Country: United States
Language: English
Source: NLM (National Library of Medicine)
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)
State of Florida DOH Central Pharmacy
ENALAPRIL MALEATE
ENALAPRIL MALEATE 2.5 mg
ORAL
PRESCRIPTION DRUG
Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY , Heart Failure, Mortality Trials for details and limitations of survival trials). In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤ 35 percent), enalapril maleate tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY ,
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: PROTECT FROM MOISTURE. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. All trademarks are the property of their respective owners. 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
Abbreviated New Drug Application
ENALAPRIL MALEATE - ENALAPRIL MALEATE TABLET STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- ENALAPRIL MALEATE TABLETS USP 2.5 MG, 5 MG, 10 MG AND 20 MG RX ONLY WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE AS SOON AS POSSIBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS (SEE WARNINGS, FETAL TOXICITY). DESCRIPTION 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 (_S_)-1-[_N_- [1- (ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (_Z_)-2-butenedioate salt (1:1), and its structural formula is: C H N O ·C H O M.W. 492.53 Enalapril maleate, USP 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 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. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstri Read the complete document