Chlorhexidine Gluconate 0.12% Oral Rinse

Description

Chlorhexidine Gluconate is an oral rinse that contains 0.12% chlorhexidine gluconate, which is chemically defined as 1,1-hexamethylene bis5-(p-chlorophenyl) biguanide di-D-gluconate. The formulation of the rinse includes water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1 as inactive ingredients. Chlorhexidine Gluconate is characterized as a near-neutral solution with a pH range of 5-7. It is a salt formed 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.

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.

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 as an oral rinse twice daily. Patients should perform the 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 rinse. Chlorhexidine Gluconate Oral Rinse is not intended for ingestion; therefore, 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.

Additionally, the use of this oral rinse is not recommended for patients for whom permanent discoloration of the teeth or oral mucosa is unacceptable, as this may occur with treatment.

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 an increase in subgingival calculus 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 cause staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. While not all patients will experience significant staining, clinical testing revealed 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 higher plaque accumulation; however, such staining does not adversely affect the health of the gingivae or other oral tissues.

Stains resulting from the use of Chlorhexidine can typically be removed through conventional professional prophylactic techniques, although additional time may be necessary to complete the procedure. Caution is advised when prescribing this rinse to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be effectively removed from these surfaces during dental prophylaxis, patients may need to be excluded from treatment with Chlorhexidine Gluconate Oral Rinse, particularly if permanent discoloration is deemed unacceptable. In some cases, stains in these areas may be challenging to remove and could necessitate the replacement of restorations.

Patients may also experience alterations in taste perception during treatment with Chlorhexidine Gluconate Oral Rinse. Rare instances of permanent taste alteration have been reported through post-marketing surveillance.

No specific laboratory tests are recommended for monitoring the use of Chlorhexidine Gluconate Oral Rinse. Healthcare professionals should exercise clinical judgment and discretion when considering the use of this product in their patients.

Side Effects

Patients using the product may experience a range of adverse reactions, which can be categorized into common side effects and those reported during clinical trials and postmarketing experiences.

Common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and alterations in taste perception. Notably, 56% of users exhibited a measurable increase in facial anterior stain, and some patients may experience changes in taste perception, with rare instances of permanent taste alteration reported.

In clinical trials, oral mucosal side effects were observed in less than 1% of participants. These included aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Postmarketing experiences have revealed additional adverse reactions, including 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).

Warnings associated with the use of this product include the potential for anaphylaxis and serious allergic reactions, which have been reported during postmarketing use of dental products containing chlorhexidine.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 require careful consideration 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 underscores the importance of evaluating its use in geriatric populations.

In clinical testing, an increase in supragingival calculus was observed among users of Chlorhexidine Gluconate Oral Rinse compared to control users. While staining resulting from the use of this rinse does not adversely affect the health of the gingivae or other oral tissues, it is advisable to exercise discretion when prescribing to elderly patients, particularly those with anterior facial restorations that have rough surfaces or margins.

Elderly patients may also experience alterations in taste perception during treatment with Chlorhexidine Gluconate Oral Rinse. It is important to note that rare instances of permanent taste alteration have been reported through post-marketing surveillance. Therefore, healthcare providers should monitor for any changes in taste and counsel patients accordingly.

Regular reevaluation of patients using Chlorhexidine Gluconate Oral Rinse is recommended, with thorough prophylaxis provided at intervals no longer than six months. This approach ensures ongoing assessment of oral health and the effectiveness of the treatment in geriatric patients.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety information and the importance of discussing any potential pregnancy with their healthcare provider.

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 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 outlined 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 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 to mitigate any potential complications arising from the overdosage.

Nonclinical Toxicology

Pregnancy Category B. Reproduction studies conducted in rats and rabbits at chlorhexidine gluconate doses of up to 300 mg/kg/day and 40 mg/kg/day, respectively, did not reveal 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.

In a drinking water study involving 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 with chlorhexidine gluconate. The highest doses administered in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. 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.

Among the most frequently reported oral mucosal symptoms linked to Chlorhexidine Gluconate Oral Rinse are stomatitis, gingivitis, glossitis, ulceration, dry mouth, hypesthesia, glossal edema, and paresthesia. Additionally, minor irritation and superficial desquamation of the oral mucosa have been observed in patients using this rinse.

There have also been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients utilizing Chlorhexidine Gluconate Oral Rinse. Furthermore, rare cases of permanent taste alteration following the use of this product have been noted through post-marketing product surveillance.

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, in conjunction with daily brushing. Patients should be advised to spit out the rinse after use and to avoid swallowing it.

Healthcare providers should counsel patients to seek immediate medical attention if they experience any allergic symptoms, which may include skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. It is important to note that Chlorhexidine Gluconate Oral Rinse should not be used by individuals who have 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 stains and tartar typically accumulate. Regular dental visits for the removal of any stain or tartar are crucial, with a recommendation to see the dentist at least every six months, or more frequently if advised.

Additionally, patients should be informed that Chlorhexidine Gluconate Oral Rinse may cause permanent discoloration of some front-tooth fillings. To minimize this risk, patients should be encouraged to maintain a diligent oral hygiene routine, including daily brushing and flossing, with particular attention to areas that begin to discolor.

Patients may find that Chlorhexidine Gluconate Oral Rinse has a bitter taste and can alter the taste of foods and beverages. This taste interference is generally less noticeable with continued use. To mitigate this effect, patients should be advised to rinse with Chlorhexidine Gluconate Oral Rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward.

For any questions or concerns regarding Chlorhexidine Gluconate Oral Rinse, patients should be encouraged to contact their dentist or pharmacist. They should also be informed to call their healthcare provider for medical advice about any side effects experienced and that side effects can be reported to the FDA at 1-800-FDA-1088.

Storage and Handling

The product is supplied as a blue liquid in single-dose 0.5 fluid ounce (15 mL) amber plastic bottles, each equipped with child-resistant dispensing closures.

Storage conditions require the product to be maintained 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 handling and storage are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

Chlorhexidine Gluconate Oral Rinse may cause staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue; however, this staining does not negatively impact the health of the gingivae or other oral tissues. Most stains can be removed through conventional professional prophylactic techniques. Clinicians should exercise caution when prescribing this rinse to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed by dental prophylaxis and permanent discoloration is deemed unacceptable, patients should be excluded from treatment with Chlorhexidine Gluconate Oral Rinse.

Additionally, some patients may experience alterations in taste perception during treatment. Post-marketing surveillance has reported rare cases of permanent taste alteration following the use of Chlorhexidine Gluconate Oral Rinse.

FDA Insert (PDF)

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

View full prescribing information (PDF)