Accupril® (quinapril hydrochloride)

USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACCUPRIL should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

Chemical formula: C₂₅H₃₀N₂O₅ •HCl

Systematic (IUPAC) name: [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride.

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.

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.

Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017. Revised April 2009.