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Profile Profile Uses and Administration Pharmacokinetics Adverse Effects

Profile Profile Uses and Administration Pharmacokinetics Adverse Effects

1754 and Preservatives

Glyoxal solutions, it is advisable to incorporatea sequestrant such as atogenic effects is subject to debate.t2 However, it is con­ disodium edetate.2 sidered best to avoid its use during pregnancy.

l. Walter G, Gump W. Effect of pH on . Soap Chern Spec 1. Halling H. Suspected link between exposure to hexachlorophene and 1963; 39: 55-6. malformed infants. Ann NYAcad Sci 1979; 320: 426-3 5. 2. Bell M. Hexachlorophene-based skin cleansers. Specialities 1965; I: 16- 2. Baltzar B, et al. Pregnancy outcome among women working in Swedish 18. hospitals. N Eng! J Med 1979; 300: 627-8. Uses and Administration Pharmacokinetics Hexachlorophene is a chlorinated bisphenol with Hexachlorophene is absorbed from the gastrointestinal tract a bacteriostatic action against Gram-positive organisms, but after accidental ingestion, and through intact and denuded Profile much less effective against Gram-negative organisms. It is , skin. Percutaneous absorption may be significant in premature infants and through damaged skin. Hexachlor­ Glyoxal is an aldehyde used for the disinfection of surfaces most active at pH 5 to 6. 1 and of medical and surgical instruments. Hexachlorophene is mainly used in soaps and creams in a ophene crosses the placenta. concentration of 0.23 to 3% and is an ingredient of various i preparations used for skin disorders. After repeated use of P.r....epa.. .ra. t..ons...... these preparations for several days there is a marked ProprietaryPreparations (details are given in Volume B) ProprietaryPreparations (details are given in Volume B) diminution of the bacterial flora due to accumulation of hexachlorophene in the skin. This residual effect is rapidiy Single·ingredient Preparations. Gr.: Acnemaskt; Incoliquid; Multi-ingredient Preparations. Ger.: Buraton 10 Ft; Freka-Nolt; , lost after washing with unmedicated soap or alcohol. Indon.: Dermisan; Thai.: Hexa Clean; Venez. : Solu-Hex. Incidin perfekt; Incidur; Lysoformin 3000; Meliseptol; Melsept A preparation containing 3% is used for the disinfection SF; Ultrasol-F; Ita!.: Inddin Spezialt; Indulfant; Melsept SF; Multi-ingredientPreparations. Canad. : pHisoHex; Cz. : Septonex; Melsept Spray; Melsept. of the hands of surgeons and other healthcare personnel. Gr.: Creme Phyllis de Jeunesse; Hemorrocort; Hemorroidal-H; Thorough rinsing is recommended before drying. Hexa­ Rysolone; Hung.: Phlogosol; Indon.: Topicidet; Irl. : Torbetolt; chlorophene has been applied as a 0. 3 3% dusting powder to Port. : Anacal; Spain: Cresophene; Thai.: Cibist; USA: pHiso­ the umbilical cord stump for the control of staphylococcal Hex; Venez. : Permucal. infection in the newborn. However, care is necessary when Pharmacopaeial Preparations using hexachlorophene in neonates (see below). BP 2014: Hexachlorophene Dusting Powder; Hexachlorophene sodium has also been used. USP 36: Hexachlorophene Cleansing Emulsion; Hexachloro­ phene Liquid Soap. Disinfection. Eradication of an outbreak of infection with meticillin-resistant Staphylococcus aureus in a neonatal intensive care unit was achieved by use of hexachloro­ lsetionate(BANM, rtNNMI phene soap for hand washing. Previous infection -control USP 36: (). A white crystalline powder with a measures including the use of had failed. 1 characteristic odour of . Soluble 1 in more than For a discussion of staphylococcal infections and their 1000 of water and of , I in 140 of alcohol, and 1 treatment, see p. 208.2. in more than 2000 of ether; soluble in glacial acetic acid. It 1. Reboli AC. et al. Epidemic methicillin-gentamicin-resistant Staphylo­ coccus aureus in a neonatal intensive care unit. Am J DisChild 1989; I43: dissolves in solutions of alkali hydroxides and carbonates 34--9. with the formation of a salt. Store in airtight containers. Protect from light. Adverse Effects and Treatment After ingestion of hexachlorophene, anorexia, nausea, Profile vomiting, diarrhoea, abdominal cramps, dehydration, Halazone is a with the general properties of shock, and confusion may occur. Convulsions and death chlorine (p. I 7 46.2) in aqueous solution and is used for the may follow. CNS stimulation, convulsions, and death have disinfection of drinking water (p. 1731.3 ). It contains about also occurred after absorption of hexachlorophene from 52% of 'available chlorine' (see p. 1746.3). One tablet burns and damaged skin. There have been reports showing containing 4 mg of halazone, stabilised with sodium that hexachlorophene can be absorbed through the skin of carbonate and sodium chloride, may be sufficient to treat infants in amounts sufficient to produce spongy lesions of NOTE. The name Hexamidinum has been used for primidone about I litre of water in about 30 minutes to 1 hour. The the brain, sometimes fatal. (p. 547. 