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 regimen involves oral rinsing twice daily, specifically in the morning and evening, for a duration of 30 seconds after tooth brushing. The usual dosage is 15 ml, as indicated by the marked line on the cap, of undiluted chlorhexidine gluconate oral rinse.

Patients must be instructed to avoid rinsing with water or other mouthwashes, brushing their teeth, or consuming food immediately after the use of chlorhexidine gluconate oral rinse. It is essential to emphasize that this product is not intended for ingestion; patients should expectorate the rinse after use.

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 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 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 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 through 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 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).

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 an alteration in taste perception during treatment, rare instances of permanent taste alteration have been documented through post-marketing product 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 is not recommended. Healthcare professionals should exercise caution when considering this treatment for children and adolescents, as the lack of data limits the ability to assess potential risks and benefits.

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 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 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 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 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 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 harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been performed. Due to the limitations of animal reproduction studies in predicting human responses, this drug should be utilized during pregnancy only when clearly necessary.

In terms of non-teratogenic effects, a drinking water study in rats revealed no 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 reported oral mucosal symptoms linked to chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, 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). Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of chlorhexidine gluconate 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 and should be expectorated after rinsing.

Healthcare providers should inform patients that chlorhexidine gluconate oral rinse can cause staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue. However, not all patients will experience a visually significant increase in tooth staining. In clinical testing, 56% of chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain compared to 35% of control users after six months. Additionally, 15% of chlorhexidine gluconate oral rinse users developed what was judged to be heavy stain, in contrast to only 1% of control users after the same period. It is noteworthy that the stain resulting from the use of chlorhexidine gluconate oral rinse does not adversely affect the health of the gingivae or other oral tissues, and stain can typically be removed from most tooth surfaces by conventional professional prophylactic techniques.

Healthcare providers should exercise discretion when prescribing chlorhexidine gluconate oral rinse to patients with anterior facial restorations that have rough surfaces or margins. If natural stain cannot be removed from these surfaces by dental prophylaxis, patients should be excluded from treatment with chlorhexidine gluconate oral rinse if permanent discoloration is unacceptable.

Patients may also experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following the use of this rinse have been reported through post-marketing product surveillance.

It is recommended that patients using chlorhexidine gluconate oral rinse be reevaluated and receive a thorough prophylaxis at intervals no longer than six months. The recommended usage is twice daily oral rinsing for 30 seconds, in the morning and evening after tooth brushing, with a usual dosage of 15 ml (as marked in the cap) of undiluted chlorhexidine gluconate oral rinse.

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Currently, there are no specific storage instructions or handling details provided. It is recommended that healthcare professionals follow standard storage practices for pharmaceutical products to ensure optimal quality and efficacy.

Additional Clinical Information

Patients using chlorhexidine gluconate oral rinse are advised to perform twice daily oral rinsing for 30 seconds, both 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, and advise caution when prescribing to those with anterior facial restorations that have rough surfaces. Some patients may experience alterations in taste perception during treatment. Postmarketing reports have indicated serious allergic reactions, including anaphylaxis, as well as rare cases of permanent taste alteration. Common oral mucosal symptoms reported include stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Additionally, instances of parotid gland swelling and sialadenitis have been documented.

FDA Insert (PDF)

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

View full prescribing information (PDF)