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ACCUPRIL (QUINAPRIL HYDROCHLORIDE): PRESCRIBING INFORMATION

DESCRIPTION

Accupril (Quinapril Hydrochloride) is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 x HCl.

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 crospovidone, candelilla wax, gelatin, magnesium carbonate, lactose, magnesium stearate, synthetic red iron oxide, and titanium dioxide.


INDICATIONS AND USAGE

Accupril indications and usage


CONTRAINDICATIONS

Accupril (Quinapril HCl) is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.


DOSAGE AND ADMINISTRATION

Accupril dosage and administration


CLINICAL PHARMACOLOGY

Accupril clinical pharmacology


PHARMACODYNAMICS

Accupril pharmacodynamics


WARNINGS

Accupril warnings


PRECAUTIONS

Accupril precautions


DRUG INTERACTIONS

Accupril drug interactions


SPECIAL POPULATIONS

Accupril special populations


ADVERSE REACTIONS

Accupril adverse reactions


OVERDOSAGE

Accupril overdosage


STORAGE / HOW SUPPLIED

Accupril (Quinapril Hydrochloride) tablets are supplied in bottles and blisters as follows:

5 mg tablets: brown, film-coated, elliptical scored tablets, coded "PD 527" on one side and "5" on the other

10 mg tablets: brown, film-coated, triangular tablets, coded "PD 530" on one side and "10" on the other.

20 mg tablets: brown, film-coated, round tablets, coded "PD 532" on one side and "20" on the other.

40 mg tablets: brown, film-coated, elliptical tablets, coded "PD 535" on one side and "40" on the other.

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

Storage

Store Quinapril (Accupril) tablets at controlled room temperature 15° - 30° (59° - 86°).

Protect from light.

Manufactured and distributed by Pfizer, Parke-Davis pharmaceutical companies and their divisions.

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