ENALAPRIL MALEATE
Bryant Ranch Prepack
Bryant Ranch Prepack
ENALAPRIL MALEATE TABLETS, USP Rx only
FULL PRESCRIBING INFORMATION: CONTENTS*
- ENALAPRIL MALEATE DESCRIPTION
- CLINICAL PHARMACOLOGY
- ENALAPRIL MALEATE INDICATIONS AND USAGE
- ENALAPRIL MALEATE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ENALAPRIL MALEATE ADVERSE REACTIONS
- OVERDOSAGE
- ENALAPRIL MALEATE DOSAGE AND ADMINISTRATION
- Enalapril Maleate 10mg Tablet
FULL PRESCRIBING INFORMATION
ENALAPRIL MALEATE DESCRIPTION
202825444CLINICAL 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 TrialsAsymptomatic Left Ventricular Dysfunction
Heart Failure, Mortality TrialsHead 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 InteractionsNeutropenia/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 Patients2
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***
Enalapril Maleate 10mg Tablet
ENALAPRIL MALEATEENALAPRIL MALEATE TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
