Buprenex: Uses, Dosage and Side Effects Uses, Dosage & Side Effects
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Drug classOpioids
Strength0.3 mg/mL buprenorphine hydrochloride in a 1 mL ampule or single-dose vial, depending on the product presentation.
Dosage formSterile solution for intramuscular or intravenous injection.
Registration numberUS FDA New Drug Application (NDA) No. 018401.
Uses and indications
Buprenex is indicated for the relief of moderate to severe pain when an opioid analgesic is appropriate. It acts on opioid receptors in the central nervous system to reduce the perception of pain.
Contraindications
Buprenex is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment, known or suspected gastrointestinal obstruction including paralytic ileus, and hypersensitivity to…
Buprenex is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment, known or suspected gastrointestinal obstruction including paralytic ileus, and hypersensitivity to buprenorphine or any component of the formulation.
Side effects
Common adverse reactions include nausea, vomiting, dizziness, drowsiness, sweating, headache, and low blood pressure. Other possible effects include constipation, itching, and respiratory depression. Serious adverse reactions include life-threatening respiratory depression…
Common adverse reactions include nausea, vomiting, dizziness, drowsiness, sweating, headache, and low blood pressure. Other possible effects include constipation, itching, and respiratory depression. Serious adverse reactions include life-threatening respiratory depression, severe hypotension, adrenal insufficiency, opioid-induced hyperalgesia, and physical dependence. Misuse can cause addiction, overdose, or death.
Precautions
Buprenex is a potent opioid and must be administered by qualified healthcare professionals in a setting where respiratory and cardiovascular monitoring and emergency support are available. Use extreme caution in patients with respiratory disease, sleep apnea, head injury…
Buprenex is a potent opioid and must be administered by qualified healthcare professionals in a setting where respiratory and cardiovascular monitoring and emergency support are available. Use extreme caution in patients with respiratory disease, sleep apnea, head injury, reduced consciousness, liver impairment, or concurrent use of alcohol, benzodiazepines, or other central nervous system depressants. Monitor for sedation, respiratory depression, hypotension, and signs of misuse or dependence. Naloxone and appropriate resuscitation equipment should be available. Avoid abrupt discontinuation after prolonged use unless medically directed.
Dosage
The usual adult dose in the US prescribing information is 0.3 mg by deep intramuscular injection or slow intravenous injection over at least two minutes. If necessary, a further 0.3 mg dose may be given after 30–60 minutes, subject to the prescribing information and clinical…
The usual adult dose in the US prescribing information is 0.3 mg by deep intramuscular injection or slow intravenous injection over at least two minutes. If necessary, a further 0.3 mg dose may be given after 30–60 minutes, subject to the prescribing information and clinical assessment. In selected circumstances, a single dose may be increased to 0.6 mg under medical supervision. Dosing must be individualized according to pain severity, response, age, clinical condition, and other medications. Buprenex is for administration by healthcare professionals, not for unsupervised self-injection.
Drug interactions
Concurrent use with benzodiazepines, alcohol, sedatives, general anesthetics, muscle relaxants, or other opioids may increase the risk of profound sedation, respiratory depression, coma, and death. CYP3A4 inhibitors, including certain azole antifungals and macrolide antibiotics…
Concurrent use with benzodiazepines, alcohol, sedatives, general anesthetics, muscle relaxants, or other opioids may increase the risk of profound sedation, respiratory depression, coma, and death. CYP3A4 inhibitors, including certain azole antifungals and macrolide antibiotics, may increase buprenorphine exposure. CYP3A4 inducers, such as rifampin and carbamazepine, may reduce exposure or alter treatment response. Other medications that lower blood pressure may increase hypotension risk. Review all prescription medicines, over-the-counter products, and supplements before administration.
References
DailyMed, US National Library of Medicine; US Food and Drug Administration (FDA); official Buprenex prescribing information.
Important: The information on this page is provided for reference only and is not a substitute for diagnosis, prescribing, or treatment guidance from a doctor or pharmacist.
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