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SUBUTEX is most often used for the first 1 or 2 days to help you start with treatment.

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Dosage and administrations

Prescription use of this product is limited under the Drug Addiction Treatment Act. Administer SUBUTEX sublingually as a single daily dose. To avoid precipitating withdrawal, induction with SUBUTEX should be undertaken when objective and clear signs of withdrawal are evident. SUBOXONE® ( buprenorphine and naloxone ) sublingual film or SUBOXONE® (buprenorphine and naloxone) sublingual tablet is generally initiated after two days of SUBUTEX titration. Administer SUBUTEX as directed in the Full Prescribing Information.SUBUTEX must be administered whole. Do not cut, chew, or swallow SUBUTEX when discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal.

Side Effects

• Nausea and vomiting.
• Muscle pains and cramping.
• Reduced quality and quantity of sleep.
• Increased cravings for the substance.
• Mild feelings of euphoria.
• Reduced sensations of pain.
• Physical and mental relaxation.
• Slowed breathing.

Contraindications

SUBUTEX sublingual tablet should not be administered to patients who have been shown to be hypersensitive to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported

WARNINGS

Buprenorphine can be abused in a manner similar to other opioids, legal or illicit. Prescribe and dispense buprenorphine with appropriate precautions to minimize risk of misuse, abuse, or diversion, and ensure appropriate protection from theft, including in the home. Clinical monitoring appropriate to the patient’s level of stability is essential. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits. Buprenorphine, particularly when taken by the IV route, in combination with benzodiazepines or other CNS depressants (including alcohol), has been associated with significant respiratory depression and death. Many, but not all post-marketing reports regarding coma and death associated with the concomitant use of buprenorphine and benzodiazepines involved misuse by self-injection. Deaths have also been reported in association with concomitant administration of buprenorphine with other depressants such as alcohol or other CNS depressant drugs. Patients should be warned of the potential danger of self-administration of benzodiazepines or other depressants while under treatment with SUBUTEX sublingual tablet

Neonatal withdrawal has been reported following use of buprenorphine by the mother during pregnancy

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