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. |
| Molecular Weight | 545.5 |
| 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 | Insufficient human data; animal studies show no evidence of harm. Use only if clearly needed. |
| 2nd trimester | Insufficient human data; limited animal studies show no teratogenicity. Use if benefit outweighs risk. |
| 3rd trimester | Insufficient human data; avoid near term due to potential for neonatal hypoglycemia (structurally related to fusidic acid). |
Clinical note
Comprehensive clinical and safety monograph for DORIBAX (DORIBAX).
| Placental transfer | Crosses placenta in animals; human data limited but likely crosses due to low molecular weight. |
| Breastfeeding | Not recommended during breastfeeding due to potential for infant hypoglycemia and gastrointestinal disturbance; drug excreted in milk in small amounts. |
| Lactation Rating |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to fusidic acid or any component of the formulationConcomitant use with statins metabolized by CYP3A4 (e.g., atorvastatin, simvastatin) due to increased risk of rhabdomyolysis
| 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 |
| Food/Dietary | No specific food restrictions. However, alcoholic beverages should be limited or avoided as they may increase the risk of gastrointestinal side effects and may interact with the underlying infectious process. |
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| L4 (Possibly Hazardous) |
| 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 | 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. |
| Clinical Pearls | Doribax (doripenem) is a carbapenem antibiotic with broad-spectrum activity against Gram-positive, Gram-negative, and anaerobic bacteria. It is FDA-approved for complicated intra-abdominal infections and complicated urinary tract infections. Due to its stability against many beta-lactamases, it is useful for resistant organisms. Dosing adjustment is required for renal impairment (CrCl <50 mL/min). It is administered IV over 1 hour; prolonged infusion (4 hours) may be used for more resistant organisms. Doripenem is not recommended for nosocomial pneumonia due to increased mortality seen in trials. It can cause seizures, especially with high doses or renal impairment. |
| Patient Advice | This medication is given intravenously (IV) by a healthcare provider. · You may experience diarrhea, nausea, headache, or injection site reactions. · Report any severe diarrhea, especially if watery or bloody, as this may indicate Clostridium difficile infection. · Inform your doctor if you have a history of seizures or kidney problems. · Do not stop treatment early, even if you feel better, unless directed by your doctor. |