CLARITHROMYCIN

Patients with respiratory tract/skin and soft tissue infections Adults:

The usual dose is 250 mg twice daily for 7 days although this may be increased to 500 mg twice daily for up to 14 days in severe infections.

Children younger than 12 years:

Use of clarithromycin tablets is not recommended for children younger than 12 years. Use clarithromycin Paediatric Suspension.

Children older than 12 years:

As for adults. The usual duration of treatment is 6 to 14 days. Eradication of H. pylori in patients with duodenal ulcers (Adults) Triple Therapy (7 - 14 days) Clarithromycin 500 mg twice daily and lansoprazole 30 mg twice daily should be given with amoxycillin 1000 mg twice daily for 7 - 14 days.

Triple Therapy (7 days) Clarithromycin 500 mg twice daily and lansoprazole 30 mg twice daily should be given with metronidazole 400 mg twice daily for 7 days. Triple Therapy (7 days) Clarithromycin 500 mg twice daily and omeprazole 40 mg daily should be given with amoxycillin 1000 mg twice daily or metronidazole 400 mg twice daily for 7 days.

Triple Therapy (10 days) Clarithromycin 500 mg twice daily should be given with amoxycillin 1000 mg twice daily and omeprazole 20 mg daily for 10 days. Dual Therapy (14 days) The usual dose of clarithromycin is 500 mg three times daily for 14 days.

Clarithromycin should be administered with oral omeprazole 40 mg once daily for 14 days.

Elderly:

As for adults.

Renal impairment:

Dosage adjustments are not usually required except in patients with severe renal impairment (creatinine clearance < 30 ml/min). g. 250 mg once daily or 250 mg twice daily in more severe infections. Clarithromycin Tablets may be given without regard to meals as food does not affect the extent of bioavailability.

Infections and infestations:

Oral monilla, genital candidiasis.

Blood and lymphatic system disorders:

Isolated cases of leukopenia and thrombocytopenia have been reported.

Immune system disorders:

Allergic reactions ranging from urticaria, mild skin eruptions and angioedema to anaphylaxis and rarely Stevens-Johnson syndrome / toxic epidermal necrolysis.

Metabolic disorders:

There have been rare reports of hypoglycaemia, some of which have occurred in patients on concomitant oral hypoglycaemic agents or insulin.

Sense organs disorders (Eye disorders, Ear and labyrinth disorders, taste):

Reports of alteration of the sense of smell, usually in conjunction with taste perversion have also been received. There have been reports of hearing loss with clarithromycin which is usually reversible on withdrawal of therapy. Tinnitus.

There have been very rare reports of uveitis mainly in patients treated with concomitant rifabutin, most of these were reversible.

Psychiatric and nervous system disorders:

There have been reports of transient central nervous system side-effects including headache, dizziness, vertigo, anxiety, insomnia, bad dreams, confusion, disorientation, hallucinations, psychosis and depersonalisation. Convulsions have been reported rarely.

Cardiac disorders:

As with other macrolides, QT prolongation, ventricular tachycardia and Torsade de Pointes have been rarely reported with clarithromycin.

g. Acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome, toxic epidermal necrolysis and drug rash with eosinophilia and systemic symptoms (DRESS)), clarithromycin therapy should be discontinued immediately and appropriate treatment should be urgently initiated.

Clarithromycin is principally excreted by the liver and kidney. Caution should be exercised in administering this antibiotic to patients with impaired hepatic or renal function. Prolonged or repeated used of clarithromycin may result in an overgrowth of non- susceptible bacteria or fungi.

If super-infection occurs, clarithromycin should be discontinued and appropriate therapy instituted. H. pylori organisms may develop resistance to clarithromycin. 5). 8). Therefore as the following situations may lead to an increased risk for ventricular arrhythmias (including torsades de pointes), clarithromycin should be used with caution in the following patients; • Patients with coronary artery disease, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia, • Patients with electrolyte disturbances such as hypomagnesaemia.

3). 5). 3). 3). Epidemiological studies investigating the risk of adverse cardiovascular outcomes with macrolides have shown variable results. Some observational studies have identified a rare short- term risk of arrhythmia, myocardial infarction and cardiovascular mortality associated with macrolides including clarithromycin.

5)

Clarithromycin is contra-indicated in patients with known hypersensitivity to clarithromycin, other macrolide antibiotics or to any of the excipients in the tablet. Clarithromycin and ergot derivatives must not be co-administered. Concomitant administration of clarithromycin and any of the following drugs is contra-indicated: cisapride, pimozide, ticagrelor, ivabradine, ranolazine and terfenadine.

Elevated cisapride, pimozide, ivabradine and terfenadine levels have been reported in patients receiving either of these drugs and clarithromycin concomitantly. This may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade de Pointes.

Similar effects have been observed with concomitant administration of astemizole and other macrolides. 5). Clarithromycin should not be given to patient with electrolyte disturbances (hypokalaemia or hypomagnesaemia, due to the risk of prolongation of the QT interval).