Entresto Sacubitril Valsartan Sodium Tablets

1. Indications and Usage
Heart Failure (HFrEF):
Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA class II–IV) and reduced ejection fraction.
Heart Failure (HFpEF):
Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure with preserved ejection fraction.
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY.
Recommended Dosage:
Maintenance Dose: The target maintenance dose is 97 mg/103 mg (sacubitril/valsartan) twice daily.
Starting Dose:
Patients currently not taking an ACE inhibitor or ARB: Start at 49 mg/51 mg twice daily.
Patients currently taking an ACE inhibitor or ARB: Start at 24 mg/26 mg twice daily (to minimize hypotension risk).
Titration: Double the dose approximately every 2–4 weeks based on clinical tolerability.
Administration Instructions:
Can be administered with or without food.
Critical Switching Interval:
Do not administer within 36 hours of stopping an Angiotensin-Converting Enzyme Inhibitor (ACEI) to reduce the risk of angioedema.
3. Mechanism of Action
Dual-Action (ARNI):
Sacubitril Valsartan is a first-in-class ARNI.
Sacubitril: A prodrug that is hydrolyzed to LBQ657, which inhibits neprilysin (NLE). This increases levels of natriuretic peptides and other vasoactive peptides, promoting natriuresis, diuresis, and vasodilation.
Valsartan: An ARB that blocks the angiotensin II type 1 (AT1) receptor, inhibiting the vasoconstrictor and aldosterone-secreting effects of the renin-angiotensin-aldosterone system (RAAS).
4. Safety and Warnings
Angioedema:
Angioedema has been reported. Contraindicated in patients with a history of angioedema related to previous ACEI or ARB therapy.
Hypotension:
Symptomatic hypotension may occur; consider dose reduction or temporary interruption if hypotension persists.
Renal Impairment:
Monitor renal function periodically, especially in patients with severe renal impairment.
Hyperkalemia:
Monitor serum potassium levels.
Fetal Toxicity:
Can cause injury and death to the developing fetus. Discontinue as soon as pregnancy is detected.
5. Adverse Reactions
Most Common:
Hypotension, hyperkalemia, dizziness, and renal impairment.
Other Reactions:
Cough (less frequent compared to ACEI).
6. Drug Interactions
ACE Inhibitors:
Contraindicated. Do not co-administer with ACEIs.
Aliskiren:
Contraindicated in patients with diabetes mellitus or renal impairment.
Potassium-Sparing Diuretics:
Concomitant use with potassium supplements or potassium-sparing diuretics (e.g., spironolactone) may increase the risk of hyperkalemia.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Sacubitril Valsartan Sodium.
Appearance: Film-coated tablets (Available in 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg strengths).
Storage:
Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F).