The extent of absorption, however, 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 1. After oral administration of clindamycin hydrochloride, the average elimination half-life is increased to approximately 4 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. 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. Dosage schedules do not need to be modified in patients with renal disease. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. The elimination half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic function. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces the remainder is excreted as bioinactive metabolites. The average biological half-life is 2.4 hours. In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly metabolized by Cytochrome P450 3A4 (CYP3A4), with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin. No significant concentrations of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges. Clindamycin is widely distributed in body fluids and tissues (including bones). Serum concentrations exceed the MIC (minimum inhibitory concentration) for most indicated organisms for at least six hours following administration of the usually recommended doses. Doses of up to 2 grams of clindamycin per day for 14 days have been well tolerated by healthy volunteers, except that the incidence of gastrointestinal side effects is greater with the higher doses.Ĭoncentrations of clindamycin in the serum increased linearly with increased dose. Pharmacokinetic studies following multiple doses of clindamycin hydrochloride for up to 14 days show no evidence of accumulation or altered metabolism of drug. Absorption of an oral dose is virtually complete (90%), and the concomitant administration of food does not appreciably modify the serum concentrations serum concentrations have been uniform and predictable from person to person and dose to dose. An average peak serum concentration of 2.50 mcg/mL was reached in 45 minutes serum concentrations averaged 1.51 mcg/mL at 3 hours and 0.70 mcg/mL at 6 hours. Pharmacokinetic studies with a 150 mg oral dose of clindamycin hydrochloride in 24 normal adult volunteers showed that clindamycin was rapidly absorbed after oral administration. difficile, and surgical evaluation should be instituted as clinically indicated. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. CDAD must be considered in all patients who present with diarrhea following antibiotic use. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. difficile produces toxins A and B, which contribute to the development of CDAD. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.Ĭ. difficile.īecause clindamycin hydrochloride therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. ![]() Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. Note: Inactive ingredients may vary.Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. ![]() Inactive Ingredients lactose monohydrate, ![]() Labeler / Supplier Sun Pharmaceutical Industries Inc. Clindamycin Hydrochloride Imprint RX692 RX692 Strength 150 mg Color Blue / Green Size 19.00 mm Shape Capsule/Oblong Availability Prescription only Drug Class Lincomycin derivatives Pregnancy Category B - No proven risk in humans CSA Schedule
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