Indications

Treatment of dermatophytosis, trichomycosis, onychomycosis, fungal intertrigo.

Present

Tube of 10g. Box of 1 tube.

Composition

Griseofulvin……………………………………………….0.5g
Excipients s.q. for………………………………………..10g
(White soft paraffin, paraffin oil, hydrogenated castor oil, sodium lauryl sulfate, glycerin, glyceryl monostearate, rose oil, ethanol 96%, purified water).

Pharmacology

– Griseofulvin is a fungistatic antibiotic produced by Penicillium griseofulvum, or other species of Penicillium.
Griseofulvin exerts its fungistatic action primarily by disrupting the cell’s mitotic spindle structure thus arresting the metaphase of cell division. Another proposed mechanism of action is that griseofulvin causes production of defective DNA which is unable to replicate. Griseofulvin is deposited in keratin precursor cells, which renders them an unfavorable environment for fungal invasion. Infected skin, hair, or nails are then replaced with tissue not infected with the dermatophyte.
– Griseofulvin inhibits species of Trichophyton (specifically T. rubrum, T. tonsurans, T. mentagrophytes, T. verrucosum, T. megninii, T. gallinae and T. schoenleinii), Microsporum (such as M. audouinii, M. canis, M. gypseum) and Epidermophyton floccosum.

Pharmacokinetics

Griseofulvin cream is used as topical antifungal drug.

Contra-Indications

Hypersensitivity to any ingredient of the medicine.

Side effect

– There may be local reactions (irritation or sensitization).
– Frequent: urticaria, rash due to photosensitivity, erythema multiforme, bullous or measles– like rash,…
– Infrequent: reactions resembling serum sickness, angioedema,…
– Discontinue the medicine and inform your doctor about side– effects when using this medicine.

Precaution

– Avoid contact with the eyes.
– Since griseofulvin has occasionally associated with photosensitivity reactions, patients should be cautioned to avoid exposure to intense sunlight. Photosensitivity reactions may aggravate lupus erythematosus.
– Because griseofulvin is produced by species of Penicillium, the possibility of cross– sensitivity with penicillin should be considered.
– System absorption of griseofulvin may occur following topical application on large area of the body or to nursing infants.
PREGNANCY AND LACTATION:
Caution should be exercised when using this drug for pregnant women and nursing mothers.

Interaction

– Caution should be exercised when griseofulvin is used on large areas of the body with ingestion of alcohol, concomitant administration of phenobarbital, coumarin anticoagulants, oral contraceptives, theophylline, aspirin, cyclosporine.
– Inform your doctor or pharmacist about other drugs you are taking to avoid possible interactions.
OVERDOSAGE & MANAGEMENT:
Should overdosage occur, turn to the nearest healthcare facility for medical attention of the healthcare professionals.

Shelf life

36 months from the manufacturing date.

Storage

Store in a dry place, protect from light, not exceeding 30^oC.

Dosage

– Clean and dry affected area, apply to this area 3 – 4 times daily.
– Therapy duration:
* Dermatophytosis: 1 – 3 weeks.
* Intertriginous rash of skin folds and toes: 2 – 4 weeks.
* Trichomycosis: 4 – 6 weeks.
– It should be coadministered with systemic griseofulvin (tablets) in majority of cases.
– During the therapy, it should be observed general hygienic measures and monitored in order to get control of contamination and reinfection.