Entresto Film-Coated Tablets 200 Milligrams (Sacubitril / Valsartan Sodium Hydrate)

Adult dose

1. Adults 1) Chronic heart failure (1) Initial dose: The recommended initial dose of this medicine is 100mg (equivalent to 48.6/51.4mg of sacubitril/valsartan) twice daily. For patients who are not taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB), or who were previously taking these medicines at low doses, it is recommended to start with an initial dose of 50mg (equivalent to 24.3/25.7mg of sacubitril/valsartan) twice daily. (2) Maintenance dose: Depending on the patient's tolerability, double the dose of this medicine every 2-4 weeks until the target maintenance dose of 200mg (equivalent to 97.2/102.8mg of sacubitril/valsartan) twice daily is reached. If the patient has problems tolerating the medicine (e.g., symptomatic hypotension, hyperkalemia, or renal dysfunction), consider adjusting concomitant medicines or temporarily reducing the dose of this medicine. 2) Essential hypertension The recommended initial dose of this medicine is 200mg (equivalent to 97.2/102.8mg of sacubitril/valsartan) once daily. For patients whose blood pressure is not adequately controlled with 200mg once daily, the dose may be increased to 400mg once daily. Before deciding to administer this medicine, consider the magnitude of its blood pressure-lowering effect, the patient's underlying medical conditions, and the patient's response. Consider administering an initial dose of 100mg (equivalent to 48.6/51.4mg of sacubitril/valsartan) in elderly patients. For hypertensive patients with heart failure, it is recommended to follow the dosage and administration instructions for heart failure. 2. Patients with renal impairment For patients with chronic heart failure and severe renal impairment (eGFR < 30 mL/min/1.73m2), an initial dose of 50mg (equivalent to 24.3/25.7mg of sacubitril/valsartan) twice daily is recommended. Experience with this medicine in patients with severe renal impairment is limited; therefore, use with caution in these patients. The safety and efficacy of this medicine have not been established in patients with essential hypertension and severe renal impairment (eGFR < 30 mL/min/1.73m2). No dose adjustment is required in patients with mild (eGFR 60~90 mL/min/1.73m2) to moderate (eGFR 30~60 mL/min/1.73m2) renal impairment. 3. Patients with hepatic impairment For patients with chronic heart failure and moderate hepatic impairment (Child-Pugh B), an initial dose of 50mg (equivalent to 24.3/25.7mg of sacubitril/valsartan) twice daily is recommended. For patients with essential hypertension and moderate hepatic impairment (Child-Pugh B), an initial dose of 100mg (equivalent to 48.6/51.4mg of sacubitril/valsartan) once daily is recommended. No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A).

This drug should not be taken by women who are pregnant or planning to become pregnant as it can cause severe harm to the fetus and newborn. Women who may become pregnant must use contraception during treatment and for one week after the last dose. This drug should not be taken if there are allergies to the main ingredient or constituents, or if being taken with certain medications. In particular, it may be dangerous to take this medication if used alongside angiotensin-converting enzyme inhibitors (ACE inhibitors) or recently discontinued them. Patients with severely impaired liver or kidney function, those with a history of angioedema, and specific heart disease conditions should use this medication cautiously. This drug has a strong effect of lowering blood pressure and may cause symptoms of hypotension, such as dizziness or fainting. Blood pressure and blood potassium levels, as well as kidney function, should be monitored regularly during treatment, and dosage adjustments or discontinuation may be necessary if abnormalities are found. Additionally, this drug can cause a serious allergic reaction called angioedema; if swelling of the face, lips, tongue, or throat occurs, or if experiencing shortness of breath, treatment should be stopped immediately and medical attention sought. Occasionally, psychiatric symptoms (hallucinations, paranoia, etc.), gastrointestinal edema, skin rashes, etc., may occur, so consult a doctor if unusual symptoms arise. Due to numerous drug interactions, caution is needed when taking this drug simultaneously with potassium-sparing diuretics, NSAIDs, lithium, statins, PDE5 inhibitors, etc. While older adults do not require special dose adjustments, their condition should be carefully monitored to prevent excessively low blood pressure. In case of overdose, hypotension is the most common issue, and appropriate treatment should be provided, as dialysis is not effective in removing this drug from the bloodstream. It is advisable not to use this medication in children under 18 years of age as safety and efficacy have not been established.

• Renal failure
• hyperkalemia
• hypotension
• dizziness
• headache
• syncope
• orthostatic dizziness
• lightheadedness
• orthostatic hypotension
• cough

Store this medication in a tightly closed container, protected from air and moisture. Additionally, keep it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance

Biconvex film-coated tablets in oval shape, light pink in color

Package unit

60 tablets (10 tablets/PTP packaging x 6)