1). taste of residual chlorine may be removed by adding sodium Photosensitivity and skin sensitisation have occasionally In Bur. (see p. vii). thiosulfate. occurred after repeated use of hexachlorophene. Pharmacopoeias. Treatment of adverse effects is as for , p. 1764.3. Ph. Eur. 8: (Hexamidine Diisetionate; Hexamidine i Isetionate BP 2014). A white or slightly yellow hygroscopic ..P...rep...... ar.a...t..ons.... powder. Sparingly soluble in water; slightly soluble in . .. (details are given in Volume B) Effects on therespiratory system. Asthma developed in a ProprietaryPreparations 43-year-old nurse after long-term exposure to hexachloro­ alcohol; practically insoluble in dichloromethane. Store in airtight containers. Single-ingredient Preparations,Gr.: Helporide; Turk.: Haloseptil. phene powder 1 l. Nagy L, Orosz M. Occupational asthma due to hexachlorophene. Thorax PharmacopaeialPreparations 1984; 39: 630-l. Profile USP 36: Halazone Tablets for Solution. Hexamidine isetionate has antibacterial and antifungal Precautions properties and is available in preparations for the local Hexachlorophene should not be applied to mucous treatment of minor infections. membranes, large areas of skin, or to burnt, damaged, or denuded skin and should not be used vaginally, applied Acanthamoeba keratitis. Hexamidine was suggested 1 as a under occlusive dressings, or applied to areas affected by possible alternative to for the treatment of dermatoses. It should be used with caution on infants, Acanthamoeba keratitis (p. 919.3) due to the poor cysticidal especially premature and low birth-weight neonates. Its use activity, chronic conjunctival infection, and resistance of I 2 is not advised in pregnancy. some Acanthamoeba strains seen with propamidine. . Preparations of hexachlorophene are liable to contam­ Cures have been reported with 0.1% hexamidine used 2 2 ination, especially with Gram-negative bacteria. either as monotherapy .3 or with polihexanide. l. Perrine D, et al. Amoebicidal efficiencies of various diamidines against two strains of Acanthamoeba polyphaga. Antimicrob Agents Chemother Breast feeding. The American Academy of Pediatrics1 con­ 1995; 39: 339--42. siders that, while no effects on the infant have been 2. Murdoch D, et al. Acanthamoeba keratitis in New Zealand, including two reported, there is a possibility of contamination of breast cases with in vivo resistance to polyhexamethylene . Aust N ZJ milk with hexachlorophene used by breast-feeding Ophthalmol l998; 26: 231-6. (Hexachlorophene). A white or pale buff, 3. Seal DV. Acamhamocba keratitis update-incidence, molecular mothers for nipple washing. I7: odourless or almost odourless, crystalline powder. epidemiology and new drugs for treatment. Eye 2003; 893-905. I. American Academy of Pediatrics. The transfer of drugs and other Practically insoluble in water; freely soluble in alcohol; chemicals into human milk. Pediatrics 2001; 108: 776-89. [Retired May Adverse effects. A systemic allergic reaction in a patient very soluble in and in ether. It dissolves in dilute 2010] Correction. ibid.; 1029. Also available at: http:l/aappolicy. after use of a topical antiseptic cream was confirmed, by solutions of alkali hydroxides. Protect from light. aappublications. org/ cgi/ content /full/pediatrics% 3 b l 08/3177 6 (accessed 15/03/06) skin prick tests, to be caused by hexamidine.1 USP 36: (Hexachlorophene). A white or light tan, 1. Mullins RJ. Systemic allergy to topical hexamidine. Med J Aust 2006; crystalline powder which is odourless or has a slight 185: Neonates. Spongi!orm encephalopathy has occurred in 177. phenolic odour. Insoluble in water; freely soluble in alcohol, neonates who were treated topically with hexachloro­ in acetone, and in ether; soluble in chloroform and in dilute phene 1 Neonates with a birth-weight of 1.4kg or less solutions of fixed alkali hydroxides. Store in airtight appeared to be most susceptible, whereas those weighing containers. Protect from light. ProprietaryPreparations (details are given in Volume B) over 2 kg were not considered to be at risk. 1•2 Also most of the reports involved hexachlorophene applied in a con­ Single-ingredient Preparations. Belg.: Desomedine; Hexomedine; Ophtamedine; Fr.: Desomedine; Hexaseptine; Hexomedine; Incompatibility. The activity of hexachlorophene may be centration of 3%. reduced in the presence of blood or other organic material. Ger.: Laryngomedin Nt; Gr. : Ophtamedine; Singapore: Deso­ 1. Anonymous. Hexachlorophene today. Lancet 1982; i: 87-8. medine; Switz. : Dcsomcdine; Venez. : Hcxomcdine. It retains some activity in the presence of soap. 2. Plueckhabn VD, Collins RB. Hexachlorophene emulsions and antiseptic The activity has been reported1 to be reduced by alkaline skin care of newborn infants. Med J Aust 1976; I: 815-19. Multi-ingredientPreparations. Austral.: Medi Creme; Medi Pulv; media and by nonionic surfactants such as polysorbate 80. It Austria: Imazol Duo; Belg.: Colludol; Hexomedinet; Braz.: is extremely sensitive to iron, and to avoid discoloration due Pregnancy. Hexachlorophene is absorbed from the skin Hexomedine; Cz. : Cyteal; Imacort; Imazol Plus; Fr. : Aurigoutte; to traces of this metal in hexachlorophene detergent and crosses the placenta, but whether it has produced ter- Colludol; Cyteal; Doli Mal de Gorge; Ergix mal de gorge; Oto-

