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

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ENALAPRIL MALEATE

NCS HealthCare of KY, Inc dba Vangard Labs

Enalapril Maleate


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

202825444

ENALAPRIL MALEATE


CLINICAL PHARMACOLOGY


Mechanism of Action




Pharmacokinetics and Metabolism







14

Pharmacodynamics and Clinical Effects

Hypertension:















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,

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




 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 SUPPLIED


Enalapril Maleate Tablets, USP
NDC number
 Strength
 Description
 Quantity
 NDC 0615-4589-39
  2.5 mg
  White, round flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.                                                                                          923 Blisterpacks of 30's.
 NDC 0615-4590-39
NDC 0615-4590-31
  5 mg
  White, round flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side.                                                                                          924  Blisterpacks of 30's and 31's.
 NDC 0615-4591-39
NDC 0615-4591-31		  10 mg
  Light Salmon, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                                   925  Blisterpacks of 30's and 31's.
 NDC 0615-4593-39
  20 mg
  Light Beige, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side.                                                                                                               926
 Blisterpacks of 30's.
Storage




**
***


Wockhardt Limited



Wockhardt USA LLC.




PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Enalapril Maleate Tablets,

USP 2.5mg

ENALAPRIL MALEATE

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Enalapril Maleate Tablets,

USP 5mg

ENALAPRIL MALEATE

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Enalapril Maleate Tablets,

USP 10mg

ENALAPRIL MALEATE

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Enalapril Maleate Tablets,

USP 20mg

ENALAPRIL MALEATE

ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0615-4589(NDC:64679-923)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

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

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
ANHYDROUS LACTOSE
STARCH, CORN
STEARIC ACID
talc

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:0615-4589-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2009-12-11


ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0615-4590(NDC:64679-924)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

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

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
ANHYDROUS LACTOSE
STARCH, CORN
STEARIC ACID
talc

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:0615-4590-31 31 in 1 BLISTER PACK
2 NDC:0615-4590-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2009-12-11


ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0615-4591(NDC:64679-925)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

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

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
ANHYDROUS LACTOSE
STARCH, CORN
STEARIC ACID
talc

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:0615-4591-31 31 in 1 BLISTER PACK
2 NDC:0615-4591-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2009-12-11


ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0615-4593(NDC:64679-926)
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
HYPROMELLOSES
ANHYDROUS LACTOSE
STARCH, CORN
STEARIC ACID
talc

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:0615-4593-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2009-12-11


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Be sure to consult your doctor before taking any medication!
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