CLARITHROMYCIN Film-coated tablets Ref.[6721] Active ingredients: Clarithromycin

Posology

The dosage of Clarithromycin film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician.

Adults and adolescents (12 years and older)

Standard dosage: The usual dose is 250 mg twice daily (in the morning and in the evening)

High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections.

Children younger than 12 years

Use of Clarithromycin film-coated tablets is not recommended for children younger than 12 years with a body weight less than 30 kg. Clinical trials have been conducted using clarithromycin pediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric suspension.

For children with a body weight of more than 30kg, the dose for adults apply.

Dosage in renal functional impairment

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.

Patients with hepatic impairment

Caution should be exercised when administrating clarithromycin in patients with hepatic impairment (see section 4.3 and 4.4).

H. pylori eradication in peptic ulcer disease

For the eradication of H. pylori the selection of antibiotics should consider the individual patient’s drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.

Usually clarithromycin is administered in combination with another antibiotic and a proton-pump inhibitor for one week.

The therapy may be repeated if the patient is still H. pylori-positive

Duration of therapy

The duration of therapy with Clarithromycin film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician.

• The usual duration of treatment is 7 to 14 days.
• Therapy should be continued at least for 2 days after symptoms have subsided.
• In Streptococcus pyogenes (group A beta-haemolytic streptococcus) infections the duration of therapy should be at least 10 days.
• Combination therapy for the eradication of H. pylori infection should be continued for 7 days.

Method of administration

The tablet should be swallowed whole with a sufficient amount of fluid (eg. one glass of water).

Clarithromycin film-coated tablets may be given irrespective of food intake.

Symptoms of intoxication

Reports indicate that the ingestion of large amounts of clarithromycin can be expected to produce gastrointestinal symptoms. One patient who had a history of bipolar disorder ingested eight grams of clarithromycin and showed altered mental status, paranoid behaviour, hypokalaemia and hypoxemia.

Therapy of intoxication

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 hemodialysis or peritoneal dialysis.

In the case of overdosage, clarithromycin IV (powder for solution for injection) should be discontinued and all other appropriate supportive measures should be instituted.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

Clarithromycin 250 mg tablets are available in clear PVC /PVdC/Aluminium blister packs of: 7, 12, 14 and 21 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.