Enalapril Maleate

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Overview

What is Enalapril Maleate?

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 ()-1-[- [1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, ()-2-butenedioate salt (1:1), and its structural formula is:

CHNO∙CHO 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.

What does Enalapril Maleate look like?

What are the available doses of Enalapril Maleate?

Sorry No records found.

What should I talk to my health care provider before I take Enalapril Maleate?

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How should I use Enalapril Maleate?

Enalapril maleate tablets are indicated for the treatment of hypertension.

Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril maleate. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with enalapril maleate to reduce the likelihood of hypotension (see ). If the patient's blood pressure is not controlled with enalapril maleate alone, diuretic therapy may be resumed.

If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see and , ).

The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with enalapril maleate alone, a diuretic may be added.

Concomitant administration of enalapril maleate with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see ).

What interacts with Enalapril Maleate?

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.

What are the warnings of Enalapril Maleate?

Anaphylactoid and Possibly Related Reactions

Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including enalapril maleate) may be subject to a variety of adverse reactions, some of them serious.

Head and Neck Angioedema

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including enalapril maleate. This may occur at any time during treatment. In such cases enalapril maleate should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. In instances where swelling has been confined to the face and lips the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. (see ).

Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see also and ).

Intestinal angioedema

Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angiodema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Anaphylactoid reactions during desensitization

Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.

Anaphylactoid reactions during membrane exposure

Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.

Hypotension

Excessive hypotension is rare in uncomplicated hypertensive patients treated with enalapril maleate alone. Patients with heart failure given enalapril maleate commonly have some reduction in blood pressure, especially with the first dose, but discontinuation of therapy for continuing symptomatic hypotension usually is not necessary when dosing instructions are followed; caution should be observed when initiating therapy (see ). Patients at risk for excessive hypotension, sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death, include those with the following conditions or characteristics: heart failure, hyponatremia, high dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, renal dialysis, or severe volume and/or salt depletion of any etiology. It may be advisable to eliminate the diuretic (except in patients with heart failure), reduce the diuretic dose or increase salt intake cautiously before initiating therapy with enalapril maleate in patients at risk for excessive hypotension who are able to tolerate such adjustments (see , and ). In patients at risk for excessive hypotension, therapy should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of enalapril and/or diuretic is increased. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.

If excessive hypotension occurs, the patient should be placed in the supine position and, if necessary, receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses of enalapril maleate, which usually can be given without difficulty once the blood pressure has stabilized. If symptomatic hypotension develops, a dose reduction or discontinuation of enalapril maleate or concomitant diuretic may be necessary.

Neutropenia/Agranulocytosis

Another angiotensin converting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients but more frequently in patients with renal impairment especially if they also have a collagen vascular disease. Available data from clinical trials of enalapril are insufficient to show that enalapril does not cause agranulocytosis at similar rates. Marketing experience has revealed cases of neutropenia or agranulocytosis in which a causal relationship to enalapril cannot be excluded. Periodic monitoring of white blood cell counts in patients with collagen vascular disease and renal disease should be considered.

Hepatic Failure

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis, and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.

Fetal/Neonatal Morbidity and Mortality

ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible.

The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to the ACE-inhibitor exposure.

These adverse effects do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to ACE inhibitors only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should make every effort to discontinue the use of enalapril maleate as soon as possible.

Rarely, (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intraamniotic environment.

If oligohydramnios is observed, enalapril maleate should be discontinued unless it is considered lifesaving for the mother. Contraction stress testing (CST), a non-stress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.

Infants with histories of exposure to ACE inhibitors should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. Enalapril, which crosses the placenta, has been removed from neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion, although there is no experience with the latter procedure.

No teratogenic effects of enalapril were seen in studies of pregnant rats and rabbits. On a body surface area basis, the doses used were 57 times and 12 times, respectively, the maximum recommended human daily dose (MRHDD).

In a published retrospective epidemiological study, infants whose mothers had taken an ACE inhibitor during their first trimester of pregnancy appeared to have an increased risk of major congenital malformations compared with infants whose mothers had not undergone first trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study have not yet been repeated.

What are the precautions of Enalapril Maleate?

General

Aortic Stenosis/Hypertrophic Cardiomyopathy

As with all vasodilators, enalapril should be given with caution to patients with obstruction in the outflow tract of the left ventricle.

Impaired Renal Function

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin converting enzyme inhibitors, including enalapril maleate, may be associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death.

In clinical studies in hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine were observed in 20 percent of patients. These increases were almost always reversible upon discontinuation of enalapril and/or diuretic therapy. In such patients renal function should be monitored during the first few weeks of therapy.

Some patients with hypertension or heart failure with no apparent preexisting renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when enalapril maleate has been given concomitantly with a diuretic. This is more likely to occur in patients with preexisting renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or enalapril maleate may be required.

Evaluation of patients with hypertension or heart failure should always include assessment of renal function

DOSAGE AND ADMINISTRATION

Hyperkalemia

Elevated serum potassium (greater than 5.7 mEq/L) was observed in approximately one percent of hypertensive patients in clinical trials. In most cases these were isolated values which resolved despite continued therapy. Hyperkalemia was a cause of discontinuation of therapy in 0.28 percent of hypertensive patients. In clinical trials in heart failure, hyperkalemia was observed in 3.8 percent of patients but was not a cause for discontinuation.

Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes, which should be used cautiously, if at all, with enalapril maleate (see ).

