PATHOCIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PATHOCIL (PATHOCIL).
Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), thereby inhibiting transpeptidation and leading to cell lysis.
| Metabolism | Hepatic metabolism via hydrolysis to penicilloic acid and other metabolites; renal excretion of unchanged drug and metabolites. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 70-80% of elimination; biliary excretion contributes about 5-10%; fecal elimination is minor (<5%). |
| Half-life | Terminal elimination half-life is 0.5-1 hour (normal renal function). In renal impairment, may extend to 3-4 hours; thus dose adjustment is required when creatinine clearance <30 mL/min. |
| Protein binding | Approximately 75-85% bound to serum albumin. |
| Volume of Distribution | Volume of distribution is 0.2-0.3 L/kg, indicating limited distribution primarily into extracellular fluid. |
| Bioavailability | Oral bioavailability is approximately 40-60% due to first-pass hepatic metabolism. |
| Onset of Action | Intravenous: within 5-15 minutes; intramuscular: 15-30 minutes. Oral: 30-60 minutes. |
| Duration of Action | Intravenous/intramuscular: 4-6 hours; oral: 4-6 hours. Clinical note: short duration necessitates frequent dosing (every 6 hours) for sustained effect. |
250-500 mg orally every 6 hours or 1-2 g intravenously every 4-6 hours.
| Dosage form | CAPSULE |
| Renal impairment | GFR 10-50 mL/min: 250-500 mg every 8-12 hours. GFR <10 mL/min: 250-500 mg every 12-18 hours. |
| Liver impairment | No adjustment required for mild to moderate hepatic impairment. Severe hepatic impairment (Child-Pugh C): reduce dose by 50%. |
| Pediatric use | Children: 12.5-25 mg/kg orally every 6 hours or 50-100 mg/kg/day intravenously divided every 6 hours. Maximum 4 g/day. |
| Geriatric use | Use lower end of dosing range (250 mg orally every 6 hours or 1 g intravenously every 6 hours) due to age-related renal function decline; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PATHOCIL (PATHOCIL).
| Breastfeeding | Not known if excreted in human milk. Caution advised. M/P ratio not available. |
| Teratogenic Risk | Pregnancy Category B. Animal studies have not demonstrated fetal risk, but no adequate human studies in pregnant women. Use only if clearly needed. First trimester: No evidence of teratogenicity. Second and third trimesters: FDA Category B, no known risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Known hypersensitivity to penicillins","History of anaphylactic reaction to beta-lactam antibiotics"]
| Precautions | ["Serious and occasionally fatal hypersensitivity (anaphylactic) reactions","Clostridioides difficile-associated diarrhea (CDAD)","Renal impairment: dose adjustment may be necessary","Use caution in patients with history of allergy to cephalosporins or other beta-lactams"] |
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| Monitor maternal renal and hepatic function. Fetal assessment via ultrasound if used in pregnancy. |
| Fertility Effects | No known effect on fertility in animal studies. |