Entresto Sacubitril Valsartan Sodium Tablets

1. Indications and Usage
Heart Failure: Indicated for the treatment of adult patients with chronic heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death and heart failure hospitalization.
Hypertension: Indicated for the treatment of adults with essential hypertension to lower blood pressure.
2. Dosage and Administration
Route of Administration: Oral administration.
Dosage (Heart Failure): The recommended starting dose is 50 mg twice daily. For patients tolerating 50 mg, the dose may be increased every 2–4 weeks to a target maintenance dose of 200 mg twice daily.
Dosage (Hypertension): The recommended starting dose is 50 mg twice daily. The dose may be increased to 100 mg or 200 mg twice daily based on blood pressure response.
Administration: May be taken with or without food. Dosage should not be increased if systolic blood pressure is ≤95 mmHg.
3. Mechanism of Action
Dual Inhibition: The drug is a prodrug that decomposes into sacubitril and valsartan. Sacubitril inhibits neprilysin, increasing levels of natriuretic peptides. Valsartan blocks the angiotensin II type 1 (AT1) receptor.
Physiological Effects: This dual mechanism synergistically promotes vasodilation, natriuresis, and diuresis, while inhibiting adverse cardiac remodeling and sympathetic nervous system activation.
4. Safety and Warnings
Embryo-Fetal Toxicity:By consulting the drug regulatory authority’s drug instructions, it is found that if sacubitril valsartan sodium tablets are used during pregnancy, it may cause fetal damage. The use during the second and third trimesters can reduce fetal kidney function and increase the incidence and mortality rate.
Angioedema:The guideline also points out that sacubitril/valsartan sodium may cause angioedema.
Hypotension:Sacubitril/valsartan sodium can lower blood pressure and may cause symptomatic hypotension.
Renal Impairment and Hyperkalemia:Renal function decline and hyperkalemia may occur when treated with sacubitril/valsartan sodium by acting on the renin-angiotensin-aldosterone system.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Hypotension, hyperkalemia, dizziness, renal impairment, and angioedema.
Clinical Research Highlights: The PARADIGM-HF study demonstrated that sacubitril/valsartan significantly reduced cardiovascular death and heart failure hospitalization compared to enalapril.
6. Drug Interactions
ACE Inhibitors:Sacubitril/valsartan sodium is contraindicated in combination with ACEI.
ARBs:Sacubitril/valsartan sodium should not be used in combination with ARB.
Aliskiren:The combination of sacubitril/valsartan sodium and aligilam is prohibited in patients with type 2 diabetes.
Diuretics: Concomitant use of diuretics, especially loop diuretics, may increase the risk of symptomatic hypotension and should be managed carefully.
7. Pharmaceutical Information
Chemical Composition: Active Ingredients: Sacubitril and valsartan.
Appearance: Film-coated tablets.
Packaging: Blister packs available in various dosages (e.g., 50 mg, 100 mg, 200 mg).
Storage: Store at controlled room temperature, protected from moisture.