Composition

Flumart-150: Each capsule contains Fluconazole USP 150 mg.

Pharmacology

Fluconazole is a triazole antifungal drug that acts by inhibition of the ergosterol component of the fungal cell membrane. It is active against a broad spectrum of fungal pathogens. Fluconazole is normally administered orally. Following oral administration, absorption is rapid and extensive, with > 90% of the dose being absorbed. Bioavailability is the same in the fasting and fed states. The bioavailability of Fluconazole is unaffected by gastric PH. The plasma protein binding of Fluconazole is low, at 11% and the drug is widely distributed throughout the body. Most of the dose of Fluconazole is excreted unchanged in the urine, the remainder of the dose being eliminated in the urine as metabolites.   

Indication

Flumart (Fluconazole) is indicated for the treatment of:

1. Vaginal candidiasis.
2. Mucosal candidiasis: Oropharyngeal candidiasis, esophagitis, candiduria, systemic candidiasis (including candidaemia and disseminated candidiasis).
3.  Cryptococcal infections (including meningitis).
4. Tinea pedis, tinea corporis, tinea cruiris, tinea versicolor, dermal candidiasis and onychomychosis.

Dosage and administration

Adults:

• Vaginal candidiasis: A single dose of 150 mg.
• Mucosal candidiasis (except vaginal): 50 mg daily (100 mg daily in unusually difficult infections) given for 7-14 days in oropharyngeal candidiasis; for 14-30 days in other mucosal infections (e.g. esophagitis, candiduria).
• Systemic candidiasis and cryptococcal infections (including meningitis): 400 mg initially, then 200 mg daily; increased if necessary to 400 mg daily; treatment continued according to response.
• Tinea pedis, tinea corporis, tinea cruiris, tinea versicolor, dermal candidiasis: 50 mg daily for 2-4 weeks (for up to 6 weeks in tinea pedis); maximum duration of treatment is 6 weeks.
•  Onychomychosis: 150 mg 1 day per week for 6 months.

Children:

Child over 1 year with normal renal function:

• Superficial candidial infections: 1-2 mg/kg body weight daily.
• Systemic candidiasis and cryptococcal infections: 3-6 mg/kg body weight daily. In serious life threatening infections up to 12 mg/kg daily may be given to children aged 5-13 years. The maximum approved daily dose of 400 mg should not be exceeded.

Or as directed by the physician.

Contraindication

It is contraindicated for nursing mothers and in patients hypersensitive to this drug.

Side effects

Nausea, vomiting, abdominal discomfort, diarrhea and flatulence may appear which is very rare, mild and transient.

Precaution

In patients with renal impairment the dosage schedule should be reduced in accordance with the degree of renal impairment. Children below the age of 1 year, the use of Fluconazole is not recommended.

Drug interaction

Rifampicin reduces plasma concentration of Fluconazole. Effect of nicoumalone, phenytoin and warfarin is enhanced and plasma concentrations of sulphonylureas and theophylline are possibly increased by Fluconazole.

Overdosage

In case of overdose, supportive measures and gastric lavage should be instituted. If deemed necessary, a three (3) hours hemodialysis will decrease plasma levels by about 50%.

Pharmaceutical precaution

Store in a cool, dry place and protect from light. Keep out of reach of children.

Packing

Flumart-150: Box containing 2x 6 capsules in alu-alu blister pack.