Chlorhexidine gluconate

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.

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 dosage is 15 ml of undiluted chlorhexidine gluconate oral rinse, which should be measured using the cap provided. Patients are advised to perform oral rinsing twice daily, specifically in the morning and evening, for a duration of 30 seconds after brushing their teeth.

It is essential that patients do not 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; therefore, it should be expectorated following the rinsing procedure.

Contraindications

Chlorhexidine gluconate oral rinse is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation.

Caution is advised when prescribing this product to patients with anterior facial restorations that have rough surfaces or margins. If natural stains on these surfaces cannot be removed through dental prophylaxis and permanent discoloration is deemed unacceptable by the patient, chlorhexidine gluconate oral rinse should not be used.

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 impact of chlorhexidine gluconate oral rinse on 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 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 chlorhexidine gluconate oral rinse 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 stain, in contrast to 1% of control users.

It is important to note that staining resulting from chlorhexidine gluconate oral rinse does not adversely affect the health of the gingivae or other oral tissues. Most stains can be removed through conventional professional prophylactic techniques. Caution should be exercised when prescribing this rinse to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed from these surfaces by dental prophylaxis, patients may need to be excluded from treatment with chlorhexidine gluconate oral rinse if they find permanent discoloration unacceptable.

Some patients may experience alterations in taste perception during treatment with chlorhexidine gluconate oral rinse. Rare cases of permanent taste alteration have been reported through post-marketing surveillance. Healthcare professionals should monitor patients for these potential side effects and provide appropriate guidance.

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 an alteration in taste perception.

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

Postmarketing reports have identified additional adverse reactions, such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Other observed effects include oral irritation, local allergy-type symptoms, minor irritation and superficial desquamation of the oral mucosa, parotid gland swelling, and inflammation of the salivary glands (sialadenitis).

It is important to note that anaphylaxis and serious allergic reactions have been reported during postmarketing use of dental products containing chlorhexidine. Furthermore, while some patients may experience alterations in taste perception during treatment, rare instances of permanent taste alteration have been documented through post-marketing product surveillance.

Drug Interactions

Anaphylaxis and serious allergic reactions have been reported in postmarketing experiences associated with dental products containing chlorhexidine. Healthcare professionals should be vigilant for signs of hypersensitivity in patients using these products.

Currently, there are no specific drug or laboratory test interactions identified in the available data. Monitoring for any unexpected reactions or changes in laboratory test results is advisable, although no direct interactions have been documented.

Packaging & NDC

The table below lists all NDC Code configurations of 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 should be approached with caution, as there is insufficient data to support its efficacy and safety in children and adolescents.

Geriatric Use

Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18. While there are no specific recommendations for geriatric patients, healthcare providers should exercise caution when prescribing this medication to elderly patients.

Given the absence of established guidelines for this population, it is advisable to monitor geriatric patients closely for any potential adverse effects or complications that may arise during treatment. Additionally, healthcare providers should consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriateness of chlorhexidine gluconate oral rinse for elderly patients.

Pregnancy

Pregnancy category B indicates that 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 fetal harm. However, it is important to note that 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 (2 capfuls) of the oral rinse per day.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 for potential complications and provide appropriate management based on the severity of the symptoms presented.

Nonclinical Toxicology

Pregnancy category B indicates that reproduction studies conducted in rats and rabbits at chlorhexidine gluconate doses of up to 300 mg/kg/day and 40 mg/kg/day, respectively, have not demonstrated evidence of fetal harm. However, it is important to note that adequate and well-controlled studies in pregnant women have not been performed. Due to the limitations of animal reproduction studies in predicting human responses, the use of this drug during pregnancy should be considered only when clearly necessary.

In terms of non-teratogenic effects, a drinking water study in rats did not reveal any carcinogenic effects at doses up to 38 mg/kg/day. Additionally, mutagenic effects were not observed in two mammalian in vivo mutagenesis studies involving 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. Anaphylaxis and serious allergic reactions have been reported. Among the most frequently noted 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 chlorhexidine gluconate oral rinse. Reports have also included cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis). Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through post-marketing product surveillance.

Patient Counseling

Advise patients that chlorhexidine gluconate oral rinse has been prescribed by their dentist to treat gingivitis, aiming to reduce gum redness and swelling while helping to control gum bleeding. It is essential for patients to use the oral rinse regularly, as directed by their dentist, in conjunction with daily brushing. Patients should be instructed to spit out the rinse after use and to avoid swallowing it.

Inform 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. Emphasize 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. It is important for patients to visit their dentist for the removal of any stains or tartar at least every six months, or more frequently if advised by their dentist. Both stains and tartar can be effectively removed by a dentist or hygienist. Additionally, 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. Patients may find that the rinse has a bitter taste and can alter the taste of foods and beverages; however, this effect typically diminishes with continued use. To reduce taste interference, recommend that patients rinse with chlorhexidine gluconate oral rinse after meals.

Instruct patients not to rinse with water or other mouthwashes immediately after using chlorhexidine gluconate oral rinse. Encourage patients to reach out to their dentist, pharmacist, or Benco Dental at 1-800-462-3626 if they have any questions or comments regarding the oral rinse. Additionally, advise patients to contact their healthcare provider for medical advice about any side effects they may experience, and inform them that side effects can be reported to the FDA at 1-800-FDA-1088.

Storage and Handling

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 4-ounce (118 mL) and 1-pint (473 mL) amber plastic bottles, each equipped with child-resistant dispensing closures.

For optimal storage, the product should be maintained at a temperature range of 20°C to 25°C (68°F to 77°F). Temporary excursions are permissible between 15°C to 30°C (59°F to 86°F), in accordance with USP controlled room temperature guidelines. Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

Chlorhexidine gluconate oral rinse should be used regularly as directed by a dentist, in conjunction with daily brushing. It is important for patients to spit out the rinse after use and not to swallow it. Patients should be counseled to seek immediate medical attention if they experience allergic symptoms such as skin rash, itching, swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea.

Individuals with a known sensitivity to chlorhexidine gluconate or its components should avoid using the rinse. Patients may experience tooth discoloration and increased tartar formation, particularly in areas prone to staining. Regular dental visits for stain and tartar removal are recommended, typically every six months or more frequently as advised by a dentist. To minimize discoloration, patients should maintain good oral hygiene practices, including daily brushing and flossing. The rinse may have a bitter taste that can affect the taste of foods and beverages, though this usually diminishes with continued use. To reduce taste interference, it is advisable to use the rinse after meals and avoid rinsing with water or other mouthwashes immediately afterward. For any questions or concerns, patients are encouraged to contact their dentist, pharmacist, or Benco Dental. Side effects should be reported to a healthcare provider or the FDA.

FDA Insert (PDF)

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

View full prescribing information (PDF)