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. |
| Molecular Weight | 418.5 |
| 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 | Avoid; associated with potential teratogenicity in animal studies. |
| 2nd trimester | Use only if clearly needed; risk of fetal adverse effects. |
| 3rd trimester | Avoid; risk of kernicterus or other neonatal toxicity. |
Clinical note
Comprehensive clinical and safety monograph for MANDOL (MANDOL).
| Placental transfer | Crosses placenta; reaches therapeutic concentrations in fetal serum. |
| Breastfeeding | Excreted into breast milk in low concentrations; potential for modification of infant gut flora, hypersensitivity, or diarrhea. Use with caution. |
| Lactation Rating | L2 (Limited data - probably compatible) |
■ FDA Black Box Warning
None.
| Serious Effects |
History of immediate hypersensitivity reaction to cephalosporins or penicillinsCefamandole allergy
| 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. |
| Food/Dietary | Avoid alcohol and any foods or medications containing alcohol (e.g., certain elixirs, extracts) during therapy and for 48 hours after the last dose because of disulfiram-like reaction. No other significant food interactions. |
Loading safety data…
| 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. |
| 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. |
| Clinical Pearls |
| MANDOL (cefamandole) is a second-generation cephalosporin with activity against gram-positive cocci and gram-negative bacilli, including H. influenzae and Enterobacter. It has a disulfiram-like reaction with alcohol due to the N-methylthiotetrazole side chain. Prophylactic use in surgery is common; adjust dose in renal impairment (CrCl <50 mL/min). May cause hypoprothrombinemia; monitor PT in patients at risk. |
| Patient Advice | Take exactly as prescribed; finish the full course even if you feel better. · Avoid alcohol and alcohol-containing products during treatment and for 48 hours after last dose; may cause severe nausea, vomiting, flushing, and headache. · Notify your doctor if you have a history of bleeding disorders or are taking blood thinners (e.g., warfarin). · Common side effects include diarrhea, nausea, and rash; report severe diarrhea or unusual bleeding/bruising. · If you are diabetic, this drug may cause false-positive urine glucose tests; use glucose-specific testing methods. |