ENALAPRIL MALEATE
FULL PRESCRIBING INFORMATION: CONTENTS*
- SPL UNCLASSIFIED
- ENALAPRIL MALEATE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- ENALAPRIL MALEATE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ENALAPRIL MALEATE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
SPL UNCLASSIFIED
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
CLINICAL PHARMACOLOGY
14
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
INDICATIONS & USAGE
Heart Failure, Mortality Trials
Heart Failure, Mortality Trials
Head and Neck Angioedema
ENALAPRIL MALEATE CONTRAINDICATIONS
WARNINGS
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:
Drug Interactions
in utero
PRECAUTIONS
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:
Angioedema:
Hypotension:
Hyperkalemia:
Neutropenia:
Pregnancy:
Hypotension Patients on Diuretic Therapy:
Agents Causing Renin Release:
Non-steroidal Anti-inflammatory Agents:
Other Cardiovascular Agents:
Agents Increasing Serum Potassium:
Lithium:
Gold:
E.coli,in vivo
Pregnancy Categories Cand DFetal/Neonatal Morbidity and Mortality.
Clinical Pharmacology in Pediatric Patients
2
ENALAPRIL MALEATE ADVERSE REACTIONS
|
|
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 |
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
Serum Electrolytes:
Creatinine, Blood Urea Nitrogen:
Hematology:
Liver Function Tests:Hepatic Failure
OVERDOSAGE
Anaphylactoid reactions during membrane exposure.
DOSAGE & ADMINISTRATION
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 SUPPLIED
| 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 |
**
***
Wockhardt Limited
Wockhardt USA LLC.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
ENALAPRIL MALEATEENALAPRIL MALEATE TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
