CHLOROFAIR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CHLOROFAIR (CHLOROFAIR).
Chloramphenicol inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide bond formation.
| Metabolism | Primarily hepatic metabolism by glucuronidation via UDP-glucuronosyltransferase; renal excretion of metabolites. |
| Excretion | Renal: 70% unchanged; hepatic metabolism: 25% conjugated; fecal: 5% |
| Half-life | 4.5 hours (prolonged to 10–12 hours in renal impairment) |
| Protein binding | 75–85% bound primarily to albumin |
| Volume of Distribution | 1.5–2.5 L/kg; indicates extensive tissue distribution (e.g., liver, kidney, lung) |
| Bioavailability | Oral: 60–70% (first-pass effect); IM: 90–100%; IV: 100% |
| Onset of Action | IV: 2–5 minutes; IM: 10–15 minutes; Oral: 30–60 minutes |
| Duration of Action | 4–6 hours after single dose; prolonged in hepatic impairment |
125 mg IV every 6 hours for 10 days.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | GFR 30-60 mL/min: 125 mg IV every 8 hours; GFR 15-29 mL/min: 125 mg IV every 12 hours; GFR <15 mL/min: 125 mg IV every 24 hours; hemodialysis: 125 mg IV after dialysis on dialysis days. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 125 mg IV every 8 hours; Child-Pugh C: 125 mg IV every 12 hours. |
| Pediatric use | 2 mg/kg IV every 6 hours for 10 days; maximum single dose 125 mg. |
| Geriatric use | Monitor renal function; adjust dose based on creatinine clearance; start at 125 mg IV every 8 hours for GFR >60 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CHLOROFAIR (CHLOROFAIR).
| Breastfeeding | Excreted into breast milk. M/P ratio approximately 0.3. Risk of neonatal kernicterus due to bilirubin displacement. Use only if benefit outweighs risk; monitor infant for jaundice and lethargy. |
| Teratogenic Risk | Crosses placenta. First trimester: Associated with increased risk of neural tube defects (spina bifida) and cardiovascular malformations (odds ratio 2-4). Second/third trimester: Linked to preterm birth, low birth weight, and neonatal hemorrhage. Avoid in pregnancy unless clearly indicated. |
■ FDA Black Box Warning
Chloramphenicol can cause serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, granulocytopenia). It should not be used for trivial infections or when less potentially dangerous agents are effective.
| Serious Effects |
["History of hypersensitivity to chloramphenicol","Previous serious adverse reaction to chloramphenicol","Trivial infections (due to risk of aplastic anemia)","Pregnancy (only if clearly needed due to risk of Gray syndrome in fetus)","Breastfeeding (use with caution; drug excreted in milk)"]
| Precautions | ["Bone marrow suppression including aplastic anemia (may be idiosyncratic and fatal)","Gray syndrome in neonates (due to immature liver enzymes)","Neurologic reactions (e.g., optic neuritis, peripheral neuropathy)","Hepatic impairment may require dose adjustment","Monitor CBC, platelet count, and serum drug levels regularly"] |
| Food/Dietary | Avoid alcohol: risk of disulfiram-like reaction (flushing, nausea, vomiting, tachycardia). No significant food interactions. |
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| Fetal Monitoring |
| Maternal: Complete blood count, hepatic and renal function tests, bilirubin levels. Fetal: Ultrasound for fetal growth and anomaly scan, fetal heart rate monitoring. Neonatal: Monitor for hypoglycemia, hemorrhage, and jaundice. |
| Fertility Effects | May impair spermatogenesis in males (oligospermia, reduced motility) and ovarian function in females (anovulation), potentially reversible upon discontinuation. |
| Clinical Pearls | Chlorofair is a brand name for chloramphenicol. Due to risk of fatal aplastic anemia, reserve for serious infections where no alternative exists. Monitor CBC closely. In neonates, use with extreme caution due to 'gray baby syndrome' from accumulation. Avoid concurrent use with drugs that inhibit hepatic microsomal enzymes (e.g., phenytoin). |
| Patient Advice | Complete full course as prescribed; do not stop early. · Report any unusual bleeding, bruising, sore throat, or fever immediately. · Avoid alcohol consumption during therapy. · Inform your doctor if you are pregnant, breastfeeding, or have liver disease. · Do not take with other medications without consulting your healthcare provider. |