Topics

NA | Enalapril Maleate [Physicians Total Care, Inc.] | BioPortfolio

12:16 EST 27th January 2019 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Product Information ENALAPRIL MALEATE TABLETS, USP Rx only

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 should be discontinued as soon as possible. See WARNINGS, Fetal / Neonatal Morbidity and Mortality.

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 L-Proline,1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]- , (S)-, (Z)-2-butenedioate (1:1). Its molecular formula is, CHNO·CHO, and its structural formula is:

Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. 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 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: hypromellose, anhydrous lactose, corn starch, stearic acid and talc. The 10 mg and 20 mg tablets also contain iron oxides.


SURVIVAL (%)

Six Months One Year
Enalapril Maleate (n=127)
74
64
Placebo (n=126)
56
48

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
(n=2314)
Incidence
(discontinuation)
Placebo
(n=230)
Incidence
Body As A Whole

  Fatigue
3.0 (less than 0.1)
2.6
  Orthostatic Effets
1.2 (less than 0.1) 0.0
  Asthenia
1.1 (0.1) 0.9
Digestive

  Diarrhea
1.4 (less than 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

Enalapril Maleate
(n=673)
Incidence
(discontinuation)
Placebo
(n=339)
Incidence
Body As A Whole

  Orthostatic Effects 2.2 (0.1) 0.3
  Syncope 2.2 (0.1) 0.9
  Chest Pain 2.1 (0.0)
2.1
  Fatigue 1.8 (0.0) 1.8
  Abdominal Pain 1.6 (0.4) 2.1
  Asthenia 1.6 (0.1)
0.3
Cardiovascular

  Hypotension 6.7 (1.9)
0.6
  Orthostatic Hypotension 1.6 (0.1)
0.3
  Angina Pectoris 1.5 (0.1)
1.8
  Myocardial Infarction 1.2 (0.3)
1.8
Digestive

  Diarrhea 2.1 (0.1) 1.2
  Nausea 1.3 (0.1)
0.6
  Vomiting 1.3 (0.0)
0.9
Nervous/Psychiatric

  Dizziness 7.9(0.6) 0.6
  Headache 1.8 (0.1) 0.9
  Vertigo 1.6 (0.1)
1.2
Respiratory

  Cough 2.2 (0.0) 0.6
  Bronchitis 1.3 (0.0) 0.9
  Dyspnea 1.3 (0.1) 0.4
  Pneumonia 1.0 (0.0) 2.4
Skin

  Rash 1.3 (0.0)
2.4
Urogenital

  Urinary Tract Infection 1.3 (0.0) 2.4

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.)

Renal Status
Creatinine-
Clearance
ml/min
Initial Dose
mg/day
Normal Renal Function
>80 mL/min
5 mg
Mild Impairment
≤80> 30 mL/min 5 mg
Moderate to Severe Impairment
≤30 mL/min 2.5 mg
Dialysis Patients***
- -
2.5 mg on dialysis days

S to rage Store below 30°C (86°F) and avoid transient temperatures above 50°C (122°F). Keep container tightly closed. Protect from moisture. Dispense in a tight container as per USP, if product package is subdivided.___________________________________________________________________________________________________________________________________ Registered trademark of Alza Corporation. Trademark of Paddock Laboratories, Inc. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054USA. Rev.221209 Relabeling and Repackaging by: Physicians Total Care, Inc.Tulsa, OK    74146

Enalapril Maleate Tablets, USP
Quantity
NDC Number
Strength
Description
Bottles of 30
Bottles of 60
Bottles of 100
NDC 54868-4332-1
NDC 54868-4332-0
NDC 54868-4332-2
2.5 mg
White, rount flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.
Bottles of 30
Bottles of 60
Bottles of 90
Bottles of 100
NDC 54868-4357-0
NDC 54868-4357-1
NDC 54868-4357-3
NDC 54868-4357-2
5 mg
White, rount flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.
Bottles of 30
Bottles of 60
Bottles of 90
Bottles of 100
NDC 54868-4358-0
NDC 54868-4358-1
NDC 54868-4358-3
NDC 54868-4358-2
10 mg
Light Salmon, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side.
Bottles of 30
Bottles of 60
Bottles of 90
Bottles of 100
NDC 54868-4331-1
NDC 54868-4331-2
NDC 54868-4331-3
NDC 54868-4331-0
20 mg
Light Beige, rount flat-faced beveled edged, compressed tablets with W on one side plain on the other side.

Enalapril Maleate Tablets  

2.5 mg

5 mg

10 mg

20 mg

Manufacturer

Physicians Total Care, Inc.

Active Ingredients

Source

Clinical Trials [223 Associated Clinical Trials listed on BioPortfolio]

Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

This study evaluates the effect in artery stiffness of enalapril maleate in Rheumatoid Arthritis women patients. Half of participants will receive 5mg enalapril maleate every 12 hrs, while...

Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...

Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia

This is a double blind randomised controlled feasibility study investigating the effect of postnatal enalapril on cardiovascular function in women who have had preterm pre-eclampsia. Parti...

PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer?

PROACT will establish the effectiveness of the angiotensin-converting enzyme inhibitor (ACEI) enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer unde...

Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells f...

PubMed Articles [23 Associated PubMed Articles listed on BioPortfolio]

Relative Bioavailability of Enalapril Administered as Orodispersible Minitablets in Healthy Adults.

The angiotensin-converting enzyme inhibitor enalapril is commonly used to treat chronic heart failure in children. Because some children are unable to swallow capsules or tablets, a new, age-appropria...

Early Effects of Starting Doses of Enalapril in Patients with Chronic Heart Failure in the SOLVD Treatment Trial.

In the Studies of Left Ventricular Dysfunction (SOLVD) Treatment trial, similar clinical benefits were observed between starting doses of enalapril and the target dose achieved by post-randomization u...

Effect and safety of treatment with ACE-inhibitor Enalapril and β-blocker metoprolol on the onset of left ventricular dysfunction in Duchenne muscular dystrophy - a randomized, double-blind, placebo-controlled trial.

X-linked Duchenne muscular dystrophy (DMD), the most frequent human hereditary skeletal muscle myopathy, inevitably leads to progressive dilated cardiomyopathy. We assessed the effect and safety of a ...

Neurohormonal modulation: The new paradigm of pharmacological treatment of heart failure.

The current paradigm of medical therapy for heart failure with reduced ejection fraction (HFrEF) is triple neurohormonal blockade with an angiotensin-converting enzyme inhibitor (ACEI), a beta-blocker...

Asenapine Maleate normalizes low frequency oscillatory deficits in a neurodevelopmental model of schizophrenia.

Asenapine maleate (AM) is an atypical antipsychotic that, unlike many other antipsychotics, shows some efficacy in treating cognitive dysfunction in schizophrenia. Normal cognitive function has long s...

Quick Search

Relevant Topics

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record