Chlorhexidine Gluconate 0.12% Oral Rinse

Description

Chlorhexidine Gluconate is an oral rinse formulated with 0.12% chlorhexidine gluconate (1,1-hexamethylene bis5-(p-chlorophenyl) biguanide di-D-gluconate). The formulation includes a base composed of water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. This product is characterized as a near-neutral solution, with a pH range of 5 to 7. Chlorhexidine Gluconate is classified as a salt of chlorhexidine and gluconic acid.

Uses and Indications

Chlorhexidine Gluconate Oral Rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis, characterized by redness and swelling of the gingivae, including gingival bleeding upon probing.

This product has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG). For patients presenting with coexisting gingivitis and periodontitis, healthcare professionals should refer to the PRECAUTIONS section for further guidance.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Chlorhexidine Gluconate Oral Rinse therapy should be initiated immediately following dental prophylaxis. The recommended regimen involves oral rinsing twice daily, specifically in the morning and evening, for a duration of 30 seconds after tooth brushing. The usual dosage is 15 mL of undiluted Chlorhexidine Gluconate Oral Rinse.

Patients must be instructed to avoid rinsing with water or other mouthwashes, brushing their teeth, or consuming food immediately after the use of Chlorhexidine Gluconate Oral Rinse. It is important to note that this product is not intended for ingestion; patients should expectorate the rinse after use.

Contraindications

Chlorhexidine Gluconate Oral Rinse is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation. Use in these patients may lead to adverse reactions.

Warnings and Precautions

The effect of Chlorhexidine Gluconate Oral Rinse on periodontitis has not been established. Clinical studies have indicated an increase in supragingival calculus among users of Chlorhexidine Gluconate Oral Rinse compared to control groups. The potential for increased subgingival calculus due to the use of this rinse remains undetermined. It is recommended that calculus deposits be removed through dental prophylaxis at intervals not exceeding six months.

Anaphylaxis and serious allergic reactions have been reported in postmarketing experiences with dental products containing chlorhexidine. Healthcare professionals should remain vigilant for these adverse reactions.

For patients presenting with coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with Chlorhexidine Gluconate Oral Rinse should not be relied upon as a primary indicator of underlying periodontitis.

Chlorhexidine Gluconate Oral Rinse may lead to staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. While not all patients will experience significant staining, clinical data show that 56% of users exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Furthermore, 15% of Chlorhexidine users developed what was classified as heavy staining, in contrast to 1% of control users. Staining is more pronounced in individuals with substantial plaque accumulation. Importantly, staining does not adversely affect the health of the gingivae or other oral tissues and can typically be removed through standard professional prophylactic techniques, although additional time may be required.

Healthcare providers should exercise caution when prescribing Chlorhexidine Gluconate Oral Rinse to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed from these surfaces during dental prophylaxis, patients may need to be excluded from treatment with Chlorhexidine Gluconate Oral Rinse if they find permanent discoloration unacceptable. In rare cases, staining in these areas may be difficult to eliminate and could necessitate the replacement of restorations.

Patients may also experience alterations in taste perception during treatment with Chlorhexidine Gluconate Oral Rinse. There have been rare reports of permanent taste alterations following its use, as noted in post-marketing surveillance.

No specific laboratory tests are recommended for monitoring the use of Chlorhexidine Gluconate Oral Rinse. Healthcare professionals should remain alert to the potential for adverse effects and manage patient care accordingly.

Side Effects

Patients using Chlorhexidine Gluconate Oral Rinse may experience a range of adverse reactions, which can be categorized by frequency and seriousness.

Common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and an alteration in taste perception. The alteration in taste perception may be temporary; however, rare instances of permanent taste alteration have been reported through post-marketing surveillance.

In clinical trials, several oral mucosal side effects were reported among participants, including aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each of these events occurred at a frequency of less than 1%.

Postmarketing experiences have revealed additional oral-related adverse reactions, such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, paresthesia, minor irritation, and superficial desquamation of the oral mucosa. There have also been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis).

It is important to note that serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of dental products containing chlorhexidine. Patients should be monitored for any signs of such reactions.

