|Click on "►" to expand:|
 BRAND NAMES
 MECHANISM OF ACTION
Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.
Naloxone is a potent antagonist at mu-opioid receptors and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.
Buprenorphine/Naloxone is indicated for treatment of opioid dependence.
- For patients dependent on short-acting opioid products who are in opioid withdrawal; on Day 1, administer up to 8 mg/ 2 mg Buprenorphine/Naloxone sublingual film (in divided doses). On Day 2, administer up to 16 mg/4 mg of Buprenorphine/Naloxone sublingual film as a single dose.
- For patients dependent on methadone or long-acting opioid products, induction onto sublingual buprenorphine monotherapy is recommended on Days 1 and 2 of treatment.
- For maintenance treatment, the target dosage of Buprenorphine/Naloxone sublingual film is usually 16 mg/4 mg as a single daily dose.
- Place the Buprenorphine/Naloxone sublingual film under the tongue, close to the base on the left or right side and allow to completely dissolve. Film should not be chewed, swallowed, or moved after placement.
 DOSAGE FORMS AND STRENGTHS
- 2 mg buprenorphine with 0.5 mg naloxone
- 4 mg buprenorphine with 1 mg naloxone
- 8 mg buprenorphine with 2 mg naloxone
- 12 mg buprenorphine with 3 mg naloxone
Hypersensitivity to buprenorphine or naloxone
 WARNINGS AND 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.
- 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).
- Consider dose reduction of CNS depressants, Buprenorphine/Naloxone sublingual film,or both in situations of concomitant prescription.
- Store Buprenorphine/Naloxone sublingual film safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
- Chronic administration produces opioid-type physical dependence. Abrupt discontinuation or rapid dose taper may result in opioid withdrawal syndrome.
- Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.
- Do not administer Buprenorphine/Naloxone sublingual film to patients with known hypersensitivity to buprenorphine or naloxone.
- An opioid withdrawal syndrome is likely to occur with parenteral misuse of Buprenorphine/Naloxone sublingual film by individuals physically dependent on full opioid agonists or by sublingual administration before the agonist effects of other opioids have subsided.
- Neonatal withdrawal has been reported following use of buprenorphine by the mother during pregnancy.
- Buprenorphine/Naloxone sublingual film is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2 mg sublingual dose.
- Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.
- Caution patients about the risk of driving or operating hazardous machinery.
- Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under dosing.
- Use caution in prescribing Buprenorphine/Naloxone sublingual film for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self-administration/misuse
 PREGNANCY AND LACTATION
- Pregnancy Category C (US): Based on animal data, may cause fetal harm.
- Nursing mothers: Caution should be exercised when administered to a nursing woman.
 SIDE EFFECTS
Adverse events commonly observed with the sublingual administration of the Buprenorphine/Naloxone sublingual film were oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
 RELATED LINKS
- http://www.suboxone.com/content/pdfs/SuboxonePI.pdf (Revised: April 2014)