Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
hydrocortisone (hydrocortisone acetate)
Arpimed LLC
hydrocortisone (hydrocortisone acetate)
10mg/g
ointment for topical use
Prescription
SUMMARY PRODUCT CHARACTERISTIC HYDROCORTISONE 1% OINTMENT FOR TOPICAL USE 1.1.TRADE NAME - Hydrocortisone 1.2. INTERNATIONAL NON-PROPERTY NAME–Hydrocortisone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of Hydrocortisone, 1%topical ointment, contains: _ACTIVE INGREDIENT: _hydrocortisone acetate – 10 mg; _For a full list of excipients, see section 6.1. _ _ _ 3. PHARMACEUTICAL FORM Ointment for topical use. White homogenous ointment with weak odor. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS POM: For the treatment of mild to moderate inflammatory skin disorders such as eczema, including atopic, infantile, discoid and stasis eczema; seborrhoeic dermatitis, intertrigo, otitis externa, contact dermatitis, neurodermatitis flexural psoriasis and lichen simplex. P: For the relief of irritant contact dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POM: For adults and children: Apply sparingly twice a day. P: For adults, the elderly and children over 10 years of age: Apply sparingly to a small area, once or twice a day, for a maximum of 7 days. Children under 10 years of age: Not recommended except under medical supervision. For topical application. 4.3. CONTRAINDICATIONS POM: Should not be used if allergic to any of the ingredients or on untreated, infected lesions, ulcerative conditions, rosacea, perioral dermatitis or acne. P: The product should not be used if allergic to any of the ingredients or on the eyes or face, the anogenital area or on broken or infected skin including impetigo, cold sores, acne or athlete's foot. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE POM: Avoid prolonged, continuous use, particularly in children and especially on the face, as adrenal suppression may occur. P: Medical advice should be sought if the condition does not improve. Contains Propylparaben, whichmay cause allergic reactions (possibly delayed). 4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Read the complete document