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Description

Caution should be used when prescribing CONTRAVE to patients with predisposing factors that may increase the risk of seizure including: history of head trauma or prior seizure, severe stroke, arteriovenous malformation, central nervous system tumor or infection, or metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia) excessive use of alcohol or sedatives, addiction to cocaine or stimulants, or withdrawal from sedatives patients with diabetes treated with insulin and/or oral diabetic medications (sulfonylureas and meglitinides) that may cause hypoglycemia concomitant administration of medications that may lower the seizure threshold, including other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, systemic steroids Recommendations for Reducing the Risk of Seizure: Clinical experience with bupropion suggests that the risk of seizure may be minimized by adhering to the recommended dosing recommendations [see Dosage and Administration (2)], in particular: the total daily dose of CONTRAVE does not exceed 360 mg of the bupropion component (i.e., four tablets per day) the daily dose is administered in divided doses (twice daily) the dose is escalated gradually no more than two tablets are taken at one time coadministration of CONTRAVE with high-fat meals is avoided [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)] if a dose is missed, a patient should wait until the next scheduled dose to resume the regular dosing schedule 5.4 Patients Receiving Opioid Analgesics Vulnerability to Opioid Overdose: CONTRAVE should not be administered to patients receiving chronic opioids, due to the naltrexone component, which is an opioid receptor antagonist [see Contraindications (4)]