ACCUPRIL Film-coated tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Parke-Davis Div of Pfizer Inc

Λέξεις κλειδιά

0071-0527 0071-0530 0071-0532 0071-0535 0071-1205 0071-1410 0071-1620 0071-1840

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1. Description

ACCUPRIL 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*)], ...

2. Clinical Pharmacology

Mechanism of Action Quinapril is deesterified to the principal metabolite, quinaprilat, which is an inhibitor of ACE activity in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes ...

3. Indications and Usage

Hypertension ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and ...

4. Contraindications

ACCUPRIL 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. ACCUPRIL is contraindicated ...

5. Warnings

Anaphylactoid and Possibly Related Reactions Presumably because ACE inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors ...

6. Precautions

Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, ...

6.1. General

Impaired renal function As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure ...

6.2. Information for Patients

Pregnancy Tell female patients of childbearing age about the consequences of exposure to ACCUPRIL during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report ...

6.4. Drug Interactions

Concomitant diuretic therapy As with other ACE inhibitors, patients on diuretics, especially those on recently instituted diuretic therapy, may occasionally experience an excessive reduction of blood pressure ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Quinapril hydrochloride was not carcinogenic in mice or rats when given in doses up to 75 or 100 mg/kg/day (50 to 60 times the maximum human daily dose, respectively, on an mg/kg basis and 3.8 to 10 times ...

6.9. Nursing Mothers

Because ACCUPRIL is secreted in human milk, caution should be exercised when this drug is administered to a nursing woman.

6.10. Pediatric Use

Neonates with a history of in utero exposure to ACCUPRIL If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may ...

6.11. Geriatric Use

Clinical studies of ACCUPRIL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...

7. Adverse Reactions

Hypertension ACCUPRIL has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. ACCUPRIL has been ...

9. Overdosage

Doses of 1440 to 4280 mg/kg of quinapril cause significant lethality in mice and rats. No specific information is available on the treatment of overdosage with quinapril. The most likely clinical manifestation ...

10. Dosage and Administration

Hypertension Monotherapy The recommended initial dosage of ACCUPRIL in patients not on diuretics is 10 or 20 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak ...

11. 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. NDC 0071-0527-23 bottles of 90 tablets NDC 0071-1205-23 ...

12. Storage and Handling

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

BOXED WARNING SECTION

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ACCUPRIL as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the ...