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

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ENALAPRIL MALEATE

State of Florida DOH Central Pharmacy


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 is supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0966-1 2.5 mg 30 Tablets in a Blister Pack White 64679-923
53808-0242-1 5 mg 30 Tablets in a Blister Pack White 64679-924
53808-0243-1 10 mg 30 Tablets in a Blister Pack Light Salmon 64679-925
53808-0244-1 20 mg 30 Tablets in a Blister Pack Light Beige 64679-926
Storage



**
***


Wockhardt Limited



Wockhardt USA LLC.


This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

Label Image for 2.5mg

ENALAPRIL MALEATE

Label Image for 5mg

ENALAPRIL MALEATE

Label Image for 10mg

ENALAPRIL MALEATE

Label Image for 20mg

ENALAPRIL MALEATE

ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0966(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

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:53808-0966-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2009-07-01


ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0242(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

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:53808-0242-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2009-07-01


ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0243(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

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:53808-0243-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2009-07-01


ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0244(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
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:53808-0244-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 2009-07-01


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Be sure to consult your doctor before taking any medication!
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