Lenovate 5 mg Cream

LENOVATE is used for the treatment of non-infected steroid responsive dermatoses.

LENOVATE OINTMENT: Apply a small quantity gently to the affected areas 2 or 3 times daily or use with occlusive dressings. The effect may be enhanced by application of occlusive dressings.

LENOVATE CREAM: Apply gently to the affected areas 2 to 3 times daily.

• Hypersensitivity to betamethasone or any of the excipients in the formulation (see COMPOSITION).
• Rosacea, acne vulgaris, peri-oral dermatitis, peri-anal and genital pruritus, tuberculosis of the skin and varicose ulcers.
• Skin lesions caused by infection with viruses (e.g. herpes simplex, vaccinia or varicella), fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo).
• Nappy areas of infants for flexural eruptions or dermatoses in children under one year of age, including dermatitis.
• Pregnancy (see PREGNANCY AND LACTATION). 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, LENOVATE should not be used during pregnancy.
• Long term use in patients with diabetes mellitus or tuberculosis.

FOR EXTERNAL USE ONLY. Potent topical corticosteroid preparations, such as LENOVATE, should not be applied to any skin crease areas.

Systemic absorption of topically applied LENOVATE may occur, particularly under the following conditions; when large quantities are used, or when application is made to wide areas of the body or to damaged skin, and when the occlusive dressing technique is applied. Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur, and may be precipitated by an infection or trauma. These effects are most likely to be severe in children. Treatment should be discontinued if unfavourable reactions are seen. Regular review should be made of the necessity for continuing therapy. If a secondary microbial skin infection is present suitable concomitant antimicrobial therapy should be instituted.

LENOVATE should not be used to treat infections and ulcers of the leg. It causes delayed wound healing and increased liability to infections. LENOVATE should be used with caution near the eyes and should be used for short courses only. Application to the eyes has produced corneal ulcers, raised intraocular pressure, and reduced visual function. The treatment of psoriasis with LENOVATE may provoke the pustular form of the disease. LENOVATE should not be used on infants and young children.

Co-administered medicines that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.

LENOVATE is contraindicated during pregnancy (see CONTRAINDICATIONS). Safety and efficacy during lactation have not been established. 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.

Patients should be advised to exercise caution when driving a vehicle, operating machinery or performing tasks requiring alertness, if they experience any side effects that affects their ability to perform these tasks safely.

Side effects

• Immune system disorders: Less frequent: Hypersensitivity reactions
• Endocrine disorders: Less frequent: Cushingoid features
• Nervous system disorders: Less frequent: Benign intracranial hypertension
• Skin and subcutaneous tissue disorders: Frequent: Local skin burning, pruritus; Less frequent: Atrophy of the epidermis and dermal collagen, atrophic striae, drying and thinning of the skin, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae, ecchymoses, purpura, bruising, rosacea-like dermatitis, perioral dermatitis, hyperpigmentation, acneiform eruptions. These changes are particularly likely to occur on the face and when occlusive dressings are used. Occlusive dressings are associated with maceration of the skin and miliaria. Pigmentation changes, hypertrichosis, allergic contact dermatitis, exacerbation of symptoms, pustular psoriasis. Local infection may be worsened and spread enhanced.
• Musculoskeletal, connective tissue and bone disorders: Less frequent: Growth retardation in children

Symptoms: LENOVATE may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may occur.

Treatment: In the event of overdose, LENOVATE should be withdrawn gradually by reducing the frequency of application, or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency. Treatment is supportive and symptomatic.