Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Sandoz Inc
LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 50 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, round, biconvex film-coated debossed with “SZ 349” on one side. Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. They are supplied as follows: NDC 0781-5206-31, bottle of 30 tablets NDC 0781-5206-92, bottle of 90 tablets NDC 0781-5206-01, bottle of 100 tablets NDC 0781-5206-10, bottle of 1,000 tablets NDC 0781-5206-74, bottle of 4,000 tablets Losartan potassium and hydrochlorothiazide tablets, USP 100 mg/12.5 mg are white, round, biconvex film-coated debossed with “SZ 309” on one side. Each tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. They are supplied as follows: NDC 0781-5204-31, bottle of 30 tablets NDC 0781-5204-92, bottle of 90 tablets NDC 0781-5204-01, bottle of 100 tablets NDC 0781-5204-10, bottle of 1,000 tablets NDC 0781-5204-74, bottle of 4,000 tablets Losartan potassium and hydrochlorothiazide tablets, USP 100 mg/25 mg are white, round, biconvex film-coated debossed with “SZ 390” on one side. Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. They are supplied as follows: NDC 0781-5207-31, bottle of 30 tablets NDC 0781-5207-92, bottle of 90 tablets NDC 0781-5207-01, bottle of 100 tablets NDC 0781-5207-10, bottle of 1,000 tablets NDC 0781-5207-74, bottle of 4,000 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS TABLET, FILM COATED SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS. LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS AS SOON AS POSSIBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1) INDICATIONS AND USAGE Losartan potassium and hydrochlorothiazide tablets are a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: • • DOSAGE AND ADMINISTRATION Hype rte nsion • • Hypertensive Patients with Left Ventricular Hypertrophy • DOSAGE FORMS AND STRENGTHS Tablets (losartan potassium and hydrochlorothiazide content): 50/12.5 mg; 100/12.5 mg; and 100/25 mg. (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence ≥2% and greater than placebo) are dizziness, upper respiratory infection, cough, and back pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Usual starting dose: 50/12.5 mg once daily. (2.1) Titrate as needed to a maximum dose Belgenin tamamını okuyun