Subutex

Subutex buprenomorphine 8mg, 2. QUALITAVE AND QUANTITATIVE COMPOSITION Buprenorphine hydrochloride equivalent to Subutex buprenomorphine 8mg base: 2mg or 8mg. 3. PHARMACEUTICAL FORM Sublingual tablet 4. CLINICAL PARTICULARS 4.1 Therapeutic indication Substitution treatment for opioid drug dependence, within framework of medical, social and psychological treatment. 4.2 Posology and method of administration Treatment with SUBUTEX sublingual tablets is intended for use in adults and children aged 16 years or over who have agreed to be treated for addiction. Administration is sublingual. Physicians must advise patients that the sublingual route is the only effective and safe route of administration for this drug. The tablet should be kept under the tongue until dissolved, which usually occurs within 5 to 10 minutes. Adults Initiation therapy:

Baseline liver function tests documentation of viral hepatitis status is recommended prior to commencing therapy. Patients who are positive for viral hepatitis, on concomitant medication (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury. Regular monitoring of liver function is recommended (see section 4.4) Induction: Prior to treatment induction, consideration should be given to the types of opioid dependence (i.e. long- or short- acting opioid), the time since last opioid use and the degrees of opioid dependence. To avoid precipitating withdrawal, induction with Subutex should be undertaken when objective and clear signs of withdrawal are evident. – The initial dose is from 0.8mg to 4mg, administered as a single daily dose.   Subutex buprenomorphine 8mg sublingual tablet is an uncoated oval white tablet, imprinted with a sword logo on one side and an alphanumeric imprint identifying the product and strength. It contains buprenorphine HCl and is available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as free base). Each tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy- 6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure: Subutex buprenomorphine 8mg has the molecular formula C₂₉H₄₁NO₄ • HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane.

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 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 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

The safety of SUBUTEX sublingual tablet was supported by clinical trials using SUBUTEX sublingual tablet, SUBOXONE (buprenorphine/naloxonesublingual tablet) and other trials using buprenorphine sublingual solutions. In total, safety data were available from 3214 opioid-dependent subjects exposed to Subutex buprenomorphine 8mg at doses in the range used in treatment of opioid addiction. Few differences in adverse event profile were noted betweenSubutex buprenomorphine 8mg administered as a sublingual solution.