Chlorhexidine gluconate

Description

0.12% chlorhexidine gluconate (CHG) is an oral rinse formulated with 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. The solution is near neutral, with a pH range of 5 to 7. Chlorhexidine gluconate is 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 further guidance.

Dosage and Administration

Chlorhexidine gluconate oral rinse therapy should be initiated immediately following dental prophylaxis. The recommended dosage is 15 ml (1 tablespoon) of undiluted chlorhexidine gluconate oral rinse, to be used twice daily. Patients should perform rinsing for 30 seconds in the morning and evening, after brushing their teeth.

It is essential to instruct patients not to rinse with water or other mouthwashes, brush their teeth, or consume food or beverages 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 severe allergic reactions.

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, there have been reports of anaphylaxis and serious allergic reactions associated with the use of dental products containing chlorhexidine during postmarketing surveillance. Healthcare providers should remain vigilant for signs of these adverse reactions and refer to the contraindications section for further guidance.

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 observed include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and alterations in taste perception. These reactions are generally mild and may not require medical intervention.

In clinical trials, several oral mucosal side effects were reported, albeit at a frequency of less than 1%. These include aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Postmarketing experience has revealed additional adverse reactions, including stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Oral irritation and local allergy-type symptoms have also been spontaneously reported by patients. Minor irritation and superficial desquamation of the oral mucosa have been noted in some cases.

Serious adverse reactions, although rare, have been documented. These include cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis). Furthermore, there have been rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse, as reported through post-marketing product surveillance. Anaphylaxis and other serious allergic reactions have also been reported in association with dental products containing chlorhexidine.

Healthcare professionals should monitor patients for these adverse reactions and provide appropriate management as necessary.

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, indicating the need for caution in susceptible populations.

In terms of drug and laboratory test interactions, the excretion of chlorhexidine gluconate oral rinse in human milk has not been established. Therefore, it is advisable to exercise caution when administering this rinse to nursing women, considering the potential risks to the infant. Monitoring for any adverse reactions is recommended in this population.

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 oral rinse have not been established in pediatric patients under the age of 18. Therefore, caution is advised when considering its use in this population.

Geriatric Use

Elderly patients may require special 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 need for careful evaluation in geriatric populations.

Caution is advised when administering chlorhexidine gluconate oral rinse to nursing women, as potential risks may be present. Additionally, clinical testing has indicated an increase in supragingival calculus among users of chlorhexidine gluconate oral rinse compared to control users, which may be a relevant concern for elderly patients who may already be at risk for oral health issues.

The use of chlorhexidine gluconate oral rinse can lead to staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue. Geriatric patients should be informed of this potential side effect, as it may impact their oral hygiene and aesthetic concerns. Furthermore, some patients may experience alterations in taste perception during treatment, with rare instances of permanent taste alteration reported through post-marketing surveillance. This possibility should be communicated to elderly patients to ensure they are aware of the risks involved.

It is recommended that patients, including elderly individuals, be reevaluated and provided with thorough prophylaxis at intervals no longer than six months. Chlorhexidine gluconate oral rinse therapy should ideally be initiated immediately following a dental prophylaxis to maximize its effectiveness.

Lastly, discretion should be exercised when prescribing this oral rinse to patients with anterior facial restorations that have rough surfaces or margins, as this may exacerbate staining or other adverse effects. Careful monitoring and consideration of these factors are essential to ensure the safe and effective use of chlorhexidine gluconate oral rinse in geriatric patients.

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, categorizing this drug as Pregnancy Category B. 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 human 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 100 times greater than what would result from a human ingesting 30 ml of chlorhexidine gluconate oral rinse per day.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 1000 mg/kg/day.

No relevant information is available regarding teratogenic or non-teratogenic effects, nor is there any pertinent data in the area of animal pharmacology and toxicology.

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, ulceration, 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

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.

Instruct patients to spit out the rinse after use and emphasize that chlorhexidine gluconate oral rinse should not be swallowed. Patients should be made aware of the potential for allergic reactions; they must seek immediate medical attention if they experience symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea.

Inform patients that chlorhexidine gluconate oral rinse is contraindicated for individuals with a known sensitivity to it or its components. Additionally, patients should be counseled that the rinse may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas prone to staining and tartar buildup. It is important for patients to visit their dentist for professional removal of any stain or tartar at least every six months, or more frequently if advised.

Patients should be cautioned 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 maintain a diligent oral hygiene routine, including daily brushing and flossing, with particular 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 mitigate taste interference, recommend that patients rinse with chlorhexidine gluconate oral rinse after meals. Advise them not to rinse with water or other mouthwashes immediately following the use of chlorhexidine gluconate oral rinse.

Encourage patients to reach out to their dentist, pharmacist, or the toll-free number 1-800-361-2862 if they have any questions or comments regarding chlorhexidine gluconate oral rinse. Additionally, patients should 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 two package configurations: 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.

Additional Clinical Information

No further data are available.

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)