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 drug 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, which should be administered twice daily. Patients are advised to perform oral rinsing for 30 seconds in the morning and evening, 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 after rinsing to ensure proper use and effectiveness.

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.

Hypersensitivity and generalized allergic reactions have been reported in some patients using chlorhexidine gluconate oral rinse.

For patients with coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment 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 only 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 required for thorough cleaning. 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 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, stain removal may be challenging 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.

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, several oral mucosal side effects were reported among participants, including aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each of these 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 side effects noted 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).

Warnings associated with the use of chlorhexidine gluconate oral rinse include the potential for hypersensitivity and generalized allergic reactions. Precautions should be taken as some patients may experience an alteration in taste perception during treatment. Rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have also been reported through post-marketing surveillance.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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, dosage adjustments or safety concerns have not been identified in the available data.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for any adverse effects is advisable, given the lack of established clinical 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 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 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 studies involving parturition and lactation in 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 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. For instance, a child weighing approximately 10 kg may experience gastric distress, which can manifest as nausea, following the ingestion of 1 or 2 ounces of the solution. Additionally, there may be signs resembling 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

Pregnancy category B indicates that reproduction studies conducted in rats and rabbits at doses of chlorhexidine gluconate up to 300 mg/kg/day and 40 mg/kg/day, respectively, have not demonstrated evidence of teratogenic effects. 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

Rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been reported through post-marketing surveillance. Among the reported cases, the most frequently observed oral mucosal symptoms include stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Additionally, minor irritation and superficial desquamation of the oral mucosa have been noted in patients utilizing this oral rinse. Reports also indicate occurrences of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients using chlorhexidine gluconate oral rinse.

Patient Counseling

Patients should be instructed not to rinse with water or other mouthwashes, brush their teeth, or eat immediately after using chlorhexidine gluconate oral rinse. It is important to emphasize that chlorhexidine gluconate oral rinse is not intended for ingestion; patients should expectorate the solution after rinsing.

The recommended usage involves oral rinsing twice daily for 30 seconds, specifically in the morning and evening after tooth brushing. The usual dosage is 15 ml, which is marked in the cap, of undiluted chlorhexidine gluconate oral rinse.

Healthcare providers should advise patients that chlorhexidine gluconate oral rinse therapy should be initiated immediately following a dental prophylaxis. Additionally, patients using this oral rinse should be reevaluated and provided with a thorough prophylaxis at intervals no longer than six months.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its efficacy. Freezing the product is strictly prohibited, as it may compromise its quality. After opening, any unused portion must be discarded to ensure safety and effectiveness.

Additional Clinical Information

Patients using chlorhexidine gluconate oral rinse are advised to perform a twice daily oral rinse for 30 seconds, specifically in the morning and evening after tooth brushing. The usual dosage is 15 ml of undiluted rinse, and patients should refrain from rinsing with water, using other mouthwashes, brushing teeth, or eating immediately after administration.

Clinicians should counsel patients about potential side effects, including staining of oral surfaces such as teeth and the tongue, as well as possible alterations in taste perception during treatment. Post-marketing surveillance has reported rare cases of permanent taste alteration, along with common oral mucosal symptoms such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Additionally, there have been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) associated with the use of this oral rinse.

FDA Insert (PDF)

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

View full prescribing information (PDF)