Trade Name: MICLO OINTMENT
Generic Name: Clobetasone butyrate BP 0.05%

Presentation

Miclo Cream: Each 100 mg cream contains 0.05 mg of Clobetasone butyrate. Miclo Ointment: Each 100 mg ointment contains 0.05 mg of Clobetasone butyrate.

Indications

Miclo preparations are indicated for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions.

Miclo may be used as maintenance therapy between courses of one of the more active topical steroids.

Dosage and administration

Apply to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.

Contraindications and cautions

Skin lesions caused by infection with viruses (e. g. herpes simplex, chicken pox), fungi (e. g. candidiasis, tinea) or  bacteria (e. g. impetigo), hypersensitivity to the preparations. Although generally regarded as safe, even for long-term administration in adults, there is a potential for overdosage, and in infants and children this may result in adrenal suppression. Extreme caution is required in dermatoses in such patients including napkin eruption (as the napkin may act as an occlusive dressing and increase absorption) and treatment should not normally exceed seven days.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions, which have infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.

As with all corticosteroids, prolonged application to  the face is undesirable. Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, and risk of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis, careful patient supervision is important. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye as glaucoma might result.

Side effects

In the unlikely event of signs of hypersensitivity appearing, application should stop immediately. large areas of the body are being treated with Clobelasone Butyrate, it is possible that some patients will absorb sufficient steroid to systemic activity associated with Clobetasone butyrate.

Local atrophic changes could possibly occur in situations where moisture increases absorption of Clobetasone butyrate, but only after prolonged use.

There are reports of pigmentation changes and hypertrichosis with topical steroids. Exacerbation of symptoms may occur.

Use in pregnancy and lactation

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fontal development including cleft palate and intrauterine growth retardation. There may therfore be a very small risk of such effects in the human foetus.

Commercial pack

Miclo 0.05% Cream: Each pack has an aluminum collapsible tube containing 10 gm cream.
Miclo 0.05% Ointment: Each pack has an aluminum collapsible tube containing 10 gm ointment.