البلد: أرمينيا
اللغة: الإنجليزية
المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
hydroxyzine (hydroxyzine hydrochloride)
Arpimed LLC
N05BB01
hydroxyzine (hydroxyzine hydrochloride)
25mg
tablets film-coated
(20/2x10/) in blister
Prescription
Registered
2023-07-21
SUMMARY PRODUCT CHARACTERISTIC LA-SON 25 MG FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT - La-Son 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: _ACTIVE INGREDIENT:_ Hydroxyzine hydrochloride – 25 mg; _For a full list of excipients, see section 6.1. _ _ _ 3. PHARMACEUTICAL FORM White biconvex oval scored film-coated tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS La-Son is indicated to assist in the management of anxiety in adults. La-Son is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ La-Son should be used at the lowest effective dose and for the shortest possible duration. In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day. _Anxiety _ _ADULTS _ 50-100mg daily in divided doses _ _ _Pruritus _ _ADULTS _ Starting dose of 25mg at night increasing as necessary to 25mg three or four times daily. _ _ _ELDERLY _ In the elderly, the maximum daily dose is 50 mg per day (see section 4.4). A reduced dose is advised. This is due to a possible increase in the volume of distribution, prolonged action and the possible effect of age-related changes on pharmacologic functions; including hepatic metabolism and renal excretion (see Section 5.2 'Pharmacokinetic properties') _PAEDIATRIC POPULATION _ FOR TREATING ITCHING IN CHILDREN This product is not recommended for children under 6 years of age. In children up to 40 kg in weight, other appropriate strengths and dosage forms containing hydroxyzine should be administered. _ _ For children over 6 years, starting at 15-25mg and increasing to 50-100mg daily in divided doses adjusted according to the child's weight. As with all medications, the dosage should be adjusted according to the patient's response to therapy. _HEPATIC IMPAIRMENT _ The total daily dose should be reduced by 33%. Use in اقرأ الوثيقة كاملة