Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX)
Zydus Lifesciences 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 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 70771-1204-3 in bottle of 30 tablets NDC 70771-1204-9 in bottle of 90 tablets NDC 70771-1204-5 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 70771-1205-3 in bottle of 30 tablets NDC 70771-1205-9 in bottle of 90 tablets NDC 70771-1205-5 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 70771-1206-3 in bottle of 30 tablets NDC 70771-1206-9 in bottle of 90 tablets NDC 70771-1206-1 in bottle of 100 tablets NDC 70771-1206-5 in bottle of 500 tablets NDC 70771-1206-0 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 70771-1207-3 in bottle of 30 tablets NDC 70771-1207-9 in bottle of 90 tablets NDC 70771-1207-1 in bottle of 100 tablets NDC 70771-1207-5 in bottle of 500 tablets NDC 70771-1207-0 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
Cadila Healthcare Limited ---------- 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 anesthesia. Baca dokumen lengkap
CANDESARTAN CILEXETIL - CANDESARTAN CILEXETIL TABLET ZYDUS LIFESCIENCES LIMITED ---------- CANDESARTAN CILEXETIL TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1204-5 Candesartan Cilexetil Tablets USP, 4 mg Rx Only 500 tablets NDC 70771-1205-5 Candesartan Cilexetil Tablets USP, 8 mg Rx Only 500 tablets NDC 70771-1206-5 Candesartan Cilexetil Tablets USP, 16 mg Rx Only 500 tablets NDC 70771-1207-5 Candesartan Cilexetil Tablets USP, 32 mg Rx Only 500 tablets CANDESARTAN CILEXETIL candesartan cilexetil tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1204 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL 4 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) FERRIC OXIDE RED (UNII: 1K09F3G675) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) STARCH, CORN (UNII: O8232NY3SJ) PRODUCT CHARACTERISTICS COLOR PINK (LIGHT PINK) SCORE 2 pieces SHAPE ROUND (ROUND) SIZE 7mm FLAVOR IMPRINT CODE Z E;58 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1204-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 2 NDC:70771- 1204-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 3 NDC:70771- 1204-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/22/2018 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA091390 02/22/2018 CANDESARTAN CILEXETIL candesartan cilexetil tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1205 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH CANDESARTAN CILEXETIL (UNII: R85M2X0D68) ( Baca dokumen lengkap