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Human

Flugal®

Suspension

50 mg/ 5 ml

GENERIC NAMEFluconazole

MANUFACTURED BYSquare Pharmaceuticals PLC

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Available Pack Sizes:2 Sizes

Purchase Option:Full Pack

Maximum Retail Price (MRP):

Quantity

৳ 78.53/ 10 x 3

(Unit: ৳ 78.53 / 1 Suspension)

16263

Composition

Flugal® 50 Capsule: Each capsule contains Fluconazole EP 50 mg.

Flugal® 150 Capsule: Each capsule contains Fluconazole EP 150 mg.

Flugal® 200 Capsule: Each capsule contains Fluconazole EP 200 mg.

Flugal® Oral suspension: Each 5 ml reconstituted suspension contains Fluconazole USP 50 mg.

Flugal® IV Infusion: Each ml infusion contains Fluconazole BP 2 mg.

Description

Fluconazole is a triazole antifungal drug which acts by inhibition of the ergosterol component of the fungal cell membrane. It is active against abroad spectrum of fungal pathogens and is available for oral use. Following oral administration, absorption is rapid and extensive (>90%). Bioavailability is the same in the fasting and fed states. The bioavailability of Fluconazole is unaffected by gastric pH. The plasma half-life is approximately 30h. 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.

Indications

Fluconazole is indicated in the treatment of acute or recurrent vaginal candidiasis, mucosal candidiasis (as oropharyngeal candidiasis, oesophagitis, candiduria), systemic candidiasis and cryptococcal infections (including meningitis).

Dosage & Administration

Adults:

Since oral absorption is rapid and almost complete, the daily dose of Fluconazole is the same for oral and intravenous administration.

Oropharyngeal Candidiasis: The recommended dosage of Fluconazole for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily for 7-14 days.

Esophageal Candidiasis: The recommended dosage of Fluconazole for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily for 2-3 weeks.

Systemic Candidiasis and Cryptococcal Meningitis: 400 mg daily followed by 200 mg once daily. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks.

Acute or recurrent vaginal candidiasis: Single dose of 150 mg.

Urinary Tract Infections and Peritonitis: 50 to 200 mg once daily.

Prophylaxis in Patients Undergoing Bone Marrow Transplantation: 400 mg once daily.

Children:

Oropharyngeal Candidiasis: The recommended dosage of Fluconazole for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.

Esophageal Candidiasis: Recommended dosage of Fluconazole in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily.

Cryptococcal meningitis: Initial therapy should be started with 6 to 12 mg/kg daily. Doses up to 12 mg/kg/day may be used for three weeks and treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks.

Interaction

Rifampicin reduces plasma concentration of Fluconazole. Effects of nicoumalone, phenytoin and warfarin are enhanced. Plasma concentrations of sulphonylureas & theophylline are possibly increased.

Contraindications

Fluconazole is contraindicated to patients hypersensitive to this drug and in advanced liver disease.

Side Effects

Nausea, abdominal discomfort, diarrhoea and flatulence, occasionally abnormalities of liver enzymes; rarely rash; angioedema and anaphylaxis reported.

Precautions & Warnings

Caution should be taken in renal impairment, pregnancy and breast feeding and in raised liver enzymes. The use of Fluconazole in lactating mothers is not recommended.

Storage Conditions

Store below 30°C. Protect from light & moisture. Remaining reconstituted suspension should not be used after 7 days. If it is kept under freezing temperature (2 °C - 8 °C), it can be used for 14 days. Keep out of the reach of children.

HOW SUPPLIED**.

Flugal® 50 Capsule: Box containing 30 capsules in blister pack. Flugal® 150 Capsule: Box containing 20 capsules in blister pack. Flugal® 200 Capsule: Box containing 12 capsules in blister pack. Flugal® Oral suspension: Bottle of dry powder for reconstitution to 35 ml suspension. Flugal® IV Infusion: Each glass bottle contains.

Flugal® • 10 x 3

৳ 78.53