Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Cleron 250 mg 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.
Adults: The usual dose is 250 mg twice daily although this may be increased to 500 mg twice daily in severe infections. The usual duration of treatment is 6 to 14 days.
Children older than 12 years: As for adults.
Children younger than 12 years:
Use of clarithromycin tablets is not recommended for children younger than 12 years. Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric suspension (granules for oral suspension).
Clarithromycin may be given without regard to meals as food does not affect the extent of bioavailability.
The usual duration of treatment is 6 to 14 days.
Clarithromycin (500 mg) twice daily and lansoprazole 30 mg twice daily should be given with amoxicillin 1000 mg twice daily.
Clarithromycin (500 mg) twice daily and lansoprazole 30 mg twice daily should be given with metronidazole 400 mg twice daily.
Clarithromycin (500 mg) twice daily and omeprazole 40 mg daily should be given with amoxicillin 1000 mg twice daily or metronidazole 400 mg twice daily.
Clarithromycin (500 mg) twice daily and omeprazole 20 mg daily should be given with amoxicillin 1000 mg twice daily.
As for adults.
In patients with renal impairment with creatinine clearance less than 30 mL/min, the dosage of clarithromycin should be reduced by one-half, i.e. 250 mg once daily, or 250 mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients.
Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastro-intestinal symptoms. One patient who had a history of bipolar disorder ingested 8 grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalaemia and hypoxaemia.
Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
36 months.
Store below 25ºC.
Protect from light and humidity.
PVC/Al blister strips: 7 tablets and 14 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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