Finished product reference

Losartan Potassium / Hydrochlorothiazide

Tablet · Oral · 50 mg/12.5 mg

List code
8256
Pharmacologic class
Thiazide Diuretic
Boxed warning

WARNING: FETAL TOXICITY 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 . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.

What it is and how it works

Mechanism of Action Losartan Potassium Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)], is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland).

Indications

Losartan potassium and hydrochlorothiazide tablet is 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. 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. Hypertension Losartan potassium and hydrochlorothiazide tablet is 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.

Dosage and administration (summary)

Hypertension Usual starting dose: 50/12.5 mg once daily. Titrate as needed to a maximum dose of 100/25 mg. 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. Hypertension The usual starting dose of losartan potassium and hydrochlorothiazide tablet is 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily as needed to control blood pressure .

Contraindications

Losartan potassium and hydrochlorothiazide tablet is contraindicated: In patients who are hypersensitive to any component of this product. In patients with anuria For coadministration with aliskiren in patients with diabetes Hypersensitivity to any component of losartan potassium and hydrochlorothiazide tablets. Anuria. Coadministration with aliskiren in patients with diabetes.

Warnings and precautions

Hypotension: Correct volume or salt depletion prior to administration of losartan and hydrochlorothiazide. Monitor renal function and potassium in susceptible patients. Observe for clinical signs of fluid or electrolyte imbalance. Acute angle-closure glaucoma. Exacerbation of systemic lupus erythematosus. Fetal Toxicity Losartan and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman.

Pregnancy

Pregnancy Risk Summary Losartan and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.

Storage and supply

Product: 50090-7664 NDC: 50090-7664-0 90 TABLET in a BOTTLE

Source: Losartan Potassium And Hydrochlorothiazide (Losartan Potassium And Hydrochlorothiazide) — US FDA prescribing information, 2025-10-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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