Phisohex Information
Phisohex (Hexachlorophene)
Phisohex (Hexachlorophene) Description
Phisohex (Hexachlorophene) , brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration. Phisohex (Hexachlorophene) 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:
Phisohex (Hexachlorophene) Clinical Pharmacology
Phisohex (Hexachlorophene) is a bacteriostatic cleansing agent. It cleanses the skin thoroughly and has bacteriostatic action against staphylococci and other gram-positive bacteria. Cumulative antibacterial action develops with repeated use. Cleansing with alcohol or soaps containing alcohol removes the antibacterial residue.
Detectable blood levels of hexachlorophene following absorption through intact skin have been found in subjects who regularly scrubbed with hexachlorophene emulsion 3%. (See for additional information.)
Phisohex (Hexachlorophene) has the same slight acidity as normal skin (pH value 5.0 to 6.0).
Phisohex (Hexachlorophene) Indications And Usage
Phisohex (Hexachlorophene) 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 ).
Phisohex (Hexachlorophene) Contraindications
Phisohex (Hexachlorophene) must not be used on burned or denuded skin.
Phisohex (Hexachlorophene) must not be used for bathing infants (see ). Infants may absorb the active compound in Phisohex (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.
It must not be used as an occlusive dressing, wetpack, or lotion. It must not be used routinely for prophylactic total body bathing.
It must not be used as a vaginal pack or tampon, or on any mucous membranes.
Phisohex (Hexachlorophene) must not be used on persons with sensitivity to any of its components. It must not be used on persons who have demonstrated primary light sensitivity to halogenated phenol derivatives because of the possibility of cross-sensitivity to hexachlorophene.
Phisohex (Hexachlorophene) Warnings
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.
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.
Phisohex (Hexachlorophene) Precautions
Avoid accidental contact of Phisohex (Hexachlorophene) with the eyes.
If contact occurs, promptly rinse thoroughly with water. To assist in the detection of ocular irritation, applications to the head and periorbital skin areas should be performed only in responsive patients with unanesthetized eyes.
RINSE THOROUGHLY AFTER USE,
Phisohex (Hexachlorophene) is intended for external use only. If swallowed, Phisohex (Hexachlorophene) is harmful, especially to infants and children.
The prescribing physician is requested to inform the patient about the following precautionary measures:
Phisohex (Hexachlorophene) must not be used on burned or denuded skin. Application to burns has produced neurotoxicity and death.
Phisohex (Hexachlorophene) must not be used for bathing infants (see ). Infants may absorb the active compound in Phisohex (Hexachlorophene) more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.
Phisohex (Hexachlorophene) must not be used as an occlusive dressing, wetpack, or lotion.
Phisohex (Hexachlorophene) must not be used routinely for prophylactic total body bathing.
Phisohex (Hexachlorophene) must not be used as a vaginal pack, or on any mucous membranes.
Phisohex (Hexachlorophene) must not be used on persons with sensitivity to any of its components.
Phisohex (Hexachlorophene) must not be used on persons who have demonstrated primary light sensitivity to halogenated phenol derivatives because of the possibility of cross-sensitivity to hexachlorophene.
Phisohex (Hexachlorophene) should be kept out of the eyes. If contact occurs, the patient should rinse with cold water as soon as possible and contact a physician.
Phisohex (Hexachlorophene) should not be used in sensitive areas such as the scrotum and perineum. If contact occurs, these areas should be rinsed thoroughly.
Phisohex (Hexachlorophene) is for external use only.
If Phisohex (Hexachlorophene) is inadvertently swallowed (see ), the patient should contact a physician or Poison Control Center as soon as possible.
Phisohex (Hexachlorophene) should not be poured into measuring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.
Phisohex (Hexachlorophene) should be stopped and a physician should be contacted if irritation, sensitization, or allergic reaction occurs.
Phisohex (Hexachlorophene) should be used in pregnant women or nursing mothers only if the potential benefit justifies the potential risk to the fetus or infant.
Phisohex (Hexachlorophene) Adverse Reactions
Adverse reactions to Phisohex (Hexachlorophene) may include dermatitis and photosensitivity. Sensitivity to hexachlorophene is rare; however, persons who have developed photoallergy to similar compounds also may become sensitive to hexachlorophene.
In persons with highly sensitive skin the use of Phisohex (Hexachlorophene) may at times produce a reaction characterized by redness and/or mild scaling or dryness, especially when it is combined with such mechanical factors as excessive rubbing or exposure to heat or cold.
Phisohex (Hexachlorophene) Overdosage
The accidental ingestion of Phisohex (Hexachlorophene) in amounts from 1 oz to 4 oz has caused anorexia, vomiting, abdominal cramps, diarrhea, dehydration, convulsions, hypotension, and shock, and in several reported instances, fatalities.
If patients are seen early, the stomach should be evacuated by emesis or gastric lavage. Olive oil or vegetable oil (60 mL or 2 fl oz) may then be given to delay absorption of hexachlorophene, followed by a saline cathartic to hasten removal. Treatment is symptomatic and supportive; intravenous fluids (5 percent dextrose in physiologic saline solution) may be given for dehydration. Any other electrolyte derangement should be corrected. If marked hypotension occurs, vasopressor therapy is indicated. Use of opiates may be considered if gastrointestinal symptoms (cramping, diarrhea) are severe. Scheduled medical or surgical procedures should be postponed until the patient's condition has been evaluated and stabilized.
Phisohex (Hexachlorophene) Dosage And Administration
Wet hands with water. Dispense approximately 5 mL of Phisohex (Hexachlorophene) into the palm, work up a lather with water and apply to area to be cleansed.
Rinse thoroughly after each washing.
See .
Use of baby skin products containing alcohol may decrease the antibacterial action of Phisohex (Hexachlorophene) .
Phisohex (Hexachlorophene) How Supplied
5 oz plastic squeeze bottle (NDC 0024-1535-02).1 pint plastic squeeze bottle (NDC 0024-1535-06).1 gallon plastic bottle (NDC 0024-1535-08).
Store at room temperature up to 25° C (77° F)
Prolonged direct exposure of Phisohex (Hexachlorophene) to strong light may cause brownish surface discoloration but does not affect its antibacterial or detergent properties. Shaking will disperse the color. If Phisohex (Hexachlorophene) is spilled or splashed on porous surfaces, rinse off to avoid discoloration.
Phisohex (Hexachlorophene) should not be dispensed from, or stored in, containers with ordinary metal parts. A special type of stainless steel must be used or undesirable discoloration of the product or oxidation of metal may occur.
Phisohex (Hexachlorophene) Animal Toxicity
The oral LD of hexachlorophene in male rats is 66 mg/kg bw, in females 56 mg/kg bw, and in weanling rats 120 mg/kg bw.
In suckling rats (10-days old), it is 9 mg/kg bw.
Phisohex (Hexachlorophene)
Phisohex (Hexachlorophene) Principal Display Panel - Ml Bottle Label
Mfd. for: sanofi-aventis U.S. LLCBridgewater, NJ 08807For inquiries call 1-800-446-6267
