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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  03/04/2020
 
Trade Name:  Cleocin Phosphate
 
Generic Name or Proper Name (*):  clindamycin injection; clindamycin injection in dextrose
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *The following statement was added to Dosage and Administration section: Clindamycin should be dosed on total body weight regardless of body weight. *Obese Pediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 Years: An analysis of pharmacokinetic data in obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution, normalized by total body weight, are comparable regardless of obesity. *Off-patent Written Request.
 
BPCA(B):  B
 
Sponsor:  Pfizer, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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