Introduction

Topical anti-infective; cationic bisbiguanide.

Uses for Chlorhexidine (EENT)

Gingivitis

Used as a mouthwash or oral rinse (topical oral solution) for treatment of gingivitis; used between dental visits as part of a professional program.

Periodontitis

Used subgingivally (extended-release insert) for treatment of adult periodontitis as an adjunct to scaling and root planing to reduce periodontal pocket depth; used as part of a periodontal maintenance program that includes good oral hygiene.

Prevention of Dental Caries

Has been used as a topical oral solution for prevention of dental plaque and dental caries^{† [off-label]} when conventional oral hygiene measures are difficult or impossible, such as in patients with fractured jaws, periodontal surgery, or orthodontic treatments and in patients with seizure disorders, rheumatoid arthritis, mental retardation, and cerebral palsy.

Mucositis and Other Oral Complications in Individuals with Altered Immunocompetence

Has been used as a topical oral solution to decrease incidence and severity of mucositis^{† [off-label]} and other oral complications^{† [off-label]} in patients with altered immunocompetence, including those undergoing bone marrow transplantation, radiation therapy, or chemotherapy.

Has been used as a topical oral solution as adjunct to surgical debridement, plaque removal, and systemic anti-infectives in treatment of linear gingival erythema^{† [off-label]}, necrotizing ulcerative gingivitis^{† [off-label]}, and necrotizing ulcerative periodontitis^† in immunocompromised individuals, including patients with HIV infection.

Such use has been beneficial for prevention or treatment of oral complications in some immunocompromised individuals, but inconsistent results reported in some studies.

Oropharyngeal Decontamination in Critically Ill Patients

Has been used as a topical oral solution for oral hygiene and oropharyngeal decontamination in an attempt to decrease the incidence of nosocomial respiratory tract infections in critically ill patients^†, including immunocompromised patients and those undergoing mechanical ventilation or heart surgery.

Chlorhexidine (EENT) Dosage and Administration

Administration

Oral, Topical Use Only

Topical oral solution (0.12%): Administer topically as mouthwash or oral rinse.

Oral solution is for topical use only and should not be ingested.

Consider that some commercially available topical oral solutions of the drug contain 11.6% alcohol and some are alcohol free.

Administer undiluted.

Immediately prior to initiation of treatment, provide professional dental prophylaxis. Reevaluate patient with thorough dental prophylaxis throughout treatment at intervals not exceeding 6 months.

Instruct patients to brush their teeth immediately prior to each use of the topical oral solution. Then, place appropriate volume of the oral solution into the mouth, swish for 30 seconds, and expectorate the solution.

Instruct patients to not rinse with water or other mouthwashes and to not brush their teeth or eat immediately after using the topical oral solution.

Subgingival Administration

Administered subgingivally as extended-release inserts into periodontal pockets by a dental health-care provider.

Place a single insert containing 2.5 mg of chlorhexidine gluconate into each periodontal pocket that has a probing depth ≥5 mm.

Isolate periodontal pocket and dry surrounding area prior to insertion. Grasp flat end of insert with forceps and place (curved end first) into periodontal pocket to its maximum depth. If necessary, further maneuver insert into position using tips of forceps or a flat instrument.

Advise patients to avoid dental floss at insertion sites for 10 days after placement.

If insert dislodges ≤48 hours after placement, place a new insert. If insert dislodges >48 hours but <7 days after placement, do not replace insert; reevaluate at 3 months and place new insert if pocket depth has not been reduced to <5 mm. If insert dislodges ≥7 days after placement, no action required since this is considered a full course of treatment.

Inserts will biodegrade within periodontal pockets and do not need to be manually removed.

Consult manufacturer’s literature for additional information on subgingival administration of chlorhexidine inserts.

Dosage

Available as chlorhexidine gluconate; dosage expressed in terms of the salt.

Adults

Gingivitis

Oral, Topical Use Only

0.12% topical oral solution: 15 mL as a mouthwash or oral rinse twice daily for 30 seconds (morning and evening after toothbrushing).

Periodontitis

Subgingival

Dosage varies depending on size, shape, and number of periodontal pockets treated.

2.5-mg insert: Place one insert into each periodontal pocket that has a probing depth ≥5 mm. Manufacturer states up to 8 inserts may be placed during a single visit.

Place new insert every 3 months into pockets that continue to have a probing depth of ≥5 mm.

Consider other treatment options (e.g., combination therapy, surgical intervention) if periodontal pockets with a probing depth of ≥5 mm do not respond within 9–12 months.

Prescribing Limits

Adults

Periodontitis

Subgingival

Maximum of 8 inserts during a single visit.

Contraindications

• Hypersensitivity to the drug or any ingredient in the formulation. (See Hypersensitivity Reactions under Cautions.)

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis and other serious allergic reactions reported in patients receiving dental preparations containing chlorhexidine.

Serious allergic reactions, including fatal anaphylaxis, reported rarely with topical chlorhexidine preparations used on the skin (e.g., solutions, washes, sponges, swabs), including OTC topical preparations.

