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Entresto

Entresto

sacubitril + valsartan

Manufacturer:

Novartis Healthcare

Distributor:

Novartis Healthcare
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
Reduce risk of CV death & hospitalization for heart failure in adults w/ chronic heart failure, most clearly evident in patients w/ left ventricular ejection fraction below normal.
Dosage/Direction for Use
Initially 100 mg bid, doubled at 2-4 wk up to 200 mg bid as tolerated. Patient not currently taking ACE inhibitor or ARB or taking low doses of these medicinal products Initially 50 mg bid & slow dose titration (doubling every 3-4 wk). Patient w/ systolic BP ≥100-110 mmHg Initially 50 mg bid. Moderate (eGFR 30-60 mL/min/1.73 m2), severe renal impairment (eGFR <30 mL/min/1.73 m2), moderate hepatic impairment (Child-Pugh B classification) or patient w/ AST/ALT values >2x ULN range Initially 50 mg bid.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ ACE inhibitors; do not administer until 36 hr after discontinuing. History of angioedema related to previous ACE inhibitor or 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. Pregnancy (2nd & 3rd trimester).
Special Precautions
Dual blockade of renin-angiotensin-aldosterone system (RAAS). Not recommended in combination w/ direct renin inhibitors (eg, aliskiren); ARB-containing product. Routinely monitor BP when initiating therapy or during dose titration. Temporary down-titration or discontinue if hypotension occurs. Correct Na- &/or vol-depletion before starting treatment. Not to be initiated in patients w/ serum K level >5.4 mmol/L. Monitor serum K in patients w/ risk factors eg, renal impairment, DM, hypoaldosteronism, receiving high K diet or on mineralocorticoid antagonists. Discontinue treatment immediately if angioedema occurs. Black patients. Patients w/ bilateral or unilateral renal artery stenosis; monitor renal function. NYHA functional class IV. Not suitable w/ B-type natriuretic peptide as biomarker of heart failure. Psychiatric events eg, hallucinations, paranoia & sleep disorders, in context of psychotic events; discontinuation of treatment should be considered. Renal impairment. Increased risk of decreased renal function by dehydration or concomitant use of NSAIDs. Not recommended in patients w/ ESRD. Moderate hepatic impairment (Child-Pugh B classification) or w/ AST/ALT values >2x ULN range. May influence the ability to drive & use machines. Not recommended during pregnancy (1st trimester) & lactation. Childn <18 yr.
Adverse Reactions
Hyperkalemia; hypotension; renal impairment. Anemia; hypokalemia, hypoglycemia; dizziness, headache, syncope; vertigo; orthostatic hypotension; cough; diarrhea, nausea, gastritis; renal failure; fatigue, asthenia.
Drug Interactions
Increased risk of angioedema w/ ACE inhibitors. Higher frequency of adverse events eg, hypotension, hyperkalemia & decreased renal function including acute renal failure w/ aliskiren. Not recommended w/ ARB-containing product. Increase systemic exposure of OATP1B1 & OATP1B3 substrates eg, statins. Greater BP reduction w/ PDE5 inhibitors (eg, sildenafil). Increased serum K & creatinine w/ K-sparing diuretics (eg. triamterene, amiloride), mineralocorticoid antagonists (eg, spironolactone, eplerenone), K supplements, salt substitutes containing K or other agents (eg, heparin). Increased risk of worsening renal function w/ NSAIDs including selective COX-2 inhibitors. Reversible increases in serum lithium conc & toxicity. Reduced Cmax & AUC of furosemide & metformin. Nitrates eg, nitroglycerine. May increase systemic exposures w/ inhibitors of OATP1B1, OATP1B3, OAT3 (eg, rifampicin, ciclosporin), OAT1 (eg, tenofovir, cidofovir) or MRP2 (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
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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