Chlorhexidine gluconate

Description

0.12% chlorhexidine gluconate (CHG) is an oral rinse that contains 1,1'-hexamethylene bis 5-(p-chlorophenyl) biguanidedi-D-gluconate in a base of water. The formulation includes 6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1 as inactive ingredients. The chlorhexidine gluconate product is a near neutral solution with a pH range of 5-7. Chlorhexidine gluconate 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, which is 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).

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. Use in these patients may lead to adverse reactions.

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 users exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Furthermore, 15% of chlorhexidine gluconate oral rinse users developed what was classified as heavy staining, in contrast to 1% of control users. It is important to note that staining does not adversely affect the health of the gingivae or other oral tissues and can typically be removed through conventional professional prophylactic techniques, although additional time may be required.

Caution is advised 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 with chlorhexidine gluconate oral rinse if they find permanent discoloration unacceptable. Stains in these areas may be challenging to remove and, in rare cases, may necessitate the replacement of restorations.

Some patients may experience alterations in taste perception during treatment with chlorhexidine gluconate oral rinse. There have been rare reports of permanent taste alterations following its use, as noted in post-marketing surveillance.

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 placebo-controlled adult clinical trials, several oral mucosal side effects were reported, including aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each of these effects occurred at a frequency of less than 1.0%.

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).

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 while undergoing treatment. Rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have also been documented through post-marketing surveillance.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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, 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 until further data are available to support its safety and efficacy.

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 outcomes. Monitoring for any adverse effects 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. 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 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 symptoms resembling alcohol intoxication.

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 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 harm to the fetus. However, it is important to note that adequate and well-controlled studies in pregnant women have not been performed. Given that animal reproduction studies may not always predict human responses, the use of this drug during pregnancy should be considered 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. Additionally, oral irritation and local allergy-type symptoms have been spontaneously reported in association with chlorhexidine gluconate rinse.

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, cases of parotid gland swelling and inflammation of the salivary glands, known as sialadenitis, have been reported in patients utilizing 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. Instruct patients to use the oral rinse regularly as directed, in conjunction with daily brushing. Emphasize that the rinse should be spat out after use and not swallowed.

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. Clarify that chlorhexidine gluconate oral rinse is contraindicated for individuals with a known sensitivity to it or its components.

Discuss the potential side effects of chlorhexidine gluconate oral rinse, including the possibility of tooth discoloration and increased tartar (calculus) formation, particularly in areas where stains and tartar typically accumulate. Stress the importance of regular dental visits for the removal of any stain or tartar, recommending 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, and patients should be made aware that the rinse may cause permanent discoloration of some front-tooth fillings.

To help minimize discoloration, encourage patients to maintain a diligent oral hygiene routine, including daily brushing and flossing, with particular attention to areas that begin to show discoloration. Additionally, 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, recommend that patients rinse with chlorhexidine gluconate oral rinse after meals and avoid rinsing with water or other mouthwashes immediately afterward.

Remind patients that if they have any questions or concerns regarding chlorhexidine gluconate oral rinse, they should contact their dentist, pharmacist, or Xttrium Laboratories, Inc. at 1-800-587-3721. Advise them to call their healthcare provider for medical advice regarding any side effects and to report side effects to the FDA at 1-800-FDA-1088.

Finally, instruct patients on the proper storage of chlorhexidine gluconate oral rinse, recommending that it be kept at a temperature of 20ºC to 25ºC (68ºF to 77ºF), with permissible excursions between 15ºC to 30ºC (59ºF to 86ºF) as per USP controlled room temperature guidelines.

Storage and Handling

The product is supplied as a blue liquid in single-dose amber plastic bottles equipped with child-resistant dispensing closures. The National Drug Code (NDC) numbers associated with this product are available upon request.

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 lead to staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. While this staining does not negatively impact the health of the gingivae or other oral tissues, clinicians should exercise caution when prescribing to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed through dental prophylaxis and permanent discoloration is deemed unacceptable by the patient, chlorhexidine gluconate oral rinse treatment should be avoided.

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 as submitted by Medline Industries, LP. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)