Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH), LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
Zydus Lifesciences Limited
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE 12.5 mg
ORAL
PRESCRIPTION DRUG
Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 and hydrochlorothiazide. 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 drugs, f
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/ 12.5 mg, are white to off-white, capsule-shaped, film-coated tablets debossed with "ZD18" on one side and plain on other side and are supplied as follows: NDC 65841-732-06 in bottle of 30 tablets NDC 65841-732-16 in bottle of 90 tablets NDC 65841-732-10 in bottle of 1000 tablets NDC 65841-732-40 in bottle of 5000 tablets Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/ 25 mg, are white to off-white, capsule-shaped, film-coated tablets debossed with "ZD19" on one side and plain on other side and are supplied as follows: NDC 65841-733-06 in bottle of 30 tablets NDC 65841-733-16 in bottle of 90 tablets NDC 65841-733-10 in bottle of 1000 tablets NDC 65841-733-23 in bottle of 4000 tablets 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 AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED Cadila Healthcare Limited ---------- Patient Information Losartan Potassium and Hydrochlorothiazide (loe-SAR-tan poe-TASS-ee-um and hye dro klor o THY a zide) Tablets, USP Read the Patient Information that comes with losartan potassium and hydrochlorothiazide 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 and hydrochlorothiazide tablets? • Losartan potassium and hydrochlorothiazide 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 and hydrochlorothiazide tablets tell your doctor right away. What are losartan potassium and hydrochlorothiazide tablets? Losartan potassium and hydrochlorothiazide tablets contain 2 prescription medicines, an angiotensin receptor blocker (ARB) and a diuretic (water pill). It is used to: • lower high blood pressure (hypertension). Losartan potassium and hydrochlorothiazide tablets are not usually the first medicine used to treat high blood pressure. • lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy (LVH). Losartan potassium and hydrochlorothiazide tablets may not help Black patients with this problem. Losartan potassium and hydrochlorothiazide tablets have not been studied in children less than 18 years old. 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. The losartan ingredient in losartan potassium and hydrochlorothiazide tablets can help your blood vessels relax so your blood pres Prečítajte si celý dokument
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE - LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ZYDUS LIFESCIENCES LIMITED ---------- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-732-06 Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg 30 Tablets Rx Only NDC 65841-733-06 Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg 30 Tablets Rx Only LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE losartan potassium and hydrochlorothiazide tablet, film coated PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:65841-732 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 12.5 mg LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM 50 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 12mm FLAVOR IMPRINT CODE Z D18 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:65841-732- 40 5000 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 2 NDC:65841-732- 06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 3 NDC:65841-732- 16 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 4 NDC:65841-732- 10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/10/2010 MARKETING INFORMATION MARKETING CATEGORY APPLICATION Prečítajte si celý dokument