Arnivas® 50 mg tablet: Each film-coated tablet contains Sacubitril Valsartan Sodium Hemipentahydrate INN 56.700 mg equivalent to Sacubitril 24 mg and Valsartan USP 26 mg.
Arnivas® 100 mg tablet: Each film-coated tablet contains Sacubitril Valsartan Sodium Hemipentahydrate INN 113.400 mg equivalent to Sacubitril 49 mg and Valsartan USP 51 mg.
Arnivas® 200 mg tablet: Each film-coated tablet contains Sacubitril Valsartan Sodium Hemipentahydrate INN 226.800 mg equivalent to Sacubitril 97 mg and Valsartan USP 103 mg.
Indications: Arnivas® is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced left ventricular ejection fraction.
Dosage and Administration: The recommended starting dose of Arnivas® (Sacubitril/Valsartan) is 100 mg twice daily. Double the dose of Arnivas® after 2 to 4 weeks to the target maintenance dose of 200 mg twice-daily, as tolerated by the patient.
Reduce the starting dose to 50 mg twice-daily for:
Patients are not currently taking an ACE inhibitor or an ARB or previously taking a low dose of these agents.
Patients with severe renal impairment.
Patients with moderate hepatic impairment.
Contraindications: Hypersensitivity to any component. History of angioedema related to previous ACE inhibitor or ARB therapy. Concomitant use with ACE inhibitors and aliskiren in patients with diabetes.
Side effects: The most common side effects are low blood pressure, high potassium, cough, dizziness, and kidney problems. It may cause some serious side-effects like angioedema (that may cause trouble in breath).
Use in pregnancy-and lactation: It can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of Sacubitril/Valsartan in human milk, the effects on the breastfed infant or the effects on milk production.
Precautions: Sacubitril and Valsartan should be used cautiously in patients with fetal toxicity, angioedema, hypotension, impaired renal function and hyperkalemia.
Drug interactions: Some products that may interact with this medication include: alkalioid, lithium, drugs that may increase the level of potassium in the blood.
Potassium-Sparing Diuretics: As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. spironolactone, tranterenol, amiloride), potassium supplements or salt substitutes containing potassium may lead to increase in serum potassium.
Over dosage: Limited data are available regarding to overdose in human subjects with Sacubitril and Valsartan. In healthy volunteers, a single dose of Sacubitril and Valsartan 583 mg sacubitril/617 mg valsartan and multiple doses of 437 mg sacubitril/483 mg valsartan (14 days) have been studied and were well tolerated.
Storage: Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.
Arnivas is a combination of Sacubitril, a neprilysin inhibitor and Valsartan, an angiotensin Il receptor blocker, indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class and reduced left ventricular ejection fraction.
Mode of action:
Arnivas is the combination of Sacubitril and Valsartan of which Valsartan inhibits the effects of angiotensin II receptor, thereby prevents the deleterious cardiac effects of RAAS activation and Sacubitril enhances vasoactive peptides such as natriuretic peptides by inhibiting neprilysin.
Arnivas is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class and reduced left ventricular ejection fraction.
The recommended starting dose of Arnivas (Sacubitril/Valsartan) is 100 mg twice daily. Double the dose of Arnivas after 2 to 4 weeks to the target maintenance dose of 200 mg twice-daily, as tolerated by the patient.
Reduce the starting dose to 50 mg twice-daily for:
Patients are not currently taking an ACE.
inhibitor or an ARB or previously taking a low dose of these agents Patients with severe renal impairment Patients with moderate hepatic impairment.
Some products that may interact with this medication include: aliskiren, lithium, drugs that may increase the level of potassium in the blood. Potassium-Sparing Diuretics: As with other drugs that block angiotensin Il or effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increase in serum potassium.
Over dosage: Limited data are available regarding to overdose in human subjects with Sacubitril and Valsartan. In healthy volunteers, a single dose of Sacubitril and Valsartan 583 mg sacubitril/617 mg valsartan and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated.
It can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of Sacubitril/Valsartan in human milk, the effects on the breastfed infant or the effects on milk production.
Sacubitril and Valsartan should be used cautiously in patients with fetal toxicity, angioedema, hypotension, impaired renal function and hyperkalemia.
Keep out of reach of children. Store ina dry place, below 25 C temperature and protected from light.