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Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: 04-7104): Fluconazole 50 mg
How to identify the product: Light turquoise red capsule.
Pack size: 1's (in blister).
Suspension (NRN: 04-7598): Fluconazole 50 mg per 5 mL
How to identify the product: Dry, white to off white powder which yields, on reconstitution with water, orange flavoured suspension.
Pack size: 35 mL bottle.
Fluconazole, a member of the triazole class of antifungal agents, is a potent and selective inhibitor of fungal enzymes necessary for the synthesis of ergosterol.
After oral administration Fluconazole is well absorbed. Oral absorption is not affected by concomitant food intake. Peak plasma concentrations occur between 0.5 and 1.5 hours post dose with plasma elimination half-life of approximately 30 hours. Plasma concentrations are proportional to dose, 90% steady state levels are reached by day 4-5 with multiple once daily dosing.
Fluconazole achieves good penetration in all body fluids. The levels of Fluconazole in saliva and septum are similar to plasma levels. In patients with fungal meningitis, Fluconazole levels in the CSF are approximately 80% of the corresponding plasma levels. High skin concentrations of Fluconazole, above serum concentrations, are achieved in the stratum corneum, epidermis, dermis and eccrine sweat. The major route of excretion is renal, with approximately 80% of the administered dose appearing in the urine as unchanged drug. Fluconazole clearance is proportional to the creatinine clearance. There is no evidence of circulating metabolites. The long plasma elimination half-life provides the basis for single dose therapy for genital candidiasis and once daily dosing for other indications.
Gvfluc is indicated for the treatment of the following conditions:
Genital candidiasis, vaginal candidiasis: Acute or recurrent, candidal balanitis. The treatment of partners who present with symptomatic genital candidiasis should be considered.
Mucosal candidiasis: It includes oropharyngeal oesophageal, non-invassive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis.
Tinea pedis, tinea corporis, tinea versicolor and dermal candidal infections.
Systemic candidiasis: It includes candidaemia, disseminated candidiasis, other forms of invasive candidal infection; infections of the peritoneum, endocardium and pulmonary and urinary tracts.
Cryptococcosis: It includes Cryptococcal meningitis, pulmonary & cutaneous infections.
Prevention of fungal infection in patients with malignancy, AIDS, in intensive care units and patients on immunosuppresive drugs.
Hypersensitivity to Fluconazole.
Avoid co-administration with Terfenadine or Cisapride.
Dosage & Administration
The daily dose of Gvfluc should be based on the nature and severity of the fungal infection.
Candidal vaginitis or balanitis: 150 mg single dose.
Mucosal candidiasis: 50 mg once daily for 7-14 days for oropharyngeal candidiasis; 50 mg once daily for 14 days for atrophic oral candidiasis; 50 mg once daily for 14-30 days for oesophagitis.
Tinea pedis, corporis: 50 mg daily for 2 to 4 weeks.
Candidaemia: 400 mg on first day followed by 200 mg daily based on clinical response.
Cryptococcal meningitis: 400 mg on first day followed by 200 mg daily at least for 6-8 weeks
AIDS: 100-200 mg daily.
Fungal infection: 50-400 mg once daily based on developing fungal infection.
Bone marrow transplantation: 400 mg daily.
Use in children: As with similar infections in adults, the duration of treatment is based on the clinical and mycological response.
Children over four weeks of age:
Mucosal candidiasis 6 mg/kg on first day followed by 3 mg/kg daily
Systemic candidiasis 6-12 mg/kg daily
Fungal infections 3-12 mg/kg daily depending on extent of infection
A maximum dosage of 400 mg daily should not be exceeded in children.
Children four weeks of age and younger: Neonates excrete Fluconazole slowly. In the first two weeks of life, the same mg/kg dosing as in older children should be used but administered every 72 hours. During weeks 3 and 4 weeks of life, the same dose should be given every 48 hours. A maximum dosage of 12 mg/kg every 72 hours should not be exceeded in children in the first two weeks of life. For children between 3 and 4 weeks of life, 12 mg/kg every 48 hours should not be exceeded. Once reconstituted as directed the 50 mg/5mL suspension should not be further diluted.
Use in patients with impaired renal function: Fluconazole is excreted predominantly in the urine as unchanged drug. No adjustments in single dose therapy are required. In patients (including children) with impaired renal function who will receive multiple doses of Gvfluc, the normal recommended dose (according to indication) should be given on day 1, followed dose based on the following table:
Creatinine clearance (mL/min) Percent of recommended dose
> 50 100%
< 50 (no dialysis) 50%
Regular dialysis 100% after each dialysis
Instructions: Gvfluc Capsules should be swallowed whole.
Gvfluc Oral Suspension: To reconstitute, tap the bottle to loosen powder. Add water slowly upto the mark on the bottle label and shake well to ensure dispersion. Shake well just prior to each use. Where doses of less than 5 ml are required and particularly in neonates, a suitable measuring device should be used. Dilution is not recommended.
In the event of overdose, supportive measures and symptomatic treatment, with gastric lavage if necessary, may be adequate. As Fluconazole is largely excreted in the urine, forced volume diuresis would probably increase the elimination rate.
Capsules and dry powder for suspension can be stored for 3 years before use.
The reconstituted suspension should be used within 7 days.
Reconstituted suspension should be stored between 6-25oC.
Do not freeze reconstituted suspension or infusion.