UNIPEN IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for UNIPEN IN PLASTIC CONTAINER (UNIPEN IN PLASTIC CONTAINER).
Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), inhibiting transpeptidase activity and peptidoglycan cross-linking.
| Metabolism | Primarily hepatic metabolism via hydrolysis to penicilloic acid; minor renal elimination of unchanged drug. |
| Excretion | Renal: 60-90% unchanged via glomerular filtration and tubular secretion; biliary/fecal: minor, <10% |
| Half-life | 0.5-1 hour (normal renal function); prolonged to 2-5 hours in renal impairment |
| Protein binding | 40-60% primarily to albumin |
| Volume of Distribution | 0.3-0.5 L/kg, indicating limited tissue penetration |
| Bioavailability | IM: 60-100% (variable); oral: not available |
| Onset of Action | IV: immediate; IM: 10-20 minutes |
| Duration of Action | 4-6 hours (dose-dependent); clinical note: frequent dosing required due to short half-life |
250-500 mg intravenously or intramuscularly every 4-6 hours. Maximum dose 12 g per day.
| Dosage form | INJECTABLE |
| Renal impairment | Adults with GFR 10-50 mL/min: 250-500 mg every 6-8 hours. GFR <10 mL/min: 250-500 mg every 8-12 hours. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Children >20 kg: 12.5-25 mg/kg intravenously or intramuscularly every 4-6 hours. Maximum dose 12 g per day. Infants <7 days: 25 mg/kg every 8-12 hours. |
| Geriatric use | Dose selection should be cautious, starting at the lower end of the dosing range, due to decreased renal function and increased risk of adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for UNIPEN IN PLASTIC CONTAINER (UNIPEN IN PLASTIC CONTAINER).
| Breastfeeding | Excreted into breast milk in low concentrations. M/P ratio approximately 0.2. Considered compatible with breastfeeding; monitor infant for potential allergic reactions or diarrhea. |
| Teratogenic Risk | First trimester: Penicillins cross the placenta but no increased risk of major malformations based on large cohort studies. Second and third trimesters: No known fetal toxicity; risk of neonatal diarrhea or candidiasis with high maternal doses. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Known hypersensitivity to penicillins or cephalosporins; caution in hepatic impairment.
| Precautions | Severe hypersensitivity reactions (anaphylaxis) reported; monitor renal function in high-dose therapy; use caution in patients with cephalosporin allergy; Clostridioides difficile-associated diarrhea. |
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| Monitor maternal renal function, signs of hypersensitivity, and superinfection. Fetal monitoring indicated in high-risk pregnancies; no specific fetal monitoring required. |
| Fertility Effects | No known adverse effects on human fertility based on available data. |