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Accuretic

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Accuretic

Indications
Dosage
How Supplied

INDICATIONS

ACCURETIC is indicated for the treatment of hypertension. This fixed combination is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).

In using ACCURETIC, consideration should be given to the fact that another angiotensinconverting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis).

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

As individual monotherapy, quinapril is an effective treatment of hypertension in once-daily doses of 10 to 80 mg and hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of quinapril/hydrochlorothiazide combination therapy using quinapril doses of 2.5 to 40 mg and hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing dose of either component.

The side effects (see WARNINGS) of quinapril 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 quinapril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but regimens that combine low doses of hydrochlorothiazide with quinapril produce minimal effects on serum potassium. In clinical trials of ACCURETIC, the average change in serum potassium was near zero in subjects who received HCTZ 6.25 mg in the combination, and the average subject who received 10 to 40/12.5 to 25 mg experienced a milder reduction in serum potassium than that experienced by the average subject receiving 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.

Therapy Guided By Clinical Effect

Patients whose blood pressures are not adequately controlled with quinapril monotherapy may instead be given ACCURETIC 10/12.5 or 20/12.5. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve blood pressure control with less electrolyte disturbance if they are switched to ACCURETIC 10/12.5 or 20/12.5.

Replacement Therapy

For convenience, patients who are adequately treated with 20 mg of quinapril and 25 mg of hydrochlorothiazide and experience no significant electrolyte disturbances may instead wish to receive ACCURETIC 20/25.

Use In Renal Impairment

Regimens of therapy with ACCURETIC need not take account of renal function as long as the patient's creatinine clearance is > 30 mL/min/1.73 m² (serum creatinine roughly ≤ 3 mg/dL or 265 μmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides. Therefore, ACCURETIC is not recommended for use in these patients.

HOW SUPPLIED

ACCURETIC is available in tablets of three different strengths:

10/12.5 tablets: pink, scored elliptical, biconvex, film-coated tablets coded “PD 222” on one side. Each tablet contains 10 mg of quinapril and 12.5 mg of hydrochlorothiazide.

NDC 0071-0222-23: 90 tablet bottles

20/12.5 tablets: pink, scored triangular, film-coated tablets coded “PD 220” on one side. Each tablet contains 20 mg of quinapril and 12.5 mg of hydrochlorothiazide.

NDC 0071-0220-23: 90 tablet bottles

20/25 tablets: pink, round, biconvex, film-coated tablets coded “PD 223” on one side. Each tablet contains 20 mg of quinapril and 25 mg of hydrochlorothiazide.

NDC 0071-0223-23: 90 tablet bottles

Dispense in tight containers as defined in the USP.

Store at Controlled Room Temperature 20–25°C (68–77°F) [see USP].

Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017. Revised January 2014

Last reviewed on RxList: 1/31/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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