Amlodipine and Valsartan

AMLODIPINE AND VALSARTAN

Manufacturer: Alembic Pharmaceuticals Limited

Score: 148.0

Quick Summary

Amlodipine and Valsartan is a combination tablet used to treat hypertension. It combines a dihydropyridine calcium channel blocker (amlodipine) and an angiotensin II receptor blocker (valsartan) to lower blood pressure. The drug is indicated for patients who are not adequately controlled on monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Key clinical findings include the reduction of supine and standing blood pressures, and the drug has been shown to be effective in lowering blood pressure in patients with hypertension. Important safety information includes the risk of fetal toxicity, and the drug is contraindicated in patients with known hypersensitivity to any component. The recommended starting dose is 5/160 mg once daily, and the dose can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure.

Key Clinical Findings and Indications

Treatment of hypertension
Reduction of supine and standing blood pressures
Effective in lowering blood pressure in patients with hypertension

Important Safety Information

Warning

When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Contraindications

Known hypersensitivity to any component
Do not coadminister aliskiren with amlodipine and valsartan tablets in patients with diabetes

Adverse Reactions

Peripheral edema
Nasopharyngitis
Upper respiratory tract infection
Dizziness

Dosing Recommendations

General Guidance

The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure.

Hypertension

Adult Dose

5/160 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Discontinue amlodipine and valsartan tablets as soon as possible when pregnancy is detected
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

Nursing Mothers

It is not known whether amlodipine is excreted in human milk
It is not known whether valsartan is excreted in human milk

Pediatric Use

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

Geriatric Use

No overall differences in the efficacy or safety of amlodipine and valsartan tablets were observed in this patient population
Greater sensitivity of some older individuals cannot be ruled out

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