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

CEFTIN (cefuroxime axetil) Tablets

CEFTIN (cefuroxime axetil) Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. CEFTIN (cefuroxime axetil) Tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.
2. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.
3. Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase-producing strains only). (See CLINICAL STUDIES section.) NOTE: In view of the insufficient numbers of isolates of beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis that were obtained from clinical trials with CEFTIN (cefuroxime axetil) Tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of CEFTIN (cefuroxime axetil) Tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase-producing Haemophilus influenzae or Moraxella catarrhalis.
4. Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains). (See DOSAGE AND ADMINISTRATION section and CLINICAL STUDIES section.)
5. Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes.
6. Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae.
7. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase-producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase-producing strains of Neisseria gonorrhoeae.
8. Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.

CEFTIN (cefuroxime axetil) for Oral Suspension

CEFTIN (cefuroxime axetil) for Oral Suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. The safety and effectiveness of CEFTIN (cefuroxime axetil) for Oral Suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well-controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen.

1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. CEFTIN (cefuroxime axetil) for Oral Suspension is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.
2. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.
3. Impetigo caused by Staphylococcus aureus (including beta-lactamase-producing strains) or Streptococcus pyogenes.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFTIN (cefuroxime axetil) and other antibacterial drugs, CEFTIN (cefuroxime axetil) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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

Table 7. CEFTIN (cefuroxime axetil) Tablets
(May be administered without regard to meals.)

CEFTIN (cefuroxime axetil) for Oral Suspension

CEFTIN (cefuroxime axetil) 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 (cefuroxime axetil) for Oral Suspension
(Must be administered with food. Shake well each time before using.)

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 (cefuroxime axetil) 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.

Table 9. Amount of Water Required for Reconstitution of Labeled Volumes of CEFTIN (cefuroxime axetil) for Oral Suspension

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.

CEFTIN (cefuroxime axetil) Tablets

CEFTIN Tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule-shaped, film-coated tablets engraved with “GX ES7” on one side and blank on the other side as follows:

20 Tablets/Bottle NDC 0173-0387-00

CEFTIN Tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule-shaped, film-coated tablets engraved with “GX EG2” on one side and blank on the other side as follows:

20 Tablets/Bottle NDC 0173-0394-00
60 Tablets/Bottle NDC 0173-0394-42

Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.

CEFTIN (cefuroxime axetil) for Oral Suspension

CEFTIN (cefuroxime axetil) for Oral Suspension is provided as dry, white to off-white, tutti-frutti-flavored powder. When reconstituted as directed, CEFTIN (cefuroxime axetil) for Oral Suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. It is supplied in amber glass bottles as follows:

125 mg/5 mL

100-mL Suspension NDC 0173-0740-00

250 mg/5 mL

50-mL Suspension NDC 0173-0741-10
100-mL Suspension NDC 0173-0741-00

Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).

After reconstitution, immediately store suspension between 2° and 8°C (36° and 46°F), in a refrigerator. DISCARD AFTER 10 DAYS.

GlaxoSmithKline., Research Triangle Park, NC 27709
CEFTIN (cefuroxime axetil) is a registered trademark of GlaxoSmithKline.
CLINITEST and CLINISTIX are registered trademarks of Ames Division, Miles Laboratories, Inc.
January 2007. FDA rev date: 7/23/2007

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.