CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER).
Clindamycin phosphate is a prodrug that is hydrolyzed to clindamycin, which reversibly binds to the 50S subunit of the bacterial ribosome, inhibiting protein synthesis by blocking peptide bond formation. It exhibits primarily bacteriostatic activity against susceptible gram-positive cocci and anaerobes.
| Metabolism | Clindamycin is primarily metabolized by the liver via CYP3A4 to active metabolites (clindamycin sulfoxide and N-demethylclindamycin) and inactive metabolites. Approximately 10% of the drug is excreted unchanged in urine, with the remainder as metabolites. |
| Excretion | Clindamycin is primarily eliminated via hepatic metabolism; approximately 10% is excreted unchanged in urine, 3.6% in feces, and the remainder as inactive metabolites in bile and urine. |
| Half-life | The terminal elimination half-life is approximately 2.4-3.0 hours in adults with normal renal and hepatic function; prolonged to 3-6 hours in hepatic impairment and up to 8-14 hours in severe hepatic disease. |
| Protein binding | Approximately 92-94% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution ranges from 0.6 to 1.2 L/kg, indicating extensive tissue penetration, including bone, abscess fluid, and bile. |
| Bioavailability | Bioavailability after intramuscular injection is approximately 87-100%; oral bioavailability is 90% for capsules and 87% for granules, but CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER is an intravenous formulation, thus bioavailability is 100% via the IV route. |
| Onset of Action | Intravenous administration produces therapeutic serum levels within minutes; onset of antimicrobial effect is immediate following infusion. |
| Duration of Action | Duration of action is 6-8 hours for antimicrobial effect, supporting every 6- to 8-hour dosing intervals. |
| Molecular Weight | 442.62 |
Clindamycin 600-2700 mg/day IV divided every 6-8 hours. For severe infections, up to 4800 mg/day IV may be given.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment. Clindamycin is not significantly removed by hemodialysis. |
| Liver impairment | In moderate to severe hepatic impairment (Child-Pugh B or C), reduce dose by 50-75% or increase dosing interval. Use with caution and monitor liver function. |
| Pediatric use | Neonates: 15-20 mg/kg/day IV divided every 6-8 hours. Children: 20-40 mg/kg/day IV divided every 6-8 hours. Maximum dose, 27 mg/kg/day in neonates. |
| Geriatric use | No specific dose adjustment based solely on age. Monitor for adverse effects, particularly gastrointestinal and hepatic. Consider renal function, though no adjustment needed. |
| 1st trimester | Generally considered safe; no evidence of fetal harm in human studies. Avoid if benefit does not outweigh risk. |
| 2nd trimester | Generally considered safe; indicated for treatment of bacterial vaginosis and other infections during pregnancy. |
| 3rd trimester | Generally considered safe; caution due to potential for neonatal diarrhea or pseudomembranous colitis if administered near term. |
Clinical note
Comprehensive clinical and safety monograph for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Placental transfer | Clindamycin crosses the placenta; fetal serum concentrations may reach 50% of maternal levels. |
| Breastfeeding | Clindamycin is excreted into human milk in low amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. However, caution is advised due to potential for gastrointestinal disturbances in the infant, such as diarrhea or bloody stools. Monitor infant for signs of colitis. |
■ FDA Black Box Warning
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
| Serious Effects |
Hypersensitivity to clindamycin, lincomycin, or any component of the formulationHistory of pseudomembranous colitisRegional enteritis or ulcerative colitis (unless treating infection)
| Precautions | Clostridium difficile associated diarrhea (CDAD) – monitor for diarrhea during and after therapy, Hypersensitivity reactions including anaphylaxis, Stevens-Johnson syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS), Neuromuscular blocking effects – may enhance action of neuromuscular blocking agents; use caution in patients with myasthenia gravis, Prolonged use may result in superinfection with non-susceptible organisms (e.g., Candida), Use with caution in patients with renal or hepatic impairment (dose adjustment may be necessary for severe disease), Injection site reactions (pain, induration, sterile abscess) with IV administration |
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| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | Clindamycin is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated fetal risk, but no adequate and well-controlled studies in pregnant women exist. Clindamycin crosses the placenta. Use only if clearly needed. First trimester: No known teratogenicity, but minimal data. Second/third trimester: Fetal exposure occurs; no documented adverse effects. |
| Fetal Monitoring | Monitor maternal liver function tests and renal function during prolonged therapy. No specific fetal monitoring required, but observe for maternal adverse effects (e.g., pseudomembranous colitis). |
| Fertility Effects | No evidence of impaired fertility from animal studies or human data. Clindamycin does not affect spermatogenesis or ovulation in limited studies. |
| Food/Dietary | No known food interactions. Avoid alcohol to reduce risk of gastrointestinal side effects. |
| Clinical Pearls | Clindamycin phosphate is a lincosamide antibiotic. This formulation is IV only, not for IM use. Monitor for pseudomembranous colitis due to C. difficile, which can occur during or after therapy. Rapid IV administration can cause hypotension and cardiac arrest; infuse over at least 10-60 minutes per 600 mg. Dose adjustment needed in hepatic impairment but not in renal impairment. Drug of choice for severe group A streptococcal infections and clostridial myonecrosis. Use with caution in neuromuscular disorders (e.g., myasthenia gravis) due to potential neuromuscular blockade. |
| Patient Advice | This medication is given intravenously (through a vein) to treat bacterial infections. · Complete the full course even if you feel better to prevent resistance. · Inform your healthcare provider if you develop severe or persistent diarrhea, as this could indicate a serious condition (C. difficile colitis). · Report any signs of allergic reaction such as rash, itching, or difficulty breathing. · Tell your doctor if you have a history of inflammatory bowel disease (e.g., Crohn's, ulcerative colitis) or neuromuscular disorders (e.g., myasthenia gravis). · Avoid alcohol during treatment and for at least 48 hours after to reduce risk of side effects. · No specific food interactions; maintain normal diet unless otherwise advised. |