Cleocin Vaginal Ovules

Name: Cleocin Vaginal Ovules

Microbiology

Clindamycin inhibits bacterial protein synthesis at the level of the bacterial ribosome. The antibiotic binds preferentially to the 50S ribosomal subunit and affects the process of peptide chain initiation. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis. (See INDICATIONS AND USAGE.) Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis, Mobiluncus spp, or Mycoplasma hominis, has not been defined. Nonetheless, clindamycin is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:

  • Bacteroides spp
  • Gardnerella vaginalis
  • Mobiluncus spp
  • Mycoplasma hominis
  • Peptostreptococcus spp

PRINCIPAL DISPLAY PANEL - 100 mg Suppository Foil Carton

NDC 0009-7667-01

Pfizer

Cleocin®
Vaginal Ovules

equivalent to
100 mg*
clindamycin

(clindamycin phosphate
vaginal suppositories)

For Intravaginal Use Only

3 Suppositories with one applicator

Rx only

CLEOCIN 
clindamycin phosphate suppository
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-7667
Route of Administration VAGINAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 100 mg
Packaging
# Item Code Package Description
1 NDC:0009-7667-01 1 BLISTER PACK in 1 CARTON
1 3 SUPPOSITORY in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050767 08/13/1999
Labeler - Pharmacia and Upjohn Company LLC (618054084)
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company LLC 618054084 ANALYSIS(0009-7667), API MANUFACTURE(0009-7667), LABEL(0009-7667), MANUFACTURE(0009-7667), PACK(0009-7667)
Revised: 06/2017   Pharmacia and Upjohn Company LLC
(web3)