Label: CLARITHROMYCIN tablet, film coated

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

Drug Label Information

Updated September 1, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Acute Bacterial Exacerbation of Chronic Bronchitis - Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Clarithromycin tablets may be given with or without food. 2.2 Adult Dosage - The recommended dosages of clarithromycin tablets for the treatment of ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Clarithromycin tablets USP are available as: • 250 mg: light yellow colored, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘62’ on the other side. • 500 mg ...
  • 4 CONTRAINDICATIONS
    4.1 Hypersensitivity - Clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Severe Acute Hypersensitivity Reactions - In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in the labeling: • Acute Hypersensitivity Reactions [see Warnings and Precautions (5.1)] • QT Prolongation [see ...
  • 7 DRUG INTERACTIONS
    Co-administration of clarithromycin is known to inhibit CYP3A, and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on findings from animal studies, clarithromycin is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy ...
  • 10 OVERDOSAGE
    Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea. Treat adverse reactions accompanying overdosage by the prompt elimination ...
  • 11 DESCRIPTION
    Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. The ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Clarithromycin is a macrolide antimicrobial drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics - Absorption  - The absolute bioavailability of 250 mg clarithromycin ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Mutagenesis - The following in vitro mutagenicity tests have been conducted with clarithromycin: • Salmonella/Mammalian ...
  • 14 CLINICAL STUDIES
    14.1 Mycobacterial Infections - Prophylaxis of Mycobacterial Infections - A randomized, double-blind clinical trial (trial 3) compared clarithromycin 500 mg twice a day to placebo in patients ...
  • 15 REFERENCES
    1.  Winkel P, Hilden J, Hansen JF, Kastrup J, Kolmos HJ, Kjøller E, et al. Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular mortality and cerebrovascular ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Clarithromycin Tablets USP, 500 mg are light yellow colored, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘63’ on the other side. Bottles of ...
  • 17 PATIENT COUNSELING INFORMATION
    Provide the following instructions or information about clarithromycin to patients: Important Administration Instructions - Advise patients that clarithromycin tablets can be taken with or ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (28 Tablets Bottle)
    NDC 82804-141-28 - Rx only - Clarithromycin - Tablets, USP - 500 mg - 28 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information