| 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 SUPLLIED
Enalapril Maleate is supplied by State of Florida DOH Central Pharmacy as follows:
This Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States
| 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 |
Label Image for 2.5mg
Label Image for 5mg
Label Image for 10mg
Label Image for 20mg