Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)
Zydus Pharmaceuticals USA Inc.
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 light pink, mottled, round, biconvex, uncoated scored tablets engraved with 'ZE' on one side and '58' on other side and are supplied as follows: NDC 68382-190-06 in bottle of 30 tablets NDC 68382-190-16 in bottle of 90 tablets NDC 68382-190-05 in bottle of 500 tablets Candesartan Cilexetil Tablets USP, 8 mg are pink, mottled, round, biconvex, uncoated scored tablets engraved with 'ZE' on one side and '59' on other side and are supplied as follows: NDC 68382-191-06 in bottle of 30 tablets NDC 68382-191-16 in bottle of 90 tablets NDC 68382-191-05 in bottle of 500 tablets Candesartan Cilexetil Tablets USP, 16 mg are white, round, biconvex, uncoated scored tablets engraved with 'ZE' on one side and '60' on other side and are supplied as follows: NDC 68382-192-06 in bottle of 30 tablets NDC 68382-192-16 in bottle of 90 tablets NDC 68382-192-01 in bottle of 100 tablets NDC 68382-192-05 in bottle of 500 tablets NDC 68382-192-10 in bottle of 1000 tablets Candesartan Cilexetil Tablets USP, 32 mg are white to off-white, round, biconvex, uncoated scored tablets engraved with 'ZE' on one side and '61' on other side and are supplied as follows: NDC 68382-193-06 in bottle of 30 tablets NDC 68382-193-16 in bottle of 90 tablets NDC 68382-193-01 in bottle of 100 tablets NDC 68382-193-05 in bottle of 500 tablets NDC 68382-193-10 in bottle of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep in a tightly closed container. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
Zydus Pharmaceuticals USA Inc. ---------- Patient Information Candesartan Cilexetil (kan" de sar' tan sye lex' e til) Tablets, USP Read the Patient information that comes with candesartan cilexetil tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about candesartan cilexetil tablets, ask your doctor or pharmacist. What is the most important information I should know about candesartan cilexetil tablets? Candesartan cilexetil tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking candesartan cilexetil tablets, tell your doctor right away. What are candesartan cilexetil tablets? Candesartan cilexetil tablets are a prescription medicine called an angiotensin receptor blocker (ARB). Candesartan cilexetil tablets are used to: • treat high blood pressure in adults and children, 1 to 17 years of age • treat certain types of heart failure in adults, to reduce death and hospitalization for heart damage and heart failure Heart failure is a condition where the heart does not pump blood as well as it should. Candesartan cilexetil tablets must not be used in children less than 1 year of age for high blood pressure. Who should not take candesartan cilexetil tablets? Do not take candesartan cilexetil tablets if you: • are allergic to any of the ingredients in candesartan cilexetil tablets. See the end of this leaflet for a complete list of ingredients in candesartan cilexetil tablets. • are diabetic and taking aliskiren. What should I tell my doctor before taking candesartan cilexetil tablets? Before you take candesartan cilexetil tablets, tell your doctor if you: • have heart problems • have liver problems • have kidney problems • currently have vomiting or diarrhea • are scheduled for surgery or anesth Les hele dokumentet
CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL TABLET ZYDUS PHARMACEUTICALS USA 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._ WHEN PREGNANCY IS DETECTED, DISCONTINUE CANDESARTAN CILEXETIL 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) 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: 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 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 to 32 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 coadminister aliskiren with candesartan cilexetil in patients with d Les hele dokumentet