Product Description.:
PD 527
Tablet , film-coated , brown , scored , elliptical oblong
ACCUPRIL? (quinapril hydrochloride) is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinapril.
Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents.
ACCUPRIL tablets contain 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide.
INDICATIONS
Hypertension
ACCUPRIL is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
Heart Failure
ACCUPRIL is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis.
In using ACCUPRIL, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that ACCUPRIL does not have a similar risk (see WARNINGS).
Angioedema in Black patients
Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.
DOSAGE AND ADMINISTRATION
Hypertension
Monotherapy: The recommended initial dosage of ACCUPRIL in patients not on diuretics is 10 or 20 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak (2?6 hours after dosing) and trough (predosing). Generally, dosage adjustments should be made at intervals of at least 2 weeks. Most patients have required dosages of 20, 40, or 80 mg/day, given as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients an increase in dosage or twice daily administration may be warranted. In general, doses of 40?80 mg and divided doses give a somewhat greater effect at the end of the dosing interval.
Concomitant Diuretics: If blood pressure is not adequately controlled with ACCUPRIL monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of ACCUPRIL. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy with ACCUPRIL (see WARNINGS). Then, if blood pressure is not controlled with ACCUPRIL alone, diuretic therapy should be resumed.
If the diuretic cannot be discontinued, an initial dose of 5 mg ACCUPRIL should be used with careful medical supervision for several hours and until blood pressure has stabilized.
The dosage should subsequently be titrated (as described above) to the optimal response (see WARNINGS, PRECAUTIONS: DRUG INTERACTIONS).
