Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FLUTICASONE PROPIONAT
GLAXO WELLCOME INDONESIA - Indonesia
FLUTICASONE PROPIONAT
0,05%
KRIM
DUS, 1 TUBE @ 5 GRAM
GLAXO WELLCOME INDONESIA - Indonesia
2017-11-24
Page 1 of 6 CUTIVATE TM FLUTICASONE PROPIONATE 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Fluticasone propionate (micronised) 0.05% w/w (500 micrograms/g). 2. PHARMACEUTICAL FORM Cream. 3. CLINICAL PARTICULARS 3.1 INDICATIONS _CUTIVATE_ Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as: Eczema including atopic, infantile and discoid eczemas; Prurigo nodularis; Psoriasis (excluding widespread plaque psoriasis); Neudermatoses including Lichen simplex; Lichen planus, Seborrhoeic dermatitis; Contact sensitifity reactions; Discoid lupus erythematosus; An adjunct to systemic steroid therapy in generalised erythroderma; Insect bites reactions, Prickly heat. 3.2 DOSAGE AND ADMINISTRATION For eczema/dermatitis, apply a thin of _CUTIVATE_ Cream to the affected skin areas once daily. For all other indications, apply a thin film of _CUTIVATE_ Cream to the affected skin areas twice daily. Calculation of the appropriate dosage for children should allow for their greater surface area to body weight ratio. 3.3. CONTRAINDICATIONS The following conditions should not be treated with _CUTIVATE_ Cream: Untreated cutaneous infections Rosacea_ _ Acne vulgaris Perioral dermatitis Primary cutanoeous viral infection Hypersensitivity to corticosteroids or other materials contained in _CUTIVATE_ cream Perianal and genital pruritus Primary infected skin lesion Pruritus without inflammation Dermatoses in children under one year of age, including dermatitis and napkin eruptions 3.4 WARNINGS AND PRECAUTIONS _CUTIVATE_ Cream should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (_see Adverse Reactions_) may resemble symptoms of the condition under treatment. Manifestations of hypercortisolism (Cushing’s Syndrome) and reversible hypothalamic-pituitary- adrenal (HPA) axis suppression, leading to a gluc Baca dokumen lengkapnya