Enalapril Tabs – Wockhardt

/Enalapril Tabs – Wockhardt
Enalapril Tabs – Wockhardt2018-09-06T09:12:40+00:00

Prescription Drug Name:

Enalapril Tabs – Wockhardt

ID:

35db7429-7136-43b7-a071-f77a48a864a4

Code:

34391-3

DESCRIPTION


id: de082a42-6d8c-4709-afa8-d0df28173f30
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its molecular formula is, C H N O ●C H O , and its structural formula is: Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. 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 is supplied as 2.5 mg, 5 mg,10 mg and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: hypromellose, anhydrous lactose, corn starch, stearic acid and talc. The 10 mg and 20 mg tablets also contain iron oxides.

CONTRAINDICATIONS


id: 923ff85b-3c33-49fe-9a65-79108c09fb38
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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 co-administer aliskiren with enalapril maleate in patients with diabetes (see PRECAUTIONS, DRUG INTERACTIONS).

ADVERSE REACTIONS


id: 24ae2bf5-9f6d-4cf5-8e45-8024eaec13ad
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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 conrolled 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.

OVERDOSAGE


id: 3eeb6d79-e1c1-4cbb-9f20-a643b9ef18f0
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Limited data are available in regard to overdosage in humans. Single oral doses of enalapril above 1,000 mg/kg and ≥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 WARNINGS, Anaphylactoid reactions during membrane exposure).

HOW SUPLLIED


id: 73728ead-4b37-4297-a3f3-7fc40b5717da
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Enalapril Maleate Tablets, USP
NDC number Strength Description Quantity
 NDC 68645-454-90  2.5 mg  White, round flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side                                                                                          923  Bottles of 90
 NDC 68645-455-90  5 mg  White, round flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.                                                                                          924  Bottles of 90
 NDC 68645-456-90  10 mg  Light Salmon, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                                   925  Bottles of 90
 NDC 68645-457-90  20 mg  Light Beige, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                               926  Bottles of 90
Storage

Store below 30°C (86°F) and avoid transient temperatures above 50°C (122°F). Keep container tightly closed. Protect from moisture.

Dispense in a tight container as per USP, if product package is subdivided.
___________________________________________________________________________________________________________________________________
** Registered trademark of Alza Corporation.
*** Trademark of Paddock Laboratories, Inc.

Manufactured by:

Wockhardt Limited,
Mumbai, India.

Distributed by:

Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA. Packaged by:
Legacy Pharmaceutical Packaging, LLC
Earth City, MO 63045
Distributed by:
Wal-Mart
Bentonville, AR 72716

ENALAPRIL MALEATE TABLETS, USP 2.5MG


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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

 

ENALAPRIL MALEATE TABLETS, USP 5MG


id: 17ada6d1-30cd-4fc9-a4a1-678378e824ab
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

 

ENALAPRIL MALEATE TABLETS, USP 10MG


id: 4942f3c2-5c29-4125-9de7-7fd0bd89b8af
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

 

ENALAPRIL MALEATE TABLETS, USP 20MG


id: 2a9788a3-dbc5-48c2-a341-e17f730eb400
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4