clindamycin hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- WARNING
- CLINDAMYCIN HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- CLINDAMYCIN HYDROCHLORIDE INDICATIONS AND USAGE
- CLINDAMYCIN HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- Information for Patients
- Laboratory Tests
- Drug Interactions
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Pregnancy
- Nursing Mothers
- Pediatric Use
- Geriatric Use
- CLINDAMYCIN HYDROCHLORIDE ADVERSE REACTIONS
- OVERDOSAGE
- CLINDAMYCIN HYDROCHLORIDE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- REFERENCES
FULL PRESCRIBING INFORMATION
WARNING
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
INDICATIONS AND USAGE Clostridium difficile
C. difficile
CLINDAMYCIN HYDROCHLORIDE DESCRIPTION
transthreogalacto
C18H33ClN2O5S•HClM.W. 461.45
CLINICAL PHARMACOLOGY
in vitro
in vitro INDICATIONS AND USAGE
Gram-positive aerobes
Staphylococcus aureus
Streptococcus pneumoniae
Streptococcus pyogenes
Anaerobes
Prevotella melaninogenica
Fusobacterium necrophorum
Fusobacterium nucleatum
Peptostreptococcus anaerobius
Clostridium perfringens
in vitro in vitro
Gram-positive aerobes
Staphylococcus epidermidis
Streptococcus agalactiae
Streptococcus anginosus
Streptococcus oralis
Anaerobes
Prevotella intermedia
NOTE:
in vitro
1,2,3
2,3
Pathogen | Susceptibility Interpretive Criteria | |||||
---|---|---|---|---|---|---|
Minimal Inhibitory
Concentrations (MIC in mcg/mL) |
Disk Diffusion (Zone Diameters in mm) |
|||||
|
S | I | R | S | I | R |
Staphylococcus
spp. |
≤0.5 |
1-2 |
≥4 |
≥21 |
15-20 |
≤14 |
Streptococcus
pneumoniae and other Streptococcus spp. |
≤0.25a
|
0.5 |
≥1 |
≥19b
|
16-18 |
≤15 |
Anaerobic Bacteriac
|
≤2 |
4 |
≥8 |
NA |
NA |
NA |
aS. pneumoniae Streptococcus
b2
c
NOTE:
QC Strain |
Acceptable Quality Control Ranges | |
---|---|---|
Minimum Inhibitory Concentrations (MIC in mcg/mL) |
Disk Diffusion (Zone Diameters in mm) |
|
When Testing Aerobic
Pathogens
|
|
|
Staphylococcus
aureus ATCC 29213 |
0.06–0.25 |
NA |
Staphylococcus
aureus ATCC 25923 |
NA |
24–30 |
Streptococcus
pneumoniae ATCC 49619d
|
0.03–0.12e
|
19–25f
|
When Testing Strict
Anaerobes
|
|
|
Bacteroides
fragilis ATCC 25285 |
0.5–2 |
NA |
Bacteroides
thetaiotaomicron ATCC 29741 |
2–8 |
NA |
Eubacterium lentum
ATCC 43055 |
0.06–0.25 |
NA |
dStreptococcus S. pneumoniae
eS. pneumoniae
f2
®
CLINDAMYCIN HYDROCHLORIDE INDICATIONS AND USAGE
WARNING
Anaerobes:
Streptococci:
Staphylococci:
Pneumococci:
CLINDAMYCIN HYDROCHLORIDE CONTRAINDICATIONS
WARNINGS
WARNINGPseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Clostridium difficile
C. difficile
Usage in Meningitis
PRECAUTIONS
Information for Patients
Laboratory Tests
Drug Interactions
in vitro
Carcinogenesis, Mutagenesis, Impairment of Fertility
2
Pregnancy
22
Nursing Mothers
Pediatric Use
Geriatric Use
Clostridium difficileCLINDAMYCIN HYDROCHLORIDE ADVERSE REACTIONS
Gastrointestinal: WARNING WARNINGS
Hypersensitivity Reactions:
Skin and Mucous Membranes: Hypersensitivity Reactions
Liver:
Renal:
Hematopoietic:
Musculoskeletal:
OVERDOSAGE
CLINDAMYCIN HYDROCHLORIDE DOSAGE AND ADMINISTRATION
WARNINGSerious infections More severe infections
Serious infections More severe infections
HOW SUPPLIED
Clindamycin hydrochloride capsules are available in the following strengths, colors and sizes:
150 mg Turquoise blue opaque cap and light green body printed with “RX692” on cap and body in black ink.
NDC 67296-0315-3 Bottles of 40
Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature).
222REFERENCES
- NCCLS. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard-5th ed. NCCLS document M7-A5, 2000. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898.
- NCCLS. Performance Standards for Antimicrobial Susceptibility Testing: 13th Informational Supplement. NCCLS document M100-S13 (M2 and M7), 2003. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898.
- NCCLS. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria 5th ed. Approved Standard. NCCLS document M11-A5, 2001. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898.
- NCCLS. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-8th ed. NCCLS document M2-A8 (ISBN 1-56238-393-0), 2003. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898.
Manufactured for:
Ranbaxy Pharmaceuticals Inc.
Jacksonville, FL 32257 USA
by: Ohm Laboratories Inc.
North Brunswick, NJ 08902 USA
November 2006
clindamycin hydrochlorideclindamycin hydrochloride CAPSULE
|
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!