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Chlorhexidine gluconate (oral): Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Paroex [DSC];
  • Peridex;
  • Periogard
Brand Names: Canada
  • APO-Chlorhexidine;
  • Chlorhexidine Alcohol Free [DSC];
  • DentiCare Rinse;
  • EURO-Chlorhexidine;
  • GUM Paroex Oral Rinse;
  • Oro Clear;
  • Oro-Clense;
  • Perichlor;
  • Perichlor Without Alcohol;
  • Peridex;
  • Periogard Alcohol Free;
  • Periogard [DSC]
Pharmacologic Category
  • Antibiotic, Oral Rinse
Dosing: Adult
Odontogenic infection

Odontogenic infection (adjunctive agent):

Acute simple gingivitis, plaque-associated: Note: Use as monotherapy or, for patients with rapidly advancing disease, severe pain, or an immunocompromising condition, may use in combination with systemic antibiotics (Ref).

Oral rinse: Swish for 30 seconds with 15 mL (one capful) of undiluted oral rinse after toothbrushing, then expectorate; repeat twice daily (morning and evening) until symptoms resolve. Use in addition to regular dental prophylaxis (cleaning).

Periodontitis, nonsevere, plaque-associated: Periodontal chip: Insert 1 chip into a periodontal pocket with a probing pocket depth ≥5 mm. Up to 8 chips may be inserted in a single visit. Repeat every 3 months if pocket depth remains ≥5 mm. If dislodgment occurs within 48 hours, insert a new chip. If dislodgement occurs after this time, reevaluate at 3 months; 7 days of the chip in place is considered a full course (Ref). Use in addition to periodontal debridement (Ref).

Oropharyngeal decontamination

Oropharyngeal decontamination (to reduce the risk of postoperative hospital-acquired infections) (off-label use): Note: Efficacy data are conflicting; the greatest benefit may be among patients undergoing cardiac surgery (Ref). Some experts recommend against routine use in mechanically ventilated patients not undergoing cardiac surgery (Ref). Optimal dosing and regimens are uncertain; refer to institutional protocols.

Example regimen for cardiac surgical patients:

Oral rinse/hygiene: 15 mL swished and gargled or applied to intubated patients by swabbing the oral cavity (buccal, pharyngeal, gingival, tongue, and tooth surfaces) for 30 seconds 2 or 4 times daily (Ref).

Dosing: Kidney 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: Older Adult

Refer to adult dosing.

Dosing: Pediatric

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

Gingivitis

Gingivitis: Limited data available: Children ≥8 years and Adolescents: Oral: Oral rinse (0.12%): Swish 15 mL (one capful) of undiluted oral rinse for 30 seconds after toothbrushing, then expectorate; repeat twice daily (morning and evening) (Ref).

Dosing: Kidney 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.

Adverse Reactions

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

>10%:

Gastrointestinal: Toothache (51%)

Respiratory: Upper respiratory tract infection (28%), sinusitis (14%)

1% to 10%:

Gastrointestinal: Gingival hyperplasia (4%), aphthous stomatitis (2%)

Neuromuscular & skeletal: Arthritis (3%), tendinopathy (2%)

Respiratory: Bronchitis (6%), pharyngitis (4%)

Frequency not defined:

Dermatologic: Cellulitis

Gastrointestinal: Dental discoloration (with oral rinse), dental discomfort, increased tartar formation, mouth discoloration

Infection: Abscess

<1%, postmarketing, and/or case reports: Coated tongue, desquamation, dysgeusia, erythema, geographic tongue, gingivitis, glossitis, hyperkeratosis, hypersensitivity reaction, hypoesthesia, mouth irritation, oral lesion, oral mucosa ulcer, paresthesia, parotid gland enlargement, sialadenitis, stomatitis, tongue changes (short frenum), tongue edema, tongue irritation, trauma, xerostomia

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:

• Oral rinse: Staining of oral surfaces (teeth, tooth restorations, dorsum of tongue) may occur; patients exhibited a measurable increase of staining in the facial anterior after 6 months of therapy that is more pronounced when there is a heavy accumulation of unremoved plaque. Stain does not adversely affect health of the gingivae or other oral tissues, and most stain can be removed from most tooth surfaces by dental prophylaxis. Because removal may not be possible, patients with anterior facial restorations with rough surfaces or margins should be advised of the potential permanency of the stain. An increase in supragingival calculus has been observed with use; it is not known if the incidence of subgingival calculus is increased. Dental prophylaxis to remove calculus deposits should be performed at least every 6 months. May alter taste perception during use; has rarely been associated with permanent taste alteration.

