Chlorhexidine gluconate

Description

Chlorhexidine gluconate (CHG) 0.12% is an oral rinse formulated with 1,1'-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate. The product is presented in a near neutral solution with a pH range of 5 to 7. The formulation includes a base composed of water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavoring agents, sodium saccharin, and FD&C Blue No. 1. 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 (1 tablespoon) of undiluted chlorhexidine gluconate oral rinse, administered twice daily. Patients should perform oral 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.

Caution is advised when prescribing 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 for chlorhexidine gluconate oral rinse to increase 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 staining, 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 from tooth surfaces through conventional professional prophylactic techniques, although additional time may be necessary to complete the procedure. Caution should be exercised 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 if permanent discoloration is deemed unacceptable.

Some patients may experience alterations in taste perception while using chlorhexidine gluconate oral rinse. Rare cases of permanent taste alteration have been reported through post-marketing surveillance.

Side Effects

Patients using chlorhexidine gluconate oral rinse may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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 effects are frequently reported among patients undergoing treatment.

Oral irritation and local allergy-type symptoms have been spontaneously reported in association with the use of chlorhexidine gluconate rinse. Additionally, during placebo-controlled adult clinical trials, various oral mucosal side effects were observed, including aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each of these side effects occurred at a frequency of less than 1.0%.

Postmarketing reports have identified the most frequently reported oral mucosal symptoms as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have also been noted in patients using the rinse.

Serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of dental products containing chlorhexidine. Furthermore, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have been documented in patients using chlorhexidine gluconate oral rinse.

Patients may also experience alterations in taste perception during treatment, with rare instances of permanent taste alteration reported through postmarketing surveillance.

Drug Interactions

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

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not indicated at this time.

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. However, there are no specific recommendations, dosage adjustments, or safety concerns noted for elderly patients.

Healthcare providers should exercise clinical judgment when considering the use of chlorhexidine gluconate oral rinse in geriatric patients, as individual patient factors may influence treatment decisions. Monitoring for any adverse effects or complications is advisable, given the lack of established data in this population.

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 harm to the fetus. 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 response, 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 resembling alcohol intoxication due to the formulation of the rinse.

It is imperative that medical attention is sought if a small child ingests more than 4 ounces of chlorhexidine gluconate oral rinse. The development of symptoms indicative of alcohol intoxication further necessitates immediate medical evaluation and intervention. Healthcare professionals should be vigilant in monitoring for these symptoms and provide appropriate management as required.

Nonclinical Toxicology

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 teratogenic effects. The drug is classified 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, the use of this drug during pregnancy should be considered only when clearly necessary.

In terms of carcinogenicity, 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 oral mucosal symptoms frequently noted are stomatitis, gingivitis, glossitis, ulcers, 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) in patients utilizing chlorhexidine gluconate oral rinse. Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through postmarketing surveillance.

Patient Counseling

Patients should be informed 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 advised to spit out the rinse after use and not to swallow 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 staining and tartar typically occur. Regular dental visits for the removal of any stain or tartar are recommended, at least every six months or more frequently if advised by their dentist. Both stain and tartar can be effectively removed by a dentist or hygienist. Additionally, patients should be informed 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 daily brushing and flossing routine, paying special attention to areas that begin to show discoloration. It is also important to inform patients that the rinse may have a bitter taste and can alter the taste of foods and beverages, although 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, pharmacist, or Xttrium Laboratories, Inc. at 1-800-587-3721 if they have any questions or comments regarding chlorhexidine gluconate oral rinse. For medical advice about side effects, patients should contact their healthcare provider, and they may report side effects to the FDA at 1-800-FDA-1088.

Storage and Handling

The product is supplied as a blue liquid in single-dose amber plastic bottles, each containing 15 ml. These bottles are equipped with child-resistant dispensing closures to ensure safety during use.

Storage conditions require the product to 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 adherence to these storage conditions is essential to maintain product integrity and efficacy.

Additional Clinical Information

Chlorhexidine gluconate oral rinse should be administered undiluted by swishing in the mouth for 30 seconds before spitting out, ideally after breakfast and before bedtime, or as prescribed by a clinician. Patients are advised to seek immediate medical attention if they experience allergic symptoms such as skin rash, itching, swelling, breathing difficulties, light-headedness, rapid heart rate, upset stomach, or diarrhea. This rinse is contraindicated for individuals with a known sensitivity to chlorhexidine or its components.

Patients may experience tooth discoloration and increased tartar formation, particularly in areas prone to staining. Regular dental check-ups are recommended for the removal of stains and tartar, ideally every six months. To minimize discoloration, patients should maintain a daily oral hygiene routine, including brushing and flossing. The rinse may impart a bitter taste and alter the taste of foods and beverages, though this effect typically diminishes with continued use. To mitigate taste interference, it is advisable to use the rinse after meals and avoid rinsing with water or other mouthwashes immediately afterward.

Postmarketing surveillance has reported cases of anaphylaxis and serious allergic reactions associated with chlorhexidine-containing dental products. Additionally, rare instances of permanent taste alteration and various oral mucosal symptoms, including stomatitis, gingivitis, glossitis, and dry mouth, have been documented. There have also been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients using this oral rinse.

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)