Cefuroxime axetil dosage and administration

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Cefuroxime axetil
CEFTIN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Clinical Studies
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

NOTE: CEFTIN TABLETS AND CEFTIN FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

Table 7. CEFTIN Tablets

a The safety and effectiveness of CEFTIN administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

CEFTIN for Oral Suspension

CEFTIN for Oral Suspension may be administered to pediatric patients ranging in age from 3 months to 12 years, according to dosages in Table 8:

Table 8. CEFTIN for Oral Suspension

Patients With Renal Failure

The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.

Directions for Mixing CEFTIN for Oral Suspension

Prepare a suspension at the time of dispensing as follows:

1.Shake the bottle to loosen the powder. 2.Remove the cap. 3.Add the total amount of water for reconstitution (see Table 9) and replace the cap. 4.Invert the bottle and vigorously rock the bottle from side to side so that water rises through the powder. 5.Once the sound of the powder against the bottle disappears, turn the bottle upright and vigorously shake it in a diagonal direction.


NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE EACH USE. Replace cap securely after each opening. Store the reconstituted suspension between 2° and 8°C (36° and 46°F) (in a refrigerator). DISCARD AFTER 10 DAYS.

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf