| DESCRIPTION |
Flucoder is a preparation of fluconazole. It is a triazole antifungal drug that inhibits cytochrome P-450 dependent enzymes resulting in blockade of ergosterol synthesis. Flucoder is well absorbed following oral administration and is widely distributed and achieves concentration in joint fluid, saliva, sputum, vaginal fluid and peritoneal fluid in same concentration that is achieved in plasma.
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| INDICATIONS |
Acute or recurrent vaginal candidiasis
Mucosal candidiasis e.g. oropharyngeal, oesophageal, bronchopulmonary, mucocutaneous, denture sore mouth.
Tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infection
Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of candidial infection.
Cryptococccosis, cryptococcal meningitis and infections of other sites (pulmonary and cutaneous).
For prevention of fungal infections in immunocompromised patients e.g. neutopanic cancer patients.
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| DOSAGE AND ADMINISTRATION |
Adult
Acute and recurrent vaginal candidiasis and candidal balanitis: Orally a single dose 150 mg.
Mucosal candidiasis (except vaginal): Orally 50 mg daily (100 mg daily in a single dose in unusually difficult infection) for 7-14 days. Oropharyngeal candidiasis for maximum 14 days, in atrophic oral candidiasis with denture for 14 days, in oesophagitis and candiduria for 14-30 days. Tinea pedis, corporis, cruris, pityriaisis versicolor and dermal candiaiasis: Orally 50 mg daily for 2-4 weeks (upto 6 weeks in tinea pedis) maximum duration of treatment is 6 weeks. Systemic candidiasis and cryptococcal infections (including meningitis): Orally 400 mg initially daily then 200 mg daily and continue treatment according to response. Prevention of fungal infections in immunocompromised patients 50-400 mg daily adjusted according to risk. Prevention of relapse of cryptococcal meningitis, AIDS patients after completion of primary therapy: 100 mg-200 mg orally daily.
Children: 3-6 mg/kg on first day then 3mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old) in mucosal candidiasis; 6-12 mg/kg daily (every 72 hours in neonate up to 2 weeks old, every 48 hours in neonate 2-4 weeks old) in invasive candidal infections and cryptococcal infections (maximum 400 mg daily); according to extent and duration of neutropenia, 3-12 mg/kg daily (every 72 hours in neonate upto two weeks old, every 48 hours in neonate 2-4 weeks old (maximum 400 mg daily).
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| SIDE-EFFECTS |
Fluconazole is generally well tolerated. The commonest side effects associated with fluconazole are symptoms associated with the gastro-intestinal tract; these include nausea, abdominal discomfort, diarrhoea and flatulence. Other adverse events such as rash are rarely encountered (incidence less than 1%). Less frequently dyspepsia, vomiting, taste disturbance, hepatic disorders, angioedema, dizziness, pruritismay occur.
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| CONTRAINDICATIONS |
Fluconazole should not be used in patients with known hypersensitivity to fluconazole or to related azole compounds.
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| PRECAUTIONS |
Renal impairment, pregnancy and raised liver enzymes. Discontinue if signs or symptoms of hepatic disease (risk of hepatic necrosis). Fluconazole is found in breast milk in same concentration similar to plasma, hence its use in ursing mothers is not recommended.
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| OVERDOSE |
If there is any overdose, supportive measure and gastric lavage should be instituted according to the patient's clinical conditions. As fluconazole is excreted largely in urine volume, diuresis would probably increase elimination rate. A three hour session of haemodialysis decreases plasma levels approximately 50%.
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| DRUG INTERACTION |
Fluconazole increases the prothrombin time after warfarin administration in healthy males. It has been shown to prolong the serum half life of concomitantly asministered oral sulphonyureas. Co-administration of multiple dose-hydrochlorothiazide to healthy volunteers receiving fluconazole increased plasma concentrations of fluconazole by 40%. Concomtant administration of fluconazole and phenytoin may increase the level of phenytoin to a clinically significant degree. Concomitant administration of fluconazole and rifampicin decreases availability of fluconazole. Concomitant administration of fluconazole and theophyline
decreases the availability of the later. Fluconazole increases plasma concentration of celecoxibe (dose should be reduces to halve), zidorudine (increased risk of toxicity), midazolam (prolonged sedative effect), bosentan ( avoid concomitant use) and tacrolimus. Effect of acenocounazole is enhanced by fluconazole.
pre-existing asthma.
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| PHARMACEUTICAL PRECAUTION |
Store in a cool and dry place, keep away from light. Keep out of reach of children.
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| PACKAGING |
Flucoder 50 mg capsule: Box containing 3 strips of 10 capsules each. Each capsule contains fluconazole INN 50 mg.
Flucoder 150 mg capsule: Box containing 3 strips of 10 capsules each. Each capsule contains fluconazole INN 150 mg.

Manufactured by:
ESKAYEF BANGLADESH LTD
DHAKA, BANGLADESH
® REGD.TRADEMARK |
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