FUNGICON FLUCONAZOLE USP

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QUANTITY : 10 CAPSULES

Indication :

~ Superficial candidal infections such as oral or vaginal thrush

~ Esophagitis caused by Candida or other susceptible species

~ Maintenance therapy of cryptococcal meningitis

~ Disseminated candidiasis

~ Prophylaxis for fungal infection in neutropenic cancer patients

~ Acute treatment of other systemic fungal infections

~ Dermatophyte and Candida skin infections

~ Fungal UTIs

Dosage and Administration :

                               Fluconazole is usually given orally; generally, the total daily dose is given at once unless nausea ensues, in which case the dose may be divided.

~ Vaginal candidiasis and candidal balanitis, by mouth, a single dose of 150 mg.

~ Mucosal candidiasis (except genital), by mouth, 50 mg daily (100 mg daily is usually difficult infections) given for 7-14 days in oropharyngeal candidiasis; for 14-30 days in other mucosal infections (e.g. oesophagitis, candiduria, non-invasive bronchopulmonary infections); Child : by mouth 3-6 mg/kg on 1st day then 3 mg/kg daily (every 72 hours in neonate up to 2 weeks old and every 48 hours in neonate 2-4 weeks old).

~ Tinea pedis, corporis, cruris, pityriasis Versicolor,and dermal candidiasis, by mouth, 50 mg daily for 2-4 weeks (for up to 6 weeks in tinea pedis; maximum duration of treatment six weeks.)

~ Invasive candidal infections including candidaemia and disseminated candidiasis and cryptococcal infections including meningitis, by mouth 400 mg initially then 200 mg daily, increased if necessary to 400 mg daily, treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis); Child 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily.

~ Prevention of relapse of cryptococcal meningitis, by mouth, 100-200 mg daily.

~ Prevention of fungal infections in immunocompromised patients following cytotoxic chemotherapy or radiotherapy, by mouth 50-400 mg daily adjusted according to risk; Child according to extent and duration of neutropenia, 3-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old); maximum 400 mg daily.

Contraindications

~ Known hypersensitivity

~ Advanced liver disease

Warning & Precautions

Cautions should be taken in renal impairment; in hepatic disease, liver function should be monitored and should be discontinued if signs or symptoms of the hepatic disease appear.

Pregnancy & Lactation

There are limited data on the use of Fluconazole in the pregnant woman. However, Fluconazole should be used in pregnancy only when the benefit outweighs the risk.

Fluconazole is excreted in breast milk in levels about half of those found in plasma; therefore, the drug should be avoided during lactation.

Adverse effects

Nausea, abdominal discomfort, diarrhoea, flatulence, headache, rash; less frequently dyspepsia, vomiting, abnormalities in liver enzymes, seizures, alopecia and Stevens-Johnson syndrome reported. Weight gain, abnormalities of liver function tests.

Drug Interactions

Fluconazole decreases the metabolism of Cyclosporine and Phenytoin and increases the AUC of Retinoic acid. Fluconazole increases bleeding time in patients treated with Warfarin. Concomitant use of Fluconazole reduces the mean plasma clearance of Theophylline and increases the plasma levels of Zidovudine and concentration of oral hypoglycemics. Rifampin induces the metabolism of Fluconazole.

Overdose

In the case of an overdose, supportive measures should be instituted.

Storage

Store below 30 °C in a cool and dry place. Protect from light. Keep out of reach of children.