Moexipril Hydrochloride

Moexipril hydrochloride tablets are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets do not have a similar risk (see WARNINGS ).

In considering use of moexipril hydrochloride tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema ).

Moexipril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Do not co-administer aliskiren with moexipril hydrochloride tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions ).

Moexipril hydrochloride tablets have 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 moexipril hydrochloride tablets 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 moexipril hydrochloride tablets and in 1.8% of patients treated with placebo. The most common reasons for discontinuation in patients treated with moexipril hydrochloride tablets 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 moexipril hydrochloride tablets alone and that were at least as frequent in the moexipril hydrochloride tablets group as in the placebo group are shown in the following table: ADVERSE EVENTS IN PLACEBO-CONTROLLED STUDIES ADVERSE EVENT MOEXIPRIL HYDROCHLORIDE TABLETS (N=674) PLACEBO (N=226) N (%) N (%) Cough Increased 41 (6.1) 5 (2.2) Dizziness 29 (4.3) 5 (2.2) Diarrhea 21 (3.1) 5 (2.2) Flu Syndrome 21 (3.1) 0 (0) Fatigue 16 (2.4) 4 (1.8) Pharyngitis 12 (1.8) 2 (0.9) Flushing 11 (1.6) 0 (0) Rash 11 (1.6) 2 (0.9) Myalgia 9 (1.3) 0 (0) 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.