Valsartan and Hydrochlorothiazide

VALSARTAN AND HYDROCHLOROTHIAZIDE

Manufacturer: Amneal Pharmaceuticals of New York LLC

Score: 144.0

Quick Summary

Valsartan and Hydrochlorothiazide is a combination tablet used for the treatment of hypertension, to lower blood pressure. It consists of valsartan, an angiotensin II receptor blocker, and hydrochlorothiazide, a diuretic. The drug is indicated for patients not adequately controlled with monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. However, it is contraindicated in patients with anuria, hypersensitivity to sulfonamide-derived drugs, and in patients with diabetes who are taking aliskiren. The most common adverse reactions include nasopharyngitis, dizziness, and headache. The recommended starting dose is 160/12.5 mg once daily, with a maximum dose of 320/25 mg. Special considerations are needed for pregnant women, nursing mothers, pediatric patients, and geriatric patients due to potential risks and limited data.

Key Clinical Findings and Indications

Treatment of hypertension
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events
Indicated for patients not adequately controlled with monotherapy
Indicated as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals

Important Safety Information

Warning

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

Contraindications

Anuria
Hypersensitivity to any sulfonamide-derived drugs or any component
Do not coadminister aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes

Adverse Reactions

Nasopharyngitis
Dizziness
Headache
Hypotension
Hyperkalemia

Dosing Recommendations

General Guidance

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

Hypertension

Adult Dose

160/12.5 mg once daily, with a maximum dose of 320/25 mg

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

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

Nursing Mothers

Breastfeeding is not recommended during treatment with valsartan and hydrochlorothiazide
Valsartan is present in rat milk, and hydrochlorothiazide is present in human breast milk

Pediatric Use

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

Geriatric Use

In the controlled clinical trials of valsartan and hydrochlorothiazide, 764 (17.5%) patients treated with valsartan-hydrochlorothiazide were ≥65 years and 118 (2.7%) were ≥75 years
No overall difference in the efficacy or safety of valsartan-hydrochlorothiazide was observed between these patients and younger patients

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