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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
In combination w/ other heart failure therapies in adult patients w/ chronic heart failure to reduce risk of CV death & hospitalization due to heart failure, administered in place of ACE inhibitors or ARB. Benefits are most clear in patients w/ LVEF below normal.
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Dosage/Direction for Use
Adult Initially 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. Patient w/ systolic BP (SBP) ≥100-110 mmHg, moderate (eGFR 30-60 mL/min/1.73 m2) to severe renal (eGFR <30 mL/min/1.73 m2) & moderate hepatic impairment (Child-Pugh B) Initially 50 mg bd.
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Overdosage
View Entresto overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Swallow whole w/ a glass of water.
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.
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Special Precautions
Discontinue use if angioedema occurs. Temporary down-titration or discontinuation if hypotension occurs or significant decrease in renal function develops. Not to be initiated if serum K level >5.4 mmol/L or SBP ≥100 mmHg. Not suitable w/ B-type natriuretic peptide as biomaker of heart failure. Patients w/ renal artery stenosis; NYHA class IV. Correct Na &/or vol depletion prior to treatment. Monitor BP, renal function; serum K in patients w/ risk factors eg, renal impairment, DM, hypoaldosteronism, on high K diet or mineralocorticoid antagonists. Black patients. Not recommended in combination w/ direct renin inhibitors eg, aliskiren. Not to be co-administered w/ another ARB. May affect ability to drive & use machines. Not recommended in patients w/ ESRD. Moderate hepatic & severe renal impairment. Not recommended during 1st trimester of pregnancy. Lactation. Childn & adolescent <18 yr.
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Adverse Reactions
Hyperkalaemia; hypotension; renal impairment. Anaemia; hypokalaemia, hypoglycaemia; dizziness, headache, syncope; vertigo; orthostatic hypotension; cough; diarrhoea, nausea, gastritis; renal failure; fatigue, asthenia.
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Drug Interactions
Increased risk of angioedema w/ ACE inhibitors. Higher frequency of adverse events eg, hypotension, hyperkalaemia & decreased renal function w/ aliskiren. Increased systemic exposure w/ OATP1B1 & OATP1B3 substrates (eg, statins), OAT3 (eg, rifampicin, ciclosporin), OAT1 (eg, tenofovir, cidofovir), MRP2 (eg, ritonavir). Reduced BP w/ PDE5 inhibitors eg, sildenafil. Increased serum K & creatinine w/ K-sparing diuretics, mineralocorticoid antagonists, K-supplements, K-containing salt substitutes, heparin. Increased risk of worsened renal function w/ NSAIDs including selective COX-2 inhibitors. Reversible increased serum lithium conc & toxicity. Reduced Cmax & AUC of furosemide & metformin. Not to be co-administered w/ another ARB-containing product.
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Storage
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Description
View Entresto description for details of the chemical structure and excipients (inactive components).
Action
View Entresto mechanism of action for pharmacodynamics and pharmacokinetics details.
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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