Uperio

Uperio

sacubitril + valsartan

Manufacturer:

Novartis Indonesia
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
Heart failure (NYHA II-IV) in patient w/ reduced ejection fraction (LVEF ≤40%).
Dosage/Direction for Use
100 mg twice daily can be doubled up to 200 mg twice daily every 2-4 wk. Patient not currently taking ACE inhibitor or angiotensin II receptor blocker; w/ systolic BP ≥100-110 mmHg; w/ moderate hepatic impairment or AST/ALT >2x upper limit of normal, moderate to severe renal impairment Recommended starting dose: 50 mg twice daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ ACE inhibitors, aliskiren in patients w/ type II diabetes or renal impairment (eGFR <60 mL/min/1.73 m2). History of angioedema related to previous ACE inhibitor or ARB therapy. Hereditary or idiopathic angioedema. Severe hepatic impairment, biliary cirrhosis & cholestasis. Pregnancy.
Special Precautions
Administer until 36 hr after last dose of ACE inhibitor. Co-administration w/ aliskiren in patients w/ type II diabetes & renal impairment (eGFR <60 mL/min/1.73 m2); w/ angiotensin receptor blocker. Routinely monitor BP when initiating therapy or during dose titration. Temporary down-titration/discontinue treatment if hypotension & angioedema occurs. Correct Na &/or vol depletion prior to treatment. Not recommended for end-stage renal disease. Hyperkalemia, renal artery stenosis, B-type natriuretic peptide. Immediately discontinue if angioedema occurs. Monitor serum K in patients w/ risk factors eg, severe renal impairment, DM, hypoaldosteronism or receiving a high potassium diet or on mineralocorticoid antagonist; renal function. Black patients have increased susceptibility to develop angioedema. BNP is not a suitable biomarker of heart failure in Uperio-treated patients. Patients w/ NYHA functional class IV. May affect ability to drive & use machines. Renal artery stenosis. Hepatic impairment. Females of childbearing potential must use highly effective contraception during & for 1 wk after last dose of Uperio. Discontinue Uperio as soon as pregnancy occur. Not recommended during breastfeeding. Childn <18 yr.
Adverse Reactions
Hyperkalemia, hypotension, renal impairment. Anaemia; hypokalemia, hypoglycaemia; dizziness, headache; vertigo; syncope, orthostatic hypotension; cough; diarrhoea, 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 w/ aliskiren. Not to be co-administered w/ angiotensin receptor blocker. Increased Cmax of atorvastatin. Greater BP reduction w/ sildenafil or another PDE-5 inhibitor. Increased serum K & serum creatinine w/ K-sparing diuretics (eg, triamterene, amiloride), mineralocorticoid antagonists (eg, spironolactone, eplerenone), K supplements, or salt substitutes containing K. Increased risk of worsening of renal function w/ NSAIDs. Reversible increases in serum lithium. Reduce Cmax & AUC of furosemide & metformin. May increase systemic exposure to sacubitrilat or valsartan w/ inhibitors of OATP1B1, OATP1B3, OAT3 (eg, rifampin, cyclosporine), OAT1 (eg, tenofovir, cidofovir) or MRP2 (eg, ritonavir).
MIMS Class
Angiotensin II Antagonists
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
Uperio FC tab 100 mg
Packing/Price
2 × 14's
Form
Uperio FC tab 200 mg
Packing/Price
4 × 7's
Form
Uperio FC tab 50 mg
Packing/Price
2 × 14's
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