Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/761
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Enalapril Maleate (Tablet)
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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 structural formula is: M.W. 492.53 C20H28N2O5���C4H4O4 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 angiotensinconverting enzyme inhibitor. Each tablet, for oral administration, contains 2.5 mg, 5 mg, 10 mg, or 20 mg of enalapril maleate. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, castor oil, magnesium stearate, and the coloring agents: The 2.5 mg strength contains Yellow Iron Oxide The 5 mg strength contains no dyes The 10 mg strength contains Red Iron Oxide The 20 mg strength contains Yellow and Red Iron Oxide.
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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.
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Enalapril Maleate Tablets USP, are available as: - 2.5 mg strength, round yellow tablets, bisected and de-bossed������over���114���on one side and plain on the other. - 5 mg strength, round white tablets, bisected and de-bossed������over���127���on one side, and plain on the other side. - 10 mg strength, round salmon colored tablets, de-bossed������over���147���on one side, and plain on the other side. - 20 mg strength, peach colored tablets, de-bossed������over���214���on one side, and plain on the other side. Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg are supplied in bottles of 90, 100, 180, 500, 1000, and 5000 tablets. Store at 20��-25��C (68��-77��F) [See USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN Sandoz Inc. Princeton, NJ 08540 Revised 01/07 MF0214REV0107 OS7645 MG #15588
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USE IN PREGNANCY 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 USP, should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
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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.)
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Enalapril Maleate
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Enalapril Maleate (Tablet)
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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% of patients with hypertension and in 5.7% 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.
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Enalapril Maleate
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