Modrasone Cream

Modrasone Ointment

Alclometasone Dipropionate 0.05% w/w

Cream/Ointment for topical use.

Alclometasone dipropionate is a non-fluorinated topically active synthetic corticosteroid. Modrasone is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Adult and Children:

A thin film of Modrasone should be applied to the affected area two or three times daily or as directed by the physician. Massage gently into the skin until the medication disappears.

Hypersensitivity to any of the ingredients; rosacea; acne and perioral dermatitis; tuberculous and viral lesions of the skin, particularly Herpes Simplex; vaccinia; varicella.

Modrasone should not be used in fungal or bacterial skin infections.

As with all topical steroids, long term continuous therapy should be avoided where possible, particularly in infants and children as adrenal suppression may occur even without occlusion. In infants the napkin may act as an occlusive dressing and thus increase absorption.

None known.

Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy i.e. in large amounts or for long periods.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Modrasone should be administered to nursing mothers only after careful consideration of the benefit/risk relationship.

Not applicable.

Excessive prolonged use may result in local atrophy of the skin, striae and superficial vascular dilation, particularly on the face.

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency which is usually reversible. In such cases appropriate symptomatic treatment is indicated. In cases of chronic toxicity, corticosteroids should be withdrawn.

The steroid content is so low as to have little or no effect in the unlikely event of accidental oral ingestion.

Alclometasone dipropionate is a non-fluorinated, topically active synthetic corticosteroid. Alclometasone dipropionate suppresses local inflammation at doses producing minimal systemic effects. Studies have shown alclometasone dipropionate to be approximately 2/3 as potent as betamethasone valerate and 60 x as potent as hydrocortisone.

Not applicable in view of topical action and application.

Modrasone appears to be a relatively non-toxic and non-irritating drug product that produces no unusual or unexpected teratologic effects in laboratory animals. A wide margin of safety was demonstrated in all species studied. Acute oral and intraperitoneal doses more than 3,000 times the proposed topical human dose were without any toxicologically significant effects.

Cream:

Propylene Glycol Ph Eur

White Soft Paraffin BP

Cetostearyl Alcohol BP

Glyceryl stearate PEG 100 stearate

Polyoxyethylene (20) cetyl ether

Sodium dihydrogenium phosphate dihydrate

4-Chloro-M-Cresol BP

Phosphoric Acid Ph Eur

Purified Water Ph Eur

Ointment:

Hexylene glycol

Propylene glycol monostearate

White Beeswax BP

White Soft Paraffin BP

None known

Cream and Ointment: 60 months

Store below 25°C

Cream and Ointment: Aluminium tubes with white LDPE caps. Pack size: 50g

Not applicable

Schering-Plough Ltd

Shire Park

Welwyn Garden City

Hertfordshire

AL7 1TW

Cream: PL 0201/0060

Ointment: PL 0201/0061

26 March 1995

5 March 1996

Legal Category POM

Distributed in the UK by: PLIVA Pharma Ltd., Vision House, Bedford Road, Petersfield,

Hampshire GU32 3QB