Aknefug-simplex

Aknefug-simplex 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 PATIENT INFORMATION).

1. Wet hands and forearms with water. Apply approximately 5 mL of Aknefug-simplex over the hands and rub into a copious lather by adding small amounts of water. Spread suds over hands and forearms and scrub well with a wet brush for 3 minutes. Pay particular attention to the nails and inter-digital spaces. A separate nail cleaner may be used. Rinse thoroughly under running water.
2. Apply 5 mL of Aknefug-simplex to hands again and scrub as above for another 3 minutes. Rinse thoroughly with running water and dry.
3. For repeat surgical scrubs during the day, scrub thoroughly with the same amount of Aknefug-simplex for 3 minutes only. Rinse thoroughly with water and dry.

Wet hands with water. Dispense approximately 5 mL of Aknefug-simplex into the palm, work up a lather with water and apply to area to be cleansed.

Rinse thoroughly after each washing.

Aknefug-simplex must not be used for bathing infants (see WARNINGS). Infants may absorb the active compound in Aknefug-simplex more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.

See WARNINGS.

Use of baby skin products containing alcohol may decrease the antibacterial action of Aknefug-simplex.

Aknefug-simplex must not be used on burned or denuded skin.

Aknefug-simplex must not be used for bathing infants (see WARNINGS). Infants may absorb the active compound in Aknefug-simplex 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.

Aknefug-simplex 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.

WARNINGS

Rinse Thorougly 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.

Aknefug-simplex Should Be Discontined 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.

PRECAUTIONS

Avoid accidental contact of Aknefug-simplex 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, especially from sensitive areas such as the scrotum and perineum.

Aknefug-simplex is intended for external use only. If swallowed, Aknefug-simplex is harmful, especially to infants and children. pHis oHex should not be poured into meas uring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.

The Prescribing Physician Is Requested To Inform The Patient About The Following Precautionary Measures

Aknefug-simplex must not be used on burned or denuded skin. Application to burns has produced neurotoxicity and death.

Aknefug-simplex must not be used for bathing infants (see WARNINGS). Infants may absorb the active compound in Aknefug-simplex more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions.

Aknefug-simplex must not be used as an occlusive dressing, wetpack, or lotion.

Aknefug-simplex must not be used routinely for prophylactic total body bathing.

Aknefug-simplex must not be used as a vaginal pack, or on any mucous membranes.

Aknefug-simplex must not be used on persons with sensitivity to any of its components.

Aknefug-simplex must not be used on persons who have demons trated primary light sensitivity to halogenated phenol derivatives because of the possibility of cross -sensitivity to hexachlorophene.

Aknefug-simplex 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.

Aknefug-simplex should not be used in sensitive areas such as the scrotum and perineum. If contact occurs, these areas should be rinsed thoroughly.

Aknefug-simplex is for external use only.

If Aknefug-simplex is inadvertently swallowed (see OVERDOSE), the patient should contact a physician or Poison Control Center as soon as possible.

Aknefug-simplex should not be poured into measuring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.

Aknefug-simplex should be stopped and a physician should be contacted if irritation, sensitization, or allergic reaction occurs.

Aknefug-simplex should be used in pregnant women or nursing mothers only if the potential benefit justifies the potential risk to the fetus or infant.

Hexachlorophene was tested in one experiment in rats by oral administration; it had no carcinogenic effect.

Hexachlorophene was not mutagenic in Salmonella typhimurium and was negative in a dominant lethal assay in male mice. Cytogenetic tests with cultured human lymphocytes were also negative.

No case reports or epidemiological studies were available.

Topical exposure of neonatal rats to 3% hexachlorophene solution caused reduced fertility in 7-monthold males, due to inability to ejaculate.

Placental transfer of hexachlorophene has been demonstrated in rats.

Hexachlorophene is embryotoxic and produces some teratogenic effects.

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Hexachlorophene should be used during pregnancy only if the potential benefit justifies potential risk to the fetus.

Hexachlorophene has been shown to be teratogenic and embryotoxic in rats when given by mouth or instilled into the vagina in large doses.

Administration of 500 mg/kg diet or 20 to 30 mg/kg bw/day by gavage to rats caused some malformations (angulated ribs, cleft palate, micro- and anophthalmia) and reduction in litter size.

Placental transfer and excretion in milk of hexachlorophene has been demonstrated in rats.

In another study, doses of up to 50 mg/kg diet failed to produce any effects in 3 generations of rats. Hexachlorophene did not interfere with reproduction in hamsters.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hexachlorophene, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

Aknefug-simplex must not be used for bathing infants (see WARNINGS). Infants may absorb the active compound in Aknefug-simplex more readily than older children and adults. Such absorption has been associated with central nervous system effects such as convulsions. For premature infants: see WARNINGS.

Clinical studies of Aknefug-simplex did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, use in elderly patients should be cautious, reflecting the greater frequency of dermatological disease, peripheral circulatory disease, and decreased propensity for wound healing in this group. In addition, use in elderly patients should take into account any decreased hepatic, renal, or cardiac function, as well as any concomitant disease or other drug therapy.

Adverse reactions to Aknefug-simplex 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 Aknefug-simplex 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.

The accidental ingestion of Aknefug-simplex 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.