Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
Zydus Lifesciences Limited
LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mg
ORAL
PRESCRIPTION DRUG
Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. 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 1 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 (JNC). Numerous antihypertensive
Losartan Potassium Tablets USP, 25 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z" on one side and "2"on other side and are supplied as follows: NDC 65841-729-06 in bottle of 30 tablets NDC 65841-729-16 in bottle of 90 tablets NDC 65841-729-01 in bottle of 100 tablets NDC 65841-729-10 in bottle of 1,000 tablets NDC 65841-729-24 in bottle of 10,000 tablets Losartan Potassium Tablets USP, 50 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z16" on one side and lip type breakline on other side and are supplied as follows: NDC 65841-730-06 in bottle of 30 tablets NDC 65841-730-16 in bottle of 90 tablets NDC 65841-730-01 in bottle of 100 tablets NDC 65841-730-10 in bottle of 1,000 tablets NDC 65841-730-24 in bottle of 10,000 tablets Losartan Potassium Tablets USP, 100 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z18" on one side and plain on other side and are supplied as follows: NDC 65841-731-06 in bottle of 30 tablets NDC 65841-731-16 in bottle of 90 tablets NDC 65841-731-01 in bottle of 100 tablets NDC 65841-731-10 in bottle of 1,000 tablets NDC 65841-731-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED Cadila Healthcare Limited ---------- Patient Information Losartan Potassium (loe-SAR-tan poe-TASS-ee-um) Tablets, USP Read the Patient Information that comes with losartan potassium 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 condition and treatment. What is the most important information I should know about losartan potassium tablets? • Losartan potassium 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 losartan potassium tablets, tell your doctor right away. What are losartan potassium tablets? Losartan potassium tablets are a prescription medicine called an angiotensin receptor blocker (ARB). It is used: • alone or with other blood pressure medicines to lower high blood pressure (hypertension). • to lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy. Losartan potassium tablets may not help Black patients with this problem. • to slow the worsening of diabetic kidney disease (nephropathy) in patients with type 2 diabetes who have or had high blood pressure. Losartan potassium tablets have not been studied in children less than 6 years old or in children with certain kidney problems. High Blood Pressure (hypertension). Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Losartan potassium tablets can help your blood vessels relax so your blood pressure is lower. Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart's main pumping chamber). LVH can happen from several things. High blood pressure is the most common cause of LVH. Type 2 Diabetes with Nephropath Přečtěte si celý dokument
LOSARTAN POTASSIUM - LOSARTAN POTASSIUM TABLET, FILM COATED ZYDUS LIFESCIENCES LIMITED ---------- LOSARTAN POTASSIUM TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-729-01 Losartan Potassium Tablets USP, 25 mg Rx Only 100 Tablets Zydus NDC 65841-730-01 Losartan Potassium Tablets USP, 50 mg Rx Only 100 Tablets Zydus NDC 65841-731-01 Losartan Potassium Tablets USP, 100 mg Rx Only 100 Tablets Zydus LOSARTAN POTASSIUM losartan potassium tablet, film coated PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:65841-729 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM 25 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PRODUCT CHARACTERISTICS COLOR WHITE (WHITE TO OFF-WHITE) SCORE no score SHAPE CAPSULE (CAPSULE) SIZE 8mm FLAVOR IMPRINT CODE Z ;2 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:65841-729- 06 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 2 NDC:65841-729- 16 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 3 NDC:65841-729- 01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 4 NDC:65841-729- 10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 5 NDC:65841-729- 24 10000 in 1 BOTTLE; Type 0: Not a Combination Product 10/04/2010 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA078243 10/04/2010 LOSARTAN POTASSIU Přečtěte si celý dokument