Clarithromycindrug info
clarithromycin 25 MG/ML Oral Suspension
What it is used for
Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following:
Acute Bacterial Exacerbation of Chronic Bronchitis in Adults
Acute Maxillary Sinusitis
Community-Acquired Pneumonia
Pharyngitis/Tonsillitis
Uncomplicated Skin and Skin Structure Infections
Acute Otitis Media in Pediatric Patients
Treatment and Prophylaxis of Disseminated Mycobacterial Infections Limitations of Use: To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
1.1 Acute Bacterial
Exacerbation of Chronic Bronchitis Clarithromycin is indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
1.2 Acute Maxillary
Sinusitis Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
1.3 Community-Acquired
Pneumonia Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to:
Haemophilus influenzae (in adults)
Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae clarithromycin [in adults and pediatric patients]
1.4 Pharyngitis/Tonsillitis
Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy.
1.5 Uncomplicated
Skin and Skin Structure Infections Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes.
1.6 Acute Otitis
Media Clarithromycin is indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
1.7 Treatment and
Prophylaxis of Disseminated Mycobacterial Infections Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection.
1.9 Limitations of
Use There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated. 1.10 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 13, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 ‑ methylerythromycin. The molecular formula is C 38 H 69 NO 13, and the molecular weight is 747.96.
The structural formula is: Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin is available as granules for oral suspension. After constitution, each 5 mL of clarithromycin for oral suspension, USP contains 125 mg or 250 mg of clarithromycin. Each bottle of clarithromycin granules for oral suspension contains 1250 mg (50 mL size), 2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of clarithromycin and the following inactive ingredients: citric acid (anhydrous), colloidal silicon dioxide, confectioner’s sugar, fruit punch flavor, glyceryl monostearate, hypromellose, maltodextrin, methacrylic acid copolymer dispersion, poloxamer, polyethylene glycol, polysorbate 80, potassium sorbate, povidone, titanium dioxide, triethyl citrate, and xanthan gum. structural formula
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 13, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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