Trigal 50 mg Capsule

Fluconazole 50mg

COMPOSITION

Trigal 50 Capsule: Each Capsule Contains Fluconazole USP 50 mg.

Trigal 150 Capsule: Each Capsule Contains Fluconazole USP 150 mg.

PHARMACOLOGY

Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.

INDICATION

Trigal (Fluconazole) is indicated for the treatment of:

  • Acute or recurrent vaginal candidiasis
  • Mucosal candidiasis (as oropharyngeal candidiasis, oesophagitis, candiduria)
  • Systemic candidiasis
  • Cryptococcal infections (including meningitis)
DOSAGE AND ADMINISTRATION
  • Acute or recurrent vaginal candidiasis: a single dose of 150mg.
  • Mucosal candidiasis (except vaginal): 50 mg daily (100 mg daily in unusually difficult infections) given for 7-14 days in oropharyngeal candidiasis: 14-30 days in other mucosal infections (e.g. oesophagitis, candiduria).
  • Systemic and cryptococcal infections (including maningitis): 400mg initially then 200mg daily and then increased if necessary to 400mg daily, treatment continued according to response.
Child over 1 Year
  • superficial candidal infections: 1-2 mg/kg daily
  • systemic candidiasis and cryptococcal infections (including meningitis): 3-6 mg/kg daily (in serious life threatening infections up to 12mg/kg daily has been given to children aged 5-13 years- max 400 mg daily)
CONTRAINDICATION

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

PRECAUTION

Caution should be taken in renal impairment, pregnancy and breast feeding and in raised liver enzymes. The use of Trigal (Fluconazole) in nursing mothers is not recommended. The use of Trigal (Fluconazole) in children below the age of 16 years is not recommended unless the treating physicin considers Trigal (Fluconazole) therapy imperative & its use below the as of 1 year is not recommended.

SIDE EFFECTS

Nausea, abdominal discomfort, diarrhoea and flatulence. Occasionally abnormalities of liver enzymes, rarely rash; angioedema, and anaphylaxis, Stevens-Johnson syndrome reported.

USE IN PREGNANCY AND LACTATION

Caution should be taken in pregnancy. Use of Trigal (Fluconazole) in nursing mother is not recommended.

DRUG INTERACTION

Rifampicin reduces plasma concentration of Trigal (Fluconazole), Effect of nicoumalone, Pheytion, and warfarin is enhaced. Plasma concentrations of sulphonylureas  & theopyline is possibley increased.

STORAGE

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

PACKING

Trigal 50 Capsule: Box containing 10 x 3 capsules in blister pack.

Trigal 150 Capsule: Box containing 10 x 2 capsules in blister pack.

Trigal 50 mg Capsule
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