Important Administration Instructions

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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)].

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Administer CEFTIN tablets or oral suspension as described in the appropriate dosage guidelines [see Dosage and Administration (2.2, 2.3, 2.4)].

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Administer CEFTIN tablets with or without food.

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Administer CEFTIN for oral suspension with food.

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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.

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.

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 cold 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 for at least one minute.

6.

​After reconstitution, wait one hour before administering suspension to a patient.

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Shake the oral suspension well before each use.

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Replace cap securely after each opening.

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Store the reconstituted suspension refrigerated between 2° and 8°C (36° and 46°F).

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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 less than 30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see Clinical Pharmacology (12.3)].