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 ejection fraction
Combined antihypertensive preparations
This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) 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 this tablet 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.
The recommended starting dose of this combination is 49/51 mg twice-daily. Double the dose of this combination 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 receptor blocker (ARB) and for patients previously taking low doses of these agents. Double the dose of this combination every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient. Sacubitril & Valsartan is contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor. If switching from an ACE inhibitor to Sacubitril & Valsartan allow a washout period of 36 hours between administration of the two drugs.
Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.
In patients with hypersensitivity to any component In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor With concomitant use of aliskiren in patients with diabetes
Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia
Pregnancy: Advise female patients of childbearing age about the consequences of exposure to this combination during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible Lactation: 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/valsartan is present in rat milk. Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with sacubitril/valsartan.
Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 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 this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.
Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.
.png&w=384&q=75)