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Chlorhexidine (Topical)

Class: Local Anti-infectives, Miscellaneous
Chemical Name: N,N′′-Bis(4-chlorophenyl)-3,12-diimino- 2,4,11,13-tetraazatetradecanediimidamide di-d-gluconate
Molecular Formula: C22H30Cl2N10•2C6H12O7
CAS Number: 18472-51-0
Brands: Avagard, Betasept, Biopatch, Chlorostat, Hibiclens, Hibistat

Medically reviewed by Drugs.com on Jan 25, 2021. Written by ASHP.

Warning

Special Alerts:

[Posted 02/02/2017]

AUDIENCE: Nursing, Surgery, Dentistry, Patient

ISSUE: FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. See the FDA Drug Safety Communication, available at: [Web], for a data summary.

As a result, FDA is requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels.

BACKGROUND: Chlorhexidine gluconate is mainly available in OTC products to clean and prepare the skin before surgery and before injections in order to help reduce bacteria that potentially can cause skin infections. These products are available as solutions, washes, sponges, and swabs and under many different brand names and as generics. Chlorhexidine gluconate is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease.

Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the possibility of serious allergic reactions in their labels.

In 1998, FDA issued a Public Health Notice to warn health care professionals about the risk of serious allergic reactions with medical devices such as dressings and intravenous lines that contain chlorhexidine gluconate.

RECOMMENDATION: Health care professionals should always ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product. Advise patients to seek immediate medical attention if they experience any symptoms of an allergic reaction when using the products. Consider using alternative antiseptics such as povidone-iodine, alcohols, benzalkonium chloride, benzethonium chloride, or parachlorometaxylenol (PCMX) when any previous allergy to chlorhexidine gluconate is documented or suspected.

Patients and consumers should stop using the product that contains chlorhexidine gluconate and seek medical attention immediately or call 911 if they experience symptoms of a serious allergic reaction. These reactions can occur within minutes of exposure. Symptoms include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, which is a life-threatening condition that occurs when the body is not getting enough blood flow.

For more information visit the FDA website at: [Web] and [Web].

Introduction

Cationic bisbiguanide; a topical anti-infective agent.

Uses for Chlorhexidine (Topical)

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Surgical Hand Antisepsis

Preoperative hand antisepsis in health-care personnel to inactivate microorganisms (normal and transient flora) present on the hands and forearms.

Chlorhexidine gluconate 2 or 4% skin cleanser solutions have more persistent anti-infective activity compared with other available anti-infective cleansers.

Surgical Site Preparation

Anti-infective skin cleanser for preoperative skin preparation at the surgical site.

Preoperative Whole-body Disinfection

Anti-infective skin cleanser for patient preoperative showering and bathing to decrease bacterial flora on the skin.

Hand Hygiene in Health-care Personnel

Routine hand hygiene in health-care personnel to prevent transmission of nosocomial infection.

Considered an alternative for decontaminating hands; alcohol-based preparations are recommended instead for decontaminating hands (if they are not visibly soiled) since alcohol-based preparations are most effective for standard hand antisepsis by health-care personnel.

Superficial Skin Wound and General Skin Cleansing

Used as a cleanser of superficial skin wounds and for general cleansing of skin.

Should not be used routinely in wounds that involve more than the superficial layers of the skin.

Advantage over alcohol because of a duration of action of 5–6 hours and retention of the drug’s activity in the presence of blood and organic material.

Catheter Site Preparation and Catheter Site Care

Skin disinfection prior to insertion of intravascular, central venous, or arterial catheters and for postinsertion site care to prevent catheter-related infections in patients with vascular and nonvascular percutaneous devices.

Chlorhexidine gluconate 2% solution is the preferred agent for such antisepsis.

Burns

Management of burns to clean the affected area and prevent wound infection.

Blood Collection Site Preparation

Skin disinfection prior to collection of venous blood cultures or blood donations.

Genitourinary Uses

Periurethral cleansing prior to urinary catheterization.

Topical lubricant on urinary catheters.

Bladder irrigation in an attempt to decrease the incidence of bacteriuria and bacteremia associated with the use of indwelling catheters. (See Hypersensitivity Reactions under Cautions.)

Prevent maternal-fetal transmission of vaginal bacteria, including Streptococcus agalactiae (group B streptococci), to reduce maternal and neonatal infections.

Chlorhexidine (Topical) Dosage and Administration

Administration

Topical Administration

Preparations are for external use only; avoid contact with the eyes, ears, or mouth.

Apply solutions in a sudsing base (skin cleanser) and solutions in an alcohol base with emollients (hand rub) topically to the skin and hands.

Do not use solutions in sudsing base on the face or head for preoperative skin preparation.

Apply chlorhexidine containing dressings at the site of vascular and nonvascular percutaneous devices.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adults

Surgical Hand Antisepsis
Chlorhexidine Gluconate Solution 2 or 4% (Skin Cleanser)
Topical

Wet hands and forearms with water. Apply approximately 5 mL of the skin cleanser onto the hands and rub into a copious lather by adding small amounts of water.

