국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Solco Healthcare US, LLC
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 are supplied as a film-coated tablet. Losartan/ Hydrochlorothiazide Color Shape Engraving NDC 43547-xxx-xx Bottle/ 30 Bottle/ 90 Bottle/ 1000 50/12.5 mg yellow capsule-shaped HH/211 423-03 423-09 423-11 100/12.5 mg white to off-white capsule-shaped HH/213 425-03 425-09 425-11 100/25 mg yellow capsule-shaped HH/212 424-03 424-09 424-11 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.
Abbreviated New Drug Application
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED Solco Healthcare US, LLC ---------- FDA-APPROVED PATIENT LABELING Dispense with Patient Information available at: www.solcohealthcare.com/druglabeling/losartan-hctz-tablets.pdf Patient Information Losartan Potassium and Hydrochlorothiazide Tablets, USP (loe-SAR-tanpoe-TAS-see-um and hye-droe-klor-oh-THYE-ah-zide) 50/12.5 mg, 100/12.5 mg, 100/25 mg Rx only 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. Y 전체 문서 읽기
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED SOLCO HEALTHCARE US, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LOSARTAN POSTASSIUM AND HYDROCHLOROTHIAZIDETABLETS 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 Hypertension • • Hypertensive Patients with Left Ventricular Hypertrophy • DOSAGE FORMS AND STRENGTHS Tablets (losartan potassium/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) 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 of 100/25 mg. (2.1) Not controlled on monotherapy: Initiate with 50/12.5 mg. Titrate as needed to a m 전체 문서 읽기