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Biaxin

[clarithromycin]

For adult patients, the bioavailability of 10 mL of the 125 mg/5 mL suspension or 10 mL of the 250 mg/5 mL suspension is similar to a 250 mg or 500 mg tablet, respectively. In children requiring antibiotic therapy, administration of 7.5 mg/kg q12h doses of clarithromycin as the suspension generally resulted in steady-state peak plasma concentrations of 3 to 7 µg/mL for clarithromycin and 1 to 2 µg/mL for 14-OH clarithromycin.

In HIV-infected children taking 15 mg/kg every 12 hours, steady-state clarithromycin peak concentrations generally ranged from 6 to 15 µg/mL. Clarithromycin penetrates into the middle ear fluid of children with secretory otitis media.

CONCENTRATION

Text Continues Below



(after 7.5 mg/kg q12h for 5 doses)
Middle Ear Fluid Serum
Analyte (µg/mL) (µg/mL)
Clarithromycin 2.5 1.7
14-OH Clarithromycin 1.3 0.8

In adults given 250 mg clarithromycin as suspension (n=22), food appeared to decrease mean peak plasma clarithromycin concentrations from 1.2 (± 0.4) µg/mL to 1.0 (± 0.4) µg/mL and the extent of absorption from 7.2 (± 2.5) hr µg/mL to 6.5 (± 3.7) hr µg/mL. When children (n=10) were administered a single oral dose of 7.5 mg/kg suspension, food increased mean peak plasma clarithromycin concentrations from 3.6 (± 1.5) µg/mL to 4.6 (± 2.8) µg/mL and the extent of absorption from 10.0 (± 5.5) hr µg/mL to 14.2 (± 9.4) hr µg/mL.

Clarithromycin 500 mg every 8 hours was given in combination with omeprazole 40 mg daily to healthy adult males. The plasma levels of clarithromycin and 14-hydroxy-clarithromycin were increased by the concomitant administration of omeprazole. For clarithromycin, the mean C max was 10% greater, the mean C min was 27% greater, and the mean AUC 0-8 was 15% greater when clarithromycin was administered with omeprazole than when clarithromycin was administered alone. Similar results were seen for 14-hydroxy-clarithromycin, the mean C max was 45% greater, the mean C min was 57% greater, and the mean AUC0-8 was 45% greater.
Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of omeprazole.
Clarithromycin Tissue Concentrations 2 hours after Dose (µg/mL)/(µg/g)
Treatment N antrum fundus N mucus
Clarithromycin 5 10.48 ± 2.01 20.81 ± 7.64 4 4.15 ± 7.74
Clarithromycin +
Omeprazole 5 19.96 ± 4.71 24.25 ± 6.37 4 39.29 ± 32.79

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