Dosage Forms
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)
Pharmacology
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/Pharmacodynamics
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
Excretion
Oral rinse: Feces (∼90%); Urine (<1%)
Duration of Action
Serum concentrations: Detectable levels are not present in the plasma 12 hours after administration
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
Medication-related osteonecrosis of the jaw (MRONJ), adjunctive therapy: Oral rinse:yes
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: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 DeRiso 1996, Houston 2002. Of note, one trial showed statistical significance only in patients intubated >24 hours who had the highest degree of bacterial colonization Houston 2002. 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: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 Chan 2007, Labeau 2011. 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.
Contraindications
Hypersensitivity to chlorhexidine or any component of the formulation
Dosage and Administration
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: 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)
Administration
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.
Storage
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).
Drug Interactions
There are no known significant interactions.
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
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.
Pregnancy
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.
Patient Education
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
- Bad 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 edema
- Burning 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.
