Chlorhexidine Gluconate

Drug overview for CHLORHEXIDINE GLUCONATE (chlorhexidine gluconate):

Generic name: CHLORHEXIDINE GLUCONATE (khlor-HEX-i-deen GLOO-koe-nate)
Drug class:
Therapeutic class: Mouth-Throat-Dental - Preparations

Chlorhexidine gluconate, a cationic bisbiguanide, is a topical anti-infective agent. Chlorhexidine gluconate, a cationic bisbiguanide, is a topical anti-infective agent.

Chlorhexidine gluconate 0.12% topical oral solution is used as a mouthwash or oral rinse for the treatment of gingivitis. Chlorhexidine gluconate, as a subgingival preparation containing the drug in a biodegradable extended-release insert, is used as an adjunct in the treatment of adult periodontitis.

Chlorhexidine gluconate topical oral preparations have been used in the oral cavity in an attempt to prevent dental plaque and dental caries+, decrease the incidence and severity of mucositis and other oral complications in immunocompromised patients+, and provide oral hygiene and decontamination in critically ill patients in an attempt to decrease the incidence of nosocomial respiratory tract infections+. 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. Chlorhexidine gluconate 2 or 4% solution in a sudsing base (chlorhexidine gluconate skin cleanser) is used topically as an anti-infective skin cleanser for surgical hand antisepsis (i.e., hand scrub), preoperative skin preparation, routine hand hygiene in health-care personnel, and skin wound and general skin cleansing.

Alcohol-based chlorhexidine gluconate 0.5 or 1% solution with emollients (chlorhexidine gluconate hand rub) is used topically as an anti-infective hand rub for routine hand hygiene in health-care personnel; the 1% solution in an alcohol base with emollients also is used topically for surgical hand antisepsis (i.e., hand rub). In addition, chlorhexidine gluconate is used topically for skin disinfection prior to insertion of catheters+, including intravascular, central venous, and arterial catheters, and topical dressings containing chlorhexidine gluconate 20% are used for postinsertion site care in patients with vascular and nonvascular percutaneous devices.

Topical chlorhexidine gluconate appears to have a more rapid bactericidal effect than similar topical preparations containing povidone-iodine, triclosan, or hexachlorophene. In addition, chlorhexidine gluconate has persistent or residual anti-infective activity comparable to that reported with hexachlorophene or triclosan, which prevents regrowth of microorganisms on the skin; however, chlorhexidine gluconate has a broader spectrum of activity than these other topical agents, particularly against gram-negative bacteria.

DRUG IMAGES

CHLORHEXIDINE 0.12% RINSE

The following indications for CHLORHEXIDINE GLUCONATE (chlorhexidine gluconate) have been approved by the FDA:

Indications:
Gingivitis
Mouth infection prevention

Professional Synonyms:
Mouth infection prophylaxis

The following dosing information is available for CHLORHEXIDINE GLUCONATE (chlorhexidine gluconate):

Dosing
Administration
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATE

Dosage of chlorhexidine gluconate is expressed in terms of the salt.

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.

Chlorhexidine gluconate 2 and 4% solutions in a sudsing base (skin cleanser) and chlorhexidine gluconate 0.5 and 1% solutions in an alcohol base with emollients (hand rub) are applied topically to the skin and hands. These topical preparations are for external use only, and contact with the eyes, ears, or mouth should be avoided.

Chlorhexidine gluconate 2 and 4% solutions in a sudsing base should not be used for preoperative skin preparation on the face or head. Dressings containing chlorhexidine gluconate 20% are applied topically at the site of vascular and nonvascular percutaneous devices.

