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
Ceclor Indications, Dosage, Storage, Stability - Cefaclor
Ceclor Indications, Dosage, Storage, Stability - Cefaclor
INDICATIONS
Cefaclor is indicated in the treatment
of the following infections when caused by susceptible
strains of the designated microorganisms:
Olitis media: caused by S. pneumoniae, H. influenzae,
staphylococci, and S. pyogenes (group A ß-hemolytic
streptococci)
Note: ß-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Lower respiratory
infections: including pneumonia,
caused by S. pneumoniae, H. influenzae, and S. pyogenes (group
A ß-hemolytic streptococci)
Note: ß-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Pharyntitis and Tonsillitis: including pharyngitis
and tonsillitis, caused by S. pyogenes (group A ß-hemolytic
streptococci)
Note: Penicillin is the usual drug
of choice in the treatment and prevention
of streptococcal infections,
including the prophylaxis
of rheumatic fever. Cefaclor is generally effective in the eradication
of streptococci from the nasopharynx; however, substantial data establishing
the efficacy of cefaclor
in the subsequent prevention
of rheumatic fever are not
available at present.
Urinary tract infections:
including pyelonephritis
and cystitis, caused by E. coli, P. mirabilis, Klebsiella sp, and
coagulase-negative staphylococci
Skin and skin structure
infections: caused by Staphylococcus aureus and S. pyogenes
(group A ß-hemolytic streptococci).
Appropriate culture and susceptibility
studies should be performed to determine susceptibility
of the causative organism
to cefaclor.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceclor and other antibacterial drugs, Ceclor 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.
DOSAGE AND ADMINISTRATION
Cefaclor is administered orally.
Adults
The usual adult dosage
is 250 mg every 8 hours. For more
severe infections (such as pneumonia) or those caused by less susceptible
organisms, doses may be doubled.
Children
The usual recommended daily dosage
for children is 20 mg/kg/day in divided doses every 8 hours. In
more serious infections, otitis
media, and infections caused by less susceptible
organisms, 40 mg/kg/day are recommended, with a maximum
dosage of 1 g/day.
| |
Cefaclor Suspension
20 mg/kg/day
|
| Child’s weight |
125 mg/5mL
|
250mg/5mL
|
|
9kg
|
1/ 2 tsp
t.i.d.
|
|
|
18 kg
|
1 tsp
t.i.d.
|
1/2 tsp
t.i.d.
|
| |
40 mg/kg/day
|
|
9 kg
|
1 tsp
t.i.d.
|
1/2 tsp
t.i.d.
|
|
18 kg
|
|
1 tsp
t.i.d.
|
B.I.D. Treatment Option: For the treatment
of otitis media and pharyngitis,
the total daily dosage may
be divided and administered every 12 hours.
| |
Cefaclor Suspension
20 mg/kg/day
(Pharyngitis)
|
| Child’s weight |
187 mg/ 5mL
|
375 mg/ 5mL
|
|
9kg
|
1/2 tsp
b.i.d.
|
|
|
18 kg
|
1 tsp
b.i.d.
|
1/2 tsp
b.i.d.
|
| |
40 mg/kg/day
(Otitis Media)
|
|
9 kg
|
1 tsp
b.i.d.
|
1/2 tsp
b.i.d.
|
|
18 kg
|
|
1 tsp
b.i.d.
|
Cefaclor may be administered in the presence of impaired renal
function. Under such a condition, the dosage
usually is unchanged (see PRECAUTIONS).
In the treatment of ß-hemolytic
streptococcal infections,
a therapeutic dosage of cefaclor should be administered for at least 10
days.
HOW SUPPLIED
Pulvules:
250 mg, purple and white (No. 3061)—(RxPak * of 15) NDC 0002-3061-15; (100s) NDC 0002-3061-02; (ID **/* 100) NDC 0002-3061-33
500 mg, purple and gray (No. 3062)—(RxPak of 15) NDC 0002-3062-15
For Oral Suspension:
125 mg/5 mL, strawberry flavor (M-5057 **/** )—(150-mL size) NDC 0002-5057-68
187 mg/5 mL, strawberry flavor (M-5130 **/** )—(100-mL size) NDC 0002-5130-48
250 mg/5 mL, strawberry flavor (M-5058 **/** )—(75-mL size) NDC 0002-5058-18; (150-mL size) NDC 0002-5058-68
375 mg/5 mL, strawberry flavor (M-5132 **/** )—(100-mL size) NDC 0002-5132-48
* All RxPaks (prescription packages, Lilly) have safety closures.
**/* Identi-Dose® (unit dose medication, Lilly).
**/** After mixing, store in a refrigerator. Shake well before using. Keep tightly closed. The mixture may be kept for 14 days without significant loss of potency. Discard unused portion after 14 days.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]
CAUTION: Federal (USA) law
prohibits dispensing without prescription.
REFERENCES
-
National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically—Fourth Edition. Approved Standard NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, Wayne, PA, January, 1997.
-
National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests—Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1, NCCLS, Wayne, PA, January, 1997.
Literature revised March 28, 2003
Manufactured by Eli Lilly Italia, S.p.A.
Sesto Fiorentino (Firenze), Italy
for Eli Lilly and Company
Indianapolis, IN 46285, USA
Copyright © 1979, 2003, Eli Lilly and Company. All rights reserved.
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