• Periodontal chip: Infectious events (eg, abscesses, cellulitis) have been observed rarely with adjunctive chip placement post scaling and root planing; use with caution in patients with periodontal disease and concomitant diseases potentially decreasing immune status (eg, diabetes, cancer). Use in acute periodontal abscess pocket is not recommended.

Other warnings/precautions:

• Appropriate use: Oral rinse: Effect on periodontitis has not been determined; has not been tested in patients with acute necrotizing ulcerative gingivitis.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

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

Solution, Mouth/Throat:

Paroex: 0.12% (473 mL [DSC]) [alcohol free; contains fd&c red #40 (allura red ac dye), propylene glycol]

Peridex: 0.12% (118 mL, 473 mL, 1893 mL) [contains alcohol, usp, fd&c blue #1 (brilliant blue), saccharin sodium; mint flavor]

Periogard: 0.12% (473 mL [DSC]) [contains alcohol, usp, fd&c blue #1 (brilliant blue), saccharin sodium]

Periogard: 0.12% (473 mL) [alcohol free; contains fd&c blue #1 (brilliant blue), polyoxyl/peg-35 castor oil(cremophor el), propylene glycol; mint flavor]

Generic: 0.12% (15 mL, 118 mL, 120 mL, 473 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Chlorhexidine Gluconate Mouth/Throat)

0.12% (per mL): $0.09 - $0.22

Solution (Peridex Mouth/Throat)

0.12% (per mL): $0.02

Solution (Periogard Mouth/Throat)

0.12% (per mL): $0.02

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.

Dosage Forms: Canada

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

Solution, Mouth/Throat:

DentiCare Rinse: 0.12% (500 mL) [contains alcohol, usp, fd&c blue #1 (brilliant blue), fd&c yellow #5 (tartrazine), methylparaben, propylparaben]

GUM Paroex Oral Rinse: 0.12% (473 mL) [contains fd&c red #40 (allura red ac dye), propylene glycol]

Oro Clear: 0.12% (500 mL, 4000 mL) [contains fd&c blue #1 (brilliant blue), polysorbate 80, quinoline yellow (d&c yellow #10), saccharin sodium]

Perichlor: 0.12% (475 mL) [contains alcohol, usp, fd&c blue #1 (brilliant blue)]

Perichlor Without Alcohol: 0.12% (475 mL)

Peridex: 0.12% (475 mL) [contains alcohol, usp, fd&c blue #1 (brilliant blue), saccharin sodium]

Periogard: 0.12% ([DSC]) [contains alcohol, usp, fd&c blue #1 (brilliant blue), polyethylene glycol (macrogol), saccharin sodium]

Periogard Alcohol Free: 0.12% (470 mL) [contains fd&c blue #1 (brilliant blue), polyoxyl/peg-35 castor oil(cremophor el), propylene glycol]

Generic: 0.12% (475 mL, 480 mL, 500 mL, 4000 mL)

Administration: Adult

Oral:

Oral rinse/hygiene: Swish rinse and expectorate after rinsing; do not swallow. Use in the morning and evening after brushing teeth. Following administration, do not immediately rinse with water or other mouthwashes, brush teeth, or eat. In mechanically ventilated patients, apply with oral applicator to buccal, pharyngeal, gingival, tongue, and tooth surfaces for 30 seconds (Ref).

Periodontal chip insertion: Pocket should be isolated and surrounding area dried prior to chip insertion. The chip should be grasped using forceps with the rounded edges away from the forceps. The chip should be inserted into the periodontal pocket to its maximum depth. It may be maneuvered into position using the tips of the forceps or a flat instrument. The chip biodegrades completely and does not need to be removed. Patients should avoid dental floss at the site of periodontal chip insertion for 10 days after placement because flossing might dislodge the chip.

Administration: Pediatric

Oral rinse: Swish rinse and expectorate; do not swallow. Use in the morning and evening after brushing teeth. Following administration, do not rinse with water or other mouthwashes, brush teeth, or eat immediately.

