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| ENALAPRIL MALEATE

04:50 EDT 27th August 2014 | 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.
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.
IMAGE Enalapril  Tablets_Structure.jpg

SURVIVAL (%)

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

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

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
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
Enalapril Maleate Tablets, USP
NDC number
Strength
Description
Quantity
NDC 64679-923-01
NDC 64679-923-02
NDC 64679-923-03
NDC 64679-923-07
2.5 mg
White, rount flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.                                                                                          923 90's bottle
100's bottle
1000's bottle
Unit Dose Carton of 100
NDC 64679-924-01
NDC 64679-924-02
NDC 64679-924-03
NDC 64679-924-07
5 mg
White, rount flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.                                                                                          924 90's bottle
100's bottle
1000's bottle
Unit Dose Carton of 100
NDC 64679-925-01
NDC 64679-925-02
NDC 64679-925-03
NDC 64679-925-07
10 mg
Light Salmon, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                                   925 90's bottle
100's bottle
1000's bottle
Unit Dose Carton of 100
NDC 64679-926-01
NDC 64679-926-02
NDC 64679-926-03
NDC 64679-926-07
20 mg
Light Beige, rount flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                               926
90's bottle
100's bottle
1000's bottle
Unit Dose Carton of 100
IMAGE Enalapril Tablets_Bulk Pack.jpg

Manufacturer

WOCKHARDT USA LLC

Active Ingredients

Source

Clinical Trials [202 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 [33 Associated PubMed Articles listed on BioPortfolio]

Continuous Inkjet Printing of Enalapril Maleate onto Orodispersible Film Formulations.

Piezoelectric inkjet printing onto orodispersible films (ODFs) was proven to be a successful technique applying flexible doses of active pharmaceutical ingredients (APIs) onto edible substrates. The r...

Chemoprevention with enalapril and aspirin in Men1(+/T) knockout mouse model.

Pancreatic neuroendocrine neoplasias (pNEN) are the most common cause of death in adult patients with multiple endocrine neoplasia type 1 (MEN1). So far, only few chemopreventive strategies (e.g. with...

Cytotoxic and genotoxic effects of antihypertensives distributed in Brazil by social programs: Are they safe?

Hypertension, a chronic non-transmissible multifactorial condition, it is highly frequent in Brazil, affecting about 32.5% of the population over 25 years of age. It is characterized by the sustained ...

Chronic treatment with the ACE inhibitor enalapril attenuates the development of frailty and differentially modifies pro-and anti-inflammatory cytokines in aging male and female C57BL/6 mice.

Studies on interventions that can delay or treat frailty in humans are limited. There is evidence of beneficial effects of angiotensin converting enzyme (ACE) inhibitors on aspects related to frailty,...

Sacubitril/Valsartan: potential treatment for paediatric heart failure.

The Prospective comparison of angiotensin receptor antagonist Valsartan and neprilysin inhibitor Sacubitril with angiotensin-converting enzyme inhibitor (enalapril) to determine impact on Global Morta...

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