DORIBAX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DORIBAX (DORIBAX).
Doripenem is a carbapenem antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death. It has broad-spectrum activity against Gram-positive, Gram-negative, and anaerobic bacteria.
| Metabolism | Doripenem is minimally metabolized by hydrolysis of the beta-lactam ring to an inactive metabolite. It is primarily excreted unchanged in the urine by glomerular filtration and active tubular secretion. |
| Excretion | Renal: approximately 70-75% unchanged in urine; biliary/fecal: minimal (less than 20% total, primarily as metabolite). |
| Half-life | Terminal elimination half-life approximately 1 hour in healthy adults; prolonged to ~4 hours in renal impairment (CrCl <30 mL/min). |
| Protein binding | Approximately 8-10%, primarily to albumin. |
| Volume of Distribution | Vd approximately 0.15-0.25 L/kg; indicates distribution primarily into extracellular fluid. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate (within minutes) following infusion completion. |
| Duration of Action | Dosing interval dependent on renal function; typically 8 hours in normal renal function, extended to 12-24 hours in renal impairment. |
| Action Class | Cell wall active agent -Carbapenems |
| Brand Substitutes | Midonem 500mg Injection, Doritrum 500mg Injection, Pendru 500mg Injection, Doriblast 500mg Injection, Doror 500mg Injection |
1 g IV every 8 hours over 1 hour for complicated intra-abdominal infections, complicated urinary tract infections (including pyelonephritis), and hospital-acquired pneumonia (including ventilator-associated pneumonia).
| Dosage form | INJECTABLE |
| Renal impairment | CrCl >50 mL/min: 1 g every 8 hours. CrCl 30-50: 500 mg every 8 hours. CrCl 10-29: 250 mg every 8 hours. CrCl <10: 250 mg every 12 hours. Administer after hemodialysis. |
| Liver impairment | No dose adjustment required for hepatic impairment. Not studied in Child-Pugh classes; monitor for adverse effects. |
| Pediatric use | For ages 9 months to 17 years: 20 mg/kg IV every 8 hours (max 1 g/dose) over 1 hour for complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired pneumonia. |
| Geriatric use | Dose based on renal function. Caution due to age-related decreased renal function and increased risk of adverse reactions. Monitor renal function and adjust dose accordingly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DORIBAX (DORIBAX).
| Breastfeeding | It is not known if doripenem is excreted in human milk. No M/P ratio available. Caution is advised when administered to a nursing woman. |
| Teratogenic Risk | Doripenem is classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal harm, but adequate well-controlled studies in pregnant women are lacking. No specific trimester risks are established; however, use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to doripenem or other carbapenems","Hypersensitivity to beta-lactam antibiotics (e.g., penicillins, cephalosporins)"]
| Precautions | ["Hypersensitivity reactions, including anaphylaxis","Seizures and other CNS adverse events, especially in patients with renal impairment or CNS disorders","Clostridioides difficile-associated diarrhea","Reduced efficacy in ventilator-associated pneumonia due to Acinetobacter species","Development of drug-resistant bacteria"] |
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| Monitor for signs of hypersensitivity reactions, superinfection, and diarrhea suggestive of Clostridium difficile colitis. No specific fetal monitoring required beyond routine prenatal care. |
| Fertility Effects | No human data on fertility. Animal studies have not shown impaired fertility at clinically relevant doses. |