Use: Labeled Indications

Odontogenic infection:

Gingivitis: Oral rinse: Antimicrobial dental rinse for gingivitis treatment

Periodontitis: Periodontal chip: Adjunctive therapy to scaling and root planing procedures to reduce pocket depth in patients with periodontitis

Use: Off-Label: Adult

Medication-related osteonecrosis of the jaw, adjunctive therapy: Oral rinse:; Oropharyngeal decontamination (to reduce the risk of postoperative hospital-acquired infections)

Medication Safety Issues
Sound-alike/look-alike issues:

Peridex may be confused with Precedex

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies following use of the oral rinse; use of periodontal chip has not been studied. Chlorhexidine oral rinse is poorly absorbed from the GI tract.

Breastfeeding Considerations

It is not known if chlorhexidine is present in breast milk. The manufacturer recommends that caution be exercised when administering chlorhexidine oral rinse to nursing women. However, oral rinse is not intended for ingestion; patient should expectorate after rinsing.

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.

Pharmacokinetics (Adult Data Unless Noted)

Absorption:

Oral rinse: ~30% retained in the oral cavity following rinsing and slowly released into oral fluids; poorly absorbed from GI tract. After oral administration application, serum concentrations are not detectable in plasma 12 hours after dose.

Periodontal chip: Chlorhexidine released from chip in a biphasic manner: ~40% within initial 24 hours, then remainder released linearly over 7 to 10 days; no detectable urine or plasma levels measured following insertion of 4 chips under clinical conditions

Duration of action: Serum concentrations: Detectable levels are not present in the plasma 12 hours after administration

