BACTOCILL IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BACTOCILL IN PLASTIC CONTAINER (BACTOCILL IN PLASTIC CONTAINER).
Bactericidal; inhibits cell wall synthesis by binding to penicillin-binding proteins (PBPs), inhibiting transpeptidase activity essential for peptidoglycan cross-linking.
| Metabolism | Hepatic metabolism via unknown pathways; primarily excreted unchanged in urine via renal tubular secretion. |
| Excretion | Primarily renal (60-70% unchanged by tubular secretion and glomerular filtration); biliary/fecal excretion accounts for <30%. |
| Half-life | 30-60 minutes (mean 40 min) in adults with normal renal function; prolonged to 7-10 hours in anuria. Clinical context: dosing interval adjustment required in renal impairment. |
| Protein binding | 85-90% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 0.3-0.4 L/kg (approx 20-25 L in adults). Clinical meaning: limited distribution, primarily extracellular fluid. |
| Bioavailability | Intramuscular: 70-80%; oral: not applicable (inactivated by gastric acid). |
| Onset of Action | Intravenous: within 5-10 minutes; intramuscular: 15-30 minutes. |
| Duration of Action | 2-4 hours for susceptible bacteria; prolonged slightly with probenecid. Clinical notes: requires frequent dosing (every 4-6 hours) due to short half-life. |
1-2 g intravenously every 4 hours.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 30-60 mL/min: 1 g every 8-12 hours; CrCl 10-30 mL/min: 1 g every 12-24 hours; CrCl <10 mL/min: 1 g every 24-48 hours. |
| Liver impairment | No specific dose adjustment required for Child-Pugh A or B; Child-Pugh C: use with caution, monitor liver function. |
| Pediatric use | Neonates: 50-100 mg/kg/day divided every 6-12 hours; Infants and children: 100-200 mg/kg/day divided every 4-6 hours; maximum 12 g/day. |
| Geriatric use | Adjust based on renal function; monitor for neurotoxicity with high doses. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BACTOCILL IN PLASTIC CONTAINER (BACTOCILL IN PLASTIC CONTAINER).
| Breastfeeding | Oxacillin is excreted in human milk in low concentrations. The milk-to-plasma (M/P) ratio is not well established but is estimated to be low (<0.1). Non-dose-related effects could include alteration of infant gut flora and sensitization. Caution is advised; however, oxacillin is generally considered compatible with breastfeeding. No specific M/P ratio is available from pharmacokinetic studies. |
| Teratogenic Risk | BACTOCILL (oxacillin) is a penicillinase-resistant penicillin. Available data from a limited number of human pregnancies have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oxacillin administered IV to mice and rats at doses up to 8 times the human daily dose based on body surface area produced no evidence of fetal harm. However, adequate and well-controlled studies in pregnant women are lacking. Because animal reproduction studies are not always predictive of human response, oxacillin should be used during pregnancy only if clearly needed. Fetal risks by trimester: No specific trimester-specific risks have been identified. Use across all trimesters if indicated. |
■ FDA Black Box Warning
No FDA black box warnings.
| Serious Effects |
["Hypersensitivity to penicillins or beta-lactam antibiotics","History of acute, severe hypersensitivity reaction to other beta-lactams (e.g., carbapenems, cephalosporins)"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Clostridium difficile-associated diarrhea","Superinfection with resistant organisms","Neonates and infants: risk of kernicterus due to bilirubin displacement","Renal impairment: dose adjustment may be needed","Hematologic effects: neutropenia, agranulocytosis with prolonged use"] |
| Food/Dietary | No significant food interactions. Avoid alcohol as it may increase risk of hepatotoxicity. |
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| Fetal Monitoring | Monitor for signs of hypersensitivity reactions (rash, urticaria, anaphylaxis) in the mother. Periodic assessment of renal, hepatic, and hematopoietic function is recommended during prolonged therapy. No specific fetal monitoring is required; however, standard prenatal care should continue. Observe the neonate for potential adverse effects if maternal treatment occurs near delivery. |
| Fertility Effects | No adequate studies on fertility effects in humans. Animal studies have not shown impaired fertility at doses up to 8 times the human daily dose. No specific effects on male or female fertility are anticipated based on pharmacological class. |
| Clinical Pearls |
| BACTOCILL (oxacillin) is a penicillinase-resistant penicillin used for methicillin-susceptible staphylococcal infections. It requires renal dose adjustment; monitor for hepatotoxicity and neutropenia with prolonged use. Administer IV over 10-30 minutes; avoid rapid infusion due to risk of vein irritation. Check for cross-allergy with cephalosporins in penicillin-allergic patients. |
| Patient Advice | Complete the full course of antibiotics even if you feel better. · Report any signs of allergic reaction: rash, itching, difficulty breathing. · Take precautions to avoid vein irritation: report pain or redness at IV site. · Do not take this medication with probenecid without consulting your doctor. · Inform your doctor if you have kidney or liver disease, or history of colitis. |