País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)
Macleods Pharmaceuticals Limited
CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL 4 mg
ORAL
PRESCRIPTION DRUG
Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure
Candesartan cilexetil tablets, USP 4 mg, are white to off-white, circular, biconvex, uncoated tablets, debossed with "ML 52" on one side and breakline on other side. They are supplied as follows: NDC 33342-114-07 unit of use bottles of 30 NDC 33342-114-10 unit of use bottles of 90 NDC 33342-114-51 unit of use bottles of 300 NDC 33342-114-12 unit dose blister packages of 100. Candesartan cilexetil tablets, USP 8 mg, are light pink, circular, biconvex, uncoated tablets, debossed with "ML 53" on one side and breakline on other side. They are supplied as follows: NDC 33342-115-07 unit of use bottles of 30 NDC 33342-115-10 unit of use bottles of 90 NDC-33342-115-51 unit of use bottles of 300 NDC 33342-115-12 unit dose blister packages of 100. Candesartan cilexetil tablets, USP 16 mg, are pink, circular, biconvex, uncoated tablets, debossed with "ML 54" on one side and breakline on other side.They are supplied as follows: NDC 33342-116-07 unit of use bottles of 30 NDC 33342-116-10 unit of use bottles of 90 NDC 33342-116-51 unit of use bottles of 300 NDC 33342-116-12 unit dose blister packages of 100. Candesartan cilexetil tablets, USP 32 mg, are pink, circular, biconvex, uncoated tablets, debossed with "ML 55" on one side and breakline on other side. They are supplied as follows: NDC 33342-117-07 unit of use bottles of 30 NDC 33342-117-10 unit of use bottles of 90 NDC 33342-117-51 unit of use bottles of 300 NDC 33342-117-12 unit dose blister packages of 100. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
Abbreviated New Drug Application
CANDESARTAN - CANDESARTAN TABLET MACLEODS PHARMACEUTICALS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CANDESARTAN CILEXETIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CANDESARTAN CILEXETIL TABLETS. CANDESARTAN CILEXETIL TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ · WHEN PREGNANCY IS DETECTED, DISCONTINUE CANDESARTAN CILEXETIL TABLETS AS SOON AS POSSIBLE. (5.1, 8.1) · DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1, 8.1) INDICATIONS AND USAGE Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). · Treatment of heart failure (NYHA class II-IV); candesartan reduces cardiovascular death and heart failure hospitalization (1.2). DOSAGE AND ADMINISTRATION Starting Dose Target Dose Adult Hypertension (2.1) 16 mg tablet once daily 8 - 32 mg tablet total daily dose Pediatric Hypertension (1 to < 6 years) (2.2) 0.20 mg/kg oral suspension once daily 0.05 - 0.4 mg/kg oral suspension once daily or consider divided dose Pediatric Hypertension (6 to < 17 years) (2.2) < 50 kg 4 – 8 mg tablet once daily > 50 kg 8 – 16 mg tablet once daily < 50 kg 4 – 16 mg tablet once daily or consider divided dose > 50 kg 4 – 32 mg tablet once daily or consider divided dose Adult Heart Failure (2.3) 4 mg tablet once daily 32 mg tablet once daily The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by patient. DOSAGE FORMS AND STRENGTHS Tablets 4 mg, 8 mg, 16 mg, 32 mg (3). CONTRAINDICATIONS Known hypersensitivity to product components (4 Leer el documento completo