LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Manufacturer: Granules Pharmaceuticals Inc.

Score: 144.0

Quick Summary

Losartan potassium and hydrochlorothiazide is a combination medication used to treat high blood pressure and reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. The medication works by blocking the action of angiotensin II, a potent vasoconstrictor, and increasing the excretion of sodium and chloride in the urine. The usual starting dose is 50/12.5 mg once daily, with a maximum dose of 100/25 mg. Important safety information includes the risk of fetal harm, hyperkalemia, and hypotension. Contraindications include hypersensitivity to any component of the medication, anuria, and coadministration with aliskiren in patients with diabetes. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of hypertension to lower blood pressure
Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy
Losartan potassium and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman

Important Safety Information

Warning

When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible

Contraindications

Hypersensitivity to any component of this product
Anuria
Coadministration with aliskiren in patients with diabetes

Adverse Reactions

Dizziness
Upper respiratory infection
Cough
Back pain
Hyperkalemia
Hypotension

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal impairment or hepatic insufficiency

Hypertension

Adult Dose

50/12.5 mg once daily, with a maximum dose of 100/25 mg

Pediatric Dose

Not established

Hypertensive patients with left ventricular hypertrophy

Adult Dose

50/12.5 mg once daily, with a maximum dose of 100/25 mg

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Losartan potassium and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman
Discontinue losartan potassium and hydrochlorothiazide tablets as soon as possible when pregnancy is detected

Nursing Mothers

It is not known whether losartan is excreted in human milk
Thiazides appear in human milk
A decision should be made whether to discontinue nursing or discontinue the drug

Pediatric Use

Safety and effectiveness of losartan potassium and hydrochlorothiazide in pediatric patients have not been established

Geriatric Use

In a controlled clinical study, no overall differences in effectiveness were observed between geriatric patients and younger patients
Adverse events were somewhat more frequent in the elderly compared to non-elderly patients