GRISEOFULVIN TABLETS 100 Tablets - ANTIFUNGAL 500 mg

          

Indications	Dermatophytosis.
Dosage	Adult : PO 0.5-1 g/day in single or divided doses. Treatment duration: 2-8 wk (hair and skin infections); up to 6 mth (fingernail infections); ≥12 mth (toenail infections).
Dosage Details	Oral Dermatophytosis Adult: 0.5-1 g daily in single or divided doses. Treatment duration: 2-8 wk (hair and skin infections); up to 6 mth (fingernail infections); ≥12 mth (toenail infections). Child: 10 mg/kg daily in divided doses.
Administration	Should be taken with food. Take immediately after meals.
Contraindications	Hypersensitivity to griseofulvin. SLE and porphyria. Severe liver disease, hepatocellular failure. Pregnancy.
Special Precautions	Not intended for prophylaxis of fungal infections. Men should not father children w/in 6 mth of treatment. Lactation.
Adverse Drug Reactions	Skin rashes, urticaria, GI disturbances, dry mouth, taste alteration, headache, angioedema, leucopenia and other blood dyscrasias, proteinuria, oral candidiasis, peripheral neuropathy, photosensitisation, dizziness, confusion, depression, impaired coordination, insomnia, fatigue, exacerbation of SLE. Potentially Fatal: Severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), hepatotoxicity.
Pregnancy Category (US FDA)	Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Patient Counselling	Avoid exposure to intense natural or artificial sunlight. May impair ability to drive or operate machinery.
Monitoring Parameters	Monitor hepatic, renal and haematopoietic functions (esp w/ long term use) periodically.
Drug Interactions	May reduce the efficacy of OCs, phenylbutazone, sedative and hypnotic drugs, and coumarin anticoagulants. Decreased GI absorption w/ barbiturates.
Food Interaction	Increased absorption w/ food, esp high-fat meals. May enhance the effect of alcohol.
Lab Interference	False-positive urinary vanillylmandelic acid (VMA) levels.
Mechanism of Action	Description: Griseofulvin inhibits fungal cell division at metaphase by disrupting the cell's mitotic spindle structure. It binds to human keratin, making it resistant to fungal infections; may also interfere w/ deoxyribonucleic acid (DNA) production. Pharmacokinetics:  Absorption: Variably and incompletely absorbed from the GI tract; may be increased by decreasing particle size and admin w/ fatty meals. Time to peak plasma concentrations: W/in 4 hr. Distribution: Deposited in keratin precursor cells and concentrated in stratum corneum of the skin and in the nail and hair. Plasma protein-binding: Approx 84% (mainly albumin). Metabolism: Hepatically metabolised to 6-demethylgriseofulvin and its glucuronide conjugates. Excretion: Via urine (mainly as metabolites, <1% as unchanged drug); faeces (large amount as unchanged drug); some in sweat. Elimination half-life: 9-24 hr.
Storage	Store between 15-30°C.
MIMS Class	Antifungals
ATC Classification	D01BA01 - griseofulvin ; Belongs to the class of antifungals for systemic use.  D01AA08 - griseofulvin ; Belongs to the class of antibiotics. Used in the topical treatment of fungal infection.