País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
AMLODIPINE BESILATE; ATORVASTATIN CALCIUM TRIHYDRATE
PFIZER INDONESIA - Indonesia
AMLODIPINE BESILATE; ATORVASTATIN CALCIUM TRIHYDRATE
20/5 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
PFIZER- Germany
2016-11-28
Generic Name: Amlodipine/Atorvastatin Trade Name: CADUET CDS Effective Date: December 15, 2020 Supersedes: January 24, 2020 Approved by BPOM: 2020-0064301 Page 1 of 35 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Amlodipine/Atorvastatin Trade Name: CADUET CDS Effective Date: December 15, 2020 Supersedes: January 24, 2020 NAME OF THE MEDICINAL PRODUCT CADUET QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients: amlodipine besilate, atorvastatin calcium The tablets for oral administration contain amlodipine besilate and atorvastatin calcium equivalent to 5 mg/10 mg, 5 mg/20 mg, 10 mg/10 mg, 10 mg/20 mg, amlodipine/atorvastatin dosage strengths respectively. PHARMACEUTICAL FORM Tablets CLINICAL PARTICULARS THERAPEUTIC INDICATIONS CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine is indicated for treatment of hypertension and can be used as the sole agent to control blood pressure (BP) in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoreceptor blocking agent, or an angiotensin-converting enzyme inhibitor. Amlodipine is indicated for treatment of myocardial ischemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal’s or variant angina) or coronary vasculature. Amlodipine may be used where the clinical presentation suggests a possible vasospastic/vasoconstriction has not been confirmed. Amlodipine may be used alone, as monotherapy, or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses or beta-blockers. Atorvastatin is indicated as an adjunct to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in patients with primary hy Leer el documento completo