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Losartan Potassium

LOSARTAN

Manufacturer: Granules Pharmaceuticals Inc.

Score: 144.0

Quick Summary

Losartan potassium is an angiotensin II receptor blocker used to treat hypertension, reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, and treat diabetic nephropathy in patients with type 2 diabetes and a history of hypertension. The usual starting dose is 50 mg once daily, with a maximum dose of 100 mg once daily. Losartan potassium can cause fetal harm when administered to a pregnant woman and should be discontinued as soon as possible when pregnancy is detected. The drug has been shown to be effective in reducing blood pressure and slowing the progression of nephropathy in patients with type 2 diabetes.

Key Clinical Findings and Indications

  • Treatment of hypertension in adults and pediatric patients 6 years of age and older
  • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy
  • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension

Important Safety Information

Warning

Losartan potassium can cause fetal harm when administered to a pregnant woman

Contraindications

  • Patients who are hypersensitive to any component of this product
  • Coadministration with aliskiren in patients with diabetes

Adverse Reactions

  • Dizziness
  • Upper respiratory infection
  • Nasal congestion
  • Back pain
  • Asthenia/fatigue
  • Chest pain
  • Hypotension
  • Orthostatic hypotension
  • Diarrhea
  • Anemia
  • Hyperkalemia
  • Hypoglycemia
  • Muscular weakness
  • Urinary tract infection

Dosing Recommendations

General Guidance

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

Hypertension

Adult Dose

50 mg once daily, with a maximum dose of 100 mg once daily

Pediatric Dose

0.7 mg per kg once daily (up to 50 mg total) for pediatric patients 6 years of age and older

Hypertensive patients with left ventricular hypertrophy

Adult Dose

50 mg once daily, with an increase to 100 mg once daily as needed

Pediatric Dose

Not recommended for pediatric patients less than 6 years of age

Nephropathy in type 2 diabetic patients

Adult Dose

50 mg once daily, with an increase to 100 mg once daily as needed

Pediatric Dose

Not recommended for pediatric patients less than 6 years of age

Special Population Considerations

Pregnancy

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

Nursing Mothers

  • It is not known whether losartan is excreted in human milk
  • Caution should be exercised when losartan potassium is administered to a nursing woman

Pediatric Use

  • Safety and effectiveness have not been established in pediatric patients under the age of 6
  • Losartan potassium is not recommended for pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m^2

Geriatric Use

  • No overall differences in effectiveness or safety were observed between geriatric patients and younger patients
  • Greater sensitivity of some older individuals cannot be ruled out

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