Ceftin Tablets, Oral Suspension Dosage

Generic name: CEFUROXIME AXETIL 125mg in 5mL
Dosage form: tablets, powder for oral suspension
Drug class: Second generation cephalosporins

Medically reviewed by Drugs.com. Last updated on Nov 13, 2023.

Important Administration Instructions

•: CEFTIN tablets and CEFTIN for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see Clinical Pharmacology (12.3)].
•: Administer CEFTIN tablets or oral suspension as described in the appropriate dosage guidelines [see Dosage and Administration (2.2, 2.3, 2.4)].
•: Administer CEFTIN tablets with or without food.
•: Administer CEFTIN for oral suspension with food.
•: Pediatric patients (aged 13 years and older) who cannot swallow the CEFTIN tablets whole should receive CEFTIN for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see Dosage and Administration (2.2)].

Dosage for CEFTIN Tablets

Administer CEFTIN tablets as described in the dosage guidelines table below with or without food.

Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for CEFTIN Tablets
Infection	Dosage	Duration (Days)
Adults and Adolescents (13 years and older)
Pharyngitis/tonsillitis (mild to moderate)	250 mg every 12 hours	10
Acute bacterial maxillary sinusitis (mild to moderate)	250 mg every 12 hours	10
Acute bacterial exacerbations of chronic bronchitis (mild to moderate)	250 or 500 mg every 12 hours	10a
Uncomplicated skin and skin-structure infections	250 or 500 mg every 12 hours	10
Uncomplicated urinary tract infections	250 mg every 12 hours	7 to 10
Uncomplicated gonorrhea	1,000 mg	single dose
Early Lyme disease	500 mg every 12 hours	20
Pediatric Patients younger than 13 years (who can swallow tablets whole)b
Acute bacterial otitis media	250 mg every 12 hours	10
Acute bacterial maxillary sinusitis	250 mg every 12 hours	10

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.

b When crushed, the tablet has a strong, persistent bitter taste. Therefore, patients who cannot swallow the tablet whole should receive the oral suspension.

Dosage for CEFTIN for Oral Suspension

Administer CEFTIN for oral suspension as described in the dosage guidelines table below with food.

Table 2. Pediatric Patients (3 months to 12 years) Dosage Guidelines for CEFTIN for Oral Suspension
Infection	Recommended Daily Dosea	Maximum Daily Dose	Duration (Days)
Pharyngitis/tonsillitis	20 mg/kg	500 mg	10
Acute bacterial otitis media	30 mg/kg	1,000 mg	10
Acute bacterial maxillary sinusitis	30 mg/kg	1,000 mg	10
Impetigo	30 mg/kg	1,000 mg	10

a Recommended daily dose given twice daily divided in equal doses

Preparation and Administration of 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 (Table 3) 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.

Table 3. Amount of Water Required for Reconstitution of Labeled Volumes of CEFTIN for Oral Suspension
Oral Suspension	Amount of Water Required for Reconstitution	Labeled Volume after Reconstitution
125 mg/5 mL	37 mL	100 mL
250 mg/5 mL	19 mL	50 mL
250 mg/5 mL	35 mL	100 mL

•: Shake the oral suspension well before each use.
•: Replace cap securely after each opening.
•: Store the reconstituted suspension refrigerated between 2° and 8°C (36° and 46°F).
•: Discard the reconstituted suspension after 10 days.

Dosage in Patients with Impaired Renal Function

A dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see Clinical Pharmacology (12.3)].

Table 4. Dosing in Adults with Renal Impairment
Creatinine Clearance (mL/min)	Recommended Dosage
≥30	No dosage adjustment
10 to ˂30	Standard individual dose given every 24 hours
˂10 (without hemodialysis)	Standard individual dose given every 48 hours
Hemodialysis	A single additional standard dose should be given at the end of each dialysis