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Buprenorphine (Buprenorphine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS & USAGE

Buprenorphine HCl sublingual tablets is indicated for the treatment of opioid dependence.

 

DOSAGE & ADMINISTRATION

Buprenorphine HCl sublingual tablets is administered sublingually as a single daily dose in the range of 12 to 16 mg/day. Buprenorphine HCl sublingual tablets contains no naloxone and is preferred for use during induction. Following induction, buprenorphine and naloxone sublingual tablets, due to the presence of naloxone, is preferred when clinical use includes unsupervised administration. The use of buprenorphine HCl sublingual tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine and naloxone sublingual tablets, for example those patients who have been shown to be hypersensitive to naloxone.

 

Buprenorphine HCl sublingual 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.

 

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 buprenorphine HCl sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident.

In a one-month study of buprenorphine and naloxone sublingual tablets induction was conducted with buprenorphine HCl sublingual tablets. Patients received 8 mg of buprenorphine HCl sublingual tablets on Day 1 and 16 mg buprenorphine HCl sublingual tablets on Day 2. From Day 3 onward, patients received buprenorphine and naloxone sublingual tablets at the same buprenorphine dose as Day 2. Induction in the studies of buprenorphine solution was accomplished over 3 to 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.

 

At treatment initiation, the dose of buprenorphine HCl sublingual tablets should be administered at least 4 hours after the patient last used opioids or preferably when early signs of opioid withdrawal appear.

 

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 (>30 mg) and when the first buprenorphine dose is administered shortly after the last methadone dose.

 

Buprenorphine and naloxone sublingual tablets is the preferred medication for maintenance treatment due to the presence of naloxone in the formulation.

 

The recommended target dose of buprenorphine HCl sublingual tablets is 16 mg/day. Clinical studies have shown that 16 mg of buprenorphine HCl sublingual tablets 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 buprenorphine HCl sublingual tablets 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 4 to 24 mg/day depending on the individual.

 

The decision to discontinue therapy with buprenorphine HCl sublingual tablets 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

Buprenorphine HCl sublingual tablets is supplied in white HDPE bottles.

2 mg - White, round, biconvex uncoated tablets with "2" debossed on one side and a dart "→" debossed on the other side

NDC 50383-924-93 30 tablets per bottle

8 mg - White, round, biconvex uncoated tablets with "8" debossed on one side and a dart "→" debossed on the other side

NDC 50383-930-93 30 tablets per bottle

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]

 

SPL UNCLASSIFIED

Manufactured by:
Ethypharm S.A.
76121 Le Grand Quevilly cedex
France

Distributed by:
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Tel.: 1-888-775-1770
www.hitechpharm.com/drugsafety

Rev. 924/930:00 2/11

 

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