ENALAPRIL MALEATE description, usages, side effects, indications, overdosage, supplying and lots more!

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ENALAPRIL MALEATE

Major Pharmaceuticals

Enalapril Maleate Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION



ENALAPRIL MALEATE TABLETS, USP

 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 DESCRIPTION

202825444ENALAPRIL MALEATE


CLINICAL PHARMACOLOGY


Mechanism of Action




Pharmacokinetics and Metabolism







14

Pharmacodynamics and Clinical Effects

Hypertension:













Drug Interactions.

Heart Failure:

Heart Failure, Mortality Trials:








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


Clinical Pharmacology in Pediatric Patients




Preparation of Suspension

ENALAPRIL MALEATE INDICATIONS AND USAGE


Hypertension


Heart Failure

Heart Failure, Mortality Trials

Asymptomatic Left Ventricular Dysfunction

Heart Failure, Mortality Trials



Head and Neck Angioedema

ENALAPRIL MALEATE CONTRAINDICATIONS

WARNINGS


Anaphylactoid and Possibly Related Reactions



Head and Neck Angioedema: Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., Subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway, should be promptly provided.

Intestinal Angioedema:



Anaphylactoid reactions during desensitization:

Anaphylactoid reactions during membrane exposure:

Hypotension

Drug Interactions



Neutropenia/Agranulocytosis

Hepatic Failure

Fetal/Neonatal Morbidity and Mortality







in utero

PRECAUTIONS


General

Aortic Stenosis/Hypertrophic Cardiomyopathy:

Impaired Renal Function:






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

Hyperkalemia:
Drug Interactions

Cough:

Surgery/Anesthesia:

Information for Patients

Angioedema:

Hypotension:


Hyperkalemia:

Neutropenia:

Pregnancy:

Drug Interactions

Hypotension Patients on Diuretic Therapy:
Agents Causing Renin Release:
Non-steroidal Anti-inflammatory Agents:

Other Cardiovascular Agents:
Agents Increasing  Serum Potassium:
Lithium:
Gold:

Carcinogenesis, Mutagenesis, Impairment of Fertility



E.coli,in vivo

Pregnancy

Pregnancy Categories Cand DFetal/Neonatal Morbidity and Mortality.

Nursing Mothers

Pediatric Use

Clinical Pharmacology in Pediatric Patients
2

ENALAPRIL MALEATE ADVERSE REACTIONS


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


 
  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


Body As A Whole: Anaphylactoid and Possibly Related Reactions
Cardiovascular: Hypotension
Digestive:Hepatic Failure
Hematologic:
Musculoskeletal
Nervous/Psychiatric:
Respiratory:
Skin:
Special Senses:
Urogenital:
Miscellaneous:
Angioedema:
Hypotension:
Fetal/Neonatal Morbidity and MortalityFetal/Neonatal Morbidity and Mortality
CoughCough.
Pediatric Patients

Clinical Laboratory Test Findings

Serum Electrolytes:

Creatinine, Blood Urea Nitrogen:

Hematology:

Liver Function Tests:Hepatic Failure

OVERDOSAGE



Anaphylactoid reactions during membrane exposure.

ENALAPRIL MALEATE DOSAGE AND ADMINISTRATION


Hypertension


Drug Interactions



Dosage Adjustment in Hypertensive Patients with Renal Impairment
 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†

†

Heart Failure


Drug Interactions

Asymptomatic Left Ventricular Dysfunction

Drug Interactions

Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia
Heart  Failure, Drug Interactions
Pediatric Hypertensive Patients

Clinical Pharmacology in Pediatric Patients.
2
Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)
®**TM***

HOW SUPLLIED


Enalapril Maleate Tablets, USP
NDC number
 Strength
 Description
 Quantity
NDC 0904-5609-61
  2.5 mg
  White, rount flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.                                                                                          923  
Unit Dose Carton of 100
 NDC 0904-5502-61  5 mg
  White, rount flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.                                                                                          924

Unit Dose Carton of 100
 NDC 0904-5610-61  10 mg
  Light Salmon, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                                   925

Unit Dose Carton of 100
 NDC 0904-5611-61  20 mg
  Light Beige, rount flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                               926

Unit Dose Carton of 100
Storage



**
***


Wockhardt Limited



Major Pharmaceuticals




ENALAPRIL MALEATE

ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0904-5609
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE ENALAPRILAT ANHYDROUS 2.5 mg

Product Characteristics

Color Size Imprint Code Shape
WHITE (White) 6 mm W;923 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5609-61 100 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2004-02-03


ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0904-5502
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE ENALAPRILAT ANHYDROUS 5 mg

Product Characteristics

Color Size Imprint Code Shape
WHITE (White) 8 mm W;924 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5502-61 100 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2004-02-03


ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0904-5610
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE ENALAPRILAT ANHYDROUS 10 mg

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Light Salmon) 8 mm W;925 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5610-61 100 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2004-02-03


ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0904-5611
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE ENALAPRILAT ANHYDROUS 20 mg

Inactive Ingredients

Ingredient Name Strength
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
BROWN (Light Beige) 8 mm W;926 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5611-61 100 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2004-02-03


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Be sure to consult your doctor before taking any medication!
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