Información de la droga para CLARITHROMYCIN (KAISER FOUNDATION HOSPITALS): INDICATIONS AND USAGE

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  • Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP are indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed below:

    Adults (Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP)

    Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present).

    Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

    Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae , Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

    Community-Acquired Pneumonia due to Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR).

    Uncomplicated skin and skin structure infections due to Staphylococcus aureus , or Streptococcus pyogenes (Abscesses usually require surgical drainage).

    Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare

    Clarithromycin Tablets, USP in combination with amoxicillin and PREVACID (lansoprazole) orPRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for thetreatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history ofduodenal ulcer) to eradicate H. pylori.

    Clarithromycin Tablets, USP in combination with PRILOSEC (omeprazole) capsules or TRITEC(ranitidine bismuth citrate) tablets are also indicated for the treatment of patients with an activeduodenal ulcer associated with H. pylori infection. However, regimens which contain clarithromycin asthe single antimicrobial agent are more likely to be associated with the development of clarithromycinresistance among patients who fail therapy. Clarithromycin-containing regimens should not be used inpatients with known or suspected clarithromycin resistant isolates because the efficacy of treatment isreduced in this setting.

    In patients who fail therapy, susceptibility testing should be done if possible. If resistance toclarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (Forinformation on development of resistance see Microbiology section.) The eradication of H. pylori hasbeen demonstrated to reduce the risk of duodenal ulcer recurrence.

    Children (Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP)

    Pharyngitis/Tonsillitis due to Streptococcus pyogenes

    Community-Acquired Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, orChlamydia pneumoniae (TWAR)

    Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcuspneumoniae

    Acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis,or Streptococcuspneumoniae

    NOTE: For information on otitis media, see CLINICAL STUDIES - Otitis Media.

    Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcuspyogenes (Abscesses usually require surgical drainage.)

    Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare

    Adults (BIAXIN XL Filmtab Tablets)

    BIAXIN XL Filmtab (clarithromycin extended-release tablets) are indicated for the treatment of adults with mild to moderate infection caused by susceptible strains of the designated microorganisms in the conditions listed below:

    Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

    Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

    Community-Acquired Pneumonia due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydia pneumoniae (TWAR), or Mycoplasma pneumoniae

    THE EFFICACY AND SAFETY OF BIAXIN XL IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF BIAXIN ARE APPROVED HAVE NOT BEEN ESTABLISHED.

    Prophylaxis

    Clarithromycin Tablets, USP and Clarithromycin for Oral Suspension, USP are indicated for theprevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advancedHIV infection.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycinand other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that areproven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibilityinformation are available, they should be considered in selecting or modifying antibacterial therapy. Inthe absence of such data, local epidemiology and susceptibility patterns may contribute to the empiricselection of therapy.

  • Drug Information Provided by National Library of Medicine (NLM).
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