MANDOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MANDOL (MANDOL).
Cephalosporin antibiotic; inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), disrupting peptidoglycan cross-linking.
| Metabolism | Not significantly metabolized; primarily eliminated unchanged by renal tubular secretion and glomerular filtration. |
| Excretion | Renal: 65-85% unchanged via glomerular filtration and tubular secretion; biliary/fecal: ~15-20% as active drug and metabolites; minor hepatic metabolism. |
| Half-life | Terminal elimination half-life is 1.2-1.8 hours in adults with normal renal function; prolonged to 4-8 hours in moderate renal impairment (CrCl 30-50 mL/min) and >12 hours in severe impairment (CrCl <30 mL/min). |
| Protein binding | ~30% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 0.16-0.25 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Intramuscular: ~100%. |
| Onset of Action | Intravenous: immediate; intramuscular: 15-30 minutes. |
| Duration of Action | Approximately 6-8 hours after IV/IM administration; dosing interval typically every 8 hours for moderate infections, adjusted for renal function. |
| Action Class | Opioids |
| Brand Substitutes | Tramatas Forte 50mg Tablet, TRUMP 50MG TABLET, Tramaflam 50mg Tablet, Safrodol 50mg Tablet, Tramacon 50mg Tablet, Wintram 50mg/ml Injection, Didol Injection, Pandol 50mg Injection, Tramosun Injection, Tramazol 50mg Injection |
1-2 g IV or IM every 4-8 hours; maximum 12 g/day.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 10-30 mL/min: 1-2 g every 8-12 hours; CrCl <10 mL/min: 1-2 g every 24-48 hours. |
| Liver impairment | No specific adjustment recommended; monitor for toxicity in severe hepatic impairment. |
| Pediatric use | Infants and children: 50-100 mg/kg/day IV/IM divided every 4-8 hours; severe infections: up to 150 mg/kg/day. |
| Geriatric use | Reduce initial dose based on renal function; monitor renal status. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MANDOL (MANDOL).
| Breastfeeding | Excreted into breast milk in low concentrations. M/P ratio not established; estimated <1. Considered compatible with breastfeeding as the amount is unlikely to cause adverse effects in the infant. Monitor infant for diarrhea, rash, or candidiasis. |
| Teratogenic Risk | Pregnancy category B. No evidence of fetal harm in animal studies; however, no adequate human studies in pregnant women. Use only if clearly needed. First trimester: theoretical risk based on animal data; not associated with major malformations. Second/third trimesters: no known fetal risks; cefamandole crosses the placenta in small amounts. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to cephalosporins or any component of the formulation.","Severe immediate hypersensitivity reactions to penicillins (cross-sensitivity)."]
| Precautions | ["Hypersensitivity reactions including anaphylaxis, particularly in patients with penicillin allergy.","Pseudomembranous colitis due to Clostridium difficile.","Renal impairment: dose adjustment required.","Coagulation abnormalities: monitor prothrombin time in patients at risk.","Superinfection with prolonged use."] |
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| Fetal Monitoring | Monitor maternal renal function and coagulation parameters (prolonged PT/INR due to MTT side chain). Assess for allergic reactions. Fetal monitoring not routinely required; consider nonstress test in high-risk pregnancies. |
| Fertility Effects | No known adverse effects on fertility. Animal studies show no impairment of fertility. |