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Chlorhexidine gluconate (topical): Drug information

Chlorhexidine gluconate (topical): Drug information
(For additional information see "Chlorhexidine gluconate (topical): Patient drug information" and see "Chlorhexidine gluconate (topical): Pediatric drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: US
  • Antiseptic Skin Cleanser [OTC] [DSC];
  • Betasept Surgical Scrub [OTC];
  • Biopatch Protective Disk/CHG [OTC];
  • Chlorhexidine Gluconate [OTC];
  • Dyna-Hex 2 [OTC];
  • Dyna-Hex 4 [OTC];
  • Hibiclens [OTC];
  • Tegaderm CHG Dressing [OTC]
Pharmacologic Category
  • Antibiotic, Topical
Dosing: Adult

Note: General dosing guidelines provided; refer to specific product labeling for dosing instructions.

Antiseptic: Topical:

Surgical scrub: Scrub hands and forearms with ~5 mL for 3 minutes paying close attention to nails, cuticles, and interdigital spaces, and rinse thoroughly, wash for an additional 3 minutes with 5 mL, rinse, and dry thoroughly.

Health care personnel hand antiseptic: Liquid or solution: Wash with ~5 mL for 15 seconds; rinse thoroughly with water and dry

Preoperative skin preparation:

Solution: Apply liberally to surgical site and swab for at least 2 minutes. Dry with sterile towel. Repeat procedure (swab for additional 2 minutes and dry with sterile towel).

Applicator (ChloraPrep One-Step):

Dry surgical sites (eg, abdomen, arm): Completely wet treatment area; use gentle back and forth strokes for ~30 seconds. Allow solution to air dry for ~30 seconds. If using an ignition source (eg, electrocautery), allow solution to completely dry for a minimum of 3 minutes for hairless skin and up to 1 hour in hair; do not blot or wipe away. Note: Prior to use with electrocautery procedures, consult specific product labeling to determine if the ChloraPrep product may be used near an ignition source.

Moist surgical sites (eg, inguinal area): Completely wet treatment area; use gentle back and forth strokes for ~2 minutes. Allow solution to air dry for ~ 1 minute. If using an ignition source (eg, electrocautery), allow solution to completely dry for a minimum of 3 minutes for hairless skin and up to 1 hour in hair; do not blot or wipe away. Note: Prior to use with electrocautery procedures, consult specific product labeling to determine if the ChloraPrep product may be used near an ignition source.

Wound care and general skin cleansing: Rinse area with water, then apply minimum amount necessary to cover skin or wound area and wash gently. Rinse again thoroughly.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Chlorhexidine gluconate (topical): Pediatric drug information")

Skin cleanser for preoperative skin preparation, skin wound and general skin cleanser for patients: Topical:

Infants <2 months: Note: It is recommended to use with care in this population due to potential risk of dermal irritation or chemical burns. Expert suggestions are variable depending upon site and clinical scenario. Not all products may be appropriate for use in this population; refer to product specific labeling. Some experience in neonatal patients applicable to this patient population (Garland 2009; Tamma 2010).

Preoperative skin preparation: Solution: Apply liberally to surgical site and swab for at least 2 minutes. Dry with sterile towel. Repeat procedure (swab for additional 2 minutes and dry with sterile towel).

Wound care and general skin cleansing: Rinse area with water, then apply the minimum amount of chlorhexidine necessary to cover skin or wound area and wash gently. Rinse again thoroughly.

Infants ≥2 months, Children, and Adolescents: Topical solution:

Preoperative skin preparation: Solution: Apply liberally to surgical site and swab for at least 2 minutes. Dry with sterile towel. Repeat procedure (swab for additional 2 minutes and dry with sterile towel).

