Enalapril Maleate

/Enalapril Maleate
Enalapril Maleate2018-09-06T09:12:40+00:00

Prescription Drug Name:

Enalapril Maleate

ID:

759e0a98-9e32-4caf-936c-873ddf8b85b7

Code:

34391-3

DESCRIPTION


id: 7ee6b246-a785-4364-a17c-f9e20736e449
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 L-Proline,1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]- , (S)-, (Z)-2-butenedioate (1:1). Its molecular formula is, C20H28N2O5·C4H4O4, 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, 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.

CLINICAL PHARMACOLOGY


id: a51d19ea-03d9-4e0d-a83a-6002c971b7b5
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

INDICATIONS AND USAGE


id: e06aafe8-dd56-4401-a657-c6ed8281c070
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

CONTRAINDICATIONS


id: d4f58f52-e941-4005-802d-83f5745f1c68
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.

WARNINGS


id: 44ce3a16-441d-4890-a7f8-5a184be1782f
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

PRECAUTIONS


id: d4c10524-afce-48ce-b75f-9ed8ce80ea7c
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

ADVERSE REACTIONS


id: ac619d23-af21-4b91-addd-e242760cb93d
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: d5591566-8f1f-4ad7-acc6-d2811614322e
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.)

DOSAGE AND ADMINISTRATION


id: 07ce6515-fc60-4b6c-9cf3-3774e7c4d01b
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

HOW SUPPLIED


id: 2567e0c1-3021-4f3c-a056-0e137f34de53
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Enalapril Maleate Tablets, USP
NDC number Strength Description Quantity
 NDC 0615-4589-39  2.5 mg  White, round flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.                                                                                          923 Blisterpacks of 30’s.
 NDC 0615-4590-39
NDC 0615-4590-31
 5 mg  White, round flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.                                                                                          924  Blisterpacks of 30’s and 31’s.
 NDC 0615-4591-39
NDC 0615-4591-31
 10 mg  Light Salmon, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                                   925  Blisterpacks of 30’s and 31’s.
 NDC 0615-4593-39  20 mg  Light Beige, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                               926 Blisterpacks of 30’s.

S
to
rage

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.

Rev. 080610

PACKAGE LABEL PRINCIPAL DISPLAY PANEL


id: 1e21b9cc-3786-4566-b2b6-3aa7b14db253
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Enalapril Maleate Tablets, USP 2.5mg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL


id: 2e0c55e8-3b5a-4f24-8961-d317ec0967a7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Enalapril Maleate Tablets, USP 5mg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL


id: 628763ff-a9f4-440a-a4cc-6ed9d51b2297
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Enalapril Maleate Tablets, USP 10mg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL


id: 59380d6e-8f53-4b2a-8c15-23cda9dd0169
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Enalapril Maleate Tablets, USP 20mg