Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN MOMETASONE CREAM SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPEN MOMETASONE CREAM COMPOSITION: Each 1 g cream contains: 1 mg Mometasone Furoate PHARMACOLOGICAL CLASSIFICATION A 13.4.1 Corticosteroids with or without anti-infective agents PHARMACOLOGICAL ACTION Mometasone is a medium-potency synthetic topical steroid that has antiinflammatory, antipruritic and vasoconstrictive actions. Pharmacokinetics: A minimal amount of mometasone is absorbed after topical application to normal skin. That which is absorbed is metabolised in the liver and excreted in the urine. INDICATIONS ASPEN MOMETASONE CREAM is indicated for the relief of inflammatory manifestations of psoriasis and corticosteroid-responsive dermatoses. CONTRA-INDICATIONS Hypersensitivity to any of the ingredients. Viral infections such as herpes simplex, vaccinia and varicella. Untreated fungal infections. WARNINGS ASPEN MOMETASONE CREAM is not for ophthalmic use. Safety and efficacy of ASPEN MOMETASONE CREAM in paediatric patients for more than three weeks of use have not been established. Use in paediatric patients under the age of two years is not recommended. PREGNANCY AND LACTATION Safety in pregnancy and lactation has not been established. Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents may be absorbed percutaneously, teratogenicity following topical application cannot be excluded. ASPEN MOMETASONE CREAM should therefore not be used during pregnancy. ASPEN MOMETASONE CREAM is not recommended for breast-feeding mothers. DOSAGE AND DIRECTIONS FOR USE A thin film of ASPEN MOMETASONE CREAM should be applied to completely cover the whole affected area once daily. ASPEN MOMETASONE CREAM may be used with caution in paediatric patients from t Read the complete document