Embedded Files
Pharmacologic Category
Dosing: Adult
Gingivitis: 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). Therapy should be initiated immediately following a dental prophylaxis. Patient should be reevaluated and given a dental prophylaxis at intervals no longer than every 6 months.
Periodontitis: Periodontal chip: One chip is inserted into a periodontal pocket with a probing pocket depth ≥5 mm. Up to 8 chips may be inserted in a single visit. Treatment is recommended every 3 months in pockets with a remaining depth ≥5 mm. If dislodgment occurs 7 days or more after placement, the subject is considered to have had the full course of treatment. If dislodgment occurs within 48 hours, a new chip should be inserted.
Oropharyngeal decontamination (to reduce the risk of hospital-acquired or ventilator-associated pneumonia) (off-label use): Oral rinse:
Cardiac surgical patients: 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 twice daily. Initiate preoperatively and continue postoperatively for 10 days or until extubation. Avoid food or drink for 30 minutes after rinsing (DeRiso 1996; Houston 2002).
Mechanically-ventilated patients: No specific dosing recommended due to the heterogeneous nature of the studies and paucity of conclusive data.
Dosing: Geriatric
Refer to adult dosing.
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
Gingivitis: Limited data available: Children ≥8 years and Adolescents: Oral: Oral rinse (0.12%): Swish 15 mL (one capful) for 30 seconds after toothbrushing, then expectorate; repeat twice daily (morning and evening) (de la Rosa 1998)
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.
Use: Labeled Indications
Gingivitis: Oral rinse: Antimicrobial dental rinse for gingivitis treatment
Periodontitis: Periodontal chip: Adjunctive therapy to scaling and root planning procedures to reduce pocket depth in patients with periodontitis
Use: Off-Label: Adult
Medication-related osteonecrosis of the jaw (MRONJ), adjunctive therapy: Oral rinse:Level of Evidence [G]
Based on a position paper by the American Association of Maxillofacial Surgeons (AAOMS), chlorhexidine gluconate oral rinse is an effective and recommended adjunctive treatment strategy in the management of medication-related osteonecrosis of the jaw (MRONJ) (stage 1 and above [eg, patients with exposed and necrotic bone or fistulae that probes to bone]).
Oropharyngeal decontamination to reduce the risk of ventilator-associated or hospital-acquired pneumonia, Cardiac surgical patients: Oral rinse:Level of Evidence [B]
Data from a prospective, randomized, double-blind, placebo-control trial and a prospective, randomized, case-controlled trial in patients undergoing coronary artery bypass grafting, valve, or other open heart surgical procedures who received chlorhexidine gluconate 0.12% oral rinse during the perioperative period showed a decreased rate in hospital-acquired pneumonia Ref. Of note, one trial showed statistical significance only in patients intubated >24 hours who had the highest degree of bacterial colonization Ref. Additional trials may be necessary to further define the role of chlorhexidine gluconate oral rinse in this condition.
Oropharyngeal decontamination to reduce the risk of ventilator-associated or hospital-acquired pneumonia, Mechanically-ventilated patients: Oral rinse:Level of Evidence [C]
Data from meta-analyses have suggested benefit of chlorhexidine gluconate when used for oropharyngeal decontamination in mechanically-ventilated adults for the prevention of ventilator-associated pneumonia Ref. However, the trials used in both meta-analyses were heterogeneous and included patients in a variety of settings (eg, cardiothoracic, general ICU, mixed medical-surgical ICU, trauma ICU). The trials also displayed significant variability with chlorhexidine treatment regimens. Chlorhexidine concentration varied from 0.12%, 0.2%, or 2% across studies. Frequency of administration, chlorhexidine dosage form (oral rinse, gel, paste, foam), and technique of application also varied across studies. In the US, chlorhexidine gluconate for use in the oral cavity is commercially available only as 0.12% solution. Additional trials may be necessary to further define the role of chlorhexidine gluconate oral rinse in this condition.
