Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH), LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
Zydus Pharmaceuticals USA Inc.
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 68382-142-06 in bottle of 30 tablets with child-resistant closure NDC 68382-142-16 in bottle of 90 tablets with child-resistant closure NDC 68382-142-10 in bottle of 1,000 tablets NDC 68382-142-40 in bottle of 5,000 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 68382-143-06 in bottle of 30 tablets with child-resistant closure NDC 68382-143-16 in bottle of 90 tablets with child-resistant closure NDC 68382-143-10 in bottle of 1,000 tablets NDC 68382-143-23 in bottle of 4,000 tablets Storage: Store at 20°C to 25°C (68°F 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 Zydus Pharmaceuticals (USA) Inc. ---------- 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 blo Lees het volledige document
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE - LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ZYDUS PHARMACEUTICALS USA 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 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: 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) DOSAGE AND ADMINISTRATION Hypertension Usual starting dose: 50/12.5 mg once daily. (2.1) Titrate as needed to a maximum dose of 100/25 mg. (2.1) Hypertensive Patients with Left Ventricular Hypertrophy Not controlled on monotherapy: Initiate with 50/12.5 mg. Titrate as needed to a maximum of 100/25 mg. (2.2) DOSAGE FORMS AND STRENGTHS Tablets (losartan potassium/hydrochlorothiazide content): 50/12.5 mg and 100/25 mg. (3) CONTRAINDICATIONS Hypersensitivity to any component of losartan potassium and hydrochlorothiazide. (4) Anuria. (4) Coadministration with aliskiren in patients with diabetes. (4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume or salt depletion p Lees het volledige document