sacubitril + valsartan




Zuellig Pharma
Concise Prescribing Info
Sacubitril, valsartan
Adult patients w/ chronic heart failure to reduce the risk of CV death & hospitalization due to heart failure in place of ACE inhibitor or angiotensin II receptor blocker (ARB). Benefits are most clear in patients w/ LVEF below normal.
Dosage/Direction for Use
Adult 100 mg bid, doubled up to 200 mg bid every 2-4 wk as tolerated. Patient not currently taking ACE inhibitor or ARB Initially 50 mg bid. Severe renal & moderate hepatic impairment Initially 50 mg bid.
May be taken with or without food.
Hypersensitivity. Not to be administered until 36 hr after discontinuation of ACE inhibitor therapy. Known history of angioedema related to previous ACE inhibitor or ARB therapy. Hereditary angioedema. Concomitant use w/ ACE inhibitors & aliskiren in patients w/ type 2 diabetes. Pregnancy.
Special Precautions
Discontinue use if angioedema occurs. Temporarily discontinue use if hypotension persists. Down-titration if clinically significant decreased in renal function develops. Angioedema associated w/ laryngeal edema. Increased risk of hyperkalemia. Patients w/ bilateral or unilateral renal artery stenosis. Vol-depleted patient. Black patients. Correct Na &/or vol depletion prior to initiation of treatment. Monitor serum K in patients w/ risk factors eg, DM, hypoaldosteronism, severe renal impairment, receiving high K diet. Monitor renal function in patients w/ renal artery stenosis. Not to co-administer w/ direct renin inhibitors (eg, aliskiren), ARB. Concomitant use w/ K-sparing diuretics, K supplements. Severe renal & hepatic impairment. Women of childbearing potential should use contraception during treatment & for 1 wk after last dose. Not to be used during pregnancy. Not recommended during lactation. Ped patient <18 yr.
Adverse Reactions
Hyperkalemia; hypotension; renal impairment. Hypokalemia; syncope, dizziness, headache; vertigo; orthostatic hypotension; cough; diarrhoea, nausea; renal failure; fatigue, asthenia.
Drug Interactions
Concomitant use w/ ACE inhibitors, aliskiren, sildenafil, inhibitors of OATP1B1, OATP1B3, OAT3 (eg, rifampin, cyclosporine) or multidrug resistance-associated protein 2 (eg, ritonavir). Not recommended w/ ARB-containing product. Increased Cmax of atorvastatin. Increased serum K & creatinine w/ K-sparing diuretics (eg, triamterene, amiloride), mineralocorticoid antagonists (eg, spironolactone, eplerenone), K supplements or K-containing salt substitutes. Increased risk of worsening of renal function w/ NSAIDs including selective COX-2 inhibitors. Reversible increased serum lithium conc & toxicity.
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.
Entresto FC tab 100 mg
2 × 14's
Entresto FC tab 200 mg
8 × 7's
Entresto FC tab 50 mg
2 × 14's
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