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NA | ENALAPRIL MALEATE [Dispensing Solutions, Inc.] | BioPortfolio

12:25 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.
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.

SURVIVAL (%)

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

Adverse experiences occurring in greater than one percent of patients with hypertension treated with enalapril maleate in controlled clinical trials are shown below. In patients treated with enalapril maleate, the maximum duration of therapy was three years; in placebo treated patients the maximum duration of therapy was 12 weeks.

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

Manufacturer

Dispensing Solutions, Inc.

Active Ingredients

Source

Clinical Trials [210 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 [39 Associated PubMed Articles listed on BioPortfolio]

Could cardioprotective effect of ACE2 activator "diminazene aceturate" is more potent than ACE inhibitor "Enalapril" on acute myocardial infarction in rats?

Myocardial infarction (MI) is a major cause of cardiac dysfunction. All components of the cardiac renin angiotensin system (RAS) are upregulated in MI. Angiotensin converting enzyme (ACE) and ACE2 are...

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,...

Efficacy and Safety of Besifovir Dipivoxil Maleate Compared With Tenofovir Disoproxil Fumarate in Treatment of Chronic HBV Infection.

Besifovir dipivoxil maleate (BSV) has activity against hepatitis B virus (HBV). We performed a phase 3 study to compare the antiviral efficacy and safety of BSV vs tenofovir disoproxil fumarate (TDF) ...

Edonerpic Maleate: A Promising Pharmacological Agent for Stroke Recovery.

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