CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
Clinical safety rating: safe
May enhance the effects of neuromuscular blocking agents Causes severe and sometimes fatal Clostridium difficile-associated diarrhea.
Clindamycin phosphate is a prodrug that is hydrolyzed to clindamycin, a lincosamide antibiotic. It reversibly binds to the 50S subunit of the bacterial ribosome, inhibiting protein synthesis by blocking peptide bond formation. It exhibits bacteriostatic activity against susceptible organisms.
| Metabolism | Clindamycin is primarily metabolized in the liver via oxidation to N-demethylclindamycin and sulfoxide metabolites. Some metabolism occurs via CYP3A4, but the overall contribution is minor. Approximately 10% of the drug is excreted unchanged in urine; the rest is excreted in bile and feces as metabolites. |
| Excretion | Approximately 10% of the administered dose is excreted unchanged in urine via glomerular filtration; about 90% is metabolized hepatically to inactive metabolites, which are excreted in bile and feces. Biliary excretion accounts for approximately 80% of total elimination, with enterohepatic recirculation. |
| Half-life | Terminal elimination half-life is 2-4 hours in adults with normal hepatic and renal function. In patients with severe hepatic impairment, half-life may increase to 8-12 hours. Renal impairment generally does not significantly alter half-life. In neonates, half-life ranges from 8-20 hours depending on gestational age. |
| Protein binding | Approximately 60-95% bound to plasma proteins, primarily to albumin. Binding is saturable and concentration-dependent, with higher free fraction at higher concentrations. |
| Volume of Distribution | Volume of distribution is approximately 0.6-1.2 L/kg. This exceeds total body water, indicating extensive tissue penetration. Clindamycin distributes well into bone, abscesses, and respiratory tissues; poor penetration into cerebrospinal fluid even with inflamed meninges. |
| Bioavailability | Intravenous: 100% bioavailable. Intramuscular: approximately 80-90% bioavailable. Oral: approximately 90% bioavailable (but not applicable for this IV formulation). Topical: systemic bioavailability less than 5%. |
| Onset of Action | Intravenous administration: Onset of antibacterial effect is rapid, with peak serum concentrations achieved immediately after infusion. Clinical response (reduction in fever, improvement in infection signs) typically within 24-48 hours. Intramuscular: Peak serum levels in 1-3 hours; clinical onset within 24-48 hours. Topical: Improvement in acne vulgaris lesions seen within 4-8 weeks. |
| Duration of Action | Serum concentrations decline over 6-8 hours; dosing interval is typically 6-8 hours due to rapid elimination. Clinical effect persists while serum levels exceed MIC; due to time-dependent killing, sustained levels are needed. Topical: once-daily application maintains effect; significant improvement seen by 4 weeks. |
1200-2700 mg/day IV divided every 6-12 hours; typical adult dose: 600-900 mg IV every 8 hours.
| Dosage form | INJECTABLE |
| Renal impairment | No dosage adjustment required for renal impairment; not significantly removed by hemodialysis. |
| Liver impairment | Severe hepatic impairment (Child-Pugh C): reduce dose by 50% or increase dosing interval; moderate impairment (Child-Pugh B): use with caution monitor liver function. |
| Pediatric use | Neonates: 15-20 mg/kg/day IV divided every 6-8 hours. Infants and children: 20-40 mg/kg/day IV divided every 6-8 hours. |
| Geriatric use | No specific dose adjustment; use with caution due to potential for decreased organ function and increased risk of Clostridioides difficile infection. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
May enhance the effects of neuromuscular blocking agents Causes severe and sometimes fatal Clostridium difficile-associated diarrhea.
| FDA category | Human |
| Breastfeeding | Clindamycin is excreted into human milk. The milk-to-plasma ratio (M/P) is approximately 0.5 to 1.0. Systemic absorption in the infant is minimal, but rare cases of bloody stools or diarrhea have been reported. Use with caution, weighing benefits against potential risks; monitor infant for gastrointestinal disturbances. |
| Teratogenic Risk |
■ FDA Black Box Warning
Clindamycin can cause severe and sometimes fatal colitis, including pseudomembranous colitis, due to Clostridium difficile overgrowth. This can occur during treatment or up to several weeks after discontinuation. If colitis is suspected, discontinue the drug and initiate appropriate therapy.
| Common Effects | Diarrhea (including C. difficile) |
| Serious Effects |
["Hypersensitivity to clindamycin, lincomycin, or any component of the formulation","History of pseudomembranous colitis associated with antibiotic use","Meningitis (do not use intrathecally or via IV for meningitis due to poor CNS penetration)"]
| Precautions | ["Clostridium difficile-associated diarrhea (CDAD): Can range from mild to fatal colitis; discontinue if significant diarrhea occurs.","Hypersensitivity reactions: Severe reactions including anaphylaxis, Stevens-Johnson syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.","Neuromuscular blocking agents: Clindamycin may enhance the action of neuromuscular blocking agents, use with caution.","Hepatic impairment: Use with caution in patients with hepatic impairment; monitor liver function.","Renal impairment: No dosage adjustment required for mild-moderate impairment, but caution in severe impairment.","Prolonged use: May result in overgrowth of nonsusceptible organisms, especially yeasts."] |
Loading safety data…
| Clindamycin crosses the placenta. Data from human studies are limited; however, based on animal studies and widespread clinical use, no specific teratogenic pattern has emerged. In first trimester, risk is considered low but cannot be ruled out; use only if clearly needed. In second and third trimesters, no evidence of fetal harm, but caution advised. The drug is classified as FDA Pregnancy Category B (prior to 2015 label change; current FDA labeling no longer uses categories). |
| Fetal Monitoring | Monitor maternal liver function and renal function if prolonged therapy. In neonates exposed in utero, monitor for possible alterations in gut flora and subsequent diarrhea. No specific fetal monitoring required, but consider fetal growth surveillance if used long-term. |
| Fertility Effects | No adverse effects on fertility have been reported in animal studies or human data. Clindamycin does not appear to impair fertility in either males or females. |