Drug Interactions

Chlorhexidine Gluconate Oral Rinse is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other components of the formulation. The use of this product has been associated with reports of anaphylaxis and serious allergic reactions during postmarketing surveillance, necessitating caution in patients with a history of such reactions.

Pharmacodynamic interactions may manifest as tooth discoloration or an increase in tartar (calculus) formation, particularly in areas predisposed to staining and tartar accumulation. Additionally, rare cases of permanent taste alteration have been documented following the use of Chlorhexidine Gluconate Oral Rinse.

To optimize the effectiveness of Chlorhexidine Gluconate Oral Rinse and minimize potential adverse effects, patients are advised not to rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using the rinse. This practice is essential to ensure the therapeutic benefits of the rinse are maintained.

Packaging & NDC

The table below lists all NDC Code configurations of Chlorhexidine Gluconate 0.12% Oral Rinse (chlorhexidine gluconate), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Clinical effectiveness and safety of Chlorhexidine Gluconate Oral Rinse have not been established in pediatric patients under the age of 18. Therefore, its use in this population is not recommended.

Geriatric Use

Elderly patients may experience specific considerations when using Chlorhexidine Gluconate Oral Rinse. The clinical effectiveness and safety of this product have not been established in individuals under the age of 18, which may suggest a need for caution in geriatric populations, particularly those with complex dental needs.

In clinical testing, an increase in supragingival calculus was observed among users of Chlorhexidine Gluconate Oral Rinse compared to control users. Additionally, while staining resulting from the use of this rinse does not adversely affect the health of the gingivae or other oral tissues, it is important for healthcare providers to monitor elderly patients for this side effect, as it may impact their oral hygiene and aesthetic concerns.

Discretion should be exercised when prescribing this oral rinse to elderly patients with anterior facial restorations that have rough surfaces or margins, as the rinse may interact with these dental materials. Furthermore, some patients may experience alterations in taste perception during treatment, and rare instances of permanent taste alteration have been reported through post-marketing surveillance. Oral irritation and local allergy-type symptoms have also been spontaneously reported as side effects associated with the use of Chlorhexidine Gluconate Oral Rinse.

The most common side effects noted include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and alterations in taste perception. Given these potential side effects, it is recommended that patients using Chlorhexidine Gluconate Oral Rinse undergo reevaluation and thorough prophylaxis at intervals no longer than six months. Therapy with Chlorhexidine Gluconate Oral Rinse should be initiated directly following a dental prophylaxis to optimize its effectiveness and minimize adverse effects.

Pregnancy

Pregnancy Category B. Reproduction studies conducted in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, have not demonstrated evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been performed. Due to the limitations of animal reproduction studies in predicting human response, this drug should be used during pregnancy only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against any possible risks when considering the use of this medication in pregnant patients.

Lactation

It is not known whether Chlorhexidine Gluconate Oral Rinse is excreted in human milk. Due to the potential for many drugs to be excreted in human milk, caution should be exercised when administering this medication to lactating mothers.

In animal studies involving parturition and lactation with rats, no evidence of impaired parturition or toxic effects on suckling pups was observed when chlorhexidine gluconate was administered to dams at doses exceeding 100 times the amount that would result from a human ingesting 30 mL of Chlorhexidine Gluconate Oral Rinse per day.

Renal Impairment

Patients with renal impairment should be monitored closely when using Chlorhexidine Gluconate Oral Rinse, as the effects on periodontitis in this population have not been determined. Additionally, it is not known whether the use of Chlorhexidine Gluconate Oral Rinse leads to an increase in subgingival calculus in patients with reduced kidney function. Anaphylaxis and serious allergic reactions have been reported during postmarketing use of dental products containing chlorhexidine; therefore, caution is advised in patients with a history of allergies or hypersensitivity.

Hepatic Impairment

Patients with hepatic impairment may require careful consideration when using Chlorhexidine Gluconate Oral Rinse. The effect of this product on periodontitis in patients with compromised liver function has not been determined, and it is unclear whether its use leads to an increase in subgingival calculus. However, clinical testing has indicated an increase in supragingival calculus among users of Chlorhexidine Gluconate Oral Rinse compared to control users.

