Entresto

Entresto Dosage/Direction for Use

sacubitril + valsartan

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
The target dose of Entresto is 200 mg twice daily.
The recommended starting dose of Entresto is 100 mg twice daily. A starting dose of 50 mg twice daily is recommended for patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), and should be considered for patients previously taking low doses of these agents (see Pharmacology: Clinical Studies under Actions).
The dose of Entresto should be doubled every 2-4 weeks to the target dose of 200 mg twice daily, as tolerated by the patient.
Due to the potential risk of angioedema when used concomitantly with an ACE inhibitor, Entresto must not be started until 36 hours after discontinuing ACE inhibitor therapy (see Contraindications).
Entresto should not be co-administered with an ARB due to the angiotensin II receptor blocking activity of Entresto (see Precautions and Interactions).
If patients experience tolerability issues (symptomatic hypotension, hyperkalemia, renal dysfunction), consideration should be given to adjustment of concomitant medications, or to temporary down-titration of Entresto.
Special Populations: Renal Impairment: A starting dose of 50 mg twice daily is recommended in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2). Caution is recommended when using Entresto in these patients due to limited data (see Pharmacology under Actions).
No dose adjustment is required in patients with mild (eGFR 60-90 mL/min/1.73 m2) to moderate (eGFR 30-60 mL/min/1.73 m2) renal impairment.
Hepatic Impairment: A starting dose of 50 mg twice daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification).
No dose adjustment is required when administering Entresto to patients with mild hepatic impairment (Child-Pugh A classification).
No studies have been conducted in patients with severe hepatic impairment (Child-Pugh C classification). Therefore use of Entresto in these patients is not recommended (see Pharmacology under Actions).
Pediatric Patients: The safety and efficacy of Entresto in pediatric patients aged below 18 years has not been established.
Geriatric Patients (older than 65 years): No dosage adjustment is required in patients over 65 years.
Method of Administration: For oral use. Entresto may be administered with or without food (see Pharmacology under Actions).
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