Sacuva 50: Each film-coated tablet contains Sacubitril Valsartan Sodium Hemipentahydrate equivalent to Sacubitril INN 24 mg & Valsartan USP 26 mg.
Sacuva 100: Each film-coated tablet contains Sacubitril Valsartan Sodium Hemipentahydrate equivalent to Sacubitril INN 49 mg & Valsartan USP 51 mg.
Sacuva contains a neprilysin inhibitor, Sacubitril, and an angiotensin receptor blocker, Valsartan. Sacuva inhibits neprilysin via LBQ657, the active metabolite of the prodrug Sacubitril, and blocks the angiotensin II type-1 (AT1) receptor via Valsartan. The cardiovascular and renal effects of Sacuva in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by Valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.
Route of administration: Oral.
The recommended starting dose of Sacubitril & Valsartan is 49/51 mg twice daily. Double the dose of Sacubitril & Valsartan after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
Dose adjustment for patients not taking an ACE inhibitor or ARB or previously taking low doses of these agents: A starting dose of 24/26 mg twice daily is recommended for patients not currently taking an ACE inhibitor or an angiotensin II blocker (ARB) and for patients previously taking low doses of these agents. Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily as tolerated by the patient.
Or as directed by the registered physician.
Geriatric Patient:
No relevant pharmacokinetic differences have been observed in elderly (≥ 65 years) or very elderly (≥ 75 years) patients compared to the overall population.
Renal Impairment:
No dose adjustment is required in patients with mild (eGFR 60 to 90 mL/min/1.73 m2) to moderate (eGFR 30 to 60 mL/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) is 24/26 mg twice daily.
Hepatic Disease:
No dose adjustment is required when administering Sacubitril & Valsartan to patient with mild hepatic impairment (Child-Pugh A classification). The recommended starting dose in patients with moderate hepatic impairment (Child-Pugh B classification) is 24/26 mg twice daily. The use of Sacubitril & Valsartan in patient with severe hepatic impairment (Child-Pugh C classification) is not recommended.
With medicine:Dual Blockade of the renin-angiotensin-Aldosterone System: Concomitant use of Sacubitril & Valsartan with an ACE inhibitor is contraindicated because of the increased risk of angioedema. Use of Sacubitril & Valsartan with an ARB should be avoided, because Sacubitril & Valsartan contains the angiotensin II receptor blocker Valsartan. The concomitant use of Sacubitril & Valsartan with Aliskiren is contraindicated in patients with diabetes.
Potassium-Sparing Diuretics: As with other drugs that block angiotensin II, 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.
Nonsteroidal Anti-Inflammatory Drug (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patient who are elderly, concomitant use of NSAIDs, including COX-2 inhibitors, with Sacubitril & Valsartan may result in worsening of renal function, including possible acute renal failure.
With food & others: Administration of Sacubitril & Valsartan with food has no clinically significant effect on the systemic exposures of Sacubitril or Valsartan. Therefore, Sacubitril & Valsartan can be administered with or without food.
Overdose:
Limited data are available with regard to overdosage in human subjects with Sacubitril & Valsartan. In healthy volunteers, a single dose of 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.
Hypotension is the most likely result of overdosage due to the blood pressure lowering effects of Sacubitril & Valsartan. Symptomatic treatment should be provided. Sacubitril & Valsartan is unlikely to be removed by hemodialysis because of high protein binding.
Pregnancy: Sacubitril & Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
It is not known if Sacubitril & Valsartan is safe and effective in children under 1 year of age.
Sacubitril & Valsartan should be used cautiously in patients with Fetal Toxicity, Angioedema, Hypotension, Impaired Renal Function and Hyperkalemia.
Store below 30°C temperature & dry place, protect from light.
Keep all medicine out of reach of children.