pHisoHex

Generic Name: Hexachlorophene
Class: Local Anti-infectives, Miscellaneous
ATC Class: D08AE01
VA Class: DE400
Chemical Name: Phenol, 2,2’-methylenebis[3,4,6-trichloro-]
Molecular Formula: C13H6Cl6O2
CAS Number: 70-30-4

Introduction

Antibacterial.a b

Uses for pHisoHex

Surgical Hand Antisepsis

Used by health-care personnel as a preoperative hand scrub to prevent spreading of cutaneous microorganisms from hands and forearms during surgery.a b

Antiseptic Skin Cleanser

Used topically as a disinfectant by health-care personnel, food handlers, and other individuals who are in a position to spread infection from their hands.a

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Used topically to control cutaneous gram-positive infections where other infection control procedures have been unsuccessful.a b Use only as long as necessary for infection control.a b

Not indicated for bathing infants as prophylaxis against staphylococcal infections because of serious adverse effects.a (See Pediatric Use under Cautions.)

pHisoHex Dosage and Administration

Administration

Topical Administration

Apply topically to skin as a 3% emulsion.a

For external use only; avoid contact with the eyes.a b If contact occurs, rinse thoroughly.a b Do not apply to mucous membranes.a b

Rinse thoroughly after use.b

Apply to the head and periorbital skin areas only in responsive patients with unanesthetized eyes.b

Do not pour into measuring cups, medicine bottles, or similar containers since they may be mistaken for baby formula or other medications.b

Dosage

Adults

Surgical Hand Antisepsis
Topical

Wet hands and forearms with water.a b Apply approximately 5 mL of emulsion onto hands and rub into a copious lather by adding small amounts of water.a b Spread suds over hands and forearms and scrub well with a wet brush for 3 minutes.a b Pay particular attention to nails and interdigital spaces; a separate nail cleanser may be used.a b After scrubbing, rinse hands and forearms thoroughly under running water.a b Apply a second 5-mL application and scrub hands and forearms for an additional 3 minutes.a b Rinse hands and forearms thoroughly with running water and dry.a b

For additional surgical scrubs during the same day, repeat above procedure using 5 mL for 3 minutes only.a b Rinse thoroughly with water and dry.a b

Antiseptic Skin Cleanser
Topical

Wet hands with water; apply approximately 5 mL into the palm, work up a lather with water, and apply to area to be cleansed.a b Rinse thoroughly after each washing.a b

Special Populations

No special population dosage recommendations at this time.a b

Cautions for pHisoHex

Contraindications

  • Application to burned or denuded skin.b

  • Use as an occlusive dressing, wet pack, or lotion.b

  • Routine prophylactic total body bathing.b

  • Use as a vaginal pack or tampon, or on any mucous membranes.b

  • Known primary light sensitivity to halogenated phenol derivatives. b (See Cross-hypersensitivity under Cautions.)

  • Known hypersensitivity to hexachlorophene or any ingredient in the formulation.b

Warnings/Precautions

Warnings

Neurotoxicity

Possibility of rapid and extensive absorption of hexachlorophene following topical application to generalized dermatologic conditions (e.g., lesions of ichthyosis congenita, dermatitis of Letterer-Siwe syndrome) or burns; may result in toxic serum concentrations and CNS toxicity including potentially fatal neurotoxicity (e.g., CNS stimulation, irritation, seizures).a b Rinse thoroughly after each use.a b

Monitor closely and discontinue promptly if signs or symptoms of cerebral irritability occur.b

Sensitivity Reactions

Cross-hypersensitivity

Possible cross-sensitivity of hexachlorophene and halogenated phenol derivatives; use not recommended in individuals who have demonstrated primary light sensitivity to halogenated phenol derivatives.a b

General Precautions

Administration Precautions

Avoid contact with the eyes.a b If contact occurs, rinse thoroughly.a b Apply to the head and periorbital skin areas only in responsive patients with unanesthetized eyes.b

Rinse thoroughly after use, especially from sensitive areas (e.g., scrotum, perineum).b

