Apo-Enalapril

Apo-Enalapril Adverse Reactions

enalapril

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Adverse Reactions
In controlled clinical trials involving 2314 hypertensive patients and 363 patients with congestive heart failure, the more severe adverse reactions were: angioedema (0.2%), hypotension (2.3%) and renal failure (5 cases).
In hypertensive patients, hypotension occurred in 0.9% and syncope in 0.5% with a discontinuation rate of 0.1%.
In congestive heart failure patients, hypotension occurred in 4.4% and syncope in 0.8% with a discontinuation rate of 2.5%.
The most frequent clinical adverse reactions in controlled clinical trials were: Headache (4.8%), dizziness (4.6%) and fatigue (2.8%). Discontinuation of therapy was required in 6.0% of the 2677 patients.
Adverse reactions occurring in patients treated with enalapril in controlled clinical trials are shown as follows: See Table 4.

Click on icon to see table/diagram/image

ABNORMAL LABORATORY FINDINGS: Hyperkalemia: (See Precautions).
Creatinine Blood Urea Nitrogen: Increases in serum creatinine and BUN were reported in about 20% of patients with renovascular hypertension and in about 0.2% of patients with essential hypertension treated with enalapril alone.In patients with congestive heart failure, who were also receiving diuretics and or digitilis increases in BUN and serum creatinine, usually reversible upon discontinuation of enalapril and/or concomitant therapy, were observed in about 9.7% of patients.
Hemoglobin and Hematocrit: Decreases in hemoglobin and hematocrit (mean approximately 0.34 g% and 1.0 vol% respectively) occurred frequently in either hypertensive or congestive heart failure patients treated with enalapril, but were rarely of clinical importance. In clinical trials less than 0.1% of patients discontinued therapy due to anaemia.
Hepatic: Elevations of liver enzymes and/or serum bilirubin have occurred (See Precautions).
ADVERSE REACTIONS REPORTED IN UNCONTROLLED TRIALS AND/OR MARKETING EXPERIENCE: The following occurred in an incidence of 0.5 to 1.0%: insomnia, impotence, renal dysfunction, renal failure and oliguria.
The following occurred at an incidence of <0.5%.
Cardiovascular: Myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (See Warnings).
Cardiac arrest, pulmonary embolism, rhythm disturbances, angina pectoris.
Gastrointestinal: Anorexia, ileus, pancreatitis, dyspepsia, constipation.
Hemopoietic: Neutropenia, Thrombocytopenia, bone marrow depression.
Hepatic: Liver function abnormalities, hepatitis (hepatocellular and/or cholestatic), jaundice.
Nervous System/Psychiatric: Vertigo, depression, confusion, ataxia.
Respiratory: Bronchospasm/asthma, rhinorrhea.
Other: Photosensitivity, alopecia, flushing, tinnitus, hearing impairment, glossitis, blurred vision.
A symptom complex has been reported which may include fever, myalgia and arthralgia; an elevated erythrocyte sedimentation rate may be present. Rash or other dermatologic manifestations may occur. These symptoms have disappeared after discontinuation of therapy.
Laboratory Test Findings: Hyponatremia.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in