DESCRIPTION
SPL UNCLASSIFIED SECTION
| USE IN PREGNANCYWhen 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. |
DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of Action
Pharmacokinetics and Metabolism
Pharmacodynamics and Clinical Effects
| Six Months | One Year |
| Enalapril Maleate (n=127) | 74 | 64 |
| Placebo (n=126) | 56 | 48 |
INDICATIONS AND USAGE
Hypertension
Heart Failure
Asymptomatic Left Ventricular Dysfunction
CONTRAINDICATIONS
WARNINGS
Anaphylactoid and Possibly Related Reactions
Hypotension
Neutropenia/Agranulocytosis
Hepatic Failure
Fetal/Neonatal Morbidity and Mortality
PRECAUTIONS
General
Information for Patients
Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Nursing Mothers
Pediatric Use
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 |
Clinical Laboratory Test Findings
OVERDOSAGE
DOSAGE AND ADMINISTRATION
Hypertension
| Renal Status | Creatinine-Clearanceml/min | Initial Dosemg/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† |
HOW SUPPLIED
Enalapril Maleate USP - 10 mg are light salmon, round flat-faced beveled edged, compressed tablets with W 925 on one side and plain on the other side. They are available in: Bottles of 30 - NDC # 16590-277-30Storage
Store below 30°C(86°F) and avoid transient temperaturesabove 50°C (122°F).Keep container tightly closed.Protect from moisture.
Dispense in a tight container as per USP,if product is subdivided.
Manufactured by:Wockhardt Limited, Mumbai, India.Distributed by:Wockhardt USA LLC.20 Waterview Blvd. Parsippany, NJ 07054USA.Rev.080610Relabeling and Repackaging by:STAT Rx USA LLCGainesville, GA 30501
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL