Generic name: moexipril hydrochloride and hydrochlorothiazide
Dosage form: tablet, film coated
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Moexipril and hydrochlorothiazide are effective treatments for hypertension. The recommended dosage range of moexipril is 7.5 to 30 mg daily, administered in a single or two divided doses one hour before meals, while hydrochlorothiazide is effective in a dosage of 12.5 to 50 mg daily.
The side effects (see WARNINGS) of moexipril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of moexipril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but regimens in which moexipril is combined with low doses of hydrochlorothiazide produce minimal effects on serum potassium. In uniretic® controlled clinical trials, the average change in serum potassium was near zero in subjects who received 3.75 mg / 6.25 mg or 7.5 mg / 12.5 mg, but subjects who received 15 mg / 12.5 mg or 15 mg / 25 mg experienced a mild decrease in serum potassium, similar to that experienced by subjects who received the same dose of hydrochlorothiazide monotherapy. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
Dose Titration Guided by Clinical Effect
A patient whose blood pressure is not adequately controlled with either moexipril or hydrochlorothiazide monotherapy may be given uniretic® 7.5 mg / 12.5 mg, uniretic® 15 mg / 12.5 mg or uniretic® 15 mg / 25 mg one hour before a meal. Further increases of moexipril, hydrochlorothiazide or both depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2-3 weeks have elapsed.
Total daily doses above 30 mg / 50 mg a day have not been studied in hypertensive patients. Patients whose blood pressures are adequately controlled with 25 mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve blood pressure control without electrolyte disturbance if they are switched to moexipril 3.75 mg/hydrochlorothiazide 6.25 mg (one-half of the uniretic® 7.5 mg / 12.5 tablet). For patients who experience an excessive reduction in blood pressure with uniretic® 7.5 mg / 12.5 mg, the physician may consider prescribing moexipril 3.75 mg/hydrochlorothiazide 6.25 mg.
The combination may be substituted for the titrated individual active ingredients.
Use in Renal Impairment
The usual dosage regimen of uniretic® does not need to be adjusted as long as the patient's creatinine clearance is > 40 mL/min/1.73 m2 (serum creatinine approximately ≤ 3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so uniretic® is not recommended (see PRECAUTIONS, General).