Comment
Author: Admin | 2025-04-28
Effects of potent cytochrome P450 isoenzyme inhibition, such as the ketoconazole inhibition of CYP3A4, on fluvoxamine metabolism have not been studied. A clinically significant fluvoxamine interaction is possible with drugs having a narrow therapeutic ratio such as pimozide, warfarin, theophylline, certain benzodiazepines, omeprazole and phenytoin. If fluvoxamine maleate tablets are to be administered together with a drug that is eliminated via oxidative metabolism and has a narrow therapeutic window, plasma levels and/or pharmacodynamic effects of the latter drug should be monitored closely, at least until steady-state conditions are reached [see Contraindications (4), Warnings and Precautions (5)] . 7.2 CNS Active Drugs Antipsychotics:[see Warnings and Precautions (5.2)]. Benzodiazepines:[see Warnings and Precautions (5.8)]. Alprazolam:[see Warnings and Precautions (5.8)]. Diazepam:[see Warnings and Precautions (5.8)]. Lorazepam:A study of multiple doses of fluvoxamine maleate tablets (50 mg b.i.d.) in healthy male volunteers (N = 12) and a single dose of lorazepam (4 mg single dose) indicated no significant pharmacokinetic interaction. On average, both lorazepam alone and lorazepam with fluvoxamine produced substantial decrements in cognitive functioning; however, the co-administration of fluvoxamine and lorazepam did not produce larger mean decrements compared to lorazepam alone. Alcohol:Studies involving single 40 g doses of ethanol (oral administration in one study and intravenous in the other) and multiple dosing with fluvoxamine maleate tablets (50 mg b.i.d.) revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of the other. As with other psychotropic medications, patients should be advised to avoid alcohol while taking fluvoxamine maleate tablets. Carbamazepine:Elevated carbamazepine levels and symptoms of toxicity have been reported with the co-administration of fluvoxamine maleate tablets and carbamazepine. Clozapine:[see Warnings and Precautions (5.8)]. Lithium:As with other serotonergic drugs, lithium may enhance the serotonergic effects of fluvoxamine and, therefore, the combination should be used with caution. Seizures have been reported with the co-administration of fluvoxamine maleate tablets and lithium. Methadone:[see Warnings and Precautions (5.8)]. Monoamine Oxidase Inhibitors:[see Dosage and Administration (2.4, 2.5), Contraindications (4), Warnings and Precautions (5.2)]. Pimozide:[see Contraindications (4), Warnings and Precautions (5.6)]. Ramelteon:[see Warnings and Precautions (5.8)]. Serotonergic Drugs:[see Dosage and Administration (2.4, 2.5), Contraindications (4), Warnings and Precautions (5.2)]. Tacrine:In a study of 13 healthy, male volunteers, a single 40 mg dose of tacrine added to fluvoxamine 100 mg/day administered at steady-state was associated with five-fold and eight-fold increases in tacrine C maxand AUC, respectively, compared to the administration of tacrine alone. Five subjects experienced nausea, vomiting, sweating, and diarrhea
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