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Caution should also be exercised when administering clarithromycin to patients with moderate to severe renal impairment.Cases of fatal hepatic failure (see section 4.8) have been reported. Steady state is attained within 2 days of dosing.Clarithromycin penetrates well into different compartments., with an estimated volume of distribution of 200-400 L Clarithromycin provides concentrations in some tissues that are several times higher than the circulating level of the active substance. • Skin infections 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 Consideration should be given to official guidance on the appropriate use of antibacterial agents.The dosage of Clarithromycin 125 mg/5 ml suspension depends on the clinical condition of the patient and has to be defined in any case by the physician.Standard dosage: The usual dose is 250 mg twice daily.High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections.The maximum recommended dosages should be reduced proportionately to renal impairment.At creatinine clearance rate of less than 30 ml/min, the dosage should be halved to 250 mg daily or in the most severe infections to 250 mg twice daily. In situations where the concomitant use of clarithromycin with statins cannot be avoided, it is recommended to prescribe the lowest registered dose of the statin.Use of a statin that is not dependent on CYP3A metabolism (e.g.fluvastatin) can be considered. Dosage based on body weight Weight Age Dosage (kg) (years) in mls (twice daily) 8-11 12-19 20-29 30-40 1-2 3-6 7-9 10-12 2.5 5 7.5 10 Children who weigh less than 8kg should be given a dose of 0.3 ml/kg twice a day. Food does only slightly delay the onset of absorption of clarithromycin. Clarithromycin is known to inhibit Pgp. Serum level determinations are recommended for these drugs when administered concomitantly with clarithromycin. It allows continued monitoring of the benefit/risk balance of the medicinal product. On the basis of these criteria, about 2% to 3% of those patients who received 1000mg or 2000mg of clarithromycin daily had seriously abnormal elevated levels of SGOT and SGPT, and abnormally low white blood cell and platelet counts. Visual impairment and vision blurred may have an effect on a patient's ability to drive or operate machinery (section 4.8).The most frequent and common adverse reactions related to clarithromycin therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting and taste perversion. Continue typing to refine. Doses of clarithromycin greater than 1000 mg per day should not be co-administered with protease inhibitors.Caution is advised regarding the concomitant administration of clarithromycin and calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem) due to the risk of hypotension. Due to its chemical structure (6-O-Methylerythromycin) clarithromycin is quite resistant to degradation by stomach acid. Reduction of sildenafil, tadalafil and vardenafil dosages should be considered when these drugs are co-administered with clarithromycin.Results of clinical studies indicate that there was a modest but statistically significant (p≤ 0.05) increase of circulating theophylline or carbamazepine levels when either of these drugs were administered concomitantly with clarithromycin. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness when the seriousness could be assessed. warfarin), atypical antipsychotics (e.g. Deaths have been reported in some such patients (see section 4.5). Increased levels have been found in both tonsils and lung tissue. Furthermore, it might be necessary to monitor the plasma levels of the CYP3A inducer, which could be increased owing to the inhibition of CYP3A by clarithromycin (see also the relevant product information for the CYP3A4 inhibitor administered).Concomitant administration of rifabutin and clarithromycin resulted in an increase in rifabutin, and decrease in clarithromycin serum levels together with an increased risk of uveitis.The following drugs are known or suspected to affect circulating concentrations of clarithromycin; clarithromycin dosage adjustment or consideration of alternative treatments may be required.Strong inducers of the cytochrome P450 metabolism system such as efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine may accelerate the metabolism of clarithromycin and thus lower the plasma levels of clarithromycin, while increasing those of 14-OH-clarithromycin, a metabolite that is also microbiologically active. In one study in 14 healthy volunteers, the concomitant administration of clarithromycin and terfenadine resulted in a two to three fold increase in the serum level of the acid metabolite of terfenadine and in prolongation of the QT interval which did not lead to any clinically detectable effect. Careful monitoring of glucose is recommended.Clarithromycin (500 mg every 8 hours) was given in combination with omeprazole (40 mg daily) to healthy adult subjects.

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