Buprenorphine and Nalaxone

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 freatment of opioid dependence is limited to physicians 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.

Dosage Forms And Strengths

Buprenorphine and naloxone sublingual tablets are supplied as a hexagonal light pink tablet in two dosage strengths:

• buprenorphine/naloxone 2 mg/0.5 mg, and
• buprenorphine/naloxone 8 mg/2 mg

Storage And Handling

Buprenorphine and naloxone sublingual tablets are a hexagonal light pink tablet, debossed with a numeric imprint on one side identifying the strength, supplied in white HDPE bottles:

NDC 62175-452-32 (buprenorphine and naloxone 2 mg/0.5 mg/sublingual tablet; content expressed in terms of free base) debossed with a 2 on one side - 30 tablets per bottle

NDC 62175-458-32 (buprenorphine and naloxone 8 mg/2 mg/sublingual tablet; content expressed in terms of free base) debossed with an 8 on one side - 30 tablets per bottle

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

Patients should be advised to store buprenorphine-containing medications safely and out of sight and reach of children. Destroy any unused medication appropriately [see Disposal of Unused Buprenorphine and Naloxone Sublingual Tablets].

Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Revised: Feb 2016

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Events In Clinical Trials - Buprenorphine And Naloxone Sublingual Tablets

The safety of buprenorphine and naloxone sublingual tablets was evaluated in 497 opioid-dependent subjects. The prospective evaluation of buprenorphine and naloxone sublingual tablets was supported by clinical trials using buprenorphine sublingual tablets and other trials using buprenorphine sublingual solutions. In total, safety data were available from 3214 opioid-dependent subjects exposed to buprenorphine at doses in the range used in treatment of opioid addiction.

Few differences in adverse event profile were noted between buprenorphine and naloxone sublingual tablets and buprenorphine sublingual tablets or buprenorphine administered as a sublingual solution.

The following adverse events were reported to occur by at least 5% of patients in a 4-week study (Table 1).

Table 1: Adverse Events ≥ 5% by Body System and Treatment Group in a 4-week Study

The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenorphine solution, over a range of doses in four months of treatment. Table 2 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study.

Table 2: Adverse Events ( ≥ 5% ) by Body System and Treatment Group in a 16-week Study

Adverse Events - Post-marketing Experience With Buprenorphine And Naloxone Sublingual Tablets

The most frequently reported post-marketing adverse event not observed in clinical trials was peripheral edema.