Dosing information for CHLORHEXIDINE GLUCONATE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CHLORHEXIDINE 0.12% 15 ML CUP	Maintenance	Adults place 15 milliliters in the mouth by mucous membrane route 2 times per day (after meals), swish in mouth for 30 seconds then spit out
CHLORHEXIDINE 0.12% RINSE	Maintenance	Adults place 15 milliliters in the mouth by mucous membrane route 2 times per day (after meals), swish in mouth for 30 seconds then spit out

Generic dosing information for CHLORHEXIDINE GLUCONATE
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CHLORHEXIDINE 0.12% RINSE	Maintenance	Adults place 15 milliliters in the mouth by mucous membrane route 2 times per day (after meals), swish in mouth for 30 seconds then spit out
CHLORHEXIDINE 0.12% 15 ML CUP	Maintenance	Adults place 15 milliliters in the mouth by mucous membrane route 2 times per day (after meals), swish in mouth for 30 seconds then spit out
CHLORHEXIDINE 0.12% 10 ML CUP	Maintenance	Adults place 15 milliliters in the mouth by mucous membrane route 2 times per day (after meals), swish in mouth for 30 seconds then spit out
CHLORHEXIDINE 0.12% 30 ML CUP	Maintenance	Adults place 15 milliliters in the mouth by mucous membrane route 2 times per day (after meals), swish in mouth for 30 seconds then spit out

Severe List
Large open wound

Moderate List
Periodontitis

The following adverse reaction information is available for CHLORHEXIDINE GLUCONATE (chlorhexidine gluconate):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 10 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Allergic dermatitis Anaphylaxis Angioedema Dyspnea Facial edema Hypotension Sialoadenitis Tachycardia Urticaria Wheezing

There are 18 less severe adverse reactions.

More Frequent	Less Frequent
Dental discoloration Dysgeusia Increased tartar formation Mouth discoloration	None.

Rare/Very Rare
Aphthous stomatitis Blistering skin Contact dermatitis Erythema Erythema of mouth mucous membrane Glossitis Mouth irritation Oral hypoesthesia Parotitis Pruritus of skin Skin irritation Skin rash Sore tongue Xerostomia

The following precautions are available for CHLORHEXIDINE GLUCONATE (chlorhexidine gluconate):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Reproduction studies in rats or rabbits using chlorhexidine gluconate given by gastric lavage in daily dosages up to 300 or 40 mg/kg, respectively, have not revealed evidence of harm to the fetus. Animal reproduction studies have not been performed with commercially available chlorhexidine gluconate inserts for subgingival administration because animal models that would permit use of a clinically relevant route of administration are not available. There are no adequate and controlled studies to date using chlorhexidine gluconate in pregnant women, and chlorhexidine gluconate topical oral solution and subgingival chlorhexidine gluconate inserts should be used during pregnancy only when clearly needed.

Reproduction studies in rats using chlorhexidine given by gastric lavage on days 6-15 of gestation have not revealed evidence of harm to the fetus. There are no adequate and controlled studies to date using chlorhexidine gluconate in pregnant women, and the drug should be used during pregnancy only when clearly needed.

Although systemic absorption of chlorhexidine does not appear to occur following use of chlorhexidine gluconate topical oral solution or subgingival chlorhexidine gluconate inserts, it is not known whether the drug would be distributed into milk if systemic absorption were to occur. Therefore, chlorhexidine gluconate preparations should be used with caution in nursing women. In studies in rats, there was no evidence of impaired parturition or toxic effects to suckling pups when chlorhexidine gluconate was administered to dams at dosages that were more than 100 times greater than that which would occur if a person ingested 30 mL of 0.12%

chlorhexidine gluconate topical oral solution daily. It is not known if chlorhexidine gluconate is distributed into breast milk; however, is unlikely that chlorhexidine gluconate distributes into milk following topical or intravaginal application, based on the very small amount of the drug absorbed percutaneously into maternal circulation. Although the drug is poorly absorbed from the GI tract, if chlorhexidine gluconate has been used for skin cleansing, the mother's nipples should be washed thoroughly with water prior to nursing. One neonate was reported to develop multiple episodes of bradycardia and cyanosis, with serum chlorhexidine concentrations of 11 ng/mL after oral exposure when chlorhexidine gluconate was used on the mother's breasts to prevent mastitis.

No enhanced Geriatric Use information available for this drug.

Gingivitis
K05.0	Acute gingivitis
K05.00	Acute gingivitis, plaque induced
K05.01	Acute gingivitis, non-plaque induced
K05.1	Chronic gingivitis
K05.10	Chronic gingivitis, plaque induced
K05.11	Chronic gingivitis, non-plaque induced