CLEOCIN HYDROCHLORIDE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLEOCIN HYDROCHLORIDE (CLEOCIN HYDROCHLORIDE).
Clindamycin hydrochloride is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S subunit of the ribosome, thereby interfering with peptide bond formation and chain elongation.
| Metabolism | Clindamycin is extensively metabolized in the liver, primarily by CYP3A4, to active and inactive metabolites. About 10% is excreted unchanged in urine and bile. |
| Excretion | Approximately 10% of the active drug is excreted in urine as unchanged clindamycin; about 3.6% in feces; remainder is metabolized primarily in liver. Renal excretion accounts for ~10% of elimination, biliary/fecal route accounts for ~90% including metabolites. |
| Half-life | Terminal elimination half-life is approximately 2.4 to 3.0 hours in adults with normal renal and hepatic function. In patients with severe hepatic impairment, half-life may be prolonged up to 8.5 hours. No significant change in renal impairment. |
| Protein binding | Approximately 93-94% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 0.6 to 1.2 L/kg, indicating wide distribution into body tissues and fluids, including bone, but does not cross the blood-brain barrier appreciably. |
| Bioavailability | Oral: approximately 87% (capsule); food does not significantly affect absorption. Intramuscular: 100% (absolute). |
| Onset of Action | Oral: 30-60 minutes; Intramuscular: 1-2 hours; Intravenous: rapid, within minutes. |
| Duration of Action | Serum levels exceed MIC for most susceptible organisms for 6-8 hours after oral or parenteral dosing. Duration may be prolonged in hepatic impairment. |
150-450 mg orally every 6 hours (oral capsules). Maximum dose: 1.8 g/day.
| Dosage form | CAPSULE |
| Renal impairment | No adjustment required for mild-to-moderate renal impairment. For severe renal impairment (CrCl <30 mL/min), dose interval should be increased to every 8-12 hours due to potential metabolite accumulation. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 50%. Child-Pugh Class C: avoid use or reduce dose by 75% with close monitoring. |
| Pediatric use | 10-30 mg/kg/day orally divided every 6-8 hours, maximum 1.8 g/day. For neonates: 15-20 mg/kg/day divided every 6-8 hours. |
| Geriatric use | No specific dose adjustment recommended, but monitor renal function and consider dose reduction if significant renal impairment present due to potential for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLEOCIN HYDROCHLORIDE (CLEOCIN HYDROCHLORIDE).
| Breastfeeding | Clindamycin is excreted into human breast milk with a milk-to-plasma ratio (M/P) of approximately 0.4-1.3. Limited data suggest low oral bioavailability in infants, but theoretical risk of gastrointestinal disturbances and sensitization. Use with caution, especially in neonates or preterm infants. The American Academy of Pediatrics considers clindamycin compatible with breastfeeding. |
| Teratogenic Risk | Clindamycin (CLEOCIN HYDROCHLORIDE) is classified as Pregnancy Category B. Animal studies have not demonstrated fetal risk, and there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. No documented teratogenicity in first trimester; second and third trimester risks are not increased based on cohort studies. |
■ FDA Black Box Warning
Clostridioides difficile-associated diarrhea (CDAD) can occur with clindamycin, ranging from mild diarrhea to fatal colitis. Clindamycin should be reserved for serious infections where less toxic antimicrobial agents are inappropriate.
| Serious Effects |
Hypersensitivity to clindamycin or lincomycin. Previous history of clindamycin-associated or other antibiotic-associated colitis. Use in neonates due to benzyl alcohol content in some formulations (risk of gasping syndrome).
| Precautions | Use may result in overgrowth of nonsusceptible organisms, particularly yeasts. Prolonged use should be avoided. Caution in patients with history of gastrointestinal disease, particularly colitis. Can cause neuromuscular blockade, use caution in patients with myasthenia gravis. |
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| Fetal Monitoring | Monitor maternal renal and hepatic function; prolonged use may necessitate monitoring for pseudomembranous colitis. Fetal monitoring not specifically required but standard obstetric monitoring applies. No known adverse fetal effects requiring specialized monitoring. |
| Fertility Effects | No evidence of impaired fertility in animal studies. Human data are lacking; however, clindamycin is not known to affect reproductive capacity in males or females. |