Vymada

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

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.

Initially 100 mg bid, doubled at 2-4 wk to the target of 200 mg bid, as tolerated by patient. Patient not currently taking or taking low doses of ACE inhibitor or ARB Initially 50 mg bid & slow dose titration (doubling every 3-4 wk). Patient w/ SBP ≥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.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ ACE inhibitors; do not administer until 36 hr after discontinuing ACE inhibitor therapy. Known 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 (Child-Pugh C classification). Pregnancy (2nd & 3rd trimester).

Dual blockade of the renin-angiotensin-aldosterone system. Not recommended in combination w/ direct renin inhibitors (eg, aliskiren); another ARB-containing product. Treatment should not be initiated unless SBP is ≥100 mmHg. Routinely monitor BP when initiating therapy or during dose titration. Temporary down-titration or discontinuation if hypotension occurs. Correct Na &/or vol depletion before starting treatment. Not to be initiated if serum K level is >5.4 mmol/L. Monitor serum K especially in patients w/ risk factors eg, renal impairment, DM, hypoaldosteronism or receiving a high K diet or mineralocorticoid antagonists. Discontinue treatment immediately if angioedema occurs. History of angioedema. Black patients. Patients w/ bilateral or unilateral renal artery stenosis; monitor renal function. NYHA functional classification 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. Risk of decreased renal function may be further increased 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 ability to drive & use machines. Not recommended during pregnancy (1st trimester) & lactation. Childn <18 yr.

Hyperkalemia; hypotension; renal impairment. Anemia; hypokalemia, hypoglycemia; dizziness, headache, syncope; vertigo; orthostatic hypotension; cough; diarrhea, nausea, gastritis; renal failure; fatigue, asthenia.

Increased risk of angioedema w/ ACE inhibitors. Higher frequency of adverse events eg, hypotension, hyperkalemia & decreased renal function (including acute renal failure) w/ aliskiren. Should not be co-administered w/ another 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 of renal function w/ NSAIDs & COX-2 inhibitors. Reversible increases in serum lithium conc & toxicity. Reduced C_max & AUC of furosemide & metformin. Nitrates eg, nitroglycerine. May increase the systemic exposure w/ inhibitors of OATP1B1, OATP1B3, OAT3 (eg, rifampicin, ciclosporin), OAT1 (eg, tenofovir, cidofovir) or MRP2 (eg, ritonavir).

Other Cardiovascular Drugs

C09DX04 - valsartan and sacubitril ; Belongs to the class of angiotensin II receptor blockers (ARBs), other combinations. Used in the treatment of cardiovascular disease.

Rx