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
Cleocin Indications, Dosage, Storage, Stability - Clindamycin
Cleocin Indications, Dosage, Storage, Stability - Clindamycin
INDICATIONS
Clindamycin is indicated in the treatment
of serious infections caused by susceptible
anaerobic bacteria.
Clindamycin is also indicated in the treatment
of serious infections due to susceptible
strains of streptococci, pneumococci, and staphylococci. Its use
should be reserved for penicillin
allergic patients or
other patients for whom, in the judgment
of the physician,
a penicillin is inappropriate.
Because of the risk of
colitis, as described
in the DESCRIPTION, WARNING box,
before selecting clindamycin the physician
should consider the nature of the infection
and the suitability of less toxic
alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory
tract infections such
as empyema, anaerobic
pneumonitis and
lung abscess; serious skin
and soft tissue infections; septicemia; intra-abdominal
infections such as peritonitis
and intra-abdominal
abscess (typically resulting
from anaerobic organisms
resident in the normal
gastrointestinal
tract); infections of the female pelvis and genital
tract such
as endometritis, nongonococcal tubo-ovarian abscess, pelvic
cellulitis and postsurgical
vaginal cuff
infection.
Streptococci: Serious respiratory
tract infections; serious
skin and soft tissue
infections.
Staphylococci: Serious respiratory
tract infections; serious
skin and soft tissue
infections.
Pneumococci: Serious respiratory
tract infections.
Bacteriologic studies should be performed to determine the causative
organisms and their susceptibility
to clindamycin.
In Vitro Susceptibility Testing: A standardized disk
testing procedure* is recommended for determining susceptibility
of aerobic bacteria
to clindamycin. A description is contained in the CLEOCIN Susceptibility
Disk insert. Using this method, the laboratory
can designate isolates as resistant, intermediate, or susceptible.
Tube or agar dilution
methods may be used for both anaerobic
and aerobic bacteria.
When the directions in the CLEOCIN Susceptibility Powder insert
are followed, an MIC of
1.6 mcg/mL may be considered susceptible; MICs
of 1.6 to 4.8 mcg/mL may be considered intermediate
and MICs greater than 4.8
mcg/ mL may be considered resistant.
*Bauer AW, Kirby WMM, Sherris JC, et al: Antibiotic susceptibility
testing by a standardized single disc
method. AM J Clin Pathol 45: 493-496 1966. Standardized disc
susceptibility
test. Federal Register 37: 20527-29, 1972.
CLEOCIN Susceptibility Disks 2 mcg. See package insert for use.
CLEOCIN Susceptibility Powder 20 mg. See package insert for use.
For anaerobic bacteria
the minimal inhibitory
concentration
(MIC) of clindamycin can be determined by agar
dilution and broth
dilution (including
microdilution) techniques. If MICs
are not determined routinely, the disk broth method
is recommended for routine use. THE KIRBY-BAUER DISK DIFFUSION METHOD
AND ITS INTERPRETIVE STANDARDS ARE NOT RECOMMENDED FOR ANAEROBES.
To reduce the development of drug-resistant bacteria and maintain
the effectiveness of CLEOCIN HCl and other antibacterial drugs,
CLEOCIN HCl 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
If significant
diarrhea occurs during
therapy, this antibiotic
should be discontinued (see DESCRIPTION,
WARNING box).
Adults:
Serious infections - 150 to 300 mg
every 6 hours.
More severe infections - 300 to 450 mg
every 6 hours.
Pediatric Patients:
Serious infections - 8 to 16 mg/kg/day (4 to 8 mg/lb/day)
divided into three or four equal doses. More severe infections
- 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four
equal doses.
To avoid the possibility of esophageal
irritation, clindamycin hydrochloride capsules should be taken with
a full glass of water.
Serious infections due to anaerobic
bacteria are usually
treated with CLEOCIN PHOSPHATE Sterile Solution. However, in clinically
appropriate circumstances, the physician
may elect to initiate treatment
or continue treatment with clindamycin hydrochloride
capsules.
In cases of β- hemolytic
streptococcal
infections, treatment
should continue for at least 10 days
HOW SUPPLIED
CLEOCIN HCl Capsules are available in the following
strengths, colors and sizes:
| 75 mg Green |
|
| Bottles of 100 |
NDC 0009-0331-02 |
| 150 mg Light Blue and Green |
|
| Bottles of 16 |
NDC 0009-0225-01 |
| Bottles of 100 |
NDC 0009-0225-02 |
| Unit dose package of 100 |
NDC 0009-0225-03 |
| 300 mg Light Blue |
|
| Bottles of 16 |
NDC 0009-0395-13 |
| Bottles of 100 |
NDC 0009-0395-14 |
| Unit dose package of 100 |
NDC 0009-0395-02 |
Store at controlled room temperature 20° to 25° C
(68° to 77° F) [see USP].
top
