For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible strains of Haemophilus influenzae.

PEDIAZOLE SHOULD NOT BE ADMINISTERED TO INFANTS UNDER 2 MONTHS OF AGE BECAUSE OF CONTRAINDICATIONS OF SYSTEMIC SULFONAMIDES IN THIS AGE GROUP.

For Acute Otitis Media in Children:   The dose of Pediazole can be calculated based on the erythromycin component (50 mg/kg/day) or the sulfisoxazole component (150 mg/kg/day to a maximum of 6 g/day). The total daily dose of Pediazole should be administered in equally divided doses three or four times a day for 10 days.Pediazole may be administered without regard to meals.

The following approximate dosage schedules are recommended for using Pediazole:

Children: Two months of age or older

FOUR-TIMES-A-DAY SCHEDULE

THREE-TIMES-A-DAY SCHEDULE

TO PATIENT: Shake before using. Oversize bottle provides shake space. Keep tightly closed. Store in the refrigerator. Use within 14 days. Unused portion should be discarded after 14 days.

Pediazole Suspension is available for teaspoon dosage in 100-mL ( NDC 0074-8030-13), 150-mL ( NDC 0074-8030-43), 200-mL ( NDC 0074-8030-53) and 250-mL ( NDC 0074-8030-73) bottles, in the form of granules to be reconstituted with water. The suspension provides erythromycin ethylsuccinate equivalent to 200 mg erythromycin activity and sulfisoxazole acetyl equivalent to 600 mg sulfisoxazole per teaspoonful (5 mL).

Before mixing, store below 86°F (30°C).

REFERENCES

1. Biovert A, Barbeau G, Belanger PM: Pharmacokinetics of sulfisoxazole in young and elderly subjects. Gerontology 1984;30:125-131.
2. Oie S, Gambertoglio JG, Fleckenstein L: Comparison of the disposition of total and unbound sulfisoxazole after single and multiple dosing. J Pharmacokinet Biopharm 1982;10:157-172.
3. National Committee for Clinical Laboratory Standards: Performance Standards for Antimicrobial Disk Susceptibility Tests, ed. 4. Approved Standard NCCLS Document M2-A4, Vol 10, No. 7. Villanova, Pa: NCCLS, 1990.

July, 1994

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