All cross-references refer to entries in Volume A midet; Solutricine Maux de Gorget; Ger.: Irnazolcamp; Irnazol Incompatibility. Hexylresorcinol is incompatible with alka­ Peroxide Solution (tD:volume); Hydrogen ['eroxlde Topicill Plus; Gr.: Octrene; Pulvo-Hexa; Hong Kong: Medicremet; lis and oxidising agents. Solution; f:!ydrogenii Pero)\idum 3%; Hydrogenii Peroxidum Neth.: Imazo1 Duo; NZ: Medicremet; Medipulv; Philipp.: 3 Per. Centum; OXydol;. Peroxid vodiku 3%; Peroxido de Cyteal; Pol.: Imazol Plus; Port.: Cyteal; Rus.: Cytea1 (l\Hrean); hidrogeno, .so!ucion a!3%; Van enillcipercksid0 ;!%lir alas; Singapore: Cyteal; Spain: Tantumt; Switz. : Imacort; Imazol; Profile d p Vateperoxid Vetypetok>idi 3%; Vllasserstoffperoxid� Thai.: Pulvo 47t; Turk. : Imazol; Pulvo 47; UK: Cyteal; Ukr.: , :>%; . Hexylresorcinol is a phenolic antiseptic that is used topically Losung 3 %; Wodmu. l)adtleriek3%:. Cyteal (l\Hrean); Imacort (llMaKOpT). for the treatment of minor infections of the skin and mucous ATC-A01AB02; D08AXO I; S02M 06. membranes, and in the form of lozenges for the treatment of QA01AB02; sore throat. It has also been used in vaginal spermicidal ATC \fet ...,.· QDOO.AXO I, QS02A.A 06 Hexetidine (BAN. r/NN) preparations. Pharmacopoeias. In Chin., Eur. (see p. vii), Jp n, US, and Viet. Heksetfdfini; Heksetidin; Hel!setidinas; Hexetidin; Hexetidina; High concentrations of hexylresorcinol are irritant and Ph. Eur. 8; ( Solution (3 per cent)). A corrosive to skin and mucous membranes. Alcoholic Hexetidine; Hexetidinum; feJ r:te micotico; Cz. : Cold rex Proti Bolesti v Krku; Hong Kong: at 6%; Oral hygiene. A mouthwash containing 0. 1% hexetidine Dequasin; India: Tytin; Pol.: Cholisept Intensive; Coldrext; UK: hidr6ger\o, soluci6h . SoflK'l6n .de Bi6xido. de was no more effective than placebo in the management of Beechams Max Strength Sore Throat Relief; Beechams Throat­ Hidrogeno;Sotote .0\l'i clnal d'�au bxygenee; Wasserstoffsu" ' · patients with aphthous ulceration (see Mouth illceration, Plus. peroxydJosurig. p. 1811.2) and provided no additional benefits to oral ATC-:-AOIA802,: D{IBJ\XO i;S02AA06. hygiene or gingival health 1 However, such a mouthwash Pharmacopoeial Preparations .ODI;IBAXO I; USP 36: Hexylresorcinol Lozenges. AIC Vet :- QAOI-AB02; QSC12A.A06 does appear to be of benefit in reducing supragingival In Br. plaque and gingival inflammation.' Pharmacopoeias. l. B, et al. BP 2014: (Hydrogen Peroxide Solution (6 per cent)). A clear Chadwick Hexetidine mouthrinse in the management of minor Hydrargaphen (BAN, riNN) aphthous ulceration and as an adjunct to oral hygiene. Br Dent J 1991; colourless aqueous liquid containing 5.0 to 7.0% w/v of 171: 83-7. Hidrarga eno; Hydraphen; Hydrargap�rl!Ol; Hydrargaphe­ H 0 corresponding to about 20 times its volume of 2. et al. f 2 2 Sharma NC, Antiplaque and antigingivitis effectiveness of a available oxygen. It decomposes in contact with oxidisable hexetidine mouthwash. J Clin Periodontal 2003; 30: 590-4. num; i"lygraphen; Phenylmercuric Diriaphthylme�hariedlsul- i fc nate; fl4tlpapraroxid�;m; Per6;

The symbol t denotes a preparation no longer actively marketed