Klacid Paediatric Suspension 125mg/5ml, Granules for Oral Suspension

When reconstituted as directed in section 4.2, each 5ml or sachet contains 125mg clarithromycin.

Excipients: Also contains 2.7g sucrose.

For a full list of excipients, see section 6.1.

Granules for oral suspension.

White to off-white granules for oral suspension

Klacid Paediatric Suspension is indicated for the treatment of infections caused by susceptible organisms. Indications include

• Lower respiratory tract infections

• Upper respiratory tract infections

• Skin and skin structure infections

• Acute otitis media

Klacid Paediatric Suspension 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; Chlamydia pneumoniae.

Anaerobes: Macrolide-susceptible Bacteroides fragilis; Clostridium perfringens; Peptococcus species; Peptostreptococcus species; Propionibacterium acnes.

Klacid Paediatric Suspension has bactericidal activity against several bacterial strains. These organisms include Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, Helicobacter pylori and Campylobacter species.

The activity of clarithromycin against Helicobacter pylori is greater at neutral pH than at acid pH.

Clarithromycin suspension is indicated in children, 6 months to 12 years.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Children under 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).

Recommended doses and dosage schedules:

The usual duration of treatment is for 5 to 10 days depending on the pathogen involved and the severity of the condition. The recommended daily dosage of Klacid Paediatric Suspension in children is given in the following table and is based on a 7.5mg/kg b.i.d. dosing regime. Doses up to 500mg b.i.d. have been used in the treatment of severe infections.

KLACID PAEDIATRIC SUSPENSION DOSAGE IN CHILDREN

*Children < 8 kg should be dosed on a per kg basis (approx. 7.5 mg/kg bid)

In patients with renal impairment with creatinine clearance less than 30 ml/min, the dosage of clarithromycin should be reduced by one-half. Treatments should not be continued beyond 14 days in these patients.

Preparation for use: 140ml bottle: 74ml of water should be added to the granules in the bottle and shaken to yield 140ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125mg per 5ml.

100 ml bottle: 53ml of water should be added to the granules in the bottle and shaken to yield 100ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125mg per 5ml.

70 ml bottle: 37ml of water should be added to the granules in the bottle and shaken to yield 70ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125mg per 5ml.

50 ml bottle: 27ml of water should be added to the granules in the bottle and shaken to yield 50ml of reconstituted suspension. The concentration of clarithromycin in the reconstituted suspension is 125mg per 5ml.

Sachet: After cutting along the dotted line, empty contents of sachet into a glass, half fill the sachet with cold water. Add to glass and stir thoroughly before taking.