Clindamycin palmitate hydrochloride clinical pharmacology
| Clindamycin palmitate hydrochloride |
|---|
| CLINDAMYCIN PALMITATE HYDROCHLORIDE® FDA Package Insert |
| Description |
| Clinical Pharmacology |
| Microbiology |
| Indications and Usage |
| Contraindications |
| Warnings |
| Precautions |
| Adverse Reactions |
| Overdosage |
| Dosage and Administration |
| How Supplied |
| Labels and Packages |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
CLINICAL PHARMACOLOGY
Blood level studies comparing clindamycin palmitate HCl with clindamycin hydrochloride show that both drugs reach their peak active serum levels at the same time, indicating a rapid hydrolysis of the palmitate to the clindamycin.
Clindamycin is widely distributed in body fluids and tissues (including bones). Approximately 10% of the biological activity is excreted in the urine. The average serum half-life after doses of clindamycin palmitate hydrochloride for oral solution (Pediatric) is approximately two hours in pediatric patients.
Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.
Serum level studies with clindamycin palmitate HCl in normal pediatric patients weighing 50 to 100 lbs given 2, 3 or 4 mg/kg every 6 hours (8, 12 or 16 mg/kg/day) demonstrated mean peak clindamycin serum levels of 1.24, 2.25 and 2.44 mcg/mL respectively, one hour after the first dose. By the fifth dose, the 6-hour serum concentration had reached equilibrium. Peak serum concentrations after this time would be about 2.46, 2.98 and 3.79 mcg/mL with doses of 8, 12 and 16 mg/kg/day, respectively.
Serum levels have been uniform and predictable from person to person and dose to dose. Multiple-dose studies in neonates and infants up to 6 months of age show that the drug does not accumulate in the serum and is excreted rapidly. Serum levels exceed the MICs for most indicated organisms for at least six hours following administration of the usually recommended doses of clindamycin palmitate hydrochloride for oral solution (Pediatric) in adults and pediatric patients.
No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.
Pharmacokinetic studies in elderly volunteers (61 to 79 years) and younger adults (18 to 39 years) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area under the serum concentration-time curve) after IV administration of clindamycin phosphate.
After oral administration of clindamycin hydrochloride, elimination half-life is increased to approximately 4.0 hours (range 3.4 to 5.1 h) in the elderly compared to 3.2 hours (range 2.1 to 4.2 h) in younger adults; administration of clindamycin palmitate HCl resulted in a similar elimination half-life value of about 4.5 hours in elderly subjects. However, the extent of absorption is not different between age groups and no dosage alteration is necessary for the elderly with normal hepatic function and normal (age-adjusted) renal function
References
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e1cb8caa-1e49-41e7-bbd8-a2e75bea2fe4