Active ingredient: Hexachlorophene

advertisement
What are the side effects you encounter while taking this medicine?

Hexachlorophene uses


INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

Hexachlorophene must not be used on burned or denuded skin.

Hexachlorophene must not be used for bathing infants. Infants may absorb the active compound in 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.

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.

WARNINGS

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.

Hexachlorophene 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.

advertisement

PRECAUTIONS

General

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

Hexachlorophene is intended for external use only. If swallowed, Hexachlorophene is harmful, especially to infants and children. Hexachlorophene should not be poured into measuring cups, medicine bottles, or similar containers since it may be mistaken for baby formula or other medications.

Information for Patients

The prescribing physician is requested to inform the patient about the following precautionary measures:

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

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

Hexachlorophene must not be used as an occlusive dressing, wetpack, or lotion.

Hexachlorophene must not be used routinely for prophylactic total body bathing.

Hexachlorophene must not be used as a vaginal pack, or on any mucous membranes.

Hexachlorophene must not be used on persons with sensitivity to any of its components.

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.

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.

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

Hexachlorophene is for external use only.

If Hexachlorophene is inadvertently swallowed, the patient should contact a physician or Poison Control Center as soon as possible.

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

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

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies in animals

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.

Human data

No case reports or epidemiological studies were available.

Impairment of fertility

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

Embryotoxicity and Teratogenicity

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 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.

Nursing Mothers

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.

Pediatric Use

Hexachlorophene must not be used for bathing infants. Infants may absorb the active compound in Hexachlorophene 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.

Geriatric Use

Clinical studies of Hexachlorophene 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.

advertisement

ADVERSE REACTIONS

Adverse reactions to 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 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.

OVERDOSAGE

The accidental ingestion of 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.

DOSAGE AND ADMINISTRATION

Surgical Hand Scrub

  • Wet hands and forearms with water. Apply approximately 5 mL of Hexachlorophene 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.
  • Apply 5 mL of Hexachlorophene to hands again and scrub as above for another 3 minutes. Rinse thoroughly with running water and dry.
  • For repeat surgical scrubs during the day, scrub thoroughly with the same amount of Hexachlorophene for 3 minutes only. Rinse thoroughly with water and dry.

Bacteriostatic Cleansing

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

Rinse thoroughly after each washing.

INFANT CARE

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

PREMATURE INFANTS

Use of baby skin products containing alcohol may decrease the antibacterial action of Hexachlorophene.

advertisement

HOW SUPPLIED

5 oz plastic squeeze bottle.

1 pint plastic squeeze bottle (NDC 0024-1535-06).

Store at room temperature up to 25° C (77° F)

Prolonged direct exposure of Hexachlorophene to strong light may cause brownish surface discoloration but does not affect its antibacterial or detergent properties. Shaking will disperse the color. If Hexachlorophene is spilled or splashed on porous surfaces, rinse off to avoid discoloration.

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.

Directions For Cleaning Dispensers

Before initial installation and use, run an antiseptic, such as an aqueous solution of benzalkonium chloride, NF. 1:500 to 1:750, or alcohol, through the working parts; rinse with sterile water. At weekly intervals thereafter, remove dispenser and pour off remainder of Hexachlorophene emulsion. Rinse empty dispenser with water. Run water through the working parts by operating the dispenser. Sanitize as described above. Rinse thoroughly with sterile water.

ANIMAL TOXICITY

The oral LD50 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.

Manufactured for:

sanofi-aventis U.S. LLC, A SANOFI COMPANY

Bridgewater, NJ 08807

Revised January 2012

© 2012 sanofi-aventis U.S. LLC

NDC 0024-1535-02

148 mL (5 fl oz)

Hexachlorophene®

Hexachlorophene 3%

detergent cleanser

SUDSING ANTIBACTERIAL

SKIN CLEANSER

Rx only

For inquiries call 1-800-446-6267

Manufactured for:

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

A SANOFI COMPANY

Origin Canada

©2012

Hexachlorophene available forms, composition, doses:

Price
Hexachlorophene powder11.47 USD
Phisohex 148ml Bottle35.46 USD
Phisohex 3% cleanser0.18 USD
Phisohex 473ml Bottle0.13 USD
Tersaseptic cleanser0.05 USD

Indications and Usages:

ATC codes:


ICD-10 codes:


Hexachlorophene destination | category:


advertisement

Drugs with same active ingredients (Pharmaceutical companies):


References

  1. Dailymed."PHISOHEX (HEXACHLOROPHENE) EMULSION [SANOFI-AVENTIS U.S. LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."HEXACHLOROPHENE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "hexachlorophene". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Hexachlorophene?

Depending on the reaction of the Hexachlorophene after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Hexachlorophene not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Hexachlorophene addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

advertisement

Review

sdrugs.com conducted a study on Hexachlorophene, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Hexachlorophene consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 28 here

The information was verified by Dr. Arunabha Ray, MD Pharmacology

© 2002 - 2021 "sdrugs.com". All Rights Reserved