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ENALAPRIL MALEATE TABLETS, USP Rx only | ENALAPRIL MALEATE

13:51 EDT 24th July 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.
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
IMAGE label1datamaxfda437.jpg

Manufacturer

Bryant Ranch Prepack

Active Ingredients

Source

Clinical Trials [200 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 [27 Associated PubMed Articles listed on BioPortfolio]

Flexible and precise dosing of enalapril maleate for all paediatric age groups utilizing orodispersible minitablets.

Enalapril is an off-patent angiotensin-converting enzyme inhibitor for which no paediatric age-appropriate formulation is commercially available in Europe, and enalapril maleate (EM) orodispersible mi...

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...

Investigation of the antioxidant effects of pheniramine maleate and nebivolol on testicular damage in rats with experimentally induced testis torsion.

To investigate the biochemical, histopathologic, and spermatogenetic changes in the detorsionated testicle after experimental torsion and to study the antioxidant effects of pheniramine maleate and ne...

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 ...

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