suboxone strips 8 mg
suboxone strips 8 mg film is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
INDICATIONS AND USAGE
SUBOXONE sublingual film is indicated for 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 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
SUBOXONE sublingual film is supplied as an orange rectangular sublingual film with a white printed logo in two
• buprenorphine/naloxone 2 mg/0.5 mg, and
• buprenorphine/naloxone 8 mg/2 mg.
HOW SUPPLIED / STORAGE AND HANDLING
SUBOXONE sublingual film is supplied as an orange rectangular film with a white printed logo in child‐resistant polyester/foil laminated pouches:
NDC 12496‐1202‐3 (buprenorphine 2 mg/naloxone 0.5 mg/film; content expressed in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP) ‐ 30 films per carton
- NDC 12496‐1204‐3 (buprenorphine 4 mg/naloxone 1 mg/film; content expressed in terms of free base, equivalent to 4.32 mg buprenorphine hydrochloride USP and 1.22 mg naloxone hydrochloride dihydrate USP) ‐ 30 films per carton
- NDC 12496‐1208‐3 (buprenorphine 8 mg/naloxone 2 mg/film; content expressed in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP) ‐ 30 films per carton
- NDC 12496‐1212‐3 (buprenorphine 12 mg/naloxone 3 mg/film; content expressed in terms of free base, equivalent to 12.96 mg buprenorphine hydrochloride USP and 3.66 mg naloxone hydrochloride dihydrate USP) ‐ 30 films per carton
How to take suboxone strips 8 mg
Your treatment is prescribed and monitored by doctors who are experienced in the treatment of drug dependence. Your doctor will determine the best dose for you. During your treatment, the doctor may adjust the dose, depending upon your response.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure
How to store suboxone strips 8 mg
Keep out of the sight and reach of children and other household members.
Do not use the medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month This medicinal product does not require any special storage conditions. However, Suboxone can be a target for people who abuse prescription medicine. Keep this medicine in a safe place to protect it from theft.
What suboxone strips 8 mg contains
- The active substances are buprenorphine and naloxone. Each 16 mg/4 mg sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate).
- The other ingredients are lactose monohydrate, mannitol, maize starch, povidone K30, citric acid anhydrous, sodium citrate, magnesium stearate, acesulfame potassium and natural lemon and lime flavour.
What Suboxone looks like and contents of the pack
Suboxone 16 mg/4 mg sublingual tablets are white round biconvex tablets of 10.5 mm with “N16” debossed on one side. Packed in packs of 7 and 28 tablets. Not all pack sizes may be marketed.
Indivior Europe Limited
27 Windsor Place
CYP3A4 Inhibitors and Inducers: Subjects receiving SUBOXONE sublingual film should be monitored if inhibitors of CYP3A4 such as azole antifungal agents (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin) or HIV protease inhibitors and may require dose-reduction of one or both agents.
The interaction of buprenorphine with all CYP3A4 inducers has not been studied, therefore it is recommended that patients receiving SUBOXONE sublingual film be monitored for signs and symptoms of opioid withdrawal if inducers of CYP3A4 (e.g., phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered .
Buprenorphine has been found to be a CYP2D6 and CYP3A4 inhibitor and its major metabolite, norbuprenorphine, has been found to be a moderate CYP2D6 inhibitor in in-vitro studies employing human liver microsomes. However, the relatively low plasma concentrations of buprenorphine and norbuprenorphine resulting from therapeutic doses are not expected to raise significant drug-drug interaction concerns.