Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
losartan (losartan potassium), hydrochlorothiazide
KRKA d.d.
C09DA01
losartan (losartan potassium), hydrochlorothiazide
100mg+ 12,5mg
tablets film-coated
(28/2x14/) in blister
Prescription
Registered
2023-04-21
1 1. NAME OF THE MEDICINAL PRODUCT Lorista ® H 100, 100 mg/12.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide. Excipient: lactose monohydrate. Each tablet contains: Lorista H 100 100 mg/12.5 mg lactose 83.98 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Lorista H 100, 100 mg/12.5 mg: white, oval, biconvex film coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lorista H 100, 100 mg/12.5 mg is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hypertension The combination of losartan and hydrochlorothiazide (HCTZ) is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan or hydrochlorothiazide alone. Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended. When clinically appropriate, a direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled. The usual maintenance dose of Lorista H is one tablet of Lorista H 50 mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. For patients who do not respond adequately to Lorista H 50 mg/12.5 mg, the dosage may be increased to one tablet of Lorista HD 100 mg/25 mg (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. The maximum dose is one tablet of Lorista HD 100 mg/25 mg once daily. In general, the antihypertensive effect is attained within three to four weeks after the initiation of therapy. Lorista H 100 (losartan 100 mg/HCTZ 12.5 mg) is available for those patients titrated to 100 mg of Lorista who require additional blood pressure control. CONFIDENTIAL Lorista H 100 film-coated tablet 100 mg/12.5 mg VOL: 1; P: 16 / 165 2 Use in patients with renal impairment and Прочитать полный документ