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Dosage and Administration
Administer as a single daily dose of Suboxone: The recommended daily dose for maintenance treatment is 16mg/4mg buprenorphine and naloxone.The recommended daily dose for maintenance treatment is 11.4mg/2.8mg buprenorphine and naloxone.
Suboxone tablets are to be placed under the tongue until dissolved, which usually requires 2 to 10 minutes. Patients should not swallow or consume food or drink until the tablet is completely dissolved.The dose is made up from 2 mg and 8 mg sublingual tablets, which may be taken all at the same time or in two divided portions; the second portion to be taken directly after the first portion has dissolved.
Treatment with SUBOXONE sublingual tablets is intended for adults and children aged 16 years or over who have agreed to be treated for opioid dependence. When initiating SUBOXONE treatment, the physician should be aware of the partial agonist profile of the molecule to the µ opioid receptors, which can precipitate withdrawal in opioid-dependent patients if given too soon after the administration of heroin, methadone or another opioid. To avoid precipitating withdrawal, induction with buprenorphine should be undertaken when objective and clear signs of withdrawal are evident.
The route of administration of SUBOXONE is sublingual. The sublingual formulation is not designed to be split or broken. SUBOXONE tablets should not be swallowed as this reduces the bioavailability of the medicine. Physicians must advise patien
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Nausea, Vomiting, Drug withdrawal syndrome, Headache, Sweating, Numb mouth, Constipation, Swollen and/or painful tongue, the inside of your mouth is more red than normal, Intoxication (feeling lightheaded or drunk)
- Disturbance in attention, Irregular heart beat (palpitations),Decrease in sleep (insomnia),Blurred vision, Back pain Fainting, Dizziness and Sleepiness
- Difficulty sleeping, anxiety, nervousness
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- Pain in the abdomen, back, joints and muscles, leg cramps, muscle weakness,
- Flu like symptoms, such as chills, fever, sore throat, coughing, runny nose, watery eyes and sweating,
- Upset stomach and diarrhea.
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- Chronic hepatitis B
- Chronic Hepatitis C
- Untreated Decreased Level of Thyroid Hormones
- Decreased Function of the Adrenal Gland
- Psychosis caused by Sudden Alcohol Withdrawal
- Psychosis caused by poisonous agent alcohol intoxication
- Cor Pulmonale
- Blood Pressure Drop Upon Standing
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- Enlarged Prostate
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WARNINGS AND PRECAUTIONS
- 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 (5) route in combination with benzodiazepines or other CNS depressants (including alcohol).
- Consider dose reduction of CNS depressants, buprenorphine/naloxone or buprenorphine, or both in situations of concomitant prescription.
- Store buprenorphine/naloxone or buprenorphine products 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 during treatment and evaluate suspected hepatic events.
- Do not administer buprenorphine/naloxone or buprenorphine products to patients with known hypersensitivity to buprenorphine or naloxone.
- A marked and intense opioid withdrawal syndrome is highly likely to occur with parenteral misuse of buprenorphine/naloxone by individuals physically dependent on full opioid agonists or by sublingual administration before the agonist effects of other opioids have subsided.
- Neonatal withdrawal has been reported following use of buprenorphine by the mother during pregnancy.
- Buprenorphine/naloxone or buprenorphine is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received smaller doses of buprenorphine.
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Caution patients about the risk of driving or operating hazardous machinery. WIKI