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
Adverse experiences occurring in greater than one percent of patients with hypertension treated with enalapril maleate in controlled clinical trials are shown below. In patients treated with enalapril maleate, the maximum duration of therapy was three years; in placebo treated patients the maximum duration of therapy was 12 weeks.
| 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
| NDC 64679-923-01NDC 64679-923-02NDC 64679-923-03NDC 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 bottle100's bottle1000's bottleUnit Dose Carton of 100 |
| NDC 64679-924-01 NDC 64679-924-02 NDC 64679-924-03NDC 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 bottleUnit Dose Carton of 100 |
| NDC 64679-925-01 NDC 64679-925-02 NDC 64679-925-03NDC 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 bottleUnit Dose Carton of 100 |
| NDC 64679-926-01 NDC 64679-926-02 NDC 64679-926-03NDC 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 bottleUnit Dose Carton of 100 |