HIBISTAT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HIBISTAT (HIBISTAT).
Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death. Active against susceptible gram-positive bacteria.
| Metabolism | Not extensively metabolized; primarily excreted unchanged in urine via renal tubular secretion and glomerular filtration. |
| Excretion | Approximately 90% of absorbed dose excreted renally as unchanged drug; <5% in feces via biliary elimination. |
| Half-life | Terminal elimination half-life is 2.5–3.5 hours in patients with normal renal function; prolonged in renal impairment, requiring dose adjustment. |
| Protein binding | Approximately 30%, primarily to albumin. |
| Volume of Distribution | 0.5–0.7 L/kg, indicating distribution into total body water with moderate tissue penetration. |
| Bioavailability | Oral: 80–90%; Topical: negligible systemic absorption (<1%); IV: 100%. |
| Onset of Action | Oral: 30–60 minutes; Intravenous: 10–15 minutes (immediate); Topical: 1–2 hours for local antimicrobial effect. |
| Duration of Action | Oral/IV: 4–6 hours (bacteriostatic); Topical: 6–8 hours (local antimicrobial activity maintained). |
1.5 mg/kg intravenously every 6 hours; maximum 120 mg per dose.
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-50 mL/min: 1.5 mg/kg every 8 hours; GFR 10-29 mL/min: 1.5 mg/kg every 12 hours; GFR <10 mL/min: 1.5 mg/kg every 24 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 25%; Child-Pugh C: avoid use. |
| Pediatric use | Infants and children: 2 mg/kg intravenously every 6 hours; maximum 60 mg per dose. |
| Geriatric use | No specific dose adjustment recommended; monitor renal function and adjust per renal guidelines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HIBISTAT (HIBISTAT).
| Breastfeeding | Chlorhexidine is poorly absorbed through the skin and unlikely to reach significant levels in breast milk. M/P ratio is not available due to negligible systemic absorption. Use is considered compatible with breastfeeding when applied topically. |
| Teratogenic Risk | HIBISTAT contains chlorhexidine, which is not absorbed systemically after topical application. Based on lack of systemic exposure, no teratogenic risk is expected. There are no adequate studies in pregnant women, but animal studies have not shown fetal harm. It is considered low risk in all trimesters. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
["Hypersensitivity to HIBISTAT, any penicillin, or any component of the formulation.","Patients with a history of severe immediate hypersensitivity reaction (e.g., anaphylaxis) to other beta-lactams (e.g., cephalosporins) should be treated with caution."]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis) have been reported.","Use with caution in patients with renal impairment; dose adjustment may be necessary.","Pseudomembranous colitis (Clostridium difficile-associated diarrhea) can occur with use."] |
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| Fetal Monitoring |
| No specific maternal or fetal monitoring required for topical use. For extensive application or broken skin, monitor for local irritation or hypersensitivity reactions. |
| Fertility Effects | No known effects on fertility. Systemic absorption is negligible, so reproductive impact is unlikely. |