|
Side Effects & Drug Interactions
ADVERSE REACTIONS
In controlled clinical trials involving 3269 patients (2633 patients with hypertension and 636 patients with congestive heart failure), the most frequent clinical adverse reactions were: dizziness (4.4%), headache (5.6%), asthenia/ fatigue (2.7%), diarrhea (1.8%) and cough (3.0%), all of which were more frequent than in placebo-treated patients. Discontinuation of therapy was required in 5.9% of patients. For adverse reactions which occurred in hypertensive patients and patients with congestive heart failure treated with PRINIVIL ® (lisinopril tablets, Merck Frosst Std.) in controlled clinical trials, comparative incidence data are listed in the table below. Text Continues Below
Angioedema Angioedema has been reported in patients receiving PRINIVIL ® (0.1%). Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/ or larynx occurs, treatment with PRINIVIL ® should be discontinued and appropriate therapy instituted immediately (see WARNINGS, Angioedema). Hypotension In hypertensive patients, hypotension occurred in 0.8% and syncope occurred in 0.2% of patients. Hypotension or syncope was a cause for discontinuation of therapy in 0.3% of hypertensive patients (see WARNINGS). In patients with congestive heart failure, hypotension occurred in 5.2% and syncope occurred in 1.7% of patients. Hypotension and dizziness were causes for discontinuation of therapy in 1.7% of these patients. Treatment Following Acute Myocardial Infarction In a controlled, open trial, involving 19,394 acute myocardial infarction patients (GISSI-3, see INDICATIONS AND CLINICAL USE, Treatment Following Acute Myocardial Infarction), comparing lisinopril alone, transdermal glycerol trinitrate, lisinopril and transdermal glycerol trinitrate, or control (no treatment), the most frequent in-hospital adverse events at 6 weeks were as follows: Page: 1 | 2 | 3 | 4 | Next >>
|
.gif)
