Sacubitril/Valsartan sodium tablets are indicated for chronic heart failure in adults and children, as well as for hypertension in adults. However, a thorough evaluation of contraindications and special population conditions is required before use to ensure safety and efficacy.

I. Indications

1. Chronic Heart Failure in Adults:

(1) Indicated for patients with chronic heart failure who require further control after receiving standard therapy.

(2) Must be switched from an ACE inhibitor or ARB before use; direct substitution is not allowed.

2. Chronic Heart Failure in Children (over 1 year of age):

(1) Indicated for pediatric patients with heart failure due to left ventricular systolic dysfunction.

(2) Use under the guidance of a physician experienced in treating pediatric heart failure.

3. Hypertension:

(1) Indicated for hypertension in adults, but not as a first-line antihypertensive agent in principle.

(2) In hypertensive patients with heart failure, the dosage and administration for heart failure should take priority.

II. Contraindications

1. History of Allergy:

Contraindicated in patients with a history of hypersensitivity to any component of this drug.

2. Concomitant Use of ACEI or Washout Period<36 Hours:

Contraindicated in patients currently taking an ACE inhibitor or who have discontinued an ACE inhibitor within the last 36 hours, as the risk of angioedema is significantly increased.

3. History of Angioedema:

Contraindicated in patients with a history of angioedema due to prior ACEI or ARB therapy, hereditary angioedema, or idiopathic angioedema.

4. Diabetic Patients Taking Aliskiren:

Contraindicated in diabetic patients taking aliskiren, unless blood pressure is extremely poorly controlled.

5. Severe Hepatic Impairment:

Contraindicated in patients with Child-Pugh Class C (severe) hepatic impairment.

6. Pregnancy:

Contraindicated in pregnant women or women who may become pregnant.

III. Dietary Restrictions

1. Limit High-Potassium Foods:

(1) This drug may increase serum potassium. Avoid excessive intake of high-potassium foods such as bananas, oranges, potatoes, spinach, soy products, and low-sodium salt (containing potassium chloride).

(2) Monitor serum potassium regularly and adjust diet accordingly if abnormalities occur.

2. Caution for Those on Strict Low-Salt Diets:

Patients on strict low-salt diets may experience a sharp drop in blood pressure when starting treatment. Begin with a low dose and titrate slowly.

3. Alcohol:

Alcohol may potentiate the antihypertensive effect, leading to dizziness or syncope. Limiting or avoiding alcohol during treatment is recommended.

IV. Use in Special Populations

1. Renal Impairment:

(1) Mild to moderate renal impairment (eGFR 30-90) – can be used with close monitoring; drug blood concentrations may be elevated.

(2) Severe renal impairment (eGFR<30) or hemodialysis patients – use with caution after careful assessment, start with a low dose, and closely monitor blood pressure and serum potassium.

(3) Bilateral renal artery stenosis – contraindicated in principle.

2. Hepatic Impairment:

(1) Moderate hepatic impairment (Child-Pugh Class B) – use with monitoring; drug blood concentrations may be 1.5-2.1 times higher.

(2) Severe hepatic impairment (Class C) – contraindicated.

3. Patients with Hyperkalemia:

(1) Avoid use in patients with pre-existing hyperkalemia in principle.

(2) Patients with diabetes, renal impairment, or taking potassium-sparing diuretics require enhanced monitoring of serum potassium.

4. Patients with Cerebrovascular Disease:

The antihypertensive effect may lead to inadequate cerebral blood flow and worsen the condition. Use with caution and monitor blood pressure closely.

5. Pregnant Women:

(1) Absolutely contraindicated.

(2) If pregnancy occurs during treatment, stop the drug immediately and consult a physician.

6. Breastfeeding Women:

Breastfeeding is not recommended.

7. Children:

(1) May be used in children over 1 year of age with chronic heart failure, but clinical trial data are lacking for low birth weight infants and neonates.

(2) Not studied in pediatric patients with hypertension; use is not recommended.

8. Elderly (age 65 and above):

(1) Higher incidence of hypotension, hyperkalemia, and renal dysfunction.

(2) Start with a low dose, titrate slowly, and closely monitor blood pressure, serum potassium, and renal function.