Spread suds over the hands and forearms and scrub well with a wet brush for the time interval recommended by the manufacturer (e.g., 3 minutes).

Pay particular attention to the nails, cuticles, and interdigital spaces; a separate nail cleaner may be used.

After scrubbing, rinse the hands and forearms thoroughly under running water.

Apply a second application (5 mL) and scrub the hands and forearms for an additional 3 minutes. Then rinse thoroughly with running water and dry with a sterile towel.

Prolonged scrub times (e.g., 10 minutes) not necessary and may increase incidence of skin damage.

Sponge/brush containing 4% skin cleanser: open package and remove nail cleaner. Wet hands with water and use nail cleaner under fingernails and to clean cuticles. Wet hands and forearms to elbows with warm water (avoid use of very cold or very warm water). Wet sponge side of sponge/brush; squeeze and pump immediately to work up adequate lather. Apply lather to hands and forearms using only sponge side of product; then start 3-minute scrub using brush side of product to scrub only nails, cuticles, and interdigital areas. Rinse hands and forearms thoroughly with warm water, then scrub for an additional 3 minutes using sponge side only. Rinse hands and forearms thoroughly with running water and dry with sterile towel.

Chlorhexidine Gluconate 1% Solution in Alcohol Base (Hand Rub)
Topical

Wash hands, forearms, and nails with an unmedicated soap (without an anti-infective) and dry completely. Apply 2 mL of solution onto palm of one hand; dip fingertips of other hand into solution and massage under nails.

Spread remaining solution over hand and forearms, up to just above the elbow, making certain to cover all surfaces.

Repeat procedure using another 2 mL of solution using opposite hand.

Finally, apply additional 2 mL of solution onto palm of either hand and reapply to both hands, up to wrists.

Rub hands together briskly until all solution is rubbed into hands and forearms and dries completely; do not use towels to dry since this decreases solution efficacy.

Hands and forearms should be completely dry prior to donning surgical gloves.

Never use water in conjunction with the alcohol-based solution.

Surgical Site Preparation
Chlorhexidine Gluconate 2 or 4% Solution (Skin Cleanser)
Topical

Apply liberally to the incision site and swab for at least 2 minutes; dry with a sterile towel.

Repeat procedure for an additional 2 minutes and dry area again with a sterile towel.

Hand Hygiene in Health-care Personnel
Chlorhexidine Gluconate 2 or 4% Solution (Skin Cleanser)
Topical

Wet hands with warm water (avoid use of very cold or very hot water); dispense approximately 5 mL of the skin cleanser into cupped hands. Work up a lather (do not use excessive pressure to produce additional lather) and wash hands for 15 seconds. Rinse hands thoroughly with warm water, then dry.

Chlorhexidine Gluconate 0.5 or 1% in Alcohol Base (Hand Rub)
Topical

Hands must first be physically clean and dry before application of solution. Dispense approximately 5 mL of the 0.5% solution or 2 mL of 1% solution into cupped hands and rub vigorously until dry (about 15 seconds); pay particular attention to nails and interdigital spaces. Solution dries rapidly while hands are rubbed; do not use water or other toweling.

Pledgets: vigorously rub hands with a hand wipe for approximately 15 seconds, paying particular attention to nails and interdigital spaces. Solution dries rapidly while hands are rubbed; do not use water or other toweling.

Superficial Skin Wound and General Skin Cleansing
Chlorhexidine Gluconate 2 or 4% Solution (Skin Cleanser)
Topical

Rinse the area thoroughly with water before application of the solution. Apply the minimum amount of skin cleanser to cover the skin or wound area. Wash the area gently with the skin cleanser, then thoroughly rinse again.

Catheter Site Preparation and Catheter Site Care
Topical

Apply solution and air dry before catheter insertion.

Dressing: Apply to the site using aseptic technique. Dressing may be left in place for up to 7 days. Consult manufacturer’s information for details.

Cautions for Chlorhexidine (Topical)

Contraindications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Contraindicated in patients with known hypersensitivity to the drug or any ingredient in the formulation.

Warnings/Precautions

Warnings

Topical Use

Skin cleanser and alcohol-based solutions are for external use only; do not use in eyes, ears, or mouth. Skin cleanser should not be used for preoperative skin preparation of the face or head.

Skin cleanser and alcohol-based chlorhexidine solutions should not be used routinely on individuals who have wounds involving more than the superficial layers of the skin.

Use with caution on mucous membranes and apply on wound surfaces at the lowest bactericidal concentration (0.05%) (not commercially available in the US) to decrease the risk of anaphylactic reactions.

Avoid direct contact of the drug with brain tissue or meninges.

Ocular and Otic Effects

Possible irreversible corneal damage after accidental ocular exposure.

