J Clin Pharmacol
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The Journal of Clinical Pharmacology and New Drugs, 1972; 12:74-83
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Clindamycin Palmitate Flavored Granules. Multidose Tolerance, Absorption, and Urinary Excretion Study in Healthy Children

Ray M. DeHaan M.D., M.S., F.A.C.P.1 and Diana Schellenberg M.A.1

1 Infectious Diseases Research Department, The Upjohn Company, Kalamazoo, Mich.

Fifty-two healthy children 6 months to 14 years old showed good tolerance of a 17-dose course of clindamycin palmitate flavored granules, a pediatric preparation of the antibiotic clindamycin. Serum and urine bioassay findings indicated that (1) dosages of 8 to 16 mg/kg per day are appropriate for this age group; (2) the drug is absorbed rapidly and predictably; and (3) over a 17-dose course there is neither drug accumulation nor an increase in rate of metabolism due to enzyme induction.

Note:

We thank Grover Lee Moore, M.D., who served as clinical investigator for this study; Carl M. Metzler, Ph.D., who provided the pharmacokinetic parameter estimates; Richard Wilkin and Patricia Shanko, R.N., for technical assistance; the staff of the Tidewater Seventh Day Adventist Junior Academy, Norfolk, Virginia; and especially the children who served as subjects. All bioassays were developed and performed by W. L. Lummis and staff of The Clinical Microbiology Section of the Clinical Research Laboratory, The Upjohn Company, Kalamazoo, Michigan.


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