Buprenorphine and Naloxone Sublingual Tablets for Sublingual Administration, USP CIII 8 mg/2 mg
This information is intended for U.S. healthcare professionals only.
INDICATIONS AND USAGE
Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
IMPORTANT RISK INFORMATION
- Buprenorphine and Naloxone Sublingual Tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported.
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).
- Buprenorphine and Naloxone Sublingual Tablets should be used with caution in patients with compromised respiratory function.
- Patients receiving buprenorphine in the presence of CNS depressants may exhibit increased CNS depression. Consider dose reduction of CNS depressants, Buprenorphine and Naloxone Sublingual Tablets, or both in situations of concomitant prescribing.
- Buprenorphine can cause severe, possibly fatal, respiratory depression in children. Store Buprenorphine and Naloxone Sublingual Tablets safely out of the sight and reach of children and destroy any unused medication appropriately.
- Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Observe newborns for signs of NOWS and manage accordingly; NOWS may be life‑threatening if not recognized and treated in neonates.
- Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If adrenal insufficiency is diagnosed, treat with physiologic replacement of corticosteroids and wean patient off of the opioid until adrenal function recovers.
- 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 and Naloxone Sublingual Tablets to patients with known hypersensitivity to buprenorphine or naloxone.
- A marked and intense opioid withdrawal syndrome is highly likely to occur with parenteral misuse of Buprenorphine and Naloxone Sublingual Tablets by individuals physically dependent on full opioid agonists or by sublingual administration before the agonist effects of other opioids have subsided.
- Buprenorphine and Naloxone Sublingual Tablets are 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.
- Like other opioids, Buprenorphine and Naloxone Sublingual Tablets may produce orthostatic hypotension in ambulatory patients.
- As with other opioids, buprenorphine may elevate cerebrospinal fluid pressure and should be used in caution in patients where cerebrospinal pressure may be increased.
- As with other opioids, buprenorphine has been shown to increase intracholedochal pressure and should be administered with caution in patients with biliary tract dysfunction.
- As with other opioids buprenorphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
- Buprenorphine and Naloxone Sublingual Tablets should be used with caution in debilitated patients and those with myxedema or hypothyroidism, adrenal cortical insufficiency; CNS depression or coma; toxic psychoses; prostatic hypertrophy or urethral stricture; acute alcoholism; delirium tremens; or kyphoscoliosis.
Adverse events commonly observed with the sublingual administration of the buprenorphine and naloxone sublingual tablets during clinical trials and postmarketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
This is not a complete list of potential adverse events associated with buprenorphine-containing products. Please see Full Prescribing Information for a complete list.
||Orange/hexagonal sublingual tablet
||8 mg/2 mg
||Suboxone sublingual tablets (withdrawn from market)
||8 mg/2 mg are supplied as orange, mottled, hexagonal tablets debossed “8N” on one side and “M” in a box on the other side
For additional information on Buprenorphine and Naloxone Sublingual Tablets for Sublingual Administration, USP CIII 8 mg/2 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.