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Entresto

Entresto

sacubitril + valsartan

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sacubitril, valsartan
Indications/Uses
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. Essential HTN.
Dosage/Direction for Use
Adult Heart failure Recommended dose: Initially 100 mg bid. Target dose: 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 impairment (eGFR <30 mL/min/1.73 m2) & moderate hepatic impairment (Child-Pugh B) Initially 50 mg bid. Essential HTN Recommended dose: Initially 200 mg once daily. Patient w/ inadequately controlled BP 200 mg once daily, can be increased to 400 mg once daily. Moderate hepatic impairment (Child-Pugh B) Initially 100 mg once daily.
Administration
May be taken with or without food.
Contraindications
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
Promptly administer appropriate therapy eg, SC epinephrine/adrenaline soln (0.3-0.5 mL) if tongue, glottis, or larynx, likely to cause airway obstruction is involved. Discontinue use & not to be re-administered if angioedema occurs. Temporarily discontinue use if hypotension persists. Not to be used as 1st-line treatment of HTN; in patients w/ known history of angioedema related to previous ACE inhibitor or ARB therapy, or in patients w/ hereditary angioedema. Not to be initiated until 36 hr after last dose of ACE inhibitor therapy. Consider down-titration in patients who develop a clinically significant decrease in renal function. May increase blood urea & serum creatinine levels in patients w/ bilateral or unilateral renal artery stenosis. Increased susceptibility to develop angioedema in Black patients. Correct Na &/or vol depletion before starting treatment. Reduce dietary K or adjust dose of concomitant medication if significant hyperkalemia occurs. Monitor serum K especially in patients w/ risk factors eg, severe renal impairment, DM, hypoaldosteronism or receiving high K diet. Not to be administered w/ ACE inhibitor, aliskiren, ARB. Severe renal impairment (estimated GFR <30 mL/min/1.73 m2) in patients w/ essential HTN. Not recommended in severe hepatic impairment (Child-Pugh C). Female patients 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 or another phosphodiesterase-5 inhibitor; inhibitors of OATP1B1, OATP1B3, OAT3 (eg, rifampin, cyclosporine) or multidrug resistance-associated protein 2 (eg, ritonavir); K-sparing diuretics (eg, triamterene, amiloride), mineralocorticoid antagonists (eg, spironolactone, eplerenone), K supplements or K-containing salt substitutes; NSAIDs including selective COX-2 inhibitors. Increased systemic exposure of OATP1B1 & OATP1B3 substrates eg, statins. Increased Cmax of atorvastatin. 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.
Presentation/Packing
Form
Entresto FC tab 100 mg
Packing/Price
2 × 14's
Form
Entresto FC tab 200 mg
Packing/Price
8 × 7's
Form
Entresto FC tab 50 mg
Packing/Price
2 × 14's
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