Level of Evidence Definitions
Level of Evidence Scale
Clinical Practice Guidelines
Nutritional Support:
SCCM and ASPEN: Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), 2016
Administration: Oral
Oral rinse: 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.
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 after rinsing; 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.
Storage/Stability
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat or prevent mouth infections.
• It may be given to you for other reasons. Talk with the doctor.
Frequently reported side effects of this drug
• Mouth irritation
• Change in taste
• Staining of mouth, teeth, or fillings
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Severe gingival pain or swelling
• Numbness or tingling in the mouth
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Medication Safety Issues
Sound-alike/look-alike issues:
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).
Pregnancy Risk Factor
B/C (manufacturer specific)
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.
Breast-Feeding Considerations
It is not known if chlorhexidine is excreted 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.
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
>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%), tendonitis (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
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
There are no known significant interactions.
Advanced Practitioners Physical Assessment/Monitoring
Oral rinse: Staining of teeth may occur, can be permanent.
Nursing Physical Assessment/Monitoring
Oral rinse: Monitor patient for staining of teeth and oral irritation; ensure patient is using properly.
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) [alcohol free; contains fd&c red #40, propylene glycol]
Peridex: 0.12% (118 mL, 473 mL, 1893 mL) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1), saccharin sodium; mint flavor]
Periogard: 0.12% (473 mL [DSC]) [mint flavor]
Periogard: 0.12% (473 mL) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1), saccharin sodium]
Generic: 0.12% (15 mL, 118 mL, 473 mL)
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, brilliant blue fcf (fd&c blue #1), methylparaben, propylparaben, tartrazine (fd&c yellow #5)]
GUM Paroex Oral Rinse: 0.12% (473 mL) [contains fd&c red #40, propylene glycol]
Oro Clear: 0.12% (500 mL, 4000 mL) [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow), polysorbate 80, saccharin sodium]
Perichlor: 0.12% (475 mL) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1)]
Peridex: 0.12% (475 mL) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1), saccharin sodium]
Periogard: 0.12% (15 mL, 473 mL) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1), polyethylene glycol, saccharin sodium]
Periogard: 0.12% ([DSC]) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1), saccharin sodium]
Generic: 0.12% (15 mL, 250 mL, 473 mL, 475 mL, 480 mL, 500 mL, 4000 mL)
Anatomic Therapeutic Chemical (ATC) Classification
- A01AB03
- R02AA05
Generic Available (US)
Yes
Pricing: US
Solution (Chlorhexidine Gluconate Mouth/Throat)
0.12% (per mL): $0.14 - $0.22
Solution (Paroex Mouth/Throat)
0.12% (per mL): $0.01
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.
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/Kinetics
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%)
Dental Use
Antibacterial dental rinse; chlorhexidine is active against gram-positive and gram-negative organisms, facultative anaerobes, aerobes, and yeast
Chip, for periodontal pocket insertion: Indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis; may be used as part of a periodontal maintenance program
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Increased tartar on teeth, altered taste perception, staining of oral surfaces (mucosa, teeth, dorsum of tongue), and oral/tongue irritation. Staining may be visible as soon as 1 week after therapy begins and is more pronounced when there is a heavy accumulation of unremoved plaque and when teeth fillings have rough surfaces. Stain does not have a clinically adverse effect but because removal may not be possible, patient with anterior restorations should be advised of the potential permanency of the stain.
Effects on Bleeding
No information available to require special precautions
Dental Usual Dosing
Adults:
Oral rinse (Peridex, PerioGard):
Floss and brush teeth, completely rinse toothpaste from mouth and swish 15 mL (one capful) undiluted oral rinse around in mouth for 30 seconds, then expectorate. Caution patient not to swallow the medicine and instruct not to eat for 2-3 hours after treatment (cap on bottle measures 15 mL).
Treatment of gingivitis: Oral prophylaxis: Swish for 30 seconds with 15 mL chlorhexidine, then expectorate; repeat twice daily (morning and evening). Patient should have a re-evaluation followed by a dental prophylaxis every 6 months.
