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Suboxone contains a combination of buprenorphine and naloxone. Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

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SUBOXONE SUBLINGUAL FILM contains buprenorphine hydrochloride and naloxone hydrochloride at a ratio of 4:1 buprenorphine : naloxone. SUBOXONE (buprenorphine and naloxone) sublingual film is indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

SUBOXONE SUBLINGUAL FILM is a soluble film intended for sublingual administration. It is available in two dosage strengths, 2mg buprenorphine + 0.5mg naloxone and 8mg buprenorphine + 2mg naloxone. Each soluble film also contains acesulfame potassium, citric acid anhydrous, maltitol solution, hypromellose, polyethy.

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( DOSAGE AND ADMINISTRATION)
Treatment with SUBOXONE SUBLINGUAL FILM is intended for adults and children aged 16 years or over who have agreed to be treated for addiction. When initiating buprenorphine treatment, the physician should be aware that it can precipitate withdrawal in opioid-dependent patients if given too soon after the administration of heroin, methadone or another opiate. Suboxone Sublingual Film and Suboxone Sublingual Tablet do not meet all criteria for – 13 – bioequivalence (see section Pharmacokinetics). Patients being switched between tablets and soluble films may therefore require dosage adjustment. The route of administration of SUBOXONE SUBLINGUAL FILM is sublingual. SUBOXONE SUBLINGUAL FILMS should not be swallowed whole as this reduces the bioavailability of the medicine. Physicians must advise patients that the sublingual route is the only effective and safe route of administration for this medicine.

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SIDE EFFECTS

Along with its needed effects, buprenorphine/naloxone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Cough or hoarseness
Feeling faint, dizzy, or lightheaded
Feeling of warmth or heat
Fever or chills
Flushing or redness of the skin, especially on the face and neck
Headache
Lower back or side pain
Painful or difficult urination
Sweating
CONTRAINDICATIONS
SUBOXONE sublingual film should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported . More information on Wikipedia

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