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INDICATIONS
SUBOXONE and SUBUTEX are indicated for the treatment of opioid dependence.
DOSAGE AND ADMINISTRATION
SUBUTEX or SUBOXONE is administered sublingually as a single daily dose in the range of 12 to 16 mg/ day. When taken sublingually, SUBOXONE and SUBUTEX have similar clinical effects and are interchangeable. There are no adequate and well-controlled studies using SUBOXONE as initial medication. SUBUTEX contains no naloxone and is preferred for use during induction. Following induction, SUBOXONE, due to the presence of naloxone, is preferred when clinical use includes unsupervised administration. The use of SUBUTEX for unsupervised administration should be limited to those patients who cannot tolerate SUBOXONE, for example those patients who have been shown to be hypersensitive to naloxone.
Method of administration
SUBOXONE and SUBUTEX tablets should be placed under the tongue until they are dissolved.
For doses requiring the use of more than two tablets, patients are advised to either place all the tablets at once or alternatively (if they cannot fit in more than two tablets comfortably) place two tablets at a time under the tongue. Either way, the patients should continue to hold the tablets under the tongue until they dissolve: swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.
Induction
Prior to induction, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use, and the degree or level of opioid dependence. To avoid precipitating withdrawal, induction with SUBUTEX should be undertaken when objective and clear signs of withdrawal are evident.
In a one-month study of SUBOXONE tablets induction was conducted with SUBUTEX tablets. Patients received 8 mg of SUBUTEX on day 1 and 16mg SUBUTEX on day 2. From day 3 onward, patients received SUBOXONE tablets at the same buprenorphine dose as day 2. Induction in the studies of buprenorphine solution was accomplished over 3-4 days, depending on the target dose. In some studies, gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period. Therefore it is recommended that an adequate maintenance dose, titrated to clinical effectiveness, should be achieved as rapidly as possible to prevent undue opioid withdrawal symptoms.
Patients taking heroin or other short-acting opioids:
At treatment initiation, the dose of SUBUTEX should be administered at least 4 hours after the patient last used opioids or preferably when early signs of opioid withdrawal appear.
Patients on methadone or other long-acting opioids
There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal symptoms are possible during induction to buprenorphine treatment. Withdrawal appears more likely in patients maintained on higher doses of methadone (>30mg) and when the first buprenorphine dose is administered shortly after the last methadone dose.
Maintenance
SUBOXONE is the preferred medication for maintenance treatment due to the presence of naloxone in the formulation.
Adjusting the dose until the maintenance dose is achieved
The recommended target dose of SUBOXONE is 16 mg/day. Clinical studies have shown that 16 mg of SUBUTEX or SUBOXONE is a clinically effective dose compared with placebo and indicate that doses as low as 12 mg may be effective in some patients. The dosage of SUBOXONE should be progressively adjusted in increments / decrements of 2 mg or 4 mg to a level that holds the patient in treatment and suppresses opioid withdrawal effects. This is likely to be in the range of 4mg to 24mg per day depending on the individual.
Reducing dosage and stopping treatment
The decision to discontinue therapy with SUBOXONE or SUBUTEX after a period of maintenance or brief stabilization should be made as part of a comprehensive treatment plan. Both gradual and abrupt discontinuation have been used, but no controlled trials have been undertaken to determine the best method of dose taper at the end of treatment.
HOW SUPPLIED
SUBOXONE is supplied as sublingual tablets in white HDPE bottles.
Hexagonal orange tablets containing 2 mg buprenorphine with 0.5 mg naloxone
NDC 12496-1283-2.........................30 tablets per bottle
Hexagonal orange tablets containing 8 mg buprenorphine with 2 mg naloxone
NDC 12496-1306-2.........................30 tablets per bottle
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]
SUBUTEX is supplied as sublingual tablets in white HDPE bottles.
Oval white tablets containing 2 mg buprenorphine
NDC 12496-1278-2.........................30 tablets per bottle
Oval white tablets containing 8 mg buprenorphine
NDC 12496-1310-2.........................30 tablets per bottle
Store at 25°C (77°F), excursions permitted to 15-30X (59-86°F) [see USP Controlled Room Temperature]
Manufactured by: Reckitt Benckiser Healthcare (UK) Ltd Hull, UK, HU87DS. Distributed by: Reckitt Benckiser Pharmaceuticals, Inc. Richmond, VA 23235. Last revised June 2005. FDA Rev date: 10/4/2006
Brand Name: Suboxone
Generic Name: Buprenorphine HCl and naloxone HCl