Wound care and general skin cleansing: Rinse area with water, then apply the minimum amount of chlorhexidine necessary to cover skin or wound area and wash gently. Rinse again thoroughly.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Geriatric

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Liquid, External:

Betasept Surgical Scrub: 4% (118 mL, 237 mL, 473 mL, 946 mL)

Hibiclens: 4% (15 mL, 118 mL, 236 mL, 473 mL, 946 mL, 3790 mL) [contains fd&c red #40, isopropyl alcohol]

Generic: 2% (118 mL [DSC]); 4% (118 mL [DSC], 237 mL [DSC], 473 mL [DSC], 946 mL [DSC], 3800 mL [DSC])

Miscellaneous, External:

Biopatch Protective Disk/CHG: (Dressing) (10 ea)

Tegaderm CHG Dressing: (Dressing) (1 ea)

Pad, External:

Generic: 2% (2 ea, 6 ea)

Solution, External:

Antiseptic Skin Cleanser: 4% (118 mL [DSC], 237 mL [DSC]) [dye free; contains isopropyl alcohol]

Chlorhexidine Gluconate: 2% (118 mL) [latex free; contains isopropyl alcohol]

Dyna-Hex 2: 2% (473 mL) [contains isopropyl alcohol]

Dyna-Hex 4: 4% (118 mL, 473 mL) [contains isopropyl alcohol]

Generic Equivalent Available: US

May be product dependent

Administration: Adult

Topical: Keep out of eyes, ears, and mouth. Do not routinely apply to wounds which involve more than superficial layers of skin. Avoid contact with meninges (ie, do not use on lumbar puncture sites). Solutions may be flammable (may contain alcohol); consult specific product labeling to determine if product may be used with electrocautery procedures; if product can be used near an ignition source (eg, cautery, laser), avoid exposure to open flame and/or ignition source until completely dry; avoid application to hairy areas which may significantly delay drying time. When using the ChloraPrep applicator, do not touch sponge. Hold applicator sponge down and pinch wings of applicator once to activate ampul and release antiseptic.

Administration: Pediatric

Topical: Keep out of eyes, ears, and mouth. Do not routinely apply to wounds which involve more than superficial layers of skin. Avoid contact with meninges (ie, do not use on lumbar puncture sites). Solutions may be flammable (may contain alcohol); consult specific product labeling to determine if product may be used with electrocautery procedures; if product can be used near an ignition source (eg, cautery, laser), avoid exposure to open flame and/or ignition source until completely dry; avoid application to hairy areas which may significantly delay drying time. When using the ChloraPrep applicator, do not touch sponge. Hold applicator sponge down and pinch wings of applicator once to activate ampul and release antiseptic.

Use: Labeled Indications

Antiseptic: Skin cleanser for preoperative skin preparation, skin wound and general skin cleanser for patients; surgical scrub and antiseptic hand rinse for healthcare personnel

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Chlorhexidine, when used in very low birthweight neonates, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be used with caution due to risk of chemical burns (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Dermatologic: Allergic sensitization, erythema, hypersensitivity reaction, rough skin, xeroderma

<1%, postmarketing, and/or case reports: Anaphylaxis (Health Canada May 2016), dyspnea, facial edema, nasal congestion

Contraindications

Hypersensitivity to chlorhexidine or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Serious allergic reactions, including anaphylaxis, have been reported.

Dosage form specific issues:

• Topical: For topical use only. Keep out of eyes, ears, and the mouth; if contact occurs, rinse with cold water immediately; permanent eye injury may result if agent enters and remains in the eye. Deafness has been reported following instillation in the middle ear through perforated ear drums. Avoid applying to wounds that involve more than the superficial skin layers. Avoid repeated use as general skin cleansing of large surfaces (unless necessary for condition). Not for preoperative preparation of face or head; avoid contact with meninges (do not use on lumbar puncture sites). Avoid applying to genital areas; generalized allergic reactions, irritation, and sensitivity have been reported. Solutions may be flammable (products may contain alcohol); avoid exposure to open flame and/or ignition source (eg, electrocautery) until completely dry; avoid application to hairy areas which may significantly delay drying time. Use with caution in children <2 months of age due to potential for increased absorption, and risk of irritation or chemical burns. May cause staining of fabrics (brown stain) due to a chemical reaction between chlorhexidine gluconate bound to fabric and chlorine (if sufficient chlorine is present from certain laundry detergents used during laundering process).

