Buprenorphine | Suboxone
Indications and Usage:
SUBOXONE sublingual film is indicated for maintenance treatment of opioid dependence. Prescription use of this product is limited under the Drug Addiction Treatment Act. (1)
Dosage and Administration:
Administer SUBOXONE sublingual film sublingually as a single daily dose. (2) The recommended daily dose for maintenance is 16/4 mg.
Dosage Forms and Strengths:
Sublingual film: 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. (3)
—–INDICATIONS AND USAGE—–
- See description above.
—–DOSAGE AND ADMINISTRATION—–
- See description above.
—–CONTRAINDICATIONS—–
- Hypersensitivity to buprenorphine or naloxone. (4)
—–WARNINGS & PRECAUTIONS—–
- Buprenorphine can be abused in a similar manner to other opioids. Clinical monitoring appropriate to the patient’s level of stability is essential. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits. (5.1)
- Significant respiratory depression and death have occurred in association with buprenorphine, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol). (5.2)
- Consider dose reduction of CNS depressants, SUBOXONE sublingual film, or both in situations of concomitant prescription. (5.3)
- Store SUBOXONE sublingual film safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children. (5.4)
- Chronic administration produces opioid-type physical dependence. Abrupt discontinuation or rapid dose taper may result in opioid withdrawal syndrome. (5.5) • Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events. (5.6)
- Do not administer SUBOXONE sublingual film to patients with known hypersensitivity to buprenorphine or naloxone. (5.7)
- A marked and intense opioid withdrawal syndrome is highly likely to occur with parenteral misuse of SUBOXONE sublingual film by individuals physically dependent on full opioid agonists or by sublingual administration before the agonist effects of other opioids have subsided. (5.8)
- Neonatal withdrawal has been reported following use of buprenorphine by the mother during pregnancy. (5.9)
- SUBOXONE sublingual film is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2 mg sublingual dose. (5.10)
- Caution patients about the risk of driving or operating hazardous machinery. (5.11)
—–ADVERSE REACTIONS—–
- Adverse events commonly observed with the sublingual administration of the SUBOXONE sublingual film was oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. (6.1)
—–DRUG INTERACTIONS—–
- Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under dosing. (7.1)
- Use caution in prescribing SUBOXONE sublingual film for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant selfadministration/misuse. (7.3)
—–USE IN SPECIFIC POPULATIONS—–
- SUBOXONE sublingual film is not indicated for use during pregnancy unless potential benefit justifies potential risk. (8.1)
- Buprenorphine passes into the mother’s milk. Breast-feeding is not advised while taking SUBOXONE sublingual film. (8.3)
- Safety and effectiveness of SUBOXONE sublingual film in patients below the age of 16 has not been established. (8.4)
- Administer SUBOXONE sublingual film with caution to elderly or debilitated patients. (8.5)
- Administer SUBOXONE sublingual film with caution to patients with liver dysfunction. (8.6)