CLARITHROMYCIN

Posology:

The dosage of Clarithromycin 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 250 mg clarithromycin twice daily (in the morning and in the evening) • High dosage treatment (severe infections): The usual dose may be increased to 500 mg clarithromycin twice daily in severe infections.

Adolescents 12 years and older:

As for adults.

Children younger than 12 years:

Use of Clarithromycin is not recommended for children younger than 12 years. For children younger than 12 years an appropriate dosage form (Paediatric Suspension) is available.

Eradication of Helicobacter pylori in adults:

For combination therapy of H. pylori infection the common recommendations for H. pylori eradication have to be considered. Elderly As for adults. 3. 4). 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. Treatment should not be continued beyond 14 days in these patients.

Duration of therapy:

The duration of therapy with clarithromycin depends on the clinical condition of the patient and on the type and severity of the infection. In each case the duration of therapy should be determined by the physician. • The usual duration of treatment is 6 to 14 days.

• Therapy should be continued at least for 2 days after symptoms have subsided. • In ß-haemolytic streptococcal infections the duration of therapy should be at least 10 days in order to prevent complications such as rheumatic fever and glomerulonephritis.

g. one glass of water). Clarithromycin may be given irrespective of food intake.

a. Summary of the safety profile The most frequent and common adverse reactions related to clarithromycin therapy for both adult and paediatric populations are abdominal pain, diarrhoea, nausea, vomiting and taste perversion. 8). There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without pre-existing mycobacterial infections.

b. Tabulated summary of adverse reactions The following table displays adverse reactions reported in clinical trials and from post- marketing experience with clarithromycin immediate-release tablets, granules for oral suspension, powder for solution for injection, extended-release tablets and modified-release tablets.

The reactions considered at least possibly related to clarithromycin are displayed by system organ class and frequency using the following convention: very common ( ≥ 1/10), common ( ≥ 1/100 to < 1/10), uncommon ( ≥ 1/1,000 to < 1/100) and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness when the seriousness could be assessed. 8 c) 13 Tooth discolouration is usually reversible through professional dental cleaning assistance.

c. Description of selected adverse reactions Injection site phlebitis, injection site pain, vessel puncture site pain, and injection site inflammation are specific to the clarithromycin intravenous formulation. 4). A special attention to diarrhoea should be paid as Clostridium difficile-associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents including clarithromycin, and may range in severity from mild diarrhoea to fatal colitis.

4). 5). Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin, and may range in severity from mild to life threatening. Therefore, it is […]

The selection of clarithromycin to treat an individual patient should take into account the appropriateness of using a macrolide antibacterial agent based on adequate diagnosis to ascertain the bacterial etiology of the infection in the approved indications and the prevalence of resistance to clarithromycin or other macrolides.

In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to clarithromycin and other antibiotics. 1). This should be taken into account when treating infections caused by Streptococcus pneumoniae.

In bacterial pharyngitis the use of clarithromycin is recommended only in cases where first line therapy with beta-lactams is not possible. 6). 2). Clarithromycin is principally excreted by the liver. Therefore, caution should be exercised in administering this antibiotic to patients with impaired hepatic function.

8) have been reported. Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products. Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop, such as anorexia, jaundice, dark urine, pruritus, or tender abdomen.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides, and may range in severity from mild to life-threatening. Clostridium difficile- associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents including clarithromycin, and may range in severity from mild diarrhoea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon, which may lead to overgrowth of C. difficile. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

1. 5): • Ergotamine, dihydroergotamine • Astemizole, cisapride, pimozide and terfenadine. • Colchicine • Ticagrelor, ivabradine or ranolazine • HMG-CoA reductase inhibitors (statins), that are extensively metabolised by CYP3A4 (lovastatin or simvastatin).

e. 5). Clarithromycin should not be given to patients with electrolyte disturbances (hypokalaemia or hypomagnesaemia, due to the risk of prolongation of the QT interval). Clarithromycin must not be used in patients who suffer from severe hepatic failure in combination with renal impairment.