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

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ENALAPRIL MALEATE

PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.


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 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
Storage



**
***


Wockhardt Limited



Wockhardt USA LLC.





ENALAPRIL MALEATE



ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55289-694(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:55289-694-10 10 in 1 BOTTLE, PLASTIC
2 NDC:55289-694-30 30 in 1 BOTTLE, PLASTIC
3 NDC:55289-694-90 90 in 1 BOTTLE, PLASTIC

Marketing Information

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


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