Description

Product Overview

Description

Clarithromycin is a macrolide antibiotic. It fights bacteria in your body.

Clarithromycin is used to treat many different types of bacterial infections affecting the skin and respiratory system. It is also used together with other medicines to treat stomach ulcers caused by Helicobacter pylori.

Before you take cefixime

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

Clarithromycin is indicated in adults and children 12 years and older.

Clarithromycin is indicated for the treatment of thefollowing infections caused by clarithromycin susceptible organisms.

• Bacterial pharyngitis

• Mild to moderate community-acquired pneumonia

• Acute bacterial sinusitis (adequately diagnosed)

• Acute exacerbation of chronic bronchitis

• Skin and soft tissue infections of mild to moderate severity.

• In appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing medicinal product for the eradication of Helicobacter pylori in adult patients with Helicobacter pylori-associated ulcers.

Posology and method of administration

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:

• Standard dosage: The usual dose is 250mg 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 older than 12 years: As for adults.

Children younger than 12 years: Use of Clarithromycin 250mg Tablets are not recommended for children younger than 12 years. Use clarithromycin Paediatric Suspension.

Eradication of Helicobacter pylori in adults:

In patients with gastro-duodenal ulcers due to Helicobacter pylori infection clarithromycin is given in a dosage of 500 mg twice daily. The national recommendations for Helicobacter pylori eradication have to be considered.

Duration of therapy:

The duration of therapy with clarithromycin depends on the type and severity of the infection.

The usual duration of treatment is 7 to 14 days.

Dosage in renal functional impairment:

Dosage adjustments are not usually required except in patients with severe renal impairment (creatinine clearance < 30 ml/min (<0.5 ml/s)). If adjustment of dose is necessary, the total daily dosage should be reduced by half. The duration of treatment should not exceed 14 days in these patients. Patients with hepatic impairment:

Caution should be exercised when administrating clarithromycin in patients with hepatic impairment.

Special warnings and precautions for use

Clarithromycin should be reserved for documented Group A beta-hemolytic streptococcal pharyngitis when treatment with beta-lactams cannot be used.

• Clarithromycin is mainly excreted by the liver. Therefore, clarithromycin should be administered with caution in patients with impaired hepatic function, especially in patients with impaired renal function.
When renal function is poor, dosage of clarithromycin should be suitably reduced depending on the degree of the impairment. In elderly patients, the possibility of renal impairment should be considered.

• Clarithromycin therapy for H. pylori may select for drug-resistant organisms..

• Patients who are hypersensitive to lincomycin or clindamycin may also be hypersensitive to clarithromycin. Therefore, caution is required when prescribing clarithromycin for such patients.

• Prolonged or repeated use 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.

• Attention should be paid to the possibility of cross resistance between clarithromycin and other macrolide drugs, as well as lincomycin and clindamycin.

• Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics. Therefore, it is important to consider its diagnosis in patients who develop severe diarrhoea during or after therapy with clarithromycin.

• As known for other macrolides, clarithromycin may cause exacerbation or aggravation of myasthenia gravis and should therefore be used with caution in patients with myasthenia gravis.

• Due to a risk of prolonged QT-interval, clarithromycin should be used with caution in patients with a coronary vessel disease, a history of ventricular arrhythmia, severe cardiac insufficiency, non-compensated hypokalemia and/or hypomagnesemia, bradycardia (<50 bpm), or when co-administered with other medicinal products with a QT-prolonging effect. Clarithromycin should not be used in patients with congenital or documented acquired QT prolongation. • The use of clarithromycin should be considered with particular caution whenever a patient is receiving treatment with another medicinal product known to be substrate of CYP3A4, especially when patient is treated with a CYP3A4 substrate having narrow therapeutic index (like carbamazepin) and/or is metabolised to a large extent by this enzyme clarithromycin should not be used unless clearly indicated • Clarithromycin inhibits the metabolism of some HMG-CoA reductase inhibitors, which results in increased plasma concentrations of these medicinal products • There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients