מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)
Sandoz Inc
CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL 4 mg
ORAL
PRESCRIPTION DRUG
Candesartan cilexetil tablets are indicated for the 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. 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 (J
Candesartan cilexetil tablets, USP are available containing 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil, USP. 4 mg, white to off-white, round tablets debossed with M on left side of the score and C on right side of the score on one side of the tablet and 24 on the other side. They are available as follows: 8 mg, pink, mottled round tablets debossed with M on left side of the score and C on right side of the score on one side of the tablet and 25 on the other side. They are available as follows: 16 mg, pink, mottled round tablets debossed with M on left side of the score and C on right side of the score on one side of the tablet and 31 on the other side. They are available as follows: 32 mg, pink, mottled round tablets debossed with MC above the score and 32 below the score on one side of the tablet and blank on the other side. They are available as follows: Storage
Abbreviated New Drug Application
CANDESARTAN CILEXETIL- CANDESARTAN CILEXETIL TABLET SANDOZ INC ---------- 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._ • • RECENT MAJOR CHANGES Warnings and Precautions (5.5)02/2016 INDICATIONS AND USAGE Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: • • DOSAGE AND ADMINISTRATION * STARTING DOSE TARGET DOSE Adult Hypertension (2.1) 16 mg tablet once daily 8 to32 mg tablet total daily dose Pediatric Hypertension (1 to <6 years) (2.2) 0.20 mg/kg oral suspension once daily 0.05 to 0.4 mg/kg oral suspension once daily or consider divided dose Pediatric Hypertension (6 to <17 years) (2.2) <50 kg 4 to 8 mg tablet once daily >50 kg 8 to 16 mg tablet once daily <50 kg 4 to 16 mg tablet once daily or consider divided dose >50 kg 4 to 32 mg tablet once daily or consider divided dose Adult Heart Failure (2.3) 4 mg tablet once daily 32 mg tablet once daily DOSAGE FORMS AND STRENGTHS Tablets 4 mg, 8 mg, 16 mg, 32 mg (3). CONTRAINDICATIONS Known hypersensitivity to product components (4). Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes (4). WARNINGS AND PRECAUTIONS • • ADVERSE REACTIONS • WHEN PREGNANCY IS DETECTED, DISCONTINUE CANDESARTAN CILEXETIL TABLETS AS SOON AS POSSIBLE. (5.1) DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1) 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 cilexetil קרא את המסמך השלם