Vandazole

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE VANDAZOLE ® is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in post-menarchal females. VANDAZOLE is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in post-menarchal females. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION The recommended dose is one applicator full of VANDAZOLE, (approximately 5 grams of gel containing approximately 37.5 mg of metronidazole) administered intravaginally once a day for 5 days. For once a day dosing, VANDAZOLE should be administered at bedtime [see Patient Counseling Information ( 17.4 )] . Not for ophthalmic, dermal, or oral use. One applicator full of VANDAZOLE administered intravaginally once a day for 5 days. ( 2 ) Not for ophthalmic, dermal, or oral use. ( 2 ) Warnings and cautions 5 WARNINGS AND PRECAUTIONS Central and Peripheral Nervous System Effects: Convulsive seizures and peripheral neuropathy have been reported in patients treated with oral or intravenous metronidazole; discontinue if abnormal neurologic signs develop. ( 5.1 ) Carcinogenicity in Animals: Metronidazole has been shown to be carcinogenic in mice and rats. ( 5.2 , 13.1 ) Interference with laboratory tests: Metronidazole may interfere with certain serum chemistry laboratory values ( 5.3 ) 5.1 Central and Peripheral Nervous System Effects Use of oral or intravenous metronidazole is associated with convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity [see Adverse Reactions ( 6.2 )] . VANDAZOLE should be administered with caution to patients with central nervous system diseases. Discontinue VANDAZOLE promptly if a patient develops abnormal neurologic signs. 5.2 Carcinogenicity in Animals Metronidazole has been shown to be carcinogenic in mice and rats [see Nonclinical Toxicology ( 13.1 )] . Unnecessary use of metronidazole should be avoided. Use of VANDAZOLE should be reserved for the treatment of bacterial vaginosis [see Indications and Usage ( 1 )] . 5.3 Interference with Laboratory Tests Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and glucose hexokinase. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide-adenine dinucleotides (NAD + NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7. Consider postponing chemistry laboratory tests until treatment with VANDAZOLE is completed. Drug interactions 7 DRUG INTERACTIONS The intravaginal administration of a single 5 gram dose of VANDAZOLE results in relatively lower mean systemic exposure to metronidazole that is approximately 2% to 5% of that achieved following a 500 mg oral dose of metronidazole [see Clinical Pharmacology ( 12.3 )] . The following drug interactions were reported for oral metronidazole. Warfarin and other coumarin anticoagulants: Prolonged anticoagulant effects reported with oral metronidazole; monitor INR and prothrombin time. ( 7.3 ) Lithium: Elevated lithium concentrations reported with oral metronidazole; monitor serum concentrations of lithium. ( 7.4 ) 7.1 Disulfiram Use of oral metronidazole has been associated with psychotic reactions in alcoholic patients who are using disulfiram concurrently. VANDAZOLE should not be used by patients who have taken disulfiram within the last two weeks [see Contraindications ( 4.2 )] . 7.2 Alcoholic Beverages Use of oral metronidazole has been associated with a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) to alcohol. Alcoholic beverages and preparations containing ethanol or propylene glycol should not be consumed during and for at least three days after VANDAZOLE therapy [see Contraindications ( 4.3 )] . 7.3 Coumarin and Other Oral Anticoagulants Use of oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when VANDAZOLE is prescribed for patients on this type of anticoagulant therapy. In patients on oral anticoagulants, consider monitoring prothrombin time, international normalized ratio (INR), and other coagulation parameters while on VANDAZOLE. 7.4 Lithium Short-term use of oral metronidazole has been associated with elevation of serum lithium concentrations and, in a few cases signs of lithium toxicity, in patients stabilized on relatively high doses of lithium. Use VANDAZOLE with cauti