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enalapril maleate
Overview
What is EPANED?
EPANED (enalapril maleate) Powder for Oral Solution is the maleate salt of enalapril, the ethyl ester prodrug 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 empirical formula is CHNO•CHO, and its structural formula is:
Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol.
EPANED Powder for Oral Solution is a kit consisting of 1 bottle containing a dry powder blend of enalapril maleate, USP, mannitol, and colloidal silicon dioxide and 1 bottle of Ora-Sweet SF diluent for reconstitution resulting in a 1 mg/mL EPANED oral solution. The Ora-Sweet SF diluent contains: purified water, glycerin, sorbitol, sodium saccharin, xanthan gum, and flavoring. Buffered with citric acid and sodium citrate. Preserved with methylparaben (0.03%), propylparaben (0.008%), and potassium sorbate (0.1%).
What does EPANED look like?
What are the available doses of EPANED?
EPANED Powder for Oral Solution contains 150 mg of enalapril maleate in a 150 mL bottle. Reconstitution with 150 mL of ORA-SWEET SF provided results in a 1 mg/mL EPANED oral solution. ()
What should I talk to my health care provider before I take EPANED?
How should I use EPANED?
EPANED is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month .
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
EPANED is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of EPANED and thiazides are approximately additive.
Adults
Use with diuretics:
Dosage Adjustment for Renal Impairment:
[see Clinical Pharmacology ()]
EPANED is not recommended in neonates (i.e., infants 1 month of age or less), preterm infants who have not reached a corrected post-conceptual age of 44 weeks, and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m.
What interacts with EPANED?
Sorry No Records found
What are the warnings of EPANED?
Sorry No Records found
What are the precautions of EPANED?
Sorry No Records found
What are the side effects of EPANED?
Sorry No records found
What should I look out for while using EPANED?
EPANED is contraindicated in patients with:
Do not co-administer aliskiren with EPANED in patients with diabetes .
EPANED is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer EPANED within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor .
What might happen if I take too much EPANED?
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
How should I store and handle EPANED?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture. Keep this and all medication out of the reach of children.Repackaged by Preferred Pharmaceuticals, Inc.EPANED is supplied as a kit. NDC 52652-1001-1 Store at 25°C (77°F); in a tightly closed container; excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and freezing.EPANED is supplied as a kit. NDC 52652-1001-1 Store at 25°C (77°F); in a tightly closed container; excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and freezing.EPANED is supplied as a kit. NDC 52652-1001-1 Store at 25°C (77°F); in a tightly closed container; excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and freezing.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. Although the latter decrease is small, it results in small increases of serum potassium. In hypertensive patients treated with enalapril maleate tablets alone for up to 48 weeks, mean increases in serum potassium of approximately 0.2 mEq/L were observed. In patients treated with enalapril maleate tablets plus a thiazide diuretic, there was essentially no change in serum potassium . Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity.
ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of EPANED remains to be elucidated.
While the mechanism through which EPANED lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, enalapril is antihypertensive even in patients with low-renin hypertension. Although enalapril maleate tablets was antihypertensive in all races studied, Black hypertensive patients (usually a low-renin hypertensive population) had a smaller average response to enalapril monotherapy than non-Black patients.
Non-Clinical Toxicology
EPANED is contraindicated in patients with:Do not co-administer aliskiren with EPANED in patients with diabetes .
EPANED is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer EPANED within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor .
See .
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue EPANED as soon as possible .
The following adverse reactions are described elsewhere:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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