Description
Indications
VALSATRIL is indicated for:
- Chronic heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death and hospitalization.
- Symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
Dosage and Administration
- Adults: The recommended starting dose is 49 mg sacubitril / 51 mg valsartan taken orally twice daily. After 2 to 4 weeks, the dose may be doubled to the target maintenance dose of 97 mg sacubitril / 103 mg valsartan twice daily, as tolerated.
- Pediatric Patients: For patients weighing at least 40 kg, the recommended starting dose is 24 mg sacubitril / 26 mg valsartan twice daily, titrated to 49 mg sacubitril / 51 mg valsartan and then to 72 mg sacubitril / 78 mg valsartan. For patients weighing less than 40 kg, dosing is based on body weight, and the oral suspension form is recommended.
Contraindications
VALSATRIL should not be used in patients with:
- A history of angioedema related to previous ACE inhibitor or ARB therapy.
- Concomitant use of an ACE inhibitor or aliskiren in patients with diabetes.
- Severe hepatic impairment (Child-Pugh class C).
- Pregnancy and lactation due to potential fetal and neonatal harm.
Warnings and Precautions
- Monitor for signs and symptoms of angioedema and hypotension.
- Regular monitoring of renal function and serum potassium is recommended.
- Discontinue use if hyperkalemia (elevated potassium levels) occurs.
- Use with caution in patients with volume depletion, hyponatremia, or those receiving potassium-sparing diuretics.
Adverse Reactions
Common adverse reactions may include:
- Hypotension
- Hyperkalemia
- Cough
- Dizziness
- Renal failure
Serious adverse reactions, though rare, can include angioedema and liver enzyme abnormalities.
Drug Interactions
- Avoid concomitant use with ACE inhibitors and aliskiren in patients with diabetes.
- Use caution when coadministering with potassium-sparing diuretics, NSAIDs, and lithium due to potential interactions.
Storage
Store at room temperature, away from moisture and heat. Keep out of reach of children.
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