Label: CARVEDILOL PHOSPHATE capsule, extended release

  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated April 9, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CARVEDILOL PHOSPHATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for CARVEDILOL PHOSPHATE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Heart Failure - Carvedilol phosphate extended-release capsules are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in ...
  • 2 DOSAGE AND ADMINISTRATION
    Carvedilol phosphate extended-release capsules are intended for once-daily administration. Patients controlled with immediate-release carvedilol tablets alone or in combination with other ...
  • 3 DOSAGE FORMS AND STRENGTHS
    The hard gelatin capsules are filled with carvedilol phosphate controlled-release minitablets that are coated with methacrylic acid copolymers and are available in the following strengths: 10 mg ...
  • 4 CONTRAINDICATIONS(What is this?)
    Carvedilol phosphate extended-release capsules are contraindicated in the following conditions: Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been ...
  • 5 WARNINGS AND PRECAUTIONS
    In clinical trials of carvedilol phosphate extended-release capsules in subjects with hypertension (338 subjects) and in subjects with left ventricular dysfunction following a myocardial ...
  • 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 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 phosphate extended-release capsules in pregnant women are insufficient to determine whether there are drug-associated ...
  • 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 phosphate is a nonselective beta-adrenergic blocking agent with alpha - 1-blocking activity. It is (2 - RS)-1-(9 - H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Carvedilol is a racemic mixture in which nonselective beta-adrenoreceptor blocking activity is present in the S(–) enantiomer and alpha - 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/kg/day (12 times the MRHD as mg/m - 2) or in mice given up ...
  • 14 CLINICAL STUDIES
    Support for the use of carvedilol phosphate extended-release capsules for the treatment of mild-to-severe heart failure and for patients with left ventricular dysfunction following myocardial ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Carvedilol phosphate extended-release capsules 10 mg are white opaque/white opaque capsules, imprinted MUTUAL 899. Available in: Bottles of 30 NDC 57664-663-83 - Carvedilol phosphate ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking carvedilol phosphate extended-release capsules should be advised of the following: Patients ...
  • PATIENT PACKAGE INSERT
    PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT - PATIENT INFORMATION - CARVEDILOL PHOSPHATE - (car-VED-ah-lol FOS-fate) EXTENDED-RELEASE CAPSULES - Read the Patient Information that ...
  • PRINCIPAL DISPLAY PANEL(What is this?)
    label
  • INGREDIENTS AND APPEARANCE
    Product Information