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Enalapril Maleate (Enalapril Maleate)

Trade Name : Enalapril Maleate

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 2.5 mg/1

ENALAPRIL MALEATE Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Enalapril Maleate (Enalapril Maleate) which is also known as Enalapril Maleate and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 2.5 mg/1 per ml. Read more

Enalapril Maleate (Enalapril Maleate) 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

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.

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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.

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About GNH

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.

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.

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  • No data
  • See full prescribing information for complete boxed warning.
  • Enalapril maleate, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate, USP is chemically described as ()-1-[- [1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, ()-2-butenedioate salt (1:1), and its structural formula is:
  • CHNOu2219CHO M.W. 492.53
  • Enalapril maleate, USP is an off-white, crystalline powder. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol.
  • Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme inhibitor.
  • Enalapril maleate tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium bicarbonate. Each 2.5 mg tablet contains D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, and FD&C yellow #6 aluminum lake. Each 10 mg tablet contains FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake and FD&C yellow #6 aluminum lake. Each 20 mg tablet contains FD&C Yellow #6.
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  • Enalapril maleate is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.
  • Do not coadminister aliskiren with enalapril maleate in patients with diabetes (see , ).
  • Enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see ).
  • No data
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  • Enalapril maleate has been evaluated for safety in more than 10,000 patients, including over 1000 patients treated for one year or more. Enalapril maleate has been found to be generally well tolerated in controlled clinical trials involving 2987 patients. For the most part, adverse experiences were mild and transient in nature. In clinical trials, discontinuation of therapy due to clinical adverse experiences was required in 3.3 percent of patients with hypertension and in 5.7 percent of patients with heart failure. The frequency of adverse experiences was not related to total daily dosage within the usual dosage ranges. In patients with hypertension the overall percentage of patients treated with enalapril maleate reporting adverse experiences was comparable to placebo.
  • Limited data are available in regard to overdosage in humans.
  • Single oral doses of enalapril above 1,000 mg/kg and u2265 1,775 mg/kg were associated with lethality in mice and rats, respectively.
  • The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.
  • Enalaprilat may be removed from general circulation by hemodialysis and has been removed from neonatal circulation by peritoneal dialysis (see , ).
  • No data
  • Enalapril maleate tablets USP, 2.5 mg are available as yellow, oval, convex tablets debossed u201c93u201d bisect u201c26u201d on one side, plain on the other side.
  • They are supplied as follows:
  • NDC 0093-0026-01 bottles of 100 (with desiccant)
  • NDC 0093-0026-10 bottles of 1000 (with desiccant)
  • Enalapril maleate tablets USP, 5 mg are available as white, oval, convex tablets debossed u201c93u201d bisect u201c27u201d on one side, plain on the other side.
  • They are supplied as follows:
  • NDC 0093-0027-01 bottles of 100 (with desiccant)
  • NDC 0093-0027-50 bottles of 5000 (with desiccant)
  • Enalapril maleate tablets USP, 10 mg are available as salmon, oval, convex tablets debossed u201c93 28u201d on one side, plain on the other side.
  • They are supplied as follows:
  • NDC 0093-0028-01 bottles of 100 (with desiccant)
  • NDC 0093-0028-10 bottles of 1000 (with desiccant)
  • NDC 0093-0028-50 bottles of 5000 (with desiccant)
  • Enalapril maleate tablets USP, 20 mg are available as peach, oval, convex tablets debossed u201c93 29u201d on one side, plain on the other side.
  • They are supplied as follows:
  • NDC 0093-0029-01 bottles of 100 (with desiccant)
  • NDC 0093-0029-10 bottles of 1000 (with desiccant)
  • NDC 0093-0029-50 bottles of 5000 (with desiccant)
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Keep container tightly closed.
  • Protect from moisture.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Distributed by:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. S 7/2017
  • No data
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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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