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
Cefzil Indications, Dosage, Storage, Stability - Cefprozil
Cefzil Indications, Dosage, Storage, Stability - Cefprozil
INDICATIONS
Cefprozil is indicated for the treatment
of patients with mild to moderate infections caused by susceptible
strains of the designated microorganisms in the conditions listed below:
Upper Respiratory Tract
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. Cefprozil is generally effective in the eradication
of Streptococcus pyogenes
from the nasopharynx; however, substantial data establishing the efficacy
of cefprozil in the subsequent prevention
of rheumatic fever
are not available at present.
Otitis Media: caused by Streptococcus
pneumoniae, Haemophilus influenzae (including b-lactamase-producing
strains) and Moraxella (Branhamella) catarrhalis (including b-lactamase-producing
strains). (See CLINICAL STUDIES).
NOTE: In the treatment
of otitis media
due to beta-lactamase producing organisms, cefprozil had bacteriologic
eradication rates somewhat
lower than those observed with a product
containing a specific beta-lactamase
inhibitor. In considering the use
of cefprozil, lower overall eradication rates should be balanced against
the susceptibility patterns of the common microbes in a given geographic
area and the increased potential
for toxicity with products containing beta-lactamase inhibitors.
Acute Sinusitis: Caused by Streptococcus
pneumoniae, Haemophilus influenzae (including b-lactamase-producing
strains), and Moraxella (Branhamella) catarrhalis (including b-lactamase-producing
strains).
Lower Respiratory Tract
Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial
Exacerbation of Chronic Bronchitis: Caused by Streptococcus
pneumoniae, Haemophilus influenzae (including b-lactamase-producing
strains), and Moraxella (Branhamella) catarrhalis, (including b-lactamase-producing
strains)
Skin and Skin Structure
Uncomplicated Skin and Skin-Structure Infections: Caused
by Staphylococcus aureus
(including penicillinase-producing strains) and Streptococcus pyogenes.
Abscesses usually require surgical
drainage. Culture and susceptibility testing should be performed when
appropriate to determine
susceptibility of the causative organism
to cefprozil.
DOSAGE AND ADMINISTRATION
Cefprozil is administered orally
| TABLE 10 |
| Population/Infection |
Dosage (mg) |
Duration (days) |
| Adults (13 years and older) |
| Upper Respiratory Tract |
|
|
|
|
500 q 24h |
10* |
|
|
250 q 12h or |
10 |
| (For moderate to severe infections the higher
dose should be used) |
500 q 12h |
|
| Lower Respiratory Tract |
|
|
Secondary Bacterial infection
of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic
Bronchitis
|
500 q 12h |
10 |
| Skin and Structure |
|
|
|
|
250 q 12h or |
10 |
|
|
500 q 24h or |
|
| |
500 q 12h |
|
| Children (2 years-12 years) |
| Upper Respiratory Tract† |
|
|
|
|
7.5 mg/kg |
10* |
| |
q 12h |
|
| Skin and Structure† |
|
|
|
|
20 mg/kg |
10 |
|
|
q 24h |
|
| * In
the treatment of infections
due to Streptococcus pyogenes. cefprozil should be administered
for at least 10 days. |
| † Not to exceed recommended adult
doses. |
| TABLE 11 |
| Population/Infection |
Dosage (mg) |
Duration (days) |
| Infants & Children (6 months-12
years) |
| Upper Respiratory Tract† |
|
|
|
|
15 mg/kg |
10 |
See INDICATIONS AND USAGE
and CLINICAL STUDIES sections) |
q 12h |
|
|
|
7.5 mg/kg |
10 |
For moderate to severe infections, (the higher dose
should be used)
|
q 12h or 15 mg/kg q 12h |
|
| * In
the treatment of infections
due to Streptococcus pyogenes. cefprozil should be administered
for at least 10 days. |
| † Not to exceed recommended adult
doses. |
Renal Impairment
Cefprozil may be administered to patients with impaired renal
function. The following dosage
schedule should be used.
| TABLE 12 |
| Creatinine Clearance (ml/min) |
Dosage (mg) |
Dosing Interval |
| 30-120 |
standard |
standard |
| 0-29* |
50% of standard |
standard |
| * Cefprozil is in party
removed by hemodialysis: therefore, cefprozil should be administered
after the completion of hemodialysis. |
Hepatic Impairment
No dosage adjustment
is necessary for patients with impaired hepatic function.
HOW SUPPLIED
Cefzil Tablets: Each light
orange film-coated tablet, imprinted with “7720” on one side
and “250” on the other, contains the equivalent of 250 mg
anhydrous cefprozil.
Each white film-coated tablet,
imprinted with “7721” on one side
and “500” on the other contains the equivalent
of 500 mg anhydrous
cefprozil.
Store at controlled room temperature,
59° to 86°F (15° to 30°C).
Cefzil For Oral Suspension: Each 5 ml
of constituted suspension contains the equivalent
of 125 mg anhydrous
cefprozil.
Each 5 ml of constituted suspension
contains the equivalent
of 250 mg anhydrous cefprozil.
All powder formulations for
oral suspension
contain cefprozil in a bubble-gum flavored mixture.
Reconstitution Directions for Oral Suspension: Prepare
the suspension at the time
of dispensing; for ease in preparation, add water in two portions and
shake well after each aliquot.
| TABLE 13 Total Amount of Water Required
for Reconstitution |
| Bottle |
Final Concentration |
Final Concentration |
| Size |
125 mg/5 ml |
250 mg/5 ml |
| 50 ml |
36 ml |
36 ml |
| 75 ml |
54 ml |
54 ml |
| 100 ml |
72 ml |
72 ml |
| After mixing, store in a refrigerator and
discard unused portion after 14 days. |
Store at 59° to 77°F (15° to 25°C) prior to constitution.
PRODUCT LISTING
|
|
| 50 ml |
Cefzil, Bristol-Myers Squibb
|
00087-7718-40
|
| 75 ml |
Cefzil, Bristol-Myers Squibb
|
00087-7718-62
|
| 100 ml |
Cefzil, Bristol-Myers Squibb
|
00087-7718-64
|
|
|
| 50 ml |
Cefzil, Bristol-Myers Squibb
|
00087-7719-40
|
| 75 ml |
Cefzil, Bristol-Myers Squibb
|
00087-7719-62
|
| 100 ml |
Cefzil, Bristol-Myers Squibb
|
00087-7719-64
|
|
|
| 100's |
Cefzil, Bristol-Myers Squibb
|
00087-7720-60
|
|
|
| 50's |
Cefzil, Bristol-Myers Squibb
|
00087-7721-50
|
| 100's |
Cefzil, Bristol-Myers Squibb
|
00087-7721-60
|
REFERENCES
1. National Committee for Clinical Laboratory Standards.
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria
that Grow Aerobically Third Edition. Approved Standard NCCLS Document
M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December, 1993.
2. National Committee for Clinical Laboratory Standards.
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria
Third Edition. Approved Standard NCCLS Document M11-A3, Vol. 13, No.
26, NCCLS, Villanova, PA, December, 1993.
3. National Committee for Clinical Laboratory Standards.
Performance Standards for Antimicrobial Disk Susceptibility Tests Fifth
Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS,
Villanova, PA, December, 1993.
4. Clinitest is a registered trademark of the Bayer Corporation.
5. Tes-Tape is a registered trademark of Eli Lilly and
Company.
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