Label: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 3, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: FETAL TOXICITY

    When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride as soon as possible [see Warnings and Precautions (5.1)].
    Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)].

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  • 1 INDICATIONS AND USAGE
    1.1 Hypertension - Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Considerations - The recommended initial dose is amlodipine 2.5 mg and benazepril 10 mg orally once-daily. Begin therapy with amlodipine and benazepril hydrochloride capsules only ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Amlodipine and benazepril hydrochloride capsules USP are available as follows: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg.
  • 4 CONTRAINDICATIONS
    • Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, including amlodipine and benazepril hydrochloride capsules in patients ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Fetal Toxicity - Amlodipine Benazepril hydrochloride can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Drug/Drug Interactions - Amlodipine - Simvastatin: Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Amlodipine and benazepril hydrochloride can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the RAS during the second and third ...
  • 10 OVERDOSAGE
    Only a few cases of human overdose with amlodipine have been reported. One patient was asymptomatic after a 250 mg ingestion; another, who combined 70 mg of amlodipine with an unknown large ...
  • 11 DESCRIPTION
    Amlodipine and benazepril hydrochloride capsules USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride USP is a white to off-white, crystalline ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Benazepril - Benazepril and benazeprilat inhibit ACE in human subjects and in animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity and mutagenicity studies have not been conducted with this combination.  However, these studies have been conducted ...
  • 14 CLINICAL STUDIES
    Over 950 patients received amlodipine and benazepril hydrochloride once-daily in 6 double-blind, placebo-controlled studies. The antihypertensive effect of a single dose persisted for 24 hours ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Amlodipine and benazepril hydrochloride is available as capsules containing amlodipine besylate USP (3.5 mg, 6.9 mg or 13.9 mg, equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine respectively) ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy: Advise female patients of childbearing age about the consequences of exposure to amlodipine and ...
  • Patient Information
    Amlodipine and Benazepril Hydrochloride Capsules USP - (am loe' di peen and ben az' e pril hye" droe klor' ide)    Read this Patient Information leaflet before you start taking amlodipine and ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg/20 mg (30 Capsules Bottle)
    NDC 68788-8454-3 - Rx only - Amlodipine and - Benazepril - Hydrochloride - Capsules USP  - 10 mg*/20 mg - AUROBINDO               Repackaged By: Preferred Pharmaceuticals Inc.
  • INGREDIENTS AND APPEARANCE
    Product Information