USE IN PREGNANCY
id: 1a5528c7-1ce7-480c-b9d8-24a11866cf5b
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 should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
DESCRIPTION
id: 752d7147-2336-4f7b-96ce-df1560b610fd
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), and its structural formula is:
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 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: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. Each 2.5 mg tablet contains Yellow LB-1637. Each 10 mg tablet contains Salmon LB-1668. Each 20 mg tablet contains FD&C Yellow #6.
CONTRAINDICATIONS
id: 4e41d70a-28fa-4b47-8da2-5a43c0904247
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.
ADVERSE REACTIONS
id: 4bb556a1-accd-43e9-a12d-ede774eabccd
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 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.
OVERDOSAGE
id: 8fc6911f-165a-421d-913f-ad68fd25f231
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: d9ee1ecd-2d8f-43ce-8171-a6ca938ce15a
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Enalapril maleate tablets USP, 2.5 mg are available as yellow, oval, convex tablets debossed “93” bisect “26” on one side, plain on the other side.
Enalapril maleate tablets USP, 5 mg are available as white, oval, convex tablets debossed “93” bisect “27” on one side, plain on the other side.
Enalapril maleate tablets USP, 10 mg are available as salmon, oval, convex tablets debossed “93” “28” on one side, plain on the other side.
Enalapril maleate tablets USP, 20 mg are available as peach, oval, convex tablets debossed “93” “29” on one side, plain on the other side.
They are supplied by State of Florida DOH Central Pharmacy as follows:
|
NDC
|
Strength
|
Quantity/Form
|
Color
|
Source Prod. Code
|
| 53808-0663-1 |
2.5 mg |
30 Tablets in a Blister Pack |
YELLOW |
0093-0026 |
| 53808-0648-1 |
20 mg |
30 Tablets in a Blister Pack |
peach |
0093-0029 |
PROTECT FROM MOISTURE. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Manufactured In India By:
EMCURE PHARMACEUTICALS LTD.
Hinjwadi, Pune, India
Manufactured For:
TEVA PHARMACEUTICALS
USA
Sellersville, PA 18960
This Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States
CONTAINER LABELS
id: f8536255-d3ad-4fbf-adaa-200772829899
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
