Klacid Adverse Reactions

Summary of the safety profile: The most frequent and common adverse reactions related to clarithromycin therapy for both adult and adolescents/paediatric populations are abdominal pain, diarrhoea, nausea, vomiting and taste perversion. These adverse reactions are usually mild in intensity and are consistent with the known safety profile of macrolide antibiotics (see Tabulated summary of adverse reactions as follows).
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.
Tabulated summary of adverse reactions: Film-coated tablet and Granules for oral suspension: 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. (See Table 6.)

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Modified-release tablet: The following table takes into account all adverse reactions reported in clinical studies and from post-marketing experience with clarithromycin forms and strengths.
When evaluating undesirable effects that are at least possibly associated with clarithromycin, the following frequencies are taken as a basis: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data). Within each frequency grouping, the adverse reactions are, if possible, presented in decreasing order of significance.
Undesirable events associated with clarithromycin: See Table 7.

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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/pharmaceutical form.
In some of the reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine or allopurinol (see Contraindications and Precautions).
There have been post-marketing reports of drug interactions and central nervous system (CNS) effects (e.g. somnolence and confusion) with the concomitant use of clarithromycin and triazolam. Monitoring the patient for increased CNS pharmacological effects is suggested/recommended (see Interactions).
There have been rare reports of clarithromycin ER tablets in the stool, many of which have occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times. In several reports, tablet residues have occurred in the context of diarrhoea. It is recommended that patients who experience tablet residue in the stool and no improvement in their condition should be switched to a different clarithromycin formulation (e.g. suspension) or another antibiotic.
Special population: Adverse Reactions in Immunocompromised Patients (see Other special populations as follows).
Modified-release tablet: Residues of Klacid MR tablets in stools: Residues of Klacid MR tablets have very occasionally been reported in patients with anatomical (including ileostomy or colostomy) or functional disorders of the gastrointestinal tract with a shorter GI transit time. There have been some reports of tablet residues in conjunction with diarrhoea. Patients presenting with tablet residues in stools and whose condition does not appear to have improved should be switched to another clarithromycin formulation (e.g. suspension) or another antibiotic.
Paediatric populations (Children and adolescents): Clinical trials have been conducted using clarithromycin paediatric suspension (Klacid Granules for Oral Susp 125 mg/5 ml) in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric suspension (Klacid Granules for Oral Susp 125 mg/5 ml).
Frequency, type and degree of severity of adverse reactions in children are expected to be the same as in adults.
Other special populations: Immunocompromised patients: In AIDS and other immunocompromised patients treated with the higher doses of clarithromycin over long periods of time for mycobacterial infections, it was often difficult to distinguish adverse events possibly associated with clarithromycin administration from underlying signs of Human Immunodeficiency Virus (HIV) disease or intercurrent illness.
In adult patients, the most frequently reported adverse reactions by patients treated with total daily doses of 1000 mg and 2000 mg of clarithromycin were: nausea, vomiting, taste perversion, abdominal pain, diarrhoea, rash, flatulence, headache, constipation, hearing disturbance, Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvate Transaminase (SGPT) elevations. Additional low-frequency events included dyspnoea, insomnia and dry mouth. The incidences were comparable for patients treated with 1000 mg and 2000 mg, but were generally about 3 to 4 times as frequent for those patients who received total daily doses of 4000 mg of clarithromycin.
In these immunocompromised patients, evaluations of laboratory values were made by analysing those values outside the seriously abnormal level (i.e. the extreme high or low limit) for the specified test. On the basis of these criteria, about 2% to 3% of those patients who received 1000 mg or 2000 mg of clarithromycin daily had seriously abnormal elevated levels of SGOT and SGPT, and abnormally low white blood cell and platelet counts. A lower percentage of patients in these two dosage groups also had elevated Blood Urea Nitrogen levels. Slightly higher incidences of abnormal values were noted for patients who received 4000 mg daily for all parameters except White Blood Cell.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Drug Office, Department of Health via link http://www.drugoffice.gov.hk/eps/do/en/healthcare_providers/adr_reporting/adr_report_form.html4.9