- HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BENAZEPRIL HCl TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HCl TABLETS. BENAZEPRIL HCl ...
- TABLE OF CONTENTS
Table of Contents
- BOXED WARNING (WHAT IS THIS?)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue benazepril HCl as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNINGS AND PRECAUTIONS (5.1)].
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- 1 INDICATIONS AND USAGE
Benazepril HCl tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily ...
- 2 DOSAGE AND ADMINISTRATION
2.1 Recommended - Dosage - ADULTS - The recommended initial dose for patients not receiving a diuretic is 10 mg once a day. The usual maintenance dosage range is 20 mg to 40 mg per day administered ...
- 3 DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg - Each 5 mg tablet is white, biconvex, round, uncoated tablets, debossed with "51" on one side and "A" on the other - Each 10 mg tablet is white, biconvex ...
- 4 CONTRAINDICATIONS
Benazepril HCl tablets are contraindicated in patients: who are hypersensitive to benazepril or to any other ACE inhibitor - with a history of angioedema with or without previous ACE inhibitor ...
- 5 WARNINGS AND PRECAUTIONS
5.1 Fetal - Toxicity - Benazepril can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of ...
- 6 ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical ...
- 7 DRUG INTERACTIONS
7.1 Diuretics - Hypotension - Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after ...
- 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy - Risk Summary - Benazepril HCl can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third ...
- 10 OVERDOSAGE
Single oral doses of 3 g/kg benazepril were associated with significant lethality in mice. Rats, however, tolerated single oral doses of up to 6 g/kg. Reduced activity was seen at 1 g/kg in mice ...
- 11 DESCRIPTION
Benazepril HCl, USP is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril ...
- 12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action - Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. Benazeprilat has much greater ACE inhibitory activity than does ...
- 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No evidence of carcinogenicity was found when benazepril was administered to rats and mice for up to two years at doses of up to 150 ...
- 14 CLINICAL STUDIES
Hypertension - Adult Patients - In single-dose studies, benazepril HCl lowered blood pressure within 1 hour, with peak reductions achieved between 2 and 4 hours after dosing. The antihypertensive ...
- 16 HOW SUPPLIED/STORAGE AND HANDLING
Benazepril HCl tablets, USP, 5 mg, are supplied as white, biconvex, round, uncoated tablets, debossed with "51" on one side and "A" on the other side. They are available as follows: Bottles of ...
- 17 PATIENT COUNSELING INFORMATION
Pregnancy: Tell female patients of childbearing age about the consequences of exposure to benazepril HCl during pregnancy. Discuss treatment options with women planning to become pregnant ...
- PRINCIPAL DISPLAY PANEL
NDC 65162-751-03 - Benazepril HCl Tablets USP, 5 mg - Rx only - 30 Tablets - Amneal Pharmaceuticals LLC - NDC 65162-752-03 - Benazepril HCl Tablets USP, 10 mg - Rx only - 30 ...
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