Cough

Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.

Surgery/Anesthesia

In patients undergoing major surgery or during anesthesia with agents that produce hypotension, enalapril may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.

Information for Patients

Angioedema

Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin converting enzyme inhibitors, including enalapril. Patients should be so advised and told to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.

Hypotension

Patients should be cautioned to report lightheadedness, especially during the first few days of therapy. If actual syncope occurs, the patients should be told to discontinue the drug until they have consulted with the prescribing physician.

All patients should be cautioned that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; patients should be advised to consult with the physician.

Hyperkalemia

Patients should be told not to use salt substitutes containing potassium without consulting their physician.

Neutropenia

Patients should be told to report promptly any indication of infection (e.g., sore throat, fever) which may be a sign of neutropenia.

Pregnancy

Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors. These patients should be asked to report pregnancies to their physicians as soon as possible.

NOTE: As with many other drugs, certain advice to patients being treated with enalapril is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Drug Interactions

Hypotension - Patients on Diuretic Therapy

Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with enalapril. The possibility of hypotensive effects with enalapril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with enalapril. If it is necessary to continue the diuretic, provide close medical supervision after the initial dose for at least two hours and until blood pressure has stabilized for at least an additional hour (see and ).

Agents Causing Renin Release

The antihypertensive effect of enalapril maleate is augmented by antihypertensive agents that cause renin release (e.g., diuretics).

Non-Steroidal Anti-Inflammatory Agents

In some patients with compromised renal function who are being treated with non-steroidal anti-inflammatory drugs, the coadministration of enalapril may result in a further deterioration of renal function. These effects are usually reversible.

In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensive patients receiving enalapril maleate. In this study there was no evidence of a blunting of the antihypertensive action of enalapril maleate. However, reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors.

Other Cardiovascular Agents

Enalapril maleate has been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions.

Agents Increasing Serum Potassium

Enalapril maleate attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. Potassium sparing agents should generally not be used in patients with heart failure receiving enalapril maleate.

Lithium

Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors. A few cases of lithium toxicity have been reported in patients receiving concomitant enalapril maleate and lithium and were reversible upon discontinuation of both drugs. It is recommended that serum lithium levels be monitored frequently if enalapril is administered concomitantly with lithium.

Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including enalapril maleate.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of a tumorigenic effect when enalapril was administered for 106 weeks to male and female rats at doses up to 90 mg/kg/day or for 94 weeks to male and female mice at doses up to 90 and 180 mg/kg/day, respectively. These doses are 26 times (in rats and female mice) and 13 times (in male mice) the maximum recommended human daily dose (MRHDD) when compared on a body surface area basis.

Neither enalapril maleate nor the active diacid was mutagenic in the Ames microbial mutagen test with or without metabolic activation. Enalapril was also negative in the following genotoxicity studies: rec-assay, reverse mutation assay with , sister chromatid exchange with cultured mammalian cells, and the micronucleus test with mice, as well as in an cytogenic study using mouse bone marrow.

There were no adverse effects on reproductive performance of male and female rats treated with up to 90 mg/kg/day of enalapril (26 times the MRHDD when compared on a body surface area basis).

Pregnancy

Teratogenic Effects

Pregnancy categories C (first trimester) and D (second and third trimesters)

See , .

Nursing Mothers

Enalapril and enalaprilat have been detected in human breast milk. Because of the potential for serious adverse reactions in nursing infants from enalapril, a decision should be made whether to discontinue nursing or to discontinue enalapril maleate, taking into account the importance of the drug to the mother.

Pediatric Use

Antihypertensive effects of enalapril maleate have been established in hypertensive pediatric patients age 1 month to 16 years. Use of enalapril maleate in these age groups is supported by evidence from adequate and well-controlled studies of enalapril maleate in pediatric and adult patients as well as by published literature in pediatric patients (see , and ).

Enalapril maleate is not recommended in neonates and in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m, as no data are available.

What are the side effects of Enalapril Maleate?

HYPERTENSION

Enalapril Maleate(n=2314)Incidence(discontinuation)	Placebo(n=230)Incidence
	Body As A Whole
Fatigue	3.0 (<0.1)	2.6
Orthostatic Effets	1.2 (<0.1)	0.0
Asthenia	1.1 (0.1)	0.9
	Digestive
Diarrhea	1.4 (<0.1)	1.7
Nausea	1.4 (0.2)	1.7
	Nervous/Psychiatric
Headache	5.2 (0.3)	9.1
Dizziness	4.3 (0.4)	4.3
	Respiratory
Cough	1.3 (0.1)	0.9
	Skin
Rash	1.4 (0.4)	0.4

HEART FAILURE

Clinical Laboratory Test Findings

Serum Electrolytes:

Creatinine, Blood Urea Nitrogen:

Array

Hematology:

Liver Function Tests:

Hepatic Failure

What should I look out for while using Enalapril Maleate?

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.

What might happen if I take too much Enalapril Maleate?

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 , ).

How should I store and handle Enalapril Maleate?

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyEnalapril 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 as follows: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, IndiaManufactured For:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central Pharmacy

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Clinical Information

Chemical Structure

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Clinical 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 alone for up to 48 weeks, mean increases in serum potassium of approximately 0.2 mEq/L were observed. In patients treated with enalapril plus a thiazide diuretic, there was essentially no change in serum potassium (see ). 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 enalapril remains to be elucidated.

While the mechanism through which enalapril 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 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

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.

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.

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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