Acclean

Name: Acclean

For the Consumer

Applies to chlorhexidine topical: topical application cream, topical application dressing, topical application gel/jelly, topical application liquid, topical application lotion, topical application pad, topical application solution, topical application sponge

Other dosage forms:

  • oral liquid, oral solution

Along with its needed effects, chlorhexidine topical (the active ingredient contained in Acclean) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking chlorhexidine topical:

Incidence not known
  • Blistering, burning, itching, peeling, skin rash, redness, swelling, or other signs of irritation on the skin
  • swelling of the face, hands, or feet
  • trouble breathing

For Healthcare Professionals

Applies to chlorhexidine topical: compounding liquid, mucous membrane insert, mucous membrane liquid, topical dressing, topical liquid, topical pad, topical soap, topical solution, topical sponge

General

The most commonly reported side effects include toothache, tongue coating, skin irritation and hypersensitivity reactions.[Ref]

Gastrointestinal

Very common (10% or more): Toothache (up to 50.7%)
Common (1% to 10%): Dry mouth, glossodynia, oral paresthesia, dyspepsia, ulcerative stomatitis, gum hyperplasia
Frequency not reported: Mouth irritation, coated tongue, desquamation/superficial desquamation/oral mucosa swelling, parotid gland swelling, burning sensation of the tongue, increased dental calculus formation, aphthous ulcer, gingivitis/grossly obvious gingivitis, geographic tongue, tooth disorder, dental/gingival/mouth pain, broken/cracked/fractured teeth, mobile teeth, lost bridges/crowns/fillings, discoloration of the teeth, gums, and dorsum of the tongue
Postmarketing reports: Stomatitis, glossitis, ulcer, glossal edema, sialadenitis/inflammation of the salivary glands[Ref]

Toothache occurred most often in patients receiving the periodontal chip, and included dental/gingival/mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity.

Tooth disorder occurred most often in patients receiving the periodontal chip, and included broken/cracked/fractured teeth, mobile teeth, and lost bridges/crowns/fillings.[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 28.4%), sinusitis (up to 13.8%)
Common (1% to 10%): Bronchitis, pharyngitis
Frequency not reported: Bronchospasm, rhinitis, coughing, dyspnea[Ref]

Bronchospasm occurred with hypersensitivity reactions.

Upper respiratory tract infection and sinusitis have occurred most commonly in patients receiving the periodontal chip.[Ref]

Nervous system

Common (1% to 10%): Ageusia/dysgeusia, hypoesthesia
Frequency not reported: Transient dysgeusia, headache, loss of consciousness
Postmarketing reports: Hypesthesia, paresthesia[Ref]

Musculoskeletal

Common (1% to 10%): Arthrosis, tendinitis
Frequency not reported: Back pain, myalgia, arthralgia[Ref]

Local

Frequency not reported: Ulceration, desquamation, keratinization, mucocele, short frenum, pain, tenderness, aching, throbbing, soreness, discomfort, sensitivity
Postmarketing reports: Minor irritation[Ref]

Dermatologic

Frequency not reported: Rash, erythema/generalized erythema, urticaria, dermatitis, pruritus, eczema, skin irritation, blisters, cold sweat, irritative or allergic skin reactions[Ref]

Rash, erythema, and urticaria occurred with hypersensitivity reactions.

Dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters occurred with allergic skin reactions.[Ref]

Other

Frequency not reported: Chemical burns in neonates, trauma, abscess, influenza-like symptoms, deafness, sensitive tissue irritation[Ref]

Cardiovascular

Frequency not reported: Cardiac arrest, circulatory collapse, hypotension, tachycardia, hypertension[Ref]

Cardiac arrest, circulatory collapse, hypotension, and tachycardia occurred as hypersensitivity reactions.[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic shock, anaphylactoid reactions/fatal anaphylactic reactions
Postmarketing reports: Hypersensitivity and anaphylaxis[Ref]

Ocular

Frequency not reported: Irreversible corneal damage, irritation to the conjunctiva[Ref]

Exposure of the eye to chlorhexidine cleanser, generally during preparation for facial surgery, has resulted in eye pain, edema of the epithelium, keratitis, inflammation of the conjunctiva, corneal epithelial cell loss, chronic corneal ulcers, and opacification. Corneal transplantation to correct permanent damage has been required in some patients.

Allergic conjunctivitis is rarely associated with the use of contact lens solutions which contain low concentrations of chlorhexidine as a preservative.[Ref]

Genitourinary

Hematuria occurred after bladder irrigation.[Ref]

Frequency not reported: Dysmenorrhea, hematuria[Ref]

Immunologic

Frequency not reported: Allergy[Ref]

Some side effects of Acclean may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Chlorhexidine topical Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: A US FDA pregnancy category: C (periodontal chip) US FDA pregnancy category: B (soap, solution, and oral rinse formulations)

Animal models have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Chlorhexidine topical Breastfeeding Warnings

Toxicity to suckling pups and impaired parturition were not observed in animal models receiving daily human doses equivalent to 30 mL of a 0.12% solution

Caution is recommended. Excreted into human milk: Yes

Chlorhexidine Levels and Effects while Breastfeeding

Summary of Use during Lactation

Chlorhexidine has been used vaginally or topically on the abdomen or perineum prior to delivery to prevent infection. No toxicity has been reported in breastfed infants and it has clearly less toxicity compared to povidone-iodine in these situations. Topical application of chlorhexidine to the breast before and after nursing did not appear to adversely affect the breastfed infants in one study. Use of chlorhexidine oral rinse by a nursing mother is unlikely to adversely affect her infant.

