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clindamycin hydrochloride

RedPharm Drug Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




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



transthreogalactoclindamycin hydrochloride
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
Table 1. Susceptibility Interpretive Criteria for Clindamycin
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:
Table 2. Acceptable Quality Control Ranges for Clindamycin to be Used in Validation of Susceptibility Test Results


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

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.


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 difficile


CLINDAMYCIN HYDROCHLORIDE ADVERSE REACTIONS



Gastrointestinal: WARNING WARNINGS

Hypersensitivity Reactions:

Skin and Mucous Membranes: Hypersensitivity Reactions

Liver:

Renal:

Hematopoietic:

Musculoskeletal:

OVERDOSAGE




CLINDAMYCIN HYDROCHLORIDE DOSAGE AND ADMINISTRATION

WARNING 

Serious 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).

222

REFERENCES

  • 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 hydrochloride

clindamycin hydrochloride

clindamycin hydrochloride CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:67296-0315(NDC:63304-692)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CLINDAMYCIN HYDROCHLORIDE clindamycin 150 mg

Inactive Ingredients

Ingredient Name Strength
FERROSOFERRIC OXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
lactose monohydrate
MAGNESIUM STEARATE
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
green (light green) 19 mm RX692 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67296-0315-3 40 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065442 2006-11-01


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