescribing of SUBOXONE and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. - Consider dose reduction of CNS depressants, SUBOXONE, 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 SUBOXONE by individuals not physically dependent on opioids, especially children, can result in a fatal overdose of buprenorphine (see 4 DOSAGE AND ADMINISTRATION).
• Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of SUBOXONE during pregnancy can result in a neonatal opioid withdrawal syndrome, which may be life-threatening (see 7 WARNING AND PRECAUTIONS, Neonatal Opioid Withdrawal Syndrome).
Product Monograph Master Template Template Date:
September 2020 SUBOXONE (buprenorphine / naloxone) Page 6 of 76 • Risk of Overdose in Opioid-Naïve Patients SUBOXONE is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2 mg sublingual dose.
, Gastrointestinal). SUBOXONE Tablet Administration SUBOXONE tablet should be placed under the tongue until completely dissolved. When multiple tablets are needed to achieve the prescribed dosage, a patient may place all tablets sublingually at the same time or in two separate portions, the second portion to be placed sublingually directly after the first portion has dissolved.
SUBOXONE Film Administration For induction, SUBOXONE film should be administered sublingually. Once induction is complete (typically within 2 days), patients can be switched between buccal and sublingual administration without significant risk of under- or over-dosing.
However, patients should be monitored when switching between sublingual and buccal sites of administration. SUBOXONE film should be placed under the tongue or on the inside of either cheek until completely dissolved. It is advised that patients moisten their mouths prior to dosing.
For sublingual use, when more than one film is necessary to achieve the prescribed dose, the additional film should be placed under the tongue on the opposite side from the first film avoiding overlapping or stacking the films. If a third film is necessary to achieve the prescribed dose, it should be placed under the tongue after the first two films have dissolved.
For buccal use, when more than one film is necessary to achieve the prescribed dose, an additional film should be placed on the inside of the opposite cheek. If a third film is necessary to achieve the prescribed dose, it should be placed on the inside of the right or left cheek after the first two films have dissolved.
No more than two films should be administered at the same time. SUBOXONE film should be used immediately upon opening and not stored for any length of time. Avoid manipulating the film with wet hands.
Product Monograph Master Template Template Date:
• 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 cor pulmonale.
• 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.
Product Monograph Master Template Template Date:
September 2020 SUBOXONE (buprenorphine / naloxone) Page 5 of 76
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buprenorphine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
• Interchangeability of Dosage Forms Due to the greater bioavailability of SUBOXONE film compared to SUBOXONE tablet at certain dosage strengths, patients switching from the tablet to film should be monitored for symptoms related to over-dosing.
Those switching from film to the tablet should be monitored for opioid withdrawal and other symptoms of under- dosing. Patients who are stabilized on sublingually-administered film can be switched to buccally-administered film. 2 Recommended Dose and Dosage Adjustment).
Once induction is complete, patients can be switched between buccal and sublingual administration without significant risk of under- or over-dosing. SUBOXONE should be placed under the tongue (film can also be placed on the inside of either cheek for buccal administration) until completely dissolved, and patients should not swallow or consume food or drink until the tablet or film is completely dissolved.
Altering SUBOXONE to take it by routes other than the indicated sublingual route (or also buccal route for film) can lead to serious adverse events including death. Do not cut, break, crush or chew SUBOXONE (see 7 WARNING AND PRECAUTIONS, ADDICTION, Abuse, and Misuse).
1 Dosing Considerations • Altering the tablet or film 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 SUBOXONE. Appropriate security measures should be taken to safeguard stocks of SUBOXONE against diversion.
SUBOXONE 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 SUBOXONE take-home doses. • SUBOXONE 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 Product Monograph Master Template Template Date: September 2020 SUBOXONE (buprenorphine / naloxone) Page 7 of 76 tailored for each patient depending on his/her condition.
• Patients prescribed SUBOXONE should be carefully monitored within a framework of medical, social, and psychological support as part of a comprehensive opioid-dependence treatment program. • SUBOXONE 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 SUBOXONE Training Program. The SUBOXONE 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 SUBOXONE; o maintenance of a list of SUBOXONE 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 SUBOXONE.
Take-home doses should be assessed and reviewed on a regular basis. • Physicians may obtain more information about the SUBOXONE Training Program by calling the following toll-free phone number: 1-877-782-6966. • The SUBOXONE Training Program is accessible to […]
September 2020 SUBOXONE (buprenorphine / naloxone) Page 11 of 76 Switching Between SUBOXONE Tablet and SUBOXONE Film When switching from tablet to film, SUBOXONE film should be administered sublingually. Patients who are stabilized on sublingually-administered film can be switched to buccally- administered film.
Patients being switched between SUBOXONE tablet and SUBOXONE film should be started on the same dosage of the previously administered product. However, dosage adjustments may be necessary when switching between the tablet and film and other buprenorphine products.
3 Pharmacokinetics). Patients should be monitored for symptoms related to over-dosing when switching from tablet to film or under-dosing when switching from film to tablet. Combining different formulations or alternating between film and tablet formulations is not advised.
Switching Between Sublingual and Buccal Sites of Administration (Film only) The systemic exposure of buprenorphine between buccal and sublingual administration of SUBOXONE film is similar. Therefore, once induction is complete (typically within 2 days), patients can switch between buccal and sublingual administration without significant risk of under- or over-dosing.
However, patients should be monitored when switching between sublingual and buccal sites of administration. Clinical Supervision It is recommended that treatment be initiated with supervised administration progressing to unsupervised administration as the patient’s clinical stability permits.
During the initiation of treatment, closer supervision of dosing is recommended to ensure proper sublingual placement of the dose and to observe patient response to treatment as a guide to effective dose titration according to clinical effect.
As the patient becomes stabilised in treatment, longer intervals between patient assessments may be appropriate based upon patient compliance with treatment, effectiveness of the treatment plan, and overall patient progress. It is also recommended that the prescription quantity for unsupervised administration be determined with consideration for the frequency of patient visits and the patient’s ability to manage supplies of take-home medication.
5 Missed Dose Missed doses are notable as they may contribute to a loss of tolerance to buprenorphine. The more doses a patient misses, the greater the loss of tolerance. Patients should be reassessed to ensure they are receiving an appropriate dose on resumption of SUBOXONE treatment.
The resumption dose may need to be adjusted back to levels used during SUBOXONE induction. If the patient has relapsed to full agonist opioids, the patient should be advised to suspend Product Monograph Master Template Template Date: September 2020 SUBOXONE (buprenorphine / naloxone) Page 12 of 76 resumption of their SUBOXONE until they are in moderate opioid withdrawal due to the risk of precipitated withdrawal.
5 OVERDOSAGE • Clinical Presentation Signs and symptoms of opioid overdose include miosis (pinpoint pupils), sedation, hypotension, toxic leukoencephalopathy, delayed post-hypoxic leukoencephalopathy, respiratory depression, and death.
Nausea and vomiting may be observed. The major symptom requiring intervention is respiratory depression, which could lead to respiratory arrest and death. • Treatment of Overdose In the event of overdose, general supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient.
Symptomatic treatment of respiratory depression, following standard intensive care measures, should be performed. A patent airway and assisted or controlled ventilation must be assured. The patient should be transferred to an environment where full resuscitation facilities are available.
If the patient vomits, care must be taken to […]