Drug Levels

Maternal Levels. Iodine milk levels were measured in a study of mothers who received 10% povidone-iodine (n = 21) or chlorhexidine (n = 13) topically to the perineum starting immediately before the final stage of labor and daily postpartum to the episiotomy. At 96 hours postpartum, milk iodine levels averaged 1.2 mg/L in mothers who received topical povidone-iodine compared to average milk levels of 0.1 mg/L in the mothers who received chlorhexidine.[1]

Infant Levels. In a study of mothers who received 10% povidone-iodine (n = 21) or chlorhexidine (n = 13) topically to the perineum starting immediately before the final stage of labor and daily postpartum to the episiotomy, urine iodine levels were measured in their infants. In the infants whose mothers received povidone-iodine, urine iodine levels were much higher at 24 and 48 hours postpartum. At 96 hours postpartum, the breastfed infants (n = 13) whose mothers received povidone-iodine had urine iodine levels of 8.3 mg/L compared to levels of 0.4 mg/L in infants who did not breastfeed (n = 8) and 0.6 mg/L in the infants of mothers who received chlorhexidine (n = 13).[1]

Effects in Breastfed Infants

A group of investigators in Belgium reviewed the results of infant thyrotropin levels on day 5 postpartum in 4745 newborn infants delivered over a 2-year period at their hospital. Infants were divided among those whose mothers had iodine overload (n = 3086) from topical povidone-iodine 10% solution during labor and delivery and those whose mothers had no iodine overload (n = 1659). Mothers had povidone-iodine applied either as a single application to 900 square cm for epidural anesthesia or 3 applications to the entire abdominal wall for cesarean section. Breastfed infants whose mothers had iodine overload had a greater risk for having elevated thyrotropin levels and requiring recall for retesting (3.2% with cesarean section and 2.7% with epidural anesthesia) compared to those who did not (0.1%). Bottle-fed infants were affected much less than breastfed infants.[2] After replacing povidone-iodine with chlorhexidine 0.5% in 70% isopropanol for disinfection for 6 months, 1178 infants that were delivered at this institution had no increased rate of elevations in thyroid function tests and a reduced rate of recalls in breastfed infants.[3]

In a study of mothers in Spain who received 10% povidone-iodine (n = 21) or chlorhexidine (n = 13) topically to the perineum starting immediately before the final stage of labor and daily postpartum to the episiotomy, no differences in thyrotropin, thyroxine or free thyroxine was found among their breastfed infants at day 5 to 7 postpartum.[1]

Studies in Africa have used chlorhexidine vaginally prior to delivery in an attempt to reduce the frequency of mother-to-child transmission (MTCT) of HIV. In one, cotton soaked in 0.25% chlorhexidine solution was used to swab the vaginal walls every 4 hours from admission into labor until delivery in 4078 women.[4] The other study used 120 mL of either 0.2% or 0.4% chlorhexidine solution as a vaginal lavage every 3 hours from admission to labor until delivery in 309 women. The average number of lavages was 2.1 (range 1 to 11).[5] Chlorhexidine 0.25% swabs reduced MTCT in patients whose membranes ruptured more than 4 hours before delivery, but not in other women. Vaginal lavage showed a statistically nonsignificant trend towards reduction of MTCT, with the 0.4% greater than the 0.2%. Almost all of the infants in these studies were breastfed. No adverse events were reported in the infants, but follow-up related primarily to infant mortality and HIV status rather than effects of chlorhexidine.

Effects on Lactation and Breastmilk

A randomized study compared 0.2% chlorhexidine in alcohol to distilled water as a spray to the breast in 200 mothers who were nursing newborns. The mothers sprayed their breasts with the liquid before and after each feeding. Mothers and infants were assessed at discharge and weekly thereafter. Discomfort and nipple trauma were less frequent in the chlorhexidine group than in the placebo group, particularly at the first assessment. Although skin flora on the breasts of the treated mothers was reduced, there was no difference in the frequency of mastitis between the treated and placebo groups. No obvious side effects occurred in the breastfed infants and there were no differences in the rates of oral thrush in infants between the treatments.[6] A systematic review concluded that this practice is not justified based on current evidence.[7]

Alternate Drugs to Consider

Benzalkonium Chloride

References

1. Arena Ansotegui J, Emparanza Knorr JI, San Millan Vege MJ et al. [Iodine overload in newborn infants caused by the use of PVP-iodine for perineal preparation of the mother in vaginal delivery]. An Esp Pediatr. 1989;30:23-6. PMID: 2648916

2. Chanoine JP, Boulvain M, Bourdoux P et al. Increased recall rate at screening for congenital hypothyroidism in breast fed infants born to iodine overloaded mothers. Arch Dis Child. 1988;63:1207-10. PMID: 3196047

3. Chanoine JP, Pardou A, Bourdoux P, Delange F. Withdrawal of iodinated disinfectants at delivery decreases the recall rate at neonatal screening for congenital hypothyroidism. Arch Dis Child. 1988;63:1297-8. Letter. PMID: 3196066

4. Biggar RJ, Miotti PG, Taha TE et al. Perinatal intervention trial in Africa: effect of a birth canal cleansing intervention to prevent HIV transmission. Lancet. 1996;347:1647-50. PMID: 8642957

5. Gaillard P, Mwanyumba F, Verhofstede C et al. Vaginal lavage with chlorhexidine during labour to reduce mother-to-child HIV transmission: clinical trial in Mombasa, Kenya. AIDS. 2001;15:389-96. PMID: 11273219

6. Herd B, Feeney JG. Two aerosol sprays in nipple trauma. Practitioner. 1986;230:31-8. PMID: 3513148

7. Vieira F, Bachion MM, Mota DD, Munari DB. A systematic review of the interventions for nipple trauma in breastfeeding mothers. J Nurs Scholarsh. 2013;45:116-25. PMID: 23452043

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