Label: CARVEDILOL tablet, film coated

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

Drug Label Information

Updated June 4, 2019

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Heart Failure - Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE ...
  • 2 DOSAGE AND ADMINISTRATION
    Carvedilol should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects. 2.1 Heart Failure - DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED ...
  • 3 DOSAGE FORMS AND STRENGTHS
    The white to off-white, round, film-coated tablets are available in the following strengths: 3.125 mg– debossed with Z and 1, 6.25 mg–debossed with ZC40, 12.5 mg–debossed with ZC41 and 25 ...
  • 4 CONTRAINDICATIONS
    Carvedilol tablets are contraindicated in the following conditions: Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cessation of Therapy - Patients with coronary artery disease, who are being treated with carvedilol tablets, should be advised against abrupt discontinuation of therapy. Severe exacerbation ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Studies 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 CYP2D6 Inhibitors and Poor Metabolizers - Interactions of carvedilol with potent inhibitors of CYP2D6 isoenzyme (such as quinidine, fluoxetine, paroxetine, and propafenone) have not been ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data regarding use of carvedilol in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental ...
  • 10 OVERDOSAGE
    Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, and cardiac arrest. Respiratory problems, bronchospasms, vomiting, lapses of consciousness, and ...
  • 11 DESCRIPTION
    Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Carvedilol is a racemic mixture in which nonselective β-adrenoreceptor blocking activity is present in the S(-) enantiomer and α 1-adrenergic blocking ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In 2-year studies conducted in rats given carvedilol at doses up to 75 mg per kg per day (12 times the MRHD as mg per m ...
  • 14 CLINICAL STUDIES
    14.1 Heart Failure - A total of 6,975 subjects with mild to severe heart failure were evaluated in placebo-controlled trials of carvedilol. Mild-to-Moderate Heart Failure - Carvedilol was ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Carvedilol Tablets USP, 12.5 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC41' on one side and plain on other side and are supplied as ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking carvedilol tablets should be advised of the following: Patients should take carvedilol ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Cadila Healthcare Ltd. India - Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 - Rev.: 09/17
  • PATIENT PACKAGE INSERT
    PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT - ------------------------------------------------------------------------------------------------------------ PATIENT ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Cadila Healthcare Ltd. India - Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 - Rev.: 09/17
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    carv
  • INGREDIENTS AND APPEARANCE
    Product Information