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Benicar HCT

OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE

Manufacturer: Cosette Pharmaceuticals, Inc.

Score: 148.0

Quick Summary

Benicar HCT is a combination of an angiotensin II receptor antagonist (olmesartan medoxomil) and a thiazide diuretic (hydrochlorothiazide) used to treat hypertension. It works by blocking the action of angiotensin II, a potent vasoconstrictor, and increasing the excretion of sodium and water in the urine. The recommended starting dose is 40/12.5 mg once daily, with a maximum dose of 40/25 mg. Important safety information includes a boxed warning for fetal toxicity, and contraindications for patients with hypersensitivity to any component, anuria, and coadministration with aliskiren in patients with diabetes. Adverse reactions include nausea, hyperuricemia, dizziness, and upper respiratory infection.

Key Clinical Findings and Indications

  • Hypertension
  • Angiotensin II receptor antagonist
  • Thiazide diuretic
  • Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events

Important Safety Information

Warning

Fetal toxicity: When pregnancy is detected, discontinue Benicar HCT as soon as possible.

Contraindications

  • Hypersensitivity to any component
  • Anuria
  • Coadministration with aliskiren in patients with diabetes

Adverse Reactions

  • Nausea
  • Hyperuricemia
  • Dizziness
  • Upper respiratory infection

Dosing Recommendations

General Guidance

Adjust dose after 2 to 4 weeks, as needed

Hypertension

Adult Dose

40/12.5 mg once daily, with a maximum dose of 40/25 mg

Pediatric Dose

Special Population Considerations

Pregnancy

  • 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

  • It is not known whether olmesartan is excreted in human milk, but thiazides appear in human milk

Pediatric Use

  • Safety and effectiveness of Benicar HCT in pediatric patients have not been established

Geriatric Use

  • Clinical studies of Benicar HCT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
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