Other warnings/precautions:

• Appropriate use: Topical: When used as a topical antiseptic, improper use may lead to product contamination. Although infrequent, product contamination has been associated with reports of localized and systemic infections. To reduce the risk of infection, ensure antiseptic products are used according to the labeled instructions; avoid diluting products after opening; and apply single-use containers only one time to one patient and discard any unused solution (FDA Drug Safety Communication 2013).

Warnings: Additional Pediatric Considerations

Although topical chlorhexidine is widely used in many NICUs as a skin cleanser prior to procedures (eg, central venous line placement/care) (Tamma 2010), data is lacking to support use in premature infants. Manufacturer's labeling recommends using with caution in premature neonates and infants <2 months of age as chlorhexidine-containing products may cause irritation or chemical burns. A survey of US NICU chlorhexidine use reports dermal burns occurring more frequently in neonates with birth weight <1,500 g (Tamma 2010). If used for neonatal dermal site cleansing, some suggest using sterile water or normal saline to remove excess disinfectant after procedures may help avoid chemical burns (Eichenwald 2017; Nuntnarumit 2013). Several studies have noted detectable serum concentrations in neonates after chlorhexidine exposure; no correlation between serum concentration and GA, birth weight, or PNA was identified; the clinical significance is undetermined (Chapman 2013; Garland 2009).

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

No reports of adverse effects in newborns have been reported, even though chlorhexidine is commonly used during labor and in the neonate. Moreover, only very small amounts of disinfectant reach the maternal circulation and the fetus.

Breast-Feeding Considerations

It is not known if chlorhexidine is excreted in breast milk.

Mechanism of Action

Chlorhexidine has activity against gram-positive and gram-negative organisms, facultative anaerobes, aerobes, and yeast; it is both bacteriostatic and bactericidal, depending on its concentration. The bactericidal effect of chlorhexidine is a result of the binding of this cationic molecule to negatively charged bacterial cell walls and extramicrobial complexes. At low concentrations, this causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorous resulting in a bacteriostatic effect. At high concentrations of chlorhexidine, the cytoplasmic contents of the bacterial cell precipitate and result in cell death.

Pharmacodynamics and Pharmacokinetics

Absorption: Topical: Neonates: Detectable serum concentrations have been noted following topical chlorhexidine administration (Chapman 2013; Cowen 1979; Garland 2009)

Pricing: US

Liquid (Betasept Surgical Scrub External)

4% (per mL): $0.02

Liquid (Hibiclens External)

4% (per mL): $0.03

Misc (Biopatch Protective Disk/CHG External)

(Dressing) (per each): $8.83

Misc (Tegaderm CHG Dressing External)

(Dressing) (per each): $10.01

Solution (Dyna-Hex 2 External)

2% (per mL): $0.01

Solution (Dyna-Hex 4 External)

