Entresto

Entresto

sacubitril + valsartan

Manufacturer:

Novartis

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 50 mg FC tab 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex). Per 100 mg FC tab 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex). Per 200 mg FC tab 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex)
Indications/Uses
Treatment of symptomatic chronic heart failure (NYHA class II-IV) in adult w/ reduced ejection fraction to reduce the risk of CV death & hospitalization due to heart failure.
Dosage/Direction for Use
Starting dose: 100 mg bd. Double the dose at 2-4 wk to the target dose of 200 mg bd, as tolerated by the patient. Moderate renal impairment (eGFR 30-60 mL/min/1.73 m2) Initially 50 mg bd. Moderate hepatic impairment (Child-Pugh B) Initially 50 mg bd.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to active substances or to any excipients. Concomitant use w/ ACE inhibitors. Must not be administered until 36 hr after discontinuing ACE inhibitor therapy. Known history of angioedema related to previous ACE inhibitor or angiotensin receptor blocker (ARB) therapy. Hereditary or idiopathic angioedema. Concomitant use w/ aliskiren-containing medicinal products in patients w/ DM or renal impairment (eGFR <60 mL/min/1.73 m2). Severe hepatic impairment, biliary cirrhosis & cholestasis. 2nd & 3rd trimester of pregnancy.
Special Precautions
Combination w/ an ACE inhibitor is contraindicated due to the increased risk of angioedema. Entresto must not be initiated until 36 hr after taking the last dose of ACE inhibitor therapy. If treatment is stopped, ACE inhibitor therapy must not be initiated until 36 hr after the last dose of Entresto. Combination w/ direct renin inhibitors eg, aliskiren is not recommended. Combination w/ aliskiren-containing products is contraindicated in patients w/ DM or in patients w/ renal impairment (eGFR <60 mL/min/1.73 m2). Entresto contains valsartan, & therefore should not be co-administered w/ another ARB containing product.
Adverse Reactions
Hyperkalaemia; hypotension; renal impairment.
Drug Interactions
Increased risk of angioedema w/ ACE inhibitors. Higher frequency of adverse events w/ aliskiren.
MIMS Class
Other Cardiovascular Drugs
ATC Classification
C09DX04 - valsartan and sacubitril ; Belongs to the class of angiotensin II receptor blockers (ARBs), other combinations. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Entresto FC tab 100 mg
Packing/Price
28's
Form
Entresto FC tab 200 mg
Packing/Price
56's
Form
Entresto FC tab 50 mg
Packing/Price
28's
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