Sacubitril And Valsartan (Entresto)

Trade Name : ENTRESTO

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 2426 mg/1mg/1

Storage and handling for ENTRESTO

SACUBITRIL; VALSARTAN Neprilysin Inhibitor [EPC],Neprilysin Inhibitors [MoA],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sacubitril And Valsartan (Entresto) which is also known as ENTRESTO and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 24; 26 mg/1; mg/1 per ml. Read more

Sacubitril And Valsartan (Entresto) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

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WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue ENTRESTO as soon as possible. ()
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()

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ENTRESTO is a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker 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. ()n ENTRESTO is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB. ()n n
for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. ()tttttttttnttttttttt

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Adjust adult doses every 2 to 4 weeks and pediatric doses every 2 weeks to the target maintenance dose, as tolerated by the patient. (, )nttttttttt
Reduce starting dose to half the usually recommended starting dosage for:ntttttttttt- patients not currently taking an ACE inhibitor or ARB or previously taking a low dose of these agents () - patients with severe renal impairment () - patients with moderate hepatic impairment ()nttttttttt

ENTRESTO is supplied as unscored, ovaloid, film-coated tablets in the following strengths:
ENTRESTO 24/26 mg, (sacubitril 24 mg and valsartan 26 mg) are violet white and debossed with u201cNVRu201d on one side and u201cLZu201d on the other side.
ENTRESTO 49/51 mg, (sacubitril 49 mg and valsartan 51 mg) are pale yellow and debossed with u201cNVRu201d on one side and u201cL1u201d on the other side.
ENTRESTO 97/103 mg, (sacubitril 97 mg and valsartan 103 mg) are light pink and debossed with u201cNVRu201d on one side and u201cL11u201d on the other side.

Film-coated tablets: 24/26 mg; 49/51 mg; 97/103 mg ()

ENTRESTO is contraindicated:

Hypersensitivity to any component. ()
History of angioedema related to previous ACEi or ARB therapy. ()
Concomitant use with ACE inhibitors. (, )
Concomitant use with aliskiren in patients with diabetes. (, )nttttttttt

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Observe for signs and symptoms of angioedema and hypotension. (, )n
Monitor renal function and potassium in susceptible patients. (, )

Clinically significant adverse reactions that appear in other sections of the labeling include:
Adverse reactions occurring u2265 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure. ()

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Avoid concomitant use with aliskiren in patients with eGFR < 60. ()
Potassium-sparing diuretics: May lead to increased serum potassium. ()
NSAIDs: May lead to increased risk of renal impairment. ()
Lithium: Increased risk of lithium toxicity. ()

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Lactation: Breastfeeding or drug should be discontinued. ()
Severe Hepatic Impairment: Use not recommended. (, )

Limited data are available with regard to overdosage in human subjects with ENTRESTO. In healthy volunteers, a single dose of ENTRESTO 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 ENTRESTO. Symptomatic treatment should be provided.
ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.

ENTRESTO (sacubitril and valsartan) is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker.
ENTRESTO contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1u00b4-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2u00b4-(1H-tetrazol-1-id-5-yl)[1,1u00b4-biphenyl]-4-yl]methyl}-L-valinate)u2014water (1/15).
Its empirical formula (hemipentahydrate) is CHNONa 2.5 HO. Its molecular mass is 957.99 and its schematic structural formula is:
ENTRESTO is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate (vegetable origin), talc, and colloidal silicon dioxide. The film-coat inactive ingredients are hypromellose, titanium dioxide (E 171), Macrogol 4000, talc, and iron oxide red (E 172). The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black (E 172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E 172).

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Dosing in clinical trials was based on the total amount of both components of ENTRESTO, i.e., 24/26 mg, 49/51 mg, and 97/103 mg were referred to as 50 mg, 100 mg, and 200 mg, respectively.

ENTRESTO (sacubitril/valsartan) is available as unscored, ovaloid, biconvex, film-coated tablets, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. All strengths are packaged in bottles as described below.
Store at 20u00b0C to 25u00b0C (77u00b0F), excursions permitted 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature]. Protect from moisture.

Advise patients to read the FDA-approved patient labeling (Patient Information).
Pregnancy:n- [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]
Angioedema:n- [see Contraindications (4) and Warnings and Precautions (5.2)]
T2019-106

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PRINCIPAL DISPLAY PANEL
NDC 0078-0659-20
Entreston
(sacubitril/valsartan) tablets
24 mg / 26 mg
Rx only
60 Tablets
Novartis

PRINCIPAL DISPLAY PANEL
NDC 0078-0777-20
Entreston
(sacubitril/valsartan) tablets
49 mg / 51 mg
Rx only
60 Tablets
Novartis

PRINCIPAL DISPLAY PANEL
NDC 0078-0696-20
Entreston
(sacubitril/valsartan) tablets
97 mg / 103 mg
Rx only
60 Tablets
Novartis

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