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AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE

Manufacturer: Strides Pharma Science Limited

Score: 148.0

Quick Summary

Amlodipine/valsartan/hydrochlorothiazide is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide used for the treatment of hypertension. It works by blocking the contractile effects of calcium on cardiac and vascular smooth muscle cells, blocking the vasoconstriction and sodium retaining effects of angiotensin II, and promoting the excretion of sodium and chloride in the kidney. The drug has several key clinical findings and indications, including the treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events. Important safety information includes a boxed warning about the risk of fetal toxicity, and contraindications include anuria, hypersensitivity to sulfonamide-derived drugs, and known hypersensitivity to any component of the product. Adverse reactions include dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea, and nasopharyngitis. The main dosing recommendations include dose once-daily, with a maximum dose of 10/320/25 mg, and special population considerations include use in pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events
  • Blocks the contractile effects of calcium on cardiac and vascular smooth muscle cells
  • Blocks the vasoconstriction and sodium retaining effects of angiotensin II
  • Promotes the excretion of sodium and chloride in the kidney

Important Safety Information

Warning

Fetal toxicity: When pregnancy is detected, discontinue amlodipine/valsartan/hydrochlorothiazide as soon as possible.

Contraindications

  • Anuria
  • Hypersensitivity to sulfonamide-derived drugs
  • Known hypersensitivity to any component of the product

Adverse Reactions

  • Dizziness
  • Peripheral edema
  • Headache
  • Dyspepsia
  • Fatigue
  • Muscle spasms
  • Back pain
  • Nausea
  • Nasopharyngitis

Dosing Recommendations

General Guidance

The dosage may be increased after 2 weeks of therapy.

Hypertension

Adult Dose

Dose once-daily, with a maximum dose of 10/320/25 mg

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Discontinue amlodipine/valsartan/hydrochlorothiazide as soon as possible when pregnancy is detected
  • 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 amlodipine/valsartan/hydrochlorothiazide
  • Hydrochlorothiazide is present in human milk and valsartan is present in rat milk

Pediatric Use

  • The safety and effectiveness of amlodipine/valsartan/hydrochlorothiazide in pediatric patients have not been established

Geriatric Use

  • Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40% to 60%
  • Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range
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