RINSE THOROUGHLY AFTER EACH USE. Patients should be closely monitored and use should be immediately discontinued at the first sign of any of the symptoms described below.
Rapid absorption of hexachlorophene may occur with resultant toxic blood levels when preparations containing hexachlorophene are applied to skin lesions such as ichthyosis congenita, the dermatitis of Letterer-Siwe’s syndrome, or other generalized dermatological conditions. Application to burns has also produced neurotoxicity and death.
pHisoHex SHOULD BE DISCONTINUED PROMPTLY IF SIGNS OR SYMPTOMS OF CEREBRAL IRRITABILITY OCCUR.
Infants, especially premature infants or those with dermatoses, are particularly susceptible to hexachlorophene absorption. Systemic toxicity may be manifested by signs of stimulation (irritation) of the central nervous system, sometimes with convulsions.
Infants have developed dermatitis, irritability, generalized clonic muscular contractions and decerebrate rigidity following application of a 6 percent hexachlorophene powder. Examination of brainstems of those infants revealed vacuolization like that which can be produced in newborn experimental animals following repeated topical application of 3 percent hexachlorophene. Moreover, a study of histologic sections of premature infants who died of unrelated causes has shown a positive correlation between hexachlorophene baths and lesions in white matter of brains.
There is currently no manufacturer warning information available for this drug.
pHisoHex is indicated for use as a surgical scrub and a bacteriostatic skin cleanser. It may also be used to control an outbreak of gram-positive infection where other infection control procedures have been unsuccessful. Use only as long as necessary for infection control (see PRECAUTIONS: Information for Patients).
pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration. pHisoHex contains a colloidal dispersion of hexachlorophene 3% (w/w) in a stable emulsion consisting of entsufon sodium, petrolatum, lanolin cholesterols, methylcellulose, polyethylene glycol, polyethylene glycol monostearate, lauryl myristyl diethanolamide, sodium benzoate, and water. pH is adjusted with hydrochloric acid. Entsufon sodium is a synthetic detergent.
Chemically, hexachlorophene is Phenol, 2,2′-methylenebis[3,4,6-trichloro-; and has the following structural formula:
