A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ceftin Indications, Dosage, Storage, Stability - Cefuroxime Axetil
Ceftin Indications, Dosage, Storage, Stability - Cefuroxime Axetil
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 |
|
|
250 mg bid |
10 |
|
|
250 or 500 mg
bid |
10* |
|
|
250 or 500 mg
bid |
5-10 |
|
|
250 or 500 mg
bid |
10 |
|
|
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 |
|
|
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 |
|
|
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.
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