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Diflucan - Warnings & Precautions

[Fluconazole]



Single Dose

The convenience and efficacy of the single dose oral tablet of fluconazole regimen for the treatment of vaginal yeast infections should be weighed against the acceptability of a higher incidence of drug related adverse events with DIFLUCAN (26%) versus intravaginal agents (16%) in U. S. comparative clinical studies. (See ADVERSE REACTIONS and CLINICAL STUDIES.)

Drug Interactions:

(See CLINICAL PHARMACOLOGY: Drug Interaction Studies and CONTRAINDICATIONS.)

Clinically or potentially significant drug interactions between DIFLUCAN and the following agents/ classes have been observed. These are described in greater detail below:

Oral hypoglycemics Coumarin-type anticoagulants
Phenytoin Cyclosporine
Rifampin Theophylline
Terfenadine Cisapride
Astemizole Rifabutin
Tacrolimus

Oral hypoglycemics:

Clinically significant hypoglycemia may be precipitated by the use of DIFLUCAN with oral hypoglycemic agents; one fatality has been reported from hypoglycemia in association with combined DIFLUCAN and glyburide use. DIFLUCAN reduces the metabolism of tolbutamide, glyburide, and glipizide and increases the plasma concentration of these agents. When DIFLUCAN is used concomitantly with these or other sulfonylurea oral hypoglycemic agents, blood glucose concentrations should be carefully monitored and the dose of the sulfonylurea should be adjusted as necessary. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Coumarin-type anticoagulants:

Prothrombin time may be increased in patients receiving concomitant DIFLUCAN and coumarin-type anticoagulants. Careful monitoring of prothrombin time in patients receiving DIFLUCAN and coumarin-type anticoagulants is recommended. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Phenytoin:

DIFLUCAN increases the plasma concentrations of phenytoin. Careful monitoring of phenytoin concentrations in patients receiving DIFLUCAN and phenytoin is recommended. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)
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