Страна: Индонезия
Язык: индонезийский
Источник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ITRACONAZOLE
TAISHO PHARMACEUTICAL INDONESIA - Indonesia
ITRACONAZOLE
100 MG
KAPSUL
DUS, 7 BLISTER @ 4 KAPSUL
TAISHO PHARMACEUTICAL INDONESIA - Indonesia
2016-06-15
Page 1 of 10 LODOZ BISOPROLOL FUMARATE/HYDROCHLOROTHIAZIDE Selective beta 1 adrenoceptor blocker + Diuretic 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Lodoz 2.5 mg/6.25 mg, film-coated tablet: Bisoprolol fumarate 2.5 mg Hydrochlorothiazide 6.25 mg Lodoz 5 mg/6.25 mg, film-coated tablet: Bisoprolol fumarate 5 mg Hydrochlorothiazide 6.25 mg 2. PHARMACEUTICAL FORM Film-coated tablet 3. CLINICAL PARTICULARS 3.1 INDICATIONS Treatment of hypertension. 3.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For individual therapy Lodoz is available in the strengths: Lodoz 2.5 mg/6.25 mg, film-coated tablets. Lodoz 5 mg/6.25 mg, film-coated tablets. The usual starting dose is one Bisoprolol 2.5 mg/Hydrochlorothiazide 6.25 mg tablet once daily. If the antihypertensive effect of this dosage is inadequate, the dose will be increased to one Bisoprolol 5 mg/Hydrochlorothiazide 6.25 mg tablet once daily and, if response is still inadequate, to one Bisoprolol 10 mg/Hydrochlorothiazide 6.25 mg tablet once daily. If discontinuation is necessary, gradual discontinuation of Bisoprolol treatment is recommended, since abrupt withdrawal of Bisoprolol may lead to an acute deterioration of the patient's condition, in particular in patients with ischaemic heart disease. _Patient with renal or hepatic impairment _ No dose adjustment is necessary in patients with mild-to-moderate hepatic impairment or mild-to-moderate renal impairment (creatinine clearance > 30 mL/min). _Elderly _ No dose adjustment is normally required. _Paediatric population _ Experience with Lodoz in paediatric patients is limited, therefore its use cannot be recommended in this population. METHOD OF ADMINISTRATION Lodoz should be taken in the morning with or without food. The film-coated tablets should be swallowed with some liquid and not be chewed. 3.3 CONTRAINDICATIONS Lodoz must not be used in patients with: DISETUJUI OLEH BPOM : 23/02/2021 ID : EREG100149VR12100018 EREG100149VR12100019 Page 2 of 10 • hypersensitive to Bisoprolol, Hydrochlorothiazide, other Thiazides Прочитать полный документ