Accupril

[Quinapril]

DOSE ADJUSTMENTS IN PATIENTS WITH HEART FAILURE AND RENAL IMPAIRMENT OR HYPONATREMIA

Pharmacokinetic data indicate that quinapril elimination is dependent on level of renal function. In patients with heart failure and renal impairment, the recommended initial dose of ACCUPRIL is 5 mg in patients with a creatinine clearance above 30 mL/min and 2.5 mg in patients with a creatinine clearance of 10 to 30 mL/min. There is insufficient data for dosage recommendation in patients with a creatinine clearance less than 10 mL/min. (See DOSAGE AND ADMINISTRATION, Heart Failure, WARNINGS, and PRECAUTIONS, Drug Interactions).

If the initial dose is well tolerated, ACCUPRIL may be administered the following day as a twice daily regimen. In the absence of excessive hypotension or significant deterioration of renal function, the dose may be increased at weekly intervals based on clinical and hemodynamic response.

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HOW SUPPLIED

ACCUPRIL tablets are supplied as follows:

5-mg tablets: brown, film-coated, elliptical scored tablets, coded “PD 527’’ on one side and “5’’ on the other.
N0071-0527-23 bottles of 90 tablets
N0071-0527-40 10 x 10 unit dose blisters

10-mg tablets: brown, film-coated, triangular tablets, coded “PD 530’’ on one side and “10’’ on the other.
N0071-0530-23 bottles of 90 tablets
N0071-0530-40 10 x 10 unit dose blisters

20-mg tablets: brown, film-coated, round tablets, coded “PD 532’’ on one side and “20’’ on the other.
N0071-0532-23 bottles of 90 tablets
N0071-0532-40 10 x 10 unit dose blisters

40-mg tablets: brown, film-coated, elliptical tablets, coded “PD 535’’ on one side and “40’’ on the other.
N0071-0535-23 bottles of 90 tablets

Dispense in well-closed containers as defined in the USP.

Storage: Store at controlled room temperature 15º-30ºC (59º-86ºF). Protect from light.

Rx only

©1998-2001, PDPL
Revised March 2001.
Manufactured by:
Parke Davis Pharmaceuticals, Ltd.
Vega Baja, PR 00694

Distributed by:
PARKE-DAVIS
Div of Warner-Lambert Co
Morris Plains, NJ 07950 USA

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