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Dosage and Administration
Administer SUBOXONE sublingual film sublingually as a single daily dose. The recommended daily dose for maintenance treatment is 16mg/4mg buprenorphine and naloxone. Advise patients not to cut,chew, or swallow SUBOXONE sublingual film
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- Nausea and vomiting.
- Muscle aches.
- Respiratory depression.
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 [see Warnings and Precautions.
SUBOXONE sublingual film is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2 mg sublingual dose.
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Buprenorphine can be abused in a similar manner to other
opioids. 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.
Significant respiratory depression and death have occurred in association with buprenorphine, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol).
Consider dose reduction of CNS depressants, SUBOXONE sublingual film, or both in situations of concomitant prescription.
Store SUBOXONE sublingual film safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children. Chronic administration produces opioid-type physical dependence. Abrupt discontinuation or rapid dose taper may result in opioid withdrawal syndrome.Monitor liver function tests prior to initiation and duringtreatment and evaluate suspected hepatic events.
Do not administer SUBOXONE sublingual film to patients with known hypersensitivity to buprenorphine or naloxone.
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Caution patients about the risk of driving or operating hazardous machinery. WIKI