CLEOCIN T
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLEOCIN T (CLEOCIN T).
Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, suppressing peptide bond formation. It exhibits bacteriostatic activity against susceptible organisms.
| Metabolism | Clindamycin is primarily metabolized by the liver via CYP3A4 to active and inactive metabolites. |
| Excretion | Clindamycin is primarily eliminated via hepatic metabolism and biliary excretion. Approximately 10% of the active drug is excreted renally, with the remainder as inactive metabolites in feces (biliary/fecal route). |
| Half-life | The terminal elimination half-life in adults with normal renal and hepatic function is approximately 2-3 hours. In severe hepatic impairment, half-life may increase to 5-6 hours. No significant alteration in renal impairment. |
| Protein binding | Clindamycin is approximately 90-94% bound to plasma proteins, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | The apparent volume of distribution (Vd) is approximately 0.6-1.0 L/kg, indicating extensive distribution into tissues and fluids, including bone, synovial fluid, and peritoneal fluid. |
| Bioavailability | Oral: approximately 90% bioavailability. Topical: systemic absorption is minimal (approximately 5-10%). |
| Onset of Action | Topical: onset of clinical improvement is typically seen within 2-4 weeks of regular application. Oral/IV: systemic effects begin within 1-2 hours for acute infections. |
| Duration of Action | Topical: duration of action after application is approximately 8-12 hours, requiring twice-daily application. Systemic: duration varies with dose; typically 6-8 hours for bacteriostatic effect. |
| Molecular Weight | 424.99 |
Apply a thin film of 1% solution or gel twice daily to affected skin areas.
| Dosage form | GEL |
| Renal impairment | No dose adjustment required for topical use. |
| Liver impairment | No dose adjustment required for topical use. |
| Pediatric use | Approved for use in pediatric patients aged 12 years and older; same dosing as adults. Safety and efficacy in children under 12 years not established. |
| Geriatric use | No specific dose adjustment recommended; use same dosing as younger adults. |
| 1st trimester | Topical clindamycin is poorly absorbed systemically; considered safe during the first trimester for acne vulgaris. Systemic use is generally avoided due to potential risk of congenital anomalies (limited data, but some studies suggest no major teratogenic risk). |
| 2nd trimester | Topical use is safe. Systemic use may be used cautiously if benefit outweighs risk; no known harm. |
| 3rd trimester | Topical use is safe. Systemic clindamycin can be used for short-term therapy; theoretical risk of C. difficile colitis in neonate if used near term. |
Clinical note
Comprehensive clinical and safety monograph for CLEOCIN T (CLEOCIN T).
| Placental transfer | Clindamycin crosses the placenta. Fetal serum concentrations reach 20-60% of maternal levels after maternal intravenous dosing. Limited data on topical absorption; systemic absorption is <5% after topical application. |
| Breastfeeding | Topical clindamycin is minimally absorbed; risk to infant is low. Systemic clindamycin is excreted into breast milk in small amounts (milk:plasma ratio ~0.2-0.7); may cause gastrointestinal disturbances (e.g., diarrhea, thrush) in nursing infants. Use with caution, especially if infant is premature or ill. Monitor infant for loose stools or rash. |
■ FDA Black Box Warning
Clindamycin can cause severe and sometimes fatal colitis, including Clostridioides difficile-associated diarrhea (CDAD).
| Serious Effects |
History of pseudomembranous colitisHypersensitivity to clindamycin or lincomycinRegional enteritis (Crohn's disease)Ulcerative colitisAntibiotic-associated colitis
| Precautions | Risk of Clostridioides difficile-associated diarrhea, which may range from mild diarrhea to fatal colitis., Overgrowth of nonsusceptible organisms including fungi with prolonged use., Neuromuscular blocking effects may enhance action of other neuromuscular blocking agents., Renal and hepatic impairment require dose adjustment for systemic use. |
| Food/Dietary | No known food interactions. Topical clindamycin is minimally absorbed systemically, making dietary interactions unlikely. However, if systemic absorption occurs (rare), effects similar to oral clindamycin may apply: avoid consumption of alcohol and products containing caffeine as they may increase gastrointestinal side effects such as diarrhea. |
Loading safety data…
| Lactation Rating | L2 (Probably Compatible) for topical; L3 (Moderately Safe) for systemic |
| Teratogenic Risk | Clindamycin (CLEOCIN T) is FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, but adequate human studies in pregnant women are lacking. It crosses the placenta. No specific teratogenic patterns have been consistently reported. Use only if clearly needed, especially during the first trimester. |
| Fetal Monitoring | No specific fetal monitoring is required. Monitor mother for adverse effects such as pseudomembranous colitis (C. difficile infection) and hypersensitivity reactions. Assess clinical response to therapy. Routine prenatal care including ultrasound as indicated. |
| Fertility Effects | No evidence that clindamycin adversely affects fertility in humans. No animal studies have shown impairment of fertility. |
| Clinical Pearls | Cleocin T (clindamycin phosphate 1% topical solution) is a lincosamide antibiotic primarily used for acne vulgaris. It is bacteriostatic against Propionibacterium acnes and reduces inflammatory lesions. Apply sparingly to affected areas; excessive use increases irritation without improving efficacy. Avoid use in patients with a history of pseudomembranous colitis, regional enteritis, or antibiotic-associated colitis. Can be used concurrently with benzoyl peroxide or retinoids but apply at different times to reduce irritation. Not recommended for monotherapy due to emerging resistance; combination therapy is preferred. Store at room temperature and keep away from heat. |
| Patient Advice | Apply a thin film to affected areas twice daily, such as morning and evening. · Wash the affected area gently before application using mild soap; pat dry. · Avoid contact with eyes, mouth, and mucous membranes; if contact occurs, rinse with cool water. · Do not use more than prescribed; overuse increases risk of skin irritation. · May cause transient stinging or burning; if severe, reduce frequency or discontinue. · Notify your healthcare provider if you develop severe diarrhea, abdominal cramps, or blood in stool; these may indicate pseudomembranous colitis. · Avoid using other topical acne products without consulting your provider; interaction may cause excessive dryness. · Inform your provider if you are pregnant, planning to become pregnant, or breastfeeding. · It may take 2 to 6 weeks to see improvement; continue use as directed. |