Entresto

Entresto

sacubitril + valsartan

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 50 mg FC tab Sacubitril 24.3 mg, valsartan 25.7 mg. Per 100 mg FC tab Sacubitril 48.6 mg, valsartan 51.4 mg. Per 200 mg FC tab Sacubitril 97.2 mg, valsartan 102.8 mg
Indications/Uses
Symptomatic treatment of chronic heart failure w/ reduced ejection fraction in combination w/ other heart failure therapies in place of an ACE inhibitor or angiotensin II receptor blocker (ARB).
Dosage/Direction for Use
Adult 100 mg bd doubled up to 200 mg bd every 2-4 wk as tolerated. Patient not currently taking ACE inhibitor or ARB Initially 50 mg bd, slowly titrate dose doubled every 3-4 wk. Moderate to severe renal & moderate hepatic impairment Initially 50 mg bd.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Not to be administered until 36 hr after ACE inhibitor therapy discontinuation. Known history of angioedema related to previous ACE inhibitor or ARB therapy; hereditary or idiopathic angioedema. Concomitant use w/ ACE inhibitors; 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 trimesters of pregnancy.
Special Precautions
Temporary down-titration or discontinuation if hypotension occurs. Not to be initiated until 36 hr after last dose of ACE inhibitor therapy. Not to be initiated in patients w/ serum K level >5.4 mmol/L or SBP ≥100 mmHg. Known history of hereditary or idiopathic angioedema; DM; hypoaldosteronism; NYHA class IV. Correct Na &/or vol depletion prior to treatment. Monitor serum K; renal function. Black patients. Not to be used w/ aliskiren-containing products in patients w/ DM or renal impairment. Not to be co-administered w/ ARB. Moderate hepatic & moderate to severe renal impairment. Renal artery stenosis. Elderly.
Adverse Reactions
Hyperkalaemia, hypotension, renal impairment. Anaemia, hypokalaemia, hypoglycaemia, dizziness, headache, syncope, vertigo, orthostatic hypotension, cough, diarrhea, nausea, gastritis, renal failure, fatigue, asthenia.
Drug Interactions
Contraindicated w/ ACE inhibitors. Not recommended w/ ARB-containing product. Combination w/ statins, sildenafil, K-sparing diuretics including mineral corticoid antagonists (eg, spironolactone, eplerenone), K supplements or K-containing salt substitutes, NSAIDs including selective COX-2 inhibitors, lithium, inhibitors of OATP1B1, OATP1B3, OAT3 (eg, rifampin, cyclosporine), OAT1 (eg, tenofovir, cidofovir) or MPR2 (eg, ritonavir).
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
30's;60's
Form
Entresto FC tab 200 mg
Packing/Price
60's
Form
Entresto FC tab 50 mg
Packing/Price
30's
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