Antifungals, Azole

Candidiasis (prophylaxis), Candidiasis, esophageal, Candidiasis, oropharyngeal, Candidiasis, disseminated,including peritonitis, pneumonia, and urinary tract infections, Candidiasis, vulvovaginal, Meningitis, cryptococcal, Meningitis, cryptococcal (suppression)

FDA Pregnancy Category C

Pregnancy

There are no adequate and well controlled studies in pregnant women, Fluconazole should be used in pregnancy only if the potential benefit justifies the possible risk to the fetus.

Breast-feeding

Fluconazole is distributed into breast milk at concentrations similar to those in plasma.

Patients allergic to one azole antifungal agent may also be allergic to the other antifungals in this family.

Contraindications

Except under special circumstances, this medication should not be used when the following medical problem exists:

Congestive heart failure (CHF), Congestive heart failure,History of, Ventricular dysfunction, Hypersensitivity to azole antifungals

Risk-benefit should be considered when the following medical problems exist:

Achlorhydria, Hypochlorhydria, Alcoholism, active or in remission or Hepatic function impairment, Congestive heart failure risk factors including: Cardiac ischemia, Chronic obstructive pulmonary disease, Other edematous disorders, Renal failure , Valvular disease Proarrhythmic conditions including:

Electrolyte abnormalities , Heart disease, structural , Medications , concomitant, Renal function impairment

Drug interactions

Alcohol, Hepatotoxic medications, Alprazolam, Diazepam, Midazolam, Triazolam, Antacids, Anticholinergics/antispasmodics or

Histamine H₂-receptor antagonists, Omeprazole , Other  proton pump inhibitors, Sucralfate, Antidiabetic agents oral, Astemizole, Terfenadine, Atorvastatin, Cerivastatin, Lovastatin, Simvastatin, Busulfan, Docetaxel, Vinca alkaloids, Calcium channel blockers including Felodipine, Nifedipine, Verapamil, Carbamazepine, Cisapride, Clarithromycin, Cyclosporine, Sirolimus, Tacrolimus, CYP₃A₄ inducers, CYP₃A₄ inhibitors, Didanosine, Digoxin, Disopyramide, Dofetilide, Quinidine, Drugs metabolized by CYP₃A₄ including: Alfentanil, Cilostazol, Eletriptan, Trimetrexate, Ergot alkaloids such as: Dihydroergotamine, Ergometrine(ergonovine), Ergotamine, Methylergometrine(methylergonovine), Erythromycin, Glucocorticosteroids such as Budesonide, Dexamethasone, Methylprednisolone, Halofantrine, Hydrochlorothiazide, Indinavir, Ritonavir, Saquinavir, Isoniazid, Rifampin, Levacetylmethadol(levomethadyl), Nevirapine, Phenobarbital, Phenytoin, Pimozide, Polyenes including, Amphotercin B, Rifabutin, Theophylline, Warfarin.

Candidiasis, vulvovaginal-Oral, 150 mg as a single dose

Safety and efficacy have not been established for children up to 18 years of age

Those indicating need for medical attention

Incidence less frequent:

Hypersensitivity (fever and chills; skin rash or itching)

Incidence rare:

Agranulocytosis, exfoliative skin disorders, including Stevens-Johnson syndrome, hepatotoxicity, thrombocytopenia

Incidence not determined:

Observed during clinical practice with fluconazole, estimates of frequency cannot be determined

angioedema, hypercholesterolemia, hypertriglyceridemia, hypokalemia, leukopenia including: neutropenia, QT prolongation, pruritus, seizures, torsades de pointes, toxic epidermal necrolysis

Those indicating need for medical attention only if they continue or are bothersome

Incidence less frequent:

Gastrointestinal disturbances

Incidence rare:

Gynecomastia, menstrual irregularities, photophobia

 Incidence not determined:

Observed during clinical practice with fluconazole , estimates of frequency cannot be determined

Alopecia, dyspepsia, dizziness, face edema, taste perversion

Store below 30°C (86°F). Protect from light, keep the medicine in the box and dry place.

Boxes of 7 Fluconazole Capsules  200  mg

Boxes of 10 Fluconazole Capsules 50 & 100 & 150  mg