Periodontal chip: One chip is inserted into a periodontal pocket with a probing pocket depth ≥5 mm. Up to 8 chips may be inserted in a single visit. Treatment is recommended every 3 months in pockets with a remaining depth ≥5 mm. If dislodgment occurs 7 days or more after placement, the subject is considered to have had the full course of treatment. If dislodgment occurs within 48 hours, a new chip should be inserted. The chip biodegrades completely and does not need to be removed. Patients should avoid dental floss at the site of periochip® insertion for 10 days after placement because flossing might dislodge the chip.
Insertion of periodontal chip: 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.
FDA Approval Date
August 13, 1986
References
American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278.[PubMed 9024461]
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]
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]
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]
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]
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]
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]
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]
Nupro (chlorhexidine gluconate) [prescribing information]. York, PA: Dentsply Professional; October 2017.
Nupro (chlorhexidine gluconate) [prescribing information]. St. Paul, MN: 3M ESPE Dental Products; October 2015.
Peridex (chlorhexidine gluconate) [prescribing information]. St. Paul, MN: 3M ESPE Dental Products; October 2017.
Peridex (chlorhexidine gluconate) [prescribing information]. London, Ontario, Canada: 3M Canada Dental Products; June 2017.
PerioChip (chlorhexidine gluconate) [prescribing information]. Yokneam, Israel: Dexcel Pharma Technologies; November 2012.
PerioGard (chlorhexidine gluconate) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals; July 2015.
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 ]
Ruggiero SL, Dodson TB, Fantasia J, et al; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw--2014 update. J Oral Maxillofac Surg. 2014;72(10):1938-1956. doi: 10.1016/j.joms.2014.04.031.[PubMed 25234529]
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]
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]
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 ]
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 ]
Brand Names: International
A'Fresh (IN); Afresho (IN); Alpha-Hexidine Sungkwang Gargle (KR); Amident (RU); Antiseptol (EG); Arofil (IN); Atoseptal (CH); B-Mouthwash (TH); Bacto Scrub (LK); Baxil (BE); Benodent CLX (IT); Bucogel (UY); Bucoglobin Gel Dental (UY); Bucoseptil (CL); Chlohexin Gargle (KR); Chlorasept (BH); Chlorhexamed (AT, CH, DE); Chlorhexil (PL); Cidegol C (DE); Clear Mouthwash (HK); Clohex (IN); Coglu (IN); Collunovar (FR); Corsodyl (BE, CH, CZ, FI, GB, HK, IE, IL, IS, IT, LU, NL, NO, PL, SE, SK, ZA); Corsodyl Mint (BG, LK, RO, SI); Deratin (ES); Dynexan Proaktiv (DE); Eburos (IT); Elgydium (FR, SG); Eludrilperio (FR); Elugel (FR); Everguard (IN); Fresh Breath (BD); Health Mouthwash (HK); Hexabir (IN); Hexamedal (CH); Hexidine (LK); Hexidine Mouth Wash (KW); Hexidine Mouthwash (SA); Hexisept (BG); Hexitol (EG); Medilixin (BE); Odontol Plac (PY); Oracare (BD); Oradex (MY); Orahex (PH); Oraklean (TH); Oral-C (BD); Oralgene (CL); Oralon (BD); Oralon Dental Gel (LK); Oralxidine (HK); Oraxine (BH); Paroex (FR); Peridont (VE); Perio-Aid (CL); Periochip (AT, CH, DK, FI, GB, GR, IL, IT, NL, NO, SE, SG); Periokin Gel (ID); Periokin Spray (ID); Prexidine (FR); Prodent Plac (PY); Qualikin (HK); Savacol Mouth and Throat Rinse (AU); Scrub Stat 4 (BH); Septofort (BG, CZ, HU, SK); Sorexidine (PH); Tarodent (IL); Ya Nuo (CN); Zordyl (AE, LB)
Last Updated 3/6/20
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