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Drug Description

Pediazole
(erythromycin ethylsuccinate and sulfisoxazole acetyl)

DESCRIPTION

Pediazole (erythromycin and sulfisoxazole) is a combination of erythromycin ethylsuccinate, USP, and sulfisoxazole acetyl, USP. When reconstituted with water as directed on the label, the granules form a white, strawberry-banana flavor suspension that provides the equivalent of 200 mg erythromycin activity and the equivalent of 600 mg of sulfisoxazole activity per teaspoonful (5 mL).

Erythromycin is produced by a strain of Saccaropolyspora erythraea and belongs to the macrolide group of antibiotics. It is basic and readily forms salts and esters. Erythromycin ethylsuccinate is the 2'-ethylsuccinyl ester of erythromycin. It is essentially a tasteless form of the antibiotic suitable for oral administration, particularly in suspension dosage forms. The chemical name is erythromycin 2'-(ethyl succinate).

Sulfisoxazole acetyl or N 1 -acetyl sulfisoxazole is an ester of sulfisoxazole. Chemically, sulfisoxazole is N-(3,4-Dimethyl-5-isoxazolyl)-N-sulfanilylacetamide.

Inactive Ingredients:   Citric acid, magnesium aluminum silicate, poloxamer, sodium carboxymethylcellulose, sodium citrate, sucrose and artificial flavoring.

Indications & Dosage

INDICATIONS

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

DOSAGE AND ADMINISTRATION

PEDIAZOLE (erythromycin and sulfisoxazole) 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 (erythromycin and sulfisoxazole) 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 (erythromycin and sulfisoxazole) should be administered in equally divided doses three or four times a day for 10 days.Pediazole (erythromycin and sulfisoxazole) may be administered without regard to meals.

The following approximate dosage schedules are recommended for using Pediazole (erythromycin and sulfisoxazole) :

Children: Two months of age or older

FOUR-TIMES-A-DAY SCHEDULE

Weight Dose--every 6 hours
Less than 8 kg (


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