UNIVASC has been evaluated for safety in more than 2500 patients with hypertension; more than 250 of these patients were treated for approximately one year. The overall incidence of reported adverse events was only slightly greater in patients treated with UNIVASC than patients treated with placebo.

Reported adverse experiences were usually mild and transient, and there were no differences in adverse reaction rates related to gender, race, age, duration of therapy, or total daily dosage within the range of 3.75 mg to 60 mg. Discontinuation of therapy because of adverse experiences was required in 3.4% of patients treated with UNIVASC and in 1.8% of patients treated with placebo. The most common reasons for discontinuation in patients treated with UNIVASC were cough (0.7%) and dizziness (0.4%).

All adverse experiences considered at least possibly related to treatment that occurred at any dose in placebo-controlled trials of once-daily dosing in more than 1% of patients treated with UNIVASC alone and that were at least as frequent in the UNIVASC group as in the placebo group are shown in the following table:

ADVERSE EVENTS IN PLACEBO-CONTROLLED STUDIES

Other adverse events occurring in more than 1% of patients on moexipril that were at least as frequent on placebo include: headache, upper respiratory infection, pain, rhinitis, dyspepsia, nausea, peripheral edema, sinusitis, chest pain, and urinary frequency. See WARNINGS and PRECAUTIONS for discussion of ana-phylactoid reactions, angioedema, hypotension, neutropenia/agranulocytosis, second and third trimester fetal/neonatal morbidity and mortality, hyperkalemia, and cough.

Other potentially important adverse experiences reported in controlled or uncontrolled clinical trials in less than 1% of moexipril patients or that have been attributed to other ACE inhibitors include the following:

Cardiovascular: Symptomatic hypotension, postural hypotension, or syncope were seen in 9/1750 (0.51%) patients; these reactions led to discontinuation of therapy in controlled trials in 3/1254 (0.24%) patients who had received UNIVASC monotherapy and in 1/344 (0.3%) patients who had received UNIVASC with hydrochlorothiazide (see PRECAUTIONS and WARNINGS). Other adverse events included angina/myocardial infarction, palpitations, rhythm disturbances, and cerebrovascular accident.

Renal: Of hypertensive patients with no apparent preexisting renal disease, 1% of patients receiving UNIVASC alone and 2% of patients receiving UNIVASC with hydrochlorothiazide experienced increases in serum creatinine to at least 140% of their baseline values (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

Gastrointestinal: Abdominal pain, constipation, vomiting, appetite/weight change, dry mouth, pancreatitis, hepatitis.

Respiratory: Bronchospasm, dyspnea, eosinophilic pneumonitis. Urogenital: Renal insufficiency, oliguria.

Dermatologic: Apparent hypersensitivity reactions manifested by urticaria, rash, pemphigus, pruritus, photosensitivity, alopecia.

Neurological and Psychiatric: Drowsiness, sleep disturbances, nervousness, mood changes, anxiety.

Other: Angioedema (see WARNINGS), taste disturbances, tinnitus, sweating, malaise, arthralgia, hemolytic anemia.

Clinical Laboratory Test Findings

Creatinine and Blood Urea Nitrogen: As with other ACE inhibitors, minor increases in blood urea nitrogen or serum creatinine, reversible upon discontinuation of therapy, were observed in approximately 1% of patients with essential hypertension who were treated with UNIVASC. Increases are more likely to occur in patients receiving concomitant diuretics and in patients with compromised renal function (see PRECAUTIONS, General).

Other (causal relationship unknown): Clinically important changes in standard laboratory tests were rarely associated with UNIVASC administration.

Elevations of liver enzymes and uric acid have been reported. In trials, less than 1% of moexipril-treated patients discontinued UNIVASC treatment because of laboratory abnormalities. The incidence of abnormal laboratory values with moex-ipril was similar to that in the placebo-treated group.

Serum Electrolytes: Hyperkalemia (see PRECAUTIONS), hyponatremia.

Diuretics: Excessive reductions in blood pressure may occur in patients on diuretic therapy when ACE inhibitors are started. The possibility of hypotensive effects with UNIVASC can be minimized by discontinuing diuretic therapy for several days or cautiously increasing salt intake before initiation of treatment with UNIVASC. If this is not possible, the starting dose of moexipril should be reduced. (See WARNINGS and DOSAGE AND ADMINISTRATION).

Potassium Supplements and Potassium-Sparing Diuretics: UNIVASC can increase serum potassium because it decreases aldosterone secretion. Use of potassium-sparing diuretics (spironolactone, triamterene, amiloride) or potassium supplements concomitantly with ACE inhibitors can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, they should be given with caution and the patient's serum potassium should be monitored.

Oral Anticoagulants: Interaction studies with warfarin failed to identify any clinically important effect on the serum concentrations of the anticoagulant or on its anticoagulant effect.

Lithium: Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.

Other Agents: No clinically important pharmacokinetic interactions occurred when UNIVASC was administered concomitantly with hydrochlorothiazide, digox-in, or cimetidine. UNIVASC has been used in clinical trials concomitantly with calcium-channel-blocking agents, diuretics, H₂ blockers, digoxin, oral hypoglycemic agents, and cholesterol-lowering agents. There was no evidence of clinically important adverse interactions.

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