Excretion: Oral rinse: Feces (~90%); Urine (<1%)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (KE) Kenya: Hexon;
  • (KR) Korea, Republic of: Hexidine;
  • (QA) Qatar: Antiseptol | Cloradyn | Clorasept | Corsodyl | Hexidine | Oraxine | Unisept | Zordyl
  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. Bardia A, Blitz D, Dai F, et al. Preoperative chlorhexidine mouthwash to reduce pneumonia after cardiac surgery: a systematic review and meta-analysis. J Thorac Cardiovasc Surg. 2019;158(4):1094-1100. doi:10.1016/j.jtcvs.2019.01.014 [PubMed 30826096]
  3. Bellissimo-Rodrigues F, Bellissimo-Rodrigues WT, Viana JM. Effectiveness of oral rinse with chlorhexidine in preventing nosocomial respiratory tract infections among intensive care unit patients. Infect Control Hosp Epidemiol. 2009;30(10):952-958. [PubMed 19743899]
  4. Chan EY, Ruest A, Meade MO, et al. Oral decontamination for prevention of pneumonia in mechanically ventilated adults: systematic review and meta-analysis. BMJ. 2007; 334(7599):889. doi: 10.1136/bmj.39136.528160.BE. [PubMed 17387118]
  5. Chow AW. Complications, diagnosis, and treatment of odontogenic infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 9, 2022.
  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. DeRiso AJ 2nd, Ladowski JS, Dillon TA, et al. Chlorhexidine gluconate 0.12% oral rinse reduces the incidence of total nosocomial respiratory infection and nonprophylactic systemic antibiotic use in patients undergoing heart surgery. Chest. 1996;109(6):1556-1561. [PubMed 8769511]
  8. Gonzales JR, Harnack L, Schmitt-Corsitto G, et al, "A Novel Approach to the Use of Subgingival Controlled-Release Chlorhexidine Delivery in Chronic Periodontitis: A Randomized Clinical Trial," J Periodontol, 2011;82(8):1131-9. [PubMed 21491990]
  9. Houston S, Hougland P, Anderson JJ, et al. Effectiveness of 0.12% chlorhexidine gluconate oral rinse in reducing prevalence of nosocomial pneumonia in patients undergoing heart surgery. Am J Crit Care. 2002;11(6):567-570. [PubMed 12425407]
  10. James P, Worthington HV, Parnell C, et al. Chlorhexidine mouthrinse as an adjunctive treatment for gingival health. Cochrane Database Syst Rev. 2017;3(3):CD008676. doi:10.1002/14651858.CD008676.pub2 [PubMed 28362061]
  11. Jeffcoat MK, Bray KS, Ciancio SG, et al. Adjunctive use of a subgingival controlled-release chlorhexidine chip reduces probing depth and improves attachment level compared with scaling and root planing alone. J Periodontol. 1998;69(9):989-997. doi:10.1902/jop.1998.69.9.989 [PubMed 9776027]
  12. Kasaj A, Chiriachide A, Willershausen B. The adjunctive use of a controlled-release chlorhexidine chip following treatment with a new ultrasonic device in supportive periodontal therapy: a prospective, controlled clinical study. Int J Dent Hyg. 2007;5(4):225-231. doi:10.1111/j.1601-5037.2007.00255.x [PubMed 17927635]
  13. Klompas M, Branson R, Cawcutt K, et al. Strategies to prevent ventilator-associated pneumonia, ventilator-associated events, and nonventilator hospital-acquired pneumonia in acute-care hospitals: 2022 update. Infect Control Hosp Epidemiol. 2022;43(6):687-713. doi:10.1017/ice.2022.88 [PubMed 35589091]
  14. Klompas M, Speck K, Howell MD, Greene LR, Berenholtz SM. Reappraisal of routine oral care with chlorhexidine gluconate for patients receiving mechanical ventilation: systematic review and meta-analysis. JAMA Intern Med. 2014;174(5):751-761. doi:10.1001/jamainternmed.2014.359 [PubMed 24663255]
  15. Kumar AJ, Ramesh Reddy BV, Chava VK. Effect of chlorhexidine chip in the treatment of chronic periodontitis. J Nat Sci Biol Med. 2014;5(2):268-272. doi:10.4103/0976-9668.136159 [PubMed 25097396]
  16. Labeau SO, Van de Vyver K, Brusselaers N, et al. Prevention of ventilator-associated pneumonia with oral antiseptics: a systematic review and meta-analysis. Lancet Infect Dis. 2011;11(11):845-854. doi: 10.1016/S1473-3099(11)70127-X. [PubMed 21798809]
  17. Nicolosi LN, del Carmen Rubio M, Martinez CD, González NN, Cruz ME. Effect of oral hygiene and 0.12% chlorhexidine gluconate oral rinse in preventing ventilator-associated pneumonia after cardiovascular surgery. Respir Care. 2014;59(4):504-509. doi:10.4187/respcare.02666 [PubMed 24106323]
  18. Nupro (chlorhexidine gluconate) [prescribing information]. York, PA: Dentsply Professional; October 2017.
  19. Nupro (chlorhexidine gluconate) [prescribing information]. St. Paul, MN: 3M ESPE Dental Products; October 2015.
  20. Paroex (chlorhexidine gluconate) [prescribing information]. Worcester, MA: Lohxa; received March 2020.
  21. Peridex (chlorhexidine gluconate) [prescribing information]. St. Paul, MN: 3M ESPE Dental Products; August 2022.
  22. Peridex (chlorhexidine gluconate) [prescribing information]. London, Ontario, Canada: 3M Canada Dental Products; June 2017.
  23. PerioChip (chlorhexidine gluconate) [prescribing information]. Yokneam, Israel: Dexcel Pharma Technologies Ltd; May 2021.
  24. PerioGard (chlorhexidine gluconate) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals, Inc; December 2019.
  25. Reddy MS, Jeffcoat MK, Geurs NC, et al, “Efficacy of Controlled-Release Subgingival Chlorhexidine to Enhance Periodontal Regeneration,” J Periodontol, 2003, 74(4):411-9. [PubMed 12747444]
  26. Refer to manufacturer's labeling.
  27. Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' position paper on medication-related osteonecrosis of the jaws-2022 update. J Oral Maxillofac Surg. 2022;80(5):920-943. doi:10.1016/j.joms.2022.02.008 [PubMed 35300956]
  28. Scannapieco FA, Yu J, Raghavendran K, et al. A randomized trial of chlorhexidine gluconate on oral bacterial pathogens in mechanically ventilated patients. Crit Care. 2009;13(4):R117. doi: 10.1186/cc7967. [PubMed 19765321]
  29. Segers P, Speekenbrink RG, Ubbink DT, van Ogtrop ML, de Mol BA. Prevention of nosocomial infection in cardiac surgery by decontamination of the nasopharynx and oropharynx with chlorhexidine gluconate: a randomized controlled trial. JAMA. 2006;296(20):2460-2466. doi:10.1001/jama.296.20.2460 [PubMed 17119142]
  30. 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]
  31. Smiley CJ, Tracy SL, Abt E, et al. Evidence-based clinical practice guideline on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts. J Am Dent Assoc. 2015;146(7):525-535. doi:10.1016/j.adaj.2015.01.026 [PubMed 26113100]
  32. Soskolne WA, Proskin HM, and Stabholz A, “Probing Depth Changes Following 2 Years of Periodontal Maintenance Therapy Including Adjunctive Controlled Release of Chlorhexidine,” J Periodontol, 2003, 74(4):420-7. [PubMed 12747445]
  33. 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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