Class: Antifungal

Manufacturer: Universal Corporation Ltd, Club Road, Plot No. 13777, Kenya.

Dosage Form: Capsule

Similar Brands:

Uses:

Flutrox (fluconazole) is indicated for;

1. Vaginal candidiasis,
2. Mucosal candidiasis e.g. oropharyngeal, oesophageal, mucocutaneous and chronic oral atrophic candidiasis e.t.c,
3. Systemic candidiasis: candidaemia, disseminated candidiasis, infection of peritoneum, respiratory and urinary tract.
4. Cryptococcosis: cryptoccocal meningitis, primary as well as maintenance therapy.
5. Prevention of fungal infection in patients with malignancy, AIDS, in intensive care units and patients on immunosuppressive drugs.
6. Fungal infections of the skin and nails.

Dosage:

Flutrox (fluconazole) is used as once daily dose for the following indications:

Vaginal candidiasis; 150mg single oral dose

Oropharyngeal candidiasis; 50mg once daily for 7 to 14 days

Atrophic oral candidiasis associated with dentures; 50mg once daily for 14 days

For other candidial infections; 50mg daily for 14 to 30 days

Indications	Loading Dose	Daily  Dose	Duration
Oropharyngeal candidiasis (acute)	200mg	50-100mg	15 days
Oesophageal candidiasis	200mg	50-100mg	21 days
Candidiasis	400mg	200mg	28 days
Cryptococcal meningitis (acute) negative	400mg*	200mg	10-12 weeks after CSF becomes culture negative
Cryptococcal meningitis (maintenance dose to prevent relapse)	200mg
Tinea corporis		150mg once a week	Up to 4 weeks
Tinea cruris		150mg once a week	Up to 4 weeks
Tinea pedis		150mg once a week	Up to 4 weeks
Cutaneous candidiasis		150mg once a week	Up to 4 weeks
Onychomycosis		150mg once a week	6-12 months
Tinea vericolor 400mg (pityriasis versicolor)			Single oral dose

 

*Doses of up to 400mg/day may be used based on medical judgement of the patient’s response to therapy.

Use in renal impairment: fluconazole is excreted predominantly in urine as unchanged drug. Hence in patients with impaired renal function, dosage of fluconazole must be modified in response to the degree of impairment and should be based on the patient’s measured or estimated creatinine clearance.

The recommended dosages are:

Creatinine clearance (ml/min)	Dosage interval/% of daily dose
>50	24 hrs/100%
21-50	48hrs/50%
10-20	72/25%
Patients receiving regular Haemodialysis	100% dose after dialysis

Side Effects:

Fluconazole is generally well tolerated. Commonly reported side effects are nausea, vomiting, abdominal pain, headache, skin rash and diarrhea. Mild transient, reversible increase in liver enzymes like ALT, AST, alkaline phosphatase and serum bilirubin, etc. may be seen. Serious hepatotoxicity is rarely seen. Clinical adverse reactions have been more frequently reported in HIV patients than in non-HIV infected patients, however, the patterns were similar. In rare cases, anaphylaxis has been reported

Warnings & Precautions:

Patients who develop abnormal liver function should be monitored. Immunocompromised patients who develop rash during fluconazole therapy should be monitored and the drug discontinued if lesion progresses.

Flutrox is not recommended for children below 16 years as limited data is available. A small number of patients from age 3 to 13 years have been treated safely with fluconazole using doses of 3-6mg per kg daily.

Pregnancy & Lactation:

There are no adequate and well controlled studies in pregnant women. Flutrox should be used in pregnancy only if the benefits outweigh the risks. Since it is secreted in human milk, it should not be used in lactating women.

Drug Interactions:

Fluconazole has shown to prolong prothrombin time of coumarin drugs hence requires careful monitoring. Concomitant administration of fluconazole and cyclosporine may result in an increase in cyclosporine levels. Fluconazole significantly increases phenytoin levels and AUC resulting in phenytoin toxicity. Concomitant administration of fluconazole and oral hypoglycaemic such as sulphonylurea in diabetic patients results in increased plasma concentration and reduced metabolism of anti-diabetic agents. Concomitant administration of fluconazole and rifampicin decreases AUC for fluconazole by 20 per cent.

Contraindications:

Hypersensitivity to fluconazole or related azole compounds.

Price: Ksh 50

Notes:

Composition

Flutrox 50: Each capsule contains Fluconazole U.S.P 50mg, Flutrox 150: Each capsule contains Fluconazole U.S.P 150mg, Flutrox 200: Each capsule contains Fluconazole U.S.P 200mg.

Mode of action

Flutrox (fluconazole) is a highly selective inhibitor of fungal sterol synthesis without effect on mammalian or human steroid synthesis. It acts by inhibiting the synthesis of ergosterol, a major component of the cell membrane of yeast and fungi. Specially, the nitrogen in the azole ring is thought to bind to lanosterol-14-α-demethylase, a fungal cytochrome P450 enzyme & thereby inhibits the conversion of lanosterol to egosterol. Inhibition of ergosterol synthesis is thought to lead to the accumulation of non-functional sterols and to the disruption of normal membrane functions including the co-ordination of chitin synthesis, the activity of membrane-bound sterols, and the preservation of normal permeability.

Flutrox (fluconazole) is active against many fungi, including yeast and dermatophytes. Fluconazole does not appear to have any antibacterial activity. In vivo, flutrox (fluconazole) is effective against strains of candida, Cryptococcus neoformans, blastomyces dermatidis, histoplasma capsulatum and coccidioides immitis.

Pack size:  50mg (10s), 150mg (1s), 200mg (10s)

Cost: Flutrox 50mg is Ksh 50/-, Flutrox 200mg (10s) is Ksh 300/-

Ref: 3/PLLE00045/X/001