PHISOHEX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PHISOHEX (PHISOHEX).
Disrupts bacterial cell wall synthesis by binding to the bacterial ribosome and inhibiting protein synthesis; also has surfactant properties that disrupt bacterial cell membrane integrity.
| Metabolism | Primarily excreted unchanged in urine; minor hepatic metabolism via glucuronidation. |
| Excretion | Renal (biliary/fecal negligible). Up to 10% of dose excreted unchanged in urine; remainder as metabolites (glucuronide and sulfate conjugates). |
| Half-life | Terminal elimination half-life approximately 6-7 hours in adults with normal renal function. Prolonged in renal impairment (up to 20 hours) due to reduced clearance of active metabolite (pentachlorophenol). |
| Protein binding | Hexachlorophene is highly protein-bound (approximately 90-95%), primarily to albumin. |
| Volume of Distribution | Vd approximately 1.5-2.0 L/kg, indicating extensive tissue distribution, particularly to skin and fat. Accumulation can occur with prolonged topical use. |
| Bioavailability | Topical: Percutaneous absorption is 3-10% of applied dose, depending on skin integrity and area. Oral: Not applicable; systemic use avoided. IV: Not formulated. |
| Onset of Action | Topical (skin): Antimicrobial effect begins within 15-30 minutes after application. Not used systemically due to toxicity. |
| Duration of Action | Topical: Residual antimicrobial activity persists for up to 6 hours after a single application. Cumulative effect with repeated use may extend coverage. |
Apply topically as a 3% emulsion to affected area, rinse thoroughly; typically used 1-2 times daily for up to 10 days.
| Dosage form | EMULSION |
| Renal impairment | No specific dose adjustment required; however, avoid prolonged use in patients with renal impairment due to potential systemic absorption of hexachlorophene. |
| Liver impairment | Contraindicated in patients with severe hepatic impairment (Child-Pugh class C); avoid use in any hepatic impairment due to risk of neurotoxicity from hexachlorophene accumulation. |
| Pediatric use | Do not use in infants younger than 2 months. For children 2 months and older, apply topically as a 3% emulsion; avoid use on large areas of broken skin or for prolonged periods. |
| Geriatric use | Use with caution; apply sparingly to small areas and avoid prolonged use due to increased risk of systemic absorption and neurotoxicity in elderly patients with potentially compromised skin barrier. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PHISOHEX (PHISOHEX).
| Breastfeeding | Hexachlorophene is excreted in breast milk. M/P ratio not established. Avoid use in nursing mothers due to risk of neurotoxicity in infants. |
| Teratogenic Risk | PHISOHEX (hexachlorophene) is contraindicated in pregnancy. First trimester: Risk of teratogenicity based on animal studies showing fetal toxicity and malformations. Second and third trimesters: Potential for neurotoxicity and systemic absorption through skin, especially in premature infants; avoid use. |
| Fetal Monitoring |
■ FDA Black Box Warning
There is no FDA black box warning for pHisoHex.
| Serious Effects |
Hypersensitivity to hexachlorophene; use on burned or denuded skin; use on mucous membranes; use as a wet dressing or pack; use in neonates (especially premature infants) due to risk of neurotoxicity.
| Precautions | Can cause CNS toxicity including convulsions, especially in neonates or patients with burns or denuded skin; avoid use on open wounds or mucous membranes; rinse thoroughly after use; do not use as a preoperative shower or full-body bath due to risk of neurotoxicity. |
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| Monitor for signs of systemic toxicity (e.g., CNS depression, seizures) in both mother and fetus/newborn. Avoid use on broken skin or mucous membranes in pregnant women. |
| Fertility Effects | No specific human data on fertility effects. Animal studies have shown reduced fertility at high doses; however, clinical relevance is uncertain due to limited systemic absorption with topical use. |