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. Chlorhexidine gluconate is a salt formed from chlorhexidine and gluconic acid. The product is a near neutral solution with a pH range of 5 to 7. Inactive ingredients present in the formulation include glycerin, PEG-40 sorbitan diisostearate, alcohol, sodium saccharin, and FD&C Blue No.1.

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 additional 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 is to be 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 immediately after using the chlorhexidine gluconate oral rinse. The rinse is not intended for ingestion and should be expectorated 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 from tooth surfaces through conventional professional prophylactic techniques. 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. 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 also been documented through post-marketing product surveillance.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 efficacy and safety in children and adolescents.

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 may suggest a need for caution in geriatric populations, particularly those with complex health profiles.

Caution is advised when administering chlorhexidine gluconate oral rinse to nursing women, as the implications for both the mother and infant are not fully understood. Additionally, an increase in supragingival calculus has been observed in users of chlorhexidine gluconate oral rinse compared to control users, which may be a relevant safety concern for elderly patients who may already be at risk for oral health issues.

Healthcare providers should be aware of the potential for anaphylaxis and serious allergic reactions, which have been reported during postmarketing use of dental products containing chlorhexidine. Monitoring for these adverse effects is essential, especially in geriatric patients who may have a higher susceptibility to such reactions.

Alterations in taste perception have been noted in some patients undergoing treatment with chlorhexidine gluconate oral rinse, with rare instances of permanent taste alteration reported. This may impact the quality of life for elderly patients, who may already experience sensory changes.

Furthermore, discretion 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 through dental prophylaxis, it is advisable to exclude patients from treatment if they find permanent discoloration unacceptable, as stains in these areas may be difficult to remove and could necessitate the replacement of restorations.

In summary, careful assessment and monitoring are recommended when prescribing chlorhexidine gluconate oral rinse to elderly patients, taking into account their unique health considerations and potential risks associated with treatment.

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. However, there is a lack of adequate and well-controlled studies in pregnant women. 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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic 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 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

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, there was no evidence of impaired fertility 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. Additionally, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through post-marketing product surveillance.

Among the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Furthermore, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have also been reported in patients using this 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 and should be expectorated after rinsing. Healthcare providers should advise patients that therapy with chlorhexidine gluconate oral rinse should be initiated directly following a dental prophylaxis.

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

Caution should be exercised when administering chlorhexidine gluconate oral rinse to nursing women. Patients may experience an alteration in taste perception during treatment, and healthcare providers should inform them that rare instances of permanent taste alteration have been reported through post-marketing product surveillance.

It is important to note that staining resulting from the use of chlorhexidine gluconate oral rinse does not adversely affect the health of the gingivae or other oral tissues. Stains can typically be removed from most tooth surfaces using conventional professional prophylactic techniques. Discretion should be used when prescribing to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed from these surfaces by dental prophylaxis, patients should be excluded from chlorhexidine gluconate oral rinse treatment if permanent discoloration is deemed unacceptable.

Storage and Handling

The product is supplied in 1-pint (473 ml) amber plastic bottles equipped with child-resistant dispensing closures.

It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F) in accordance with USP controlled room temperature guidelines. Proper storage conditions are essential to maintain 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; however, this staining does not negatively impact the health of the gingivae or other oral tissues. Clinicians should exercise caution when prescribing this rinse to patients with anterior facial restorations that have rough surfaces or margins. Additionally, some patients may experience changes in taste perception during treatment, with rare reports of permanent taste alteration noted in post-marketing surveillance.

FDA Insert (PDF)

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

View full prescribing information (PDF)