INDICATIONS
NOTE: CEFUROXIME AXETIL TABLETS AND
CEFUROXIME AXETIL POWDER FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT
AND ARE NOT SUBSTITUTABLE ON A MG/MG BASIS (SEE CLINICAL
PHARMACOLOGY).
Cefuroxime Axetil Tablets
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. 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.) 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 cefuroxime
axetil tablets for patients with acute bacterial maxillary
sinusitis, it was not possible to adequately evaluate
the effectiveness of 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
and CLINICAL STUDIES.)
5. Uncomplicated Skin and Skin-Structure Infections:
Caused by Staphylococcus aureus (including beta-lactamase¾producing
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-penicillinase¾producing
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
Cefuroxime Axetil Powder for Oral Suspension
Cefuroxime axetil powder 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 cefuroxime axetil powder 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. Cefuroxime axetil powder
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-lactamase¾producing strains)
or Streptococcus pyogenes.
Culture and susceptibility testing should be performed
when appropriate to determine susceptibility of the causative
microorganism(s) to cefuroxime. Therapy may be started
while awaiting the results of this testing. Antimicrobial
therapy should be appropriately adjusted according to
the results of such testing.
DOSAGE AND ADMINISTRATION
NOTE: CEFUROXIME AXETIL TABLETS AND
POWDER FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE
NOT SUBSTITUTABLE ON A MG/MG BASIS (SEE CLINICAL PHARMACOLOGY).
TABLE 11 Cefuroxime Axetil Tablets
|
(May be administered without regard to meals.)
|
Population/Infection
|
Dosage |
Duration (days) |
| Adolescents
and Adults (13 years and older) |
|
|
250 mg bid |
10 |
Acute bacterial maxillary sinusitis
|
250 mg bid |
10 |
Acute bacterial exacerbations of chronic
bronchitis
|
250 or 500 mg bid |
10* |
Secondary bacterial infections of acute
bronchitis
|
250 or 500 mg bid |
5-10 |
Uncomplicated skin
and skin-structure infections
|
250 or 500 mg bid |
10 |
Uncomplicated urinary tract
infections
|
125 or 250 mg bid |
7-10 |
|
|
1000 mg once |
single dose |
|
|
500 mg bid |
20 |
| Pediatric
Patients (who can wswallow tablets whole) |
|
|
125 mg bid |
10 |
|
|
250 mg bid |
10 |
Acute bacterial maxillary sinusitis
|
250 mg bid |
10 |
| * The
safety and effectiveness of cefuroxime axetil administered
for less than 10 days in patients with acute exacerbations
of chronic bronchitis have not been established. |
Cefuroxime Axetil Powder for Oral Suspension
Cefuroxime axetil powder for oral suspension may be administered
to pediatric patients ranging in age from 3 months to
12 years, according to dosages in TABLE 12.
TABLE 12 Cefuroxime Axetil Powder for Oral Suspension
|
(Must be administered with food. Shake well each time
before using.)
|
Population/Infection
|
Dosage |
Daily Maximum Dose |
Duration (days) |
| Pediatric
Patients (3 months to 12 years) |
|
|
20 mg/kg/day divided
bid |
500 mg |
10 |
|
|
30 mg/kg/day divided
bid |
1000 mg |
10 |
Acute bacterial maxillary sinusitis
|
30 mg/kg/day divided
bid |
1000 mg |
10 |
|
|
30 mg/kg/day divided
bid |
1000 mg |
10 |
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 Cefuroxime Axetil Powder
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 13) 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 13 Amount of Water Required for Reconstitution of
Labeled Volumes of Cefuroxime Axetil Powder for Oral Suspension
|
| Cefuroxime Axetil Powder
for Oral Suspension |
Labeled Volume After
Reconstitution |
Amount of Water Required
for Reconstitution |
125 mg/5 ml
|
50 ml |
20 ml |
| |
100 ml |
37 ml |
250 mg/5 ml
|
50 ml |
19 ml |
| |
100 ml |
35 ml |
NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE
EACH USE. Replace cap securely after each opening. The reconstituted
suspension should be stored between 2-25°C (36-77°F)
(either in the referigerator or at room temperature). DISCARD
AFTER 10 DAYS.
HOW SUPPLIED
Ceftin Tablets
Ceftin tablets, 125 mg of cefuroxime (as cefuroxime axetil),
are white, capsule-shaped, film-coated tablets engraved
with "395" on one side and "Glaxo"
on the other side.
Ceftin tablets, 250 mg of cefuroxime (as cefuroxime axetil),
are light blue, capsule shaped, film-coated tablets engraved
with "387" on one side and "Glaxo"
on the other side.
Ceftin tablets, 500 mg of cefuroxime (as cefuroxime axetil),
are dark blue, capsule-shaped, film-coated tablets engraved
with "394" on one side and "Glaxo"
on the other side.
Storage: Store the tablets between 15-30°C (59-86°F).
Replace cap securely after each opening. Protect unit
dose packs from excessive moisture.
Ceftin for Oral Suspension
Ceftin for oral suspension is provided as dry, white
to pale yellow, tutti-frutti-flavored powder. When reconstituted
as directed, Ceftin for oral suspension provides the equivalent
of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil).
Storage: Before reconstitution, store dry powder
between 2-30°C (36-86°F).
After reconstitution, store suspension between
2-25°C (36-77°F), in a refrigerator or at room
temperature. DISCARD AFTER 10 DAYS.
REFERENCES
1. National Committee for Clinical Laboratory Standards.
Methods for Dilution Antimicrobial Susceptibility Tests
for Bacteria that Grow Aerobically. 3rd ed. Approved Standard
NCCLS Document M7-A3, Vol. 13, No. 25. Villanova, Pa:
NCCLS; 1993.
2. National Committee for Clinical Laboratory Standards.
Performance Standards for Antimicrobial Disk Susceptibility
Tests. 4th ed. Approved Standard NCCLS Document M2-A4, Vol.
10, No. 7. Villanova, Pa: NCCLS; 1990.
| |