Do not touch eyes with hands that have been treated with chlorhexidine. If ocular contact occurs, rinse eye promptly and thoroughly with water.

Possible sensorineural deafness after direct application for perioperative disinfection of the ear prior to vascular myringoplasty.

Flammability

Alcohol-based preparations (Hibistat, Avagard) should not be exposed to excessive heat (i.e., temperatures exceeding 40°C); keep away from flames or devices that may generate an electric spark. These preparations dry rapidly as the hands are rubbed together and are no longer flammable after drying.

Sensitivity Reactions

Hypersensitivity Reactions

Serious, systemic hypersensitivity reactions, including hypotension, tachycardia, shortness of breath, skin erythema, and anaphylaxis, have been reported with preparations applied topically to the skin or given intraurethrally, intranasally, or on central venous catheter (CVCs) impregnated with the drug.

Dermatitis

Local contact dermatitis reported when chlorhexidine-impregnated dressings were used to cover CVC insertion site in neonates. May be severe, may require discontinuance of the chlorhexidine dressing, and have occurred most frequently in low birthweight neonates.

General Precautions

Fabric Stains

Binds to many fabrics, particularly cotton, and may not be removed by washing. Permanent brown stain may occur if sufficient chlorine is present during washing. Consult manufacturer’s recommendations for laundering advice.

Specific Populations

Pregnancy

Category B.

Lactation

Unlikely to be distributed into human milk following topical or intravaginal application.

Multiple episodes of bradycardia and cyanosis reported in a neonate when chlorhexidine was applied to the nursing mother’s breasts for prevention of mastitis. Wash nipples thoroughly with water prior to nursing if used for skin cleansing.

Pediatric Use

Keep preparations out of the reach of children.

Common Adverse Effects

Irritation, sensitization, generalized allergic reactions, especially when used in the genital area.

Interactions for Chlorhexidine (Topical)

No formal drug interaction studies to date.

Chlorhexidine (Topical) Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from GI tract or percutaneously following topical application to skin.

Low concentrations appear to be absorbed systemically following intravaginal administration.

Adsorbed onto outer layers of skin following topical application to intact skin, resulting in a persistent (residual) antimicrobial effect.

In pregnant women who received a 2% solution intravaginally as a vaginal wash during labor, concentrations ranging from 0.01–0.083 mcg/mL were detected in the blood (limits of detection 0.01 mcg/mL) of approximately 33% of these women.

Serum concentrations of 11 ng/mL reported in a neonate after oral exposure when chlorhexidine gluconate was used on the nursing mother’s nipples to prevent mastitis.

Special Populations

Possible systemic absorption when topical preparations used as skin cleansers in neonates or infants.

Distribution

Extent

Not known whether chlorhexidine crosses the placenta or is distributed into milk.

Elimination

Elimination Route

If absorbed percutaneously following topical application to the skin, appears to be mainly excreted unchanged in feces.

Stability

Storage

Topical

Dressing, Pledgets, Solution

Tight, light resistant containers; protect from excessive heat (i.e., >40°C).

Keep alcohol-based preparations (Hibistat and Avagard) away from flames or devices that may generate an electric spark.

Actions and Spectrum

  • Bacteriostatic or bactericidal in action, depending on concentration attained at site and susceptibility of organism.

  • Cationic compound; adsorbed onto negatively charged cell surfaces of susceptible organisms, with specific and strong adsorption to certain phosphate-containing compounds. Integrity of the cell membrane is disrupted, resulting in increased permeability.

  • Active against some aerobic and anaerobic gram-positive and gram-negative bacteria. Also has some activity against Chlamydia trachomatis, certain fungi, and certain viruses, but inactive against mycobacteria and generally inactive against bacterial spores.

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Importance of avoiding contact with eyes, ears, and mouth. If ocular contact occurs, rinse eye promptly and thoroughly with water to prevent irreversible injury.

  • Avoid exposure to excessive heat (i.e., >40°C) with alcohol-based preparations (Hibistat, Avagard); keep away from flames or devices that may generate an electric spark.

  • Importance of discontinuing drug and informing clinician if an allergic or hypersensitivity reaction occurs.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Chlorhexidine Gluconate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Dressing

20% w/w

Biopatch

J & J

Pledgets (saturated with solution)

0.5% w/w with isopropyl alcohol 70%

Hibistat Hand Wipe

Regent Medical

Solution

0.5% w/w with isopropyl alcohol 70%

Hibistat Hand Rinse

Regent Medical

1% w/w with alcohol 61%

Avagard Hand Antiseptic

3M

2% w/w

Chlorostat Skin Cleaner and Surgical Scrub

King

4% w/v

Betasept Surgical Scrub

Purdue Frederick

Hibiclens Skin Cleanser

Regent Medical

Sponge/Brush

4% w/v

Hibiclens Skin Cleanser

Regent Medical

AHFS DI Essentials™. © Copyright 2021, Selected Revisions February 2, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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