Beclomethasone dipropionate 0.25 mg/g in a cream base
Chlorocresol 0.1% m/m
PHARMACOLOGICAL CLASSIFICATION: A. 13.4.1 Corticosteroids with or without anti-infective agents.
PHARMACOLOGICAL ACTION: Beclomethasone dipropionate is a glucocorticoid which has anti-inflammatory, antipruritic and vasoconstrictive properties.
BECLATE CREAM is indicated for the relief of the inflammatory manifestations of psoriasis and corticosteroid responsive dermatoses.
CONTRA-INDICATIONS: Hypersensitivity to any of the ingredients.
Rosacea, acne, peri-oral dermatitis, tuberculosis of the skin and varicose ulcers. Skin lesions caused by infections with viruses (e.g. herpes simplex, vaccinia or varicella), fungi (e.g. candida, tinea) or bacteria (e.g. impetigo).
Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore BECLATE CREAM should not be used during pregnancy. The use of BECLATE CREAM is not recommended during breast feeding.
WARNINGS: For external use only. Do not use in or around the eye.
DOSAGE AND DIRECTIONS FOR USE: Topical, to the skin as a cream once or twice a day.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
BECLATE CREAM should be used for short courses only, as prolonged and intensive treatment may cause local atrophic changes in the skin such as stria, thinning, loss of elasticity, dilatation of the superficial blood vessels, telangiectasia and ecchymosis.
These changes are particularly likely to occur on the face, where occlusive dressings are used or where skin folds are involved. Prolonged use, use of large amounts, treatment of extensive areas, or application to damaged skin, when BECLATE CREAM is used and when the occlusive dressing technique is applied can result in sufficient systemic absorption to produce the features of hypercortisonism such as depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland. These effects are most likely to be severe in infants and children. Growth may be retarded and a Cushingoid state may be produced. Benign intracranial hypertension has been reported less frequently. In infants the napkin may act as an occlusive dressing, and hence these preparations should not be used in the nappy area for flexural eruptions. Ideally they should not be used in infants and young children at all.
Regular review should be made of the necessity for continuing therapy.
Treatment of psoriasis with BECLATE CREAM or its withdrawal) may provoke the pustular form of the disease. If signs of hypersensitivity appear, application should stop immediately. The least potent corticosteroids should be used with particular caution in facial dermatoses, and only for short periods.
A steroid rosacea-like facies may be produced. This must be borne in mind when treating such conditions as psoriasis, discold lupus erythematosus, and severe eczema with BECLATE CREAM.
Topical corticosteroid preparations should be used with caution near the eyes; application to the eyelids may cause glaucoma.
Corticosteroids should never be used in the presence of infection except in conjunction with effective chemotherapy. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Excessive or prolonged use of BECLATE CREAM may result in systemic absorption of steroid and complications of steroid therapy, especially growth retardation in children, suppression of pituitary adrenal function, increased susceptibility to infection, hyperglycaemia, Cushingoid state and benign intracranial hypertension. Cessation of treatment with appropriate symptomatic and supportive treatment is indicated.
IDENTIFICATION: White semi-solid cream.
PRESENTATION: Tube of 15 g.
STORAGE INSTRUCTIONS: Keep well closed.
Store below 25°C
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 32/13.4.1/0127
NAME AND BUSINESS ADDRESS OF APPLICANT: CIPLA LIFE SCIENCES (PTY) LTD
BELLVILLE 7530 RSA
DATE OF PUBLICATION OF THIS PACKAGE INSERT: OCTOBER 2000