Chlorhexidine Gluconate, 0.12% Oral Rinse Solution

Description

0.12% chlorhexidine gluconate (CHG) is an oral rinse formulated with 1,1'-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate. The product is presented in a base that includes water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. This formulation results in a near-neutral solution with a pH range of 5 to 7. Chlorhexidine gluconate is characterized as a salt derived from 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.

Limitations of Use Chlorhexidine gluconate oral rinse has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG). For patients presenting with coexisting gingivitis and periodontitis, refer to the PRECAUTIONS section for additional guidance.

Dosage and Administration

Chlorhexidine gluconate oral rinse therapy should be initiated immediately following dental prophylaxis. The recommended dosage is 15 mL of undiluted chlorhexidine gluconate oral rinse, administered twice daily. Patients should perform oral rinsing for 30 seconds in the morning and evening, ideally after tooth brushing.

It is essential to instruct patients not to rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using the oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion; patients should expectorate the solution after rinsing.

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 due to the potential for allergic responses.

Warnings and Precautions

The effect of chlorhexidine gluconate oral rinse on periodontitis has not been established. Healthcare professionals should be aware that clinical testing has indicated an increase in supragingival calculus among users of chlorhexidine gluconate oral rinse compared to control users. However, it remains unclear whether the use of this oral rinse contributes to an increase in subgingival calculus.

To mitigate the potential accumulation of calculus, it is recommended that calculus deposits be removed through dental prophylaxis at intervals not exceeding six months.

Additionally, healthcare providers should remain vigilant for the occurrence of anaphylaxis and other serious allergic reactions, which have been reported during postmarketing surveillance of dental products containing chlorhexidine. Monitoring for these adverse reactions is essential to ensure patient safety.

Side Effects

Patients using chlorhexidine gluconate oral rinse may experience a range of adverse reactions. Common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and alterations in taste perception.

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 experience has revealed additional adverse reactions, such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, paresthesia, minor irritation, superficial desquamation of the oral mucosa, parotid gland swelling, and inflammation of the salivary glands (sialadenitis).

Serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of dental products containing chlorhexidine. Furthermore, some patients may experience alterations in taste perception during treatment, with rare instances of permanent taste alteration noted in post-marketing product surveillance.

Drug Interactions

No specific drug interactions or laboratory test interactions have been identified in the available data. Therefore, there are no recommendations for dosage adjustments or monitoring related to drug interactions at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Chlorhexidine Gluconate, 0.12% Oral Rinse Solution (chlorhexidine gluconate, 0.12% oral rinse), 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. Healthcare professionals should exercise caution when considering this treatment for children and adolescents, as the lack of data limits the ability to assess potential risks and benefits.

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, indicating that its use in geriatric patients should be approached with caution, particularly in those with complex health profiles.

Caution is advised when administering chlorhexidine gluconate oral rinse to nursing women, as the effects on lactation and nursing infants have not been fully characterized. In geriatric patients, common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and alterations in taste perception. These side effects may be particularly concerning in elderly patients, who may already have compromised oral health.

Oral irritation and local allergy-type symptoms have been reported with the use of chlorhexidine gluconate rinse, necessitating careful monitoring of elderly patients for any adverse reactions. Additionally, some patients may experience alterations in taste perception during treatment, with rare instances of permanent taste alteration reported through post-marketing surveillance. This potential for lasting effects should be communicated to geriatric patients and their caregivers.

When prescribing chlorhexidine gluconate oral rinse to elderly patients, discretion is warranted, especially for those with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed through dental prophylaxis, and if permanent discoloration is deemed unacceptable by the patient, exclusion from treatment with chlorhexidine gluconate oral rinse should be considered. Overall, careful assessment and monitoring are essential to ensure the safe use of this product in the geriatric population.

Pregnancy

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 responses, chlorhexidine gluconate 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 drug in pregnant patients.

Lactation

It is not known whether chlorhexidine gluconate is excreted in human milk. Due to the potential for many drugs to be excreted in breast milk, caution should be exercised when administering chlorhexidine gluconate oral rinse 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Ingestion of chlorhexidine gluconate oral rinse can lead to significant adverse effects, particularly in small children. 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 to mitigate potential complications associated with overdosage.

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. Reports of anaphylaxis and serious allergic reactions have been documented. Additionally, rare cases of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been noted through post-marketing surveillance.

Among the most frequently reported oral mucosal symptoms linked to 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 rinse. Furthermore, instances of parotid gland swelling and inflammation of the salivary glands, known as sialadenitis, have been reported in association with the use of chlorhexidine gluconate oral rinse.

Patient Counseling

Healthcare providers should inform patients that chlorhexidine gluconate oral rinse has been prescribed to treat gingivitis, aiming to reduce gum redness and swelling while helping to control gum bleeding. Patients should be advised to use the oral rinse regularly, as directed by their dentist, and to continue their daily brushing routine.

It is essential for patients to understand that the oral rinse should be spat out after use and must not be swallowed. Providers should caution patients to seek immediate medical attention if they experience any allergic symptoms, such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. Additionally, chlorhexidine gluconate oral rinse is contraindicated for individuals with a known sensitivity to it or its components.

Patients should be made aware that the use of chlorhexidine gluconate oral rinse may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where staining and tartar typically occur. Regular dental visits for the removal of any stain or tartar are important, with a recommendation to see the dentist at least every six months, or more frequently if advised. Both stains and tartar can be effectively removed by a dentist or hygienist.

Providers should inform patients 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. It is also important to note that the rinse may have a bitter taste and can alter the taste of food and beverages, although this effect typically diminishes with continued use. To mitigate taste interference, patients should be advised to rinse with chlorhexidine gluconate oral rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward.

Patients should be 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. Furthermore, patients may report side effects to A2A Integrated Pharmaceuticals at 1-800-380-6709 or to the FDA at 1-800-FDA-1088.

Storage and Handling

The product is supplied in accordance with the following specifications. It should be stored 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) as outlined by USP controlled room temperature guidelines.

Proper storage conditions are essential to maintain the integrity of the product. It is recommended that the product be kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to ensure the product remains within the specified temperature range throughout its storage period.

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 Solution as submitted by A2A Integrated Pharmaceuticals, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)