CLEOCIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLEOCIN (CLEOCIN).
Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, blocking peptide bond formation.
| Metabolism | Clindamycin is primarily metabolized in the liver by CYP3A4, producing active metabolites (clindamycin sulfoxide and N-demethylclindamycin). |
| Excretion | Approximately 10% renal as active drug and metabolites, 90% fecal/biliary via enterohepatic circulation; <1% unchanged in urine. |
| Half-life | 2-3 hours in adults with normal renal function; prolonged to 8-12 hours in severe hepatic impairment; dialyzable but not clinically used for Clostridium difficile infection. |
| Protein binding | 90-95%, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.6-1.2 L/kg, penetrating well into bone, abscesses, and peritoneal fluid; not into CSF. |
| Bioavailability | Oral: 87-90% (clindamycin hydrochloride); topical gel: 2-5% systemic absorption; IV: 100%. |
| Onset of Action | Oral: 1-2 hours; IV: immediate; topical: 2-5 days for acne vulgaris. |
| Duration of Action | Oral/IV: 6-8 hours; topical: 6-12 hours; active against susceptible organisms for 24 hours post-dose. |
| Action Class | Lincosamides |
| Brand Substitutes | Acneclin Gel, Clincitop Gel, Aclind Gel, Clindamycin Phosphate Gel, Camyda Gel |
150-450 mg orally every 6 hours; 300-600 mg IM or IV every 6-8 hours; maximum 4.8 g/day IV.
| Dosage form | CREAM |
| Renal impairment | No adjustment needed for mild to moderate renal impairment; for severe renal failure (GFR <30 mL/min), consider extending interval to 8-12 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50% or extend interval; Child-Pugh C: avoid use or reduce dose by 75% and monitor levels. |
| Pediatric use | 10-25 mg/kg/day orally in 3-4 divided doses; 20-40 mg/kg/day IV or IM in 3-4 divided doses; maximum 4 g/day. |
| Geriatric use | No specific dose adjustment; monitor renal function and use lower end of dosing range due to potential age-related decline in renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLEOCIN (CLEOCIN).
| Breastfeeding | Clindamycin is excreted into human breast milk. The milk-to-plasma (M/P) ratio is approximately 0.1-0.5. The relative infant dose is estimated to be less than 1% of the maternal weight-adjusted dose. While considered compatible with breastfeeding by the American Academy of Pediatrics, caution is advised due to potential gastrointestinal effects (e.g., diarrhea, blood in stools) or sensitization in the infant. Monitor the infant for any adverse effects. |
| Teratogenic Risk | Clindamycin (CLEOCIN) is classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, and there are no adequate well-controlled studies in pregnant women. However, clindamycin crosses the placenta. There is no evidence of teratogenicity in humans, but use in the first trimester should be avoided unless clearly needed. For second and third trimesters, use is generally considered safe if indicated, such as for treatment of bacterial vaginosis or group B streptococcus prophylaxis. |
■ FDA Black Box Warning
Clindamycin can cause severe and sometimes fatal colitis, including pseudomembranous colitis, due to Clostridium difficile overgrowth; this must be considered in patients presenting with diarrhea after antibiotic use.
| Serious Effects |
["Hypersensitivity to clindamycin, lincomycin, or any component of the formulation","History of antibiotic-associated colitis","Bacterial meningitis (due to poor CNS penetration)","Neonates (formulations containing benzyl alcohol may cause gasping syndrome)"]
| Precautions | ["Risk of Clostridium difficile-associated diarrhea (CDAD)","Hypersensitivity reactions, including anaphylaxis","Neuromuscular blocking effects (may enhance action of neuromuscular blocking agents)","Hepatic impairment (use with caution)","Renal impairment (no dose adjustment needed for oral forms; for IV, adjust in severe renal failure)","Prolonged use may result in superinfection with non-susceptible organisms"] |
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| Fetal Monitoring | No specific routine monitoring required beyond standard obstetric care. If used for group B streptococcus prophylaxis during labor, monitor for signs of anaphylaxis or severe adverse reactions in the mother. In prolonged therapy, monitor liver function tests and renal function periodically. |
| Fertility Effects | Clindamycin has no known adverse effects on fertility in animal studies. There are no human data suggesting impairment of fertility. No specific effects on reproductive function have been reported. |