Klacid 250mg/5ml Granules for Oral Suspension

After reconstitution as directed, each 5ml of suspension contains 250mg clarithromycin.

Excipients: also contains 2.42g of sucrose per 5ml.

For a full list of excipients, see section 6.1.

Granules for oral suspension

White to off-white, free-flowing granules with an odour of fruit.

Klacid 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 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 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 Suspension 250mg/5ml in children is given in the following table and is based on a 7.5mg/kg b.i.d. dosage regimen. Doses up to 500mg b.i.d. have been used in the treatment of severe infections.

KLACID SUSPENSION 250MG/5ML

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: For instructions on the preparation of the suspension, see section 6.6.

Clarithromycin is contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs or any of its excipients.

Concomitant administration of clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide or terfenadine as this may result in QT prolongation and cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and torsades de pointe (see section 4.5).. Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated, as this may result in ergot toxicity.

Clarithromycin should not be given to patients with history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointe (see sections 4.4 and 4.5).

Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins), lovastatin or simvastatin, due to the risk of rhabdomyolysis. Treatment with these agents should be discontinued during clarithromycin treatment (see section 4.4).

Clarithromycin should not be given to patients with hypokalaemia (risk of prolongation of QT-time).

Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment.

The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benfits against risk, particularly during the first three months of pregnancy (see section 4.6). If clarithromycin is considered for patients of post-pubertal age, the physician should carefully weigh the benefits against the risk when pregnancy is either suspected or confirmed.

Caution is advised in patients with severe renal insufficiency (see section 4.2).

Clarithromycin is principal