MedCallyLooking up the FDA label…
Looking up the FDA label…
Also sold as Losartan Potassium, Losartan Potassium and Hydrochlorothiazide, Losartan potassium Tablets, 100 mg
FDA boxed warning
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue losartan potassium tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue losartan potassium tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • 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. • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. 1.1 Hypertension 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. …
Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy Advise female patients of childbearing age about the consequences of exposure to losartan potassium tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible. Potassium Supplements Advise patients receiving losartan potassium tablets not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider. Print Patient Information Leaflet at: https://www.granulespharma.com/products/ Manufactured by: Granules India Limited Hyderabad-500 081, India Distributed by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 Repackaged By: Preferred Pharmaceuticals Inc. For more information about losartan potassium tablets, please contact Granules Pharmaceuticals Inc. at 1-877-770-3183. The trademarks depicted herein are owned by their respective companies.
Most common adverse reactions (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials o…
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Ask a doctor — $19.99Losartan potassium tablets, are contraindicated: • In patients who are hypersensitive to any component of this product. • For coadministration with aliskiren in patients with diabetes. • Hypersensitivity to any component. • Coadministration with aliskiren in patients with diabetes.
Hypertension • Usual adult dose: 50 mg once daily. • Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg). Hypertensive Patients with Left Ventricular Hypertrophy • Usual starting dose: 50 mg once daily. • Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium tablets to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed. Nephropathy in Type 2 Diabetic Patients • Usual dose: 50 mg once daily. • Increase dose to 100 mg once daily if f…
7 DRUG INTERACTIONS • Agents increasing Serum Potassium: Risk of hyperkalemia. • Lithium: Risk of lithium toxicity. • NSAIDs: Increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. • Dual inhibition of the Renin-Angiotensin System: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia. 7.1 Agents Increasing Serum Potassium Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassi…
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