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Quinaretic (Quinapril Hydrochloride / Hydrochlorothiazide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

QUINARETIC 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 QUINARETIC, 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 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 hydrochloride and 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 (eg, 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 QUINARETIC, 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 QUINARETIC 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 QUINARETIC 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 QUINARETIC 20/25.

Use in Renal Impairment

Regimens of therapy with QUINARETIC 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, QUINARETIC is not recommended for use in these patients.

HOW SUPPLIED

QUINARETIC (quinapril hydrochloride and hydrochlorothiazide) Tablets 10 mg/12.5 mg: Peach colored, oval film coated tablets debossed “A238” on bisected side of the tablet. Available in bottles of 30’s, 90’s, 100’s and 500’s.

QUINARETIC (quinapril hydrochloride and hydrochlorothiazide) Tablets 20 mg/12.5 mg: Peach colored, triangular film coated tablets debossed “A239” on bisected side of the tablet. Available in bottles of 30’s, 90’s, 100’s and 500’s.

QUINARETIC (quinapril hydrochloride and hydrochlorothiazide) Tablets 20 mg/25 mg: Peach colored, round film coated tablets debossed “A240” on one side of the tablet. Available in bottles of 30’s, 90’s, 100’s and 500’s.

Dispense in tight containers as defined in the USP.

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


Manufactured by: Actavis Totowa LLC
990 Riverview Drive, Totowa, NJ 07512 USA

8263-07
06/06

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