4% (per mL): $0.03

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Acriflex (GB);
  • Alospray (PT);
  • Amident (RU);
  • Asseptic (BR);
  • Biorgasept (FR);
  • Cedium (HK);
  • Cetavlex (FR);
  • Chlorhex (TH);
  • Chlorohex (SG);
  • Clorosan (IT);
  • Clorxil (ES);
  • Descutan (SE);
  • Dettol Sterilon (NL);
  • Diaseptyl (FR);
  • Dosiseptine (CH);
  • Eczmol/Cetraben Protect Antimicrobial Cream (MT);
  • Handscrub (PT);
  • Hexene Skin Cleanser (TH);
  • Hexicon (RU);
  • Hexiscrub (BD);
  • Hexisol (BD);
  • Hexitane (BD);
  • Hexoscrub (SG);
  • Hibidil (FR);
  • Hibiscrub (BE, CH, ES, FR, GB, IE, KW, LU, MT, NL, NO, SA, SE, SG);
  • Hibitane (BE, DK, FR, IS, KW, MT, PT, SA);
  • Hydrex (HK, IE, TH);
  • Klorhexol (FI);
  • Lifo-Scrub (GR);
  • LirahexidineTopical (EC);
  • Marclorhex (BR);
  • Mediscrub (ID);
  • Microshield (AU, KR, SG);
  • Neoxene (IT);
  • Neoxinal (IT);
  • Normosept (ES);
  • Scanlin (HK);
  • Scrubing S 4% Soln (KR);
  • Septadine Scrub (IL);
  • Septal (IL);
  • Septalone (IL);
  • Sterets Unisept (IE);
  • Unisept (GB);
  • Vitawund (AT)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  2. Chapman AK, Aucott SW, Gilmore MM, Advani S, Clarke W, Milstone AM. Absorption and tolerability of aqueous chlorhexidine gluconate used for skin antisepsis prior to catheter insertion in preterm neonates. J Perinatol. 2013;33(10):768-771. [PubMed 23702618]
  3. ChloraPrep One-Step 10.6 mL (chlorhexidine) [prescribing information]. Leawood, KS: CareFusion; November 2013.
  4. ChloraPrep One-Step 3 mL (chlorhexidine) [prescribing information]. Leawood, KS: CareFusion; November 2013.
  5. Cowen J, Ellis SH, McAinsh J. Absorption of chlorhexidine from the intact skin of newborn infants. Arch Dis Child. 1979;54(5):379-383. [PubMed 475414]
  6. de la Rosa M, Sturzenberger OP, Moore DJ. The use of chlorhexidine in the management of gingivitis in children. J Periodontol. 1988;59(6):387-389. [PubMed 3164781]
  7. Food and Drug Administration. FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection. http://www.fda.gov/Drugs/DrugSafety/ucm374711.htm. Updated November 20, 2013. Accessed October 1, 2014.
  8. Garland JS, Alex CP, Mueller CD, Cisler-Kahill LA. Local reactions to a chlorhexidine gluconate-impregnated antimicrobial dressing in very low birth weight infants. Pediatr Infect Dis J. 1996;15(10):912-914. [PubMed 8895928]
  9. Garland JS, Alex CP, Uhing MR, Peterside IE, Rentz A, Harris MC. Pilot trial to compare tolerance of chlorhexidine gluconate to povidone-iodine antisepsis for central venous catheter placement in neonates. J Perinatol. 2009;29(12):808-813. [PubMed 19812587]
  10. Garland JS, Buck RK, Maloney P, et al. Comparison of 10% povidone-iodine and 0.5% chlorhexidine gluconate for the prevention of peripheral intravenous catheter colonization in neonates: a prospective trial. Pediatr Infect Dis J. 1995;14(6):510-516. [PubMed 7667056]
  11. Greenstein G, Berman C, and Jaffin R, “Chlorhexidine. An Adjunct to Periodontal Therapy,” J Periodontol, 1986, 57(6):370-7. [PubMed 3522851]
  12. Healthy Canadians Recall & Alerts. Summary safety review − topical antiseptic non-prescription chlorhexidine products − assessing the potential risk of serious allergic reactions (hypersensitivity reactions). Available at http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/chlorhexidine-eng.php. Published May 13, 2016. Accessed May 17, 2016.
  13. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  14. O'Connor C, Philip RK, Powell J, et al. Combined education and skin antisepsis intervention for persistently high blood-culture contamination rates in neonatal intensive care. J Hosp Infect. 2016;93(1):105-107. [PubMed 26944902]
  15. O'Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011;52(9):e162-193. [PubMed 21460264]
  16. PerioGard (chlorhexidine gluconate) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals; July 2015.
  17. Polin RA, Denson S, Brady MT, Committee on Fetus and Newborn, Committee on Infectious Diseases. Strategies for prevention of health care-associated infections in the NICU. Pediatrics. 2012;129(4):e1085-1093. [PubMed 22451712]
  18. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  19. Tamma PD, Aucott SW, Milstone AM. Chlorhexidine use in the neonatal intensive care unit: results from a national survey. Infect Control Hosp Epidemiol. 2010;31(8):846-849. [PubMed 20586654]
  20. Yong D, Parker FC, and Foran SM, “Severe Allergic Reactions and Intra-Urethral Chlorhexidine Gluconate,” Med J Aust, 1995, 162(5):257-8. [PubMed 7891607]
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