Clarithromycin 500 mg Film-coated Tablets
4.1 Therapeutic indications
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Clarithromycin film-coated tablets are indicated in adults and children 12 years and older.
Clarithromycin is indicated for treatment of infections caused by susceptible organisms. Indications include:
Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia (see section 4.4 and 5.1 regarding Sensitivity Testing).
Upper respiratory tract infections for example, sinusitis and pharyngitis.
Clarithromycin is appropriate for initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens as listed in the microbiology section.
Clarithromycin is also indicated in skin and soft tissue infections of mild to moderate severity (e.g. folliculitis, cellulitis, erysipelas) (see section 4.4 and 5.1 regarding Sensitivity Testing).
Clarithromycin in the presence of acid suppression effected by omeprazole or lansoprazole is also indicated for the eradication of H. pylori in patients with duodenal ulcers. See Dosage and Administration section.
Clarithromycin is usually active against the following organisms in vitro:
Gram-positive Bacteria: Staphylococcus aureus (methicillin susceptible); Streptococcus pyogenes (Group A beta-haemolytic streptococci); alpha-haemolytic streptococci (viridans group); Streptococcus (Diplococcus) pneumoniae; Streptococcus agalactiae; Listeria monocytogenes.
Gram-negative Bacteria: Haemophilus influenzae; Haemophilus parainfluenzae; Moraxella (Branhamella) catarrhalis; Neisseria gonorrhoeae; Legionella pneumophila; Bordetella pertussis; Helicobacter pylori; Campylobacter jejuni.
• Mycoplasma: Mycoplasma pneumoniae; Ureaplasma urealyticum.
• Other Organisms: Chlamydia trachomatis; Mycobacterium avium; Mycobacterium leprae.
• Anaerobes: Macrolide-susceptible Bacteroides fragilis; Clostridium perfringens; Peptococcus species; Peptostreptococcus species; Propionibacterium acnes.
• Clarithromycin has bactericidal activity against several bacterial strains. The organisms include Haemophilus influenzae; Streptococcus pneumoniae; Streptococcus pyogenes; Streptococcus agalactiae; Moraxella (Branhamella) catarrhalis; Neisseria gonorrhoeae; H. pylori and Campylobacter spp.
• The activity of clarithromycin against H. pylori is greater at neutral pH than at acid pH.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).