A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Pediazole Indications, Dosage, Storage, Stability - Erythromycin and Sulfisoxazole
Pediazole Indications, Dosage, Storage, Stability - Erythromycin and Sulfisoxazole
INDICATIONS
AND USES
For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible
strains of Haemophilus influenzae.
DOSAGE AND ADMINISTRATION
PEDIAZOLE SHOULD NOT BE ADMINISTERED TO INFANTS UNDER 2 MONTHS OF AGE BECAUSE
OF CONTRA
INDICATIONS
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
|
Weight
|
Dose--every 6 hours
|
|
Less than 8 kg
(<18 lbs)
|
Adjust dosage
by body weight
|
|
8 kg (18
lbs)
|
1 / 2 teaspoonful (2.5 mL)
|
|
16 kg (35
lbs)
|
1 teaspoonful (5 mL)
|
|
24 kg (53
lbs)
|
1 1 / 2 teaspoonfuls (7.5
mL)
|
|
Over 32 kg
(over 70 lbs)
|
2 teaspoonfuls (10 mL)
|
THREE-TIMES-A-DAY SCHEDULE
|
Weight
|
Dose--every 8 hours
|
|
Less than 6 kg
(<13 lbs)
|
Adjust dosage
by body weight
|
|
6 kg (13
lbs)
|
1 / 2 teaspoonful (2.5 mL)
|
|
12 kg (26
lbs)
|
1 teaspoonful (5 mL)
|
|
18 kg (40
lbs)
|
1 1 / 2 teaspoonfuls (7.5
mL)
|
|
24 kg (53
lbs)
|
2 teaspoonfuls (10 mL)
|
|
Over 30 kg
(over 66 lbs)
|
2 1 / 2 teaspoonfuls (12.5
mL)
|
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.
HOW SUPPLIED
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
- Biovert A, Barbeau G, Belanger PM: Pharmacokinetics of sulfisoxazole in
young and elderly subjects. Gerontology 1984;30:125-131.
- 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.
- 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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