Harmful if swallowed, especially to infants and children.b Do not pour into measuring cups, medicine bottles, or similar containers since they may be mistaken for baby formula or other medications.b

Specific Populations

Pregnancy

Category C.b

Lactation

Not known whether hexachlorophene is distributed into milk.b Use not recommended.b

Pediatric Use

Use with caution and only when necessary on infants.b

Infants, especially premature infants or those with dermatoses, are at greater risk of absorption and subsequent systemic toxicity (i.e., CNS stimulation, convulsions).a b Discontinue at the first signs of neurotoxicity (stimulation of the CNS, convulsions, clonic muscular contractions, decerebrate rigidity) or dermatitis. b (See Neurotoxicity under Cautions.)

Dermatitis, irritability, generalized clonic muscular contractions, and decerebrate rigidity reported in infants following topical application of hexachlorophene.b Do not use routinely for bathing infants.b Positive correlation between hexachlorophene baths and brain lesions in premature infants.b

Geriatric Use

Response in patients ≥65 years of age does not appear to differ from that in younger adults; however, use with caution due to greater frequency of dermatologic disease and peripheral circulatory disease and decreased propensity for wound healing. b

Common Adverse Effects

Dermatitis, photosensitivity, redness and/or mild scaling or dryness of skin.b

pHisoHex Pharmacokinetics

Absorption

Bioavailability

Absorbed from GI tract and intact and denuded skin.a Approximately 3% of a topical dose absorbed systemically.a

Rapid absorption may occur following topical application to burned or inflamed skin.a

Onset

Accumulates on the skin during the first 3 or 4 days of repeated use; concentration on skin remains relatively constant thereafter.a

Duration

Following repeated daily application, residual drug is retained on skin for several days.a Residual drug may be removed by cleansing with non-hexachlorophene-containing soaps or detergents or ethanol or isopropyl alcohol.a

Plasma Concentrations

Concentrations of ≥0.5 mcg/mL have been reported following use of a 3% hexachlorophene preparation as a surgical scrub for hands and forearms 5 times daily for 10 days.a

Serum concentrations of ≥1 mcg/mL in animals associated with CNS toxicity.a (See Neurotoxicity under Cautions.)

Special Populations

Possible greater absorption in infants, especially premature infants or those with dermatoses.a b Serum concentrations of 0.009–4.35 mcg/mL have been reported in neonates bathed daily in hexachlorophene preparations for 1–56 days.a

Distribution

Extent

Hexachlorophene crosses the placenta.a Distributed into milk in rats; not known whether distributed into human milk.b

Elimination

Half-life

6.1–44.2 hours in infants.a

Stability

Storage

Topical

Emulsion

Tight, light-resistant, nonmetallic containers at ≤25°C. b

Actions

  • Potent bacteriostatic activity against staphylococci and other gram-positive bacteria.a b

  • Exact mechanism(s) of action unknown, but at low concentrations appears to interrupt bacterial electron transport and inhibit membrane-bound enzymes.a Higher concentrations rupture bacterial membranes.a

  • Cumulative antibacterial action develops with repeated use.b

  • Rebound bacterial growth occurs following discontinuance.a

Advice to Patients

  • For topical application only; do not apply to mucous membranes or burned or denuded skin.b Importance of avoiding contact with the eyes.b

  • Importance of rinsing skin thoroughly after each use, especially the scrotum and perineum.b

  • Use of products that contain alcohol may decrease antibacterial action.b

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.b

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Hexachlorophene

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Emulsion (Hexachlorophene Cleansing Emulsion)

3% w/w

pHisoHex

Sanofi-Synthelabo Inc.

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2007. McEvoy GK, ed. Hexachlorophene. Bethesda, MD: American Society of Health-System Pharmacists; 2007:[page 3517-3518].

b. Sanofi-Synthelabo Inc. pHisoHex (Hexachlorophene) Package information. New York, NY; Dated 2006 Aug. Accessed 2008 Jan 3.

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