Hypersensitivity reactions can occur within minutes following topical exposure. Symptoms may include wheezing or difficulty breathing, facial swelling, urticaria that can quickly progress to more serious symptoms, severe rash, or life-threatening shock.

Prior to prescribing or recommending any preparation that contains chlorhexidine, ask patients whether they have ever had an allergic reaction to antiseptics or any preparation containing chlorhexidine.

If allergic reaction occurs or is suspected, discontinue the drug and carefully monitor the reaction and provide immediate respiratory and/or cardiovascular support as needed.

Precautions Related to Topical Oral Solution

Possible staining of teeth and other oral surfaces, such as tooth surfaces, restorations, and dorsum of the tongue. Stains usually can be removed by conventional professional prophylactic techniques, although additional time may be required to complete the prophylaxis.

Possible increased supragingival calculus; professional dental prophylaxis to remove calculus deposits recommended at intervals not exceeding 6 months.

Alterations in taste perception reported. May be avoided if used after meals.

Effect on periodontitis not determined. If used as a mouthwash or oral rinse in patients with coexisting gingivitis and periodontitis, presence or absence of gingival inflammation following treatment should not be used as a major indicator of underlying periodontitis.

Precautions Related to Subgingival Inserts

Use in acutely abscessed periodontal pockets not studied and not recommended. Management of periodontal disease should include consideration of potentially contributing medical disorders, such as cancer, diabetes, and compromised immune function.

Avoid dental floss at insertion site for 10 days after placement; flossing might dislodge insert.

Some mild to moderate sensitivity is normal during first week after placement of a subgingival insert; however, dentist should be promptly notified if pain, swelling, or other problems occur.

Specific Populations

Pregnancy

Topical oral solution: No adequate and controlled studies to date in pregnant women; use during pregnancy only when clearly needed.

Subgingival insert: No adequate and controlled studies to date in pregnant women; use during pregnancy only when clearly needed.

Lactation

Topical oral solution: Not known if chlorhexidine distributes into human milk following use as a mouthwash or oral rinse. Use with caution in nursing women.

Pediatric Use

Topical oral solution: Safety and efficacy not established in pediatric patients <18 years of age.

Subgingival insert: Safety and efficacy not established in pediatric patients <18 years of age.

Geriatric Use

Subgingival insert: Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. No overall differences in safety or efficacy between geriatric and younger adults.

Common Adverse Effects

Topical oral solution: Increased staining of teeth, esthetic restorations, and other oral surfaces; increased calculus formation; alteration of taste perception.

Subgingival inserts: Toothache, upper respiratory infection, headache.

Administration

Oral, Topical Use Only

Topical oral solution (0.12%): Administer topically as mouthwash or oral rinse.

Oral solution is for topical use only and should not be ingested.

Consider that some commercially available topical oral solutions of the drug contain 11.6% alcohol and some are alcohol free.

Administer undiluted.

Immediately prior to initiation of treatment, provide professional dental prophylaxis. Reevaluate patient with thorough dental prophylaxis throughout treatment at intervals not exceeding 6 months.

Instruct patients to brush their teeth immediately prior to each use of the topical oral solution. Then, place appropriate volume of the oral solution into the mouth, swish for 30 seconds, and expectorate the solution.

Instruct patients to not rinse with water or other mouthwashes and to not brush their teeth or eat immediately after using the topical oral solution.

Subgingival Administration

Administered subgingivally as extended-release inserts into periodontal pockets by a dental health-care provider.

Place a single insert containing 2.5 mg of chlorhexidine gluconate into each periodontal pocket that has a probing depth ≥5 mm.

Isolate periodontal pocket and dry surrounding area prior to insertion. Grasp flat end of insert with forceps and place (curved end first) into periodontal pocket to its maximum depth. If necessary, further maneuver insert into position using tips of forceps or a flat instrument.

Advise patients to avoid dental floss at insertion sites for 10 days after placement.

If insert dislodges ≤48 hours after placement, place a new insert. If insert dislodges >48 hours but <7 days after placement, do not replace insert; reevaluate at 3 months and place new insert if pocket depth has not been reduced to <5 mm. If insert dislodges ≥7 days after placement, no action required since this is considered a full course of treatment.

Inserts will biodegrade within periodontal pockets and do not need to be manually removed.

Consult manufacturer’s literature for additional information on subgingival administration of chlorhexidine inserts.

Dosage

Available as chlorhexidine gluconate; dosage expressed in terms of the salt.

Adults

Gingivitis

Oral, Topical Use Only

0.12% topical oral solution: 15 mL as a mouthwash or oral rinse twice daily for 30 seconds (morning and evening after toothbrushing).

Periodontitis

Subgingival

Dosage varies depending on size, shape, and number of periodontal pockets treated.

2.5-mg insert: Place one insert into each periodontal pocket that has a probing depth ≥5 mm. Manufacturer states up to 8 inserts may be placed during a single visit.

Place new insert every 3 months into pockets that continue to have a probing depth of ≥5 mm.

Consider other treatment options (e.g., combination therapy, surgical intervention) if periodontal pockets with a probing depth of ≥5 mm do not respond within 9–12 months.

Prescribing Limits

Adults

Periodontitis

Subgingival

Maximum of 8 inserts during a single visit.