For patients with hepatic impairment, it is recommended that calculus deposits be managed through dental prophylaxis, which should occur at intervals not exceeding six months. Additionally, healthcare providers should remain vigilant for potential adverse reactions, including anaphylaxis and serious allergic reactions, which have been reported during postmarketing use of dental products containing chlorhexidine. Monitoring for these reactions is advised, particularly in patients with known sensitivities or allergies.

Overdosage

Ingestion of Chlorhexidine Gluconate Oral Rinse in small children can lead to significant adverse effects. Specifically, the consumption of 1 or 2 ounces by a child weighing approximately 10 kg may result in gastric distress, which can manifest as nausea. Additionally, there may be signs indicative of alcohol intoxication due to the formulation of the rinse.

In cases where a small child ingests more than 4 ounces of Chlorhexidine Gluconate Oral Rinse, or if any signs of alcohol intoxication are observed, it is imperative to seek medical attention promptly. Healthcare professionals should be prepared to assess the child’s condition and provide appropriate management based on the severity of symptoms presented.

Nonclinical Toxicology

In a drinking water study conducted in rats, no carcinogenic effects were observed at doses up to 38 mg/kg/day. Additionally, mutagenic effects were not detected in two mammalian in vivo mutagenesis studies involving chlorhexidine gluconate. The highest doses administered in these studies included 1000 mg/kg/day in a mouse dominant-lethal assay and 250 mg/kg/day in a hamster cytogenetics test. Furthermore, no evidence of impaired fertility was noted in rats at doses up to 100 mg/kg/day.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of dental products containing chlorhexidine. Anaphylaxis and serious allergic reactions have been reported. Additionally, rare cases of permanent taste alteration following the use of Chlorhexidine Gluconate Oral Rinse have been documented through post-marketing surveillance.

Among the most frequently reported oral mucosal symptoms associated with Chlorhexidine Gluconate Oral Rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have also been observed in patients using this product.

Reports have included instances of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients utilizing Chlorhexidine Gluconate Oral Rinse. Furthermore, ingestion of 1 or 2 ounces of Chlorhexidine Gluconate Oral Rinse by a small child (approximately 10 kg body weight) may lead to gastric distress, including nausea, or signs of alcohol intoxication. Medical attention is advised if more than 4 ounces is ingested by a small child or if signs of alcohol intoxication develop.

Patient Counseling

Patients should be informed that Chlorhexidine Gluconate Oral Rinse has been prescribed by their dentist to treat gingivitis, specifically to reduce gum redness and swelling, as well as to help control gum bleeding. It is essential for patients to use the rinse regularly, as directed by their dentist, and to continue their daily brushing routine.

Patients must be advised to spit out the rinse after use and not to swallow it. They should be made aware of the potential for allergic reactions, which may include symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. In such cases, patients should seek medical attention immediately.

It is important to inform patients that Chlorhexidine Gluconate Oral Rinse should not be used by individuals who have a known sensitivity to it or its components. Patients may experience tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where stains and tartar typically accumulate. Regular dental visits for the removal of any stain or tartar are crucial, with a recommendation to see their dentist at least every six months, or more frequently if advised.

Patients should be made aware that both stains and tartar can be removed by their dentist or hygienist, and that Chlorhexidine Gluconate Oral Rinse may cause permanent discoloration of some front-tooth fillings. To minimize the risk of discoloration, patients should be encouraged to brush and floss daily, paying special attention to areas that begin to show discoloration.

Additionally, patients may find that the rinse has a bitter taste and can alter the taste of foods and beverages. This effect typically diminishes with continued use. To mitigate taste interference, patients should be advised to use the rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward.

Patients are encouraged to reach out to their dentist or pharmacist with any questions or comments regarding Chlorhexidine Gluconate Oral Rinse. They should also be instructed to contact their healthcare provider for medical advice concerning any side effects and to report side effects to the FDA at 1-800-FDA-1088.

Storage and Handling

Chlorhexidine Gluconate Oral Rinse is supplied as a blue liquid in single-dose 0.5 fluid ounce (15 mL) amber plastic bottles equipped with child-resistant dispensing closures.

It is recommended to store the product at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F) in accordance with USP controlled room temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Chlorhexidine Gluconate 0.12% Oral Rinse as submitted by Xttrium Laboratories, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)