ENALAPRIL MALEATE TABLETS, USP, 2.5 mg, 5 mg, 10 mg and 20 mg

/ENALAPRIL MALEATE TABLETS, USP, 2.5 mg, 5 mg, 10 mg and 20 mg
ENALAPRIL MALEATE TABLETS, USP, 2.5 mg, 5 mg, 10 mg and 20 mg2018-09-06T09:12:40+00:00

Prescription Drug Name:

ENALAPRIL MALEATE TABLETS, USP, 2.5 mg, 5 mg, 10 mg and 20 mg

ID:

3980589d-98fd-4bf4-9e99-1084bcfd5946

Code:

34391-3

USE IN PREGNANCY


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displayName: Boxed Warning section
FDA Article Code: 34066-1

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, enalapril maleate tablets should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

DESCRIPTION


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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). Enalapril maleate’s structural formula, molecular formula and molecular weight are as follows: C20H28N2O5•C4H4O4

M.W. 492.53 Enalapril maleate is a white to 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, for oral administration, contain 2.5 mg, 5 mg, 10 mg or 20 mg of enalapril maleate. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, maleic acid, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The 10 mg and 20 mg tablets also contain FD&C Blue No. 1 lake.

CONTRAINDICATIONS


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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Enalapril Maleate Tablets are 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.

ADVERSE REACTIONS


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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Enalapril has been evaluated for safety in more than 10,000 patients, including over 1000 patients treated for one year or more. Enalapril 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 reporting adverse experiences was comparable to placebo.

OVERDOSAGE


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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 SUPPLIED


id: 49593dfb-f7ce-4770-b4a8-91ccde6964e6
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Enalapril Maleate Tablets, USP are available containing 2.5 mg, 5 mg, 10 mg or 20 mg of enalapril maleate. The 5 mg tablets are white, round, biconvex tablets debossed with M over E16 on one side and scored on the other side. They are available as follows: NDC 67046-157-30
blister of 30 tablets
The 10 mg tablets are light blue, round, biconvex tablets debossed with M over E17 on one side and blank on the other side. They are available as follows: NDC 67046-158-30
blister of 30 tablets
The 20 mg tablets are medium blue, round, biconvex tablets debossed with M over E18 on one side and blank on the other side. They are available as follows: NDC 67046-159-30
blister of 30 tablets
NDC 67046-159-60
blister of 60 tablets

Principal Display Panel


id: b8b26b60-29fd-4c43-a38d-1dfeb83503d7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Principal Display Panel


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

Principal Display Panel


id: ccdd09e5-4cf4-4199-9a4a-5b886b6f9c50
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4