Nupro Chlorhexidine Gluconate

Description

0.12% chlorhexidine gluconate (CHG) is an oral rinse formulated with 1,1-hexamethylene bis5-(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.

Limitations of Use: Chlorhexidine gluconate oral rinse has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG). For patients 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 measured using the cap provided. Patients are advised to perform rinsing twice daily, specifically in the morning and evening, for a duration of 30 seconds after brushing their teeth.

It is essential to instruct patients not to rinse with water or other mouthwashes, nor to brush their teeth or consume food immediately after using the oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion; therefore, 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 due to the potential for allergic responses.

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. Not all patients will experience a significant increase in tooth staining; however, 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 stain, in contrast to 1% of control users.

Staining is more pronounced in patients with heavier plaque accumulation. It is important to note that staining 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 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 permanent discoloration is deemed unacceptable. In some cases, stains in these areas may be difficult to remove and could necessitate the replacement of restorations.

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

Side Effects

Patients using the product may experience a range of adverse reactions, which can be categorized by frequency and seriousness.

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. These effects are generally mild and may not require medical intervention.

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%.

Postmarketing experience has revealed additional adverse reactions, such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Oral irritation and local allergy-type symptoms have also been spontaneously reported, along with minor irritation and superficial desquamation of the oral mucosa.

Furthermore, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have been documented. Rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been noted through post-marketing product surveillance. Serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of dental products containing chlorhexidine.

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 Nupro Chlorhexidine Gluconate (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 explicitly mentioned in the available data.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, considering the lack of established clinical data in this population. Monitoring for any adverse effects or unusual responses is advisable, given the general variability in drug metabolism and response among geriatric patients.

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, adequate and well-controlled studies in pregnant women have not been performed. 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 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 indicative of 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

Reproduction studies conducted in rats and rabbits with chlorhexidine gluconate at doses of up to 300 mg/kg/day and 40 mg/kg/day, respectively, did not demonstrate 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 outcomes, the use of this drug during pregnancy should be considered only when clearly necessary.

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 utilizing 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. Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through post-marketing product surveillance.

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.

The recommended usage is for patients to rinse twice daily for 30 seconds, both in the morning and evening, after brushing their teeth. The usual dosage is 15 mL, as marked in the cap, of undiluted chlorhexidine gluconate oral rinse.

Patients should be made aware that chlorhexidine gluconate oral rinse can cause staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue. It is important to note that the staining resulting from the use of this rinse does not adversely affect the health of the gingivae or other oral tissues. Additionally, stains can typically be removed from most tooth surfaces through 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 stains cannot be removed from these surfaces by dental prophylaxis, patients should be excluded from treatment with chlorhexidine gluconate oral rinse if permanent discoloration is deemed unacceptable.

Patients may also experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse. It is important to inform them that rare instances of permanent taste alteration following the use of this rinse have been reported through post-marketing product surveillance.

Finally, patients using chlorhexidine gluconate oral rinse should be reevaluated and provided with a thorough prophylaxis at intervals no longer than six months.

Storage and Handling

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 mL) amber plastic bottles equipped with child-resistant dispensing closures.

For optimal storage, the product should 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.

Additional Clinical Information

Chlorhexidine gluconate oral rinse therapy should be initiated immediately following dental prophylaxis, with a recommended administration of 15 mL (marked in cap) of undiluted rinse twice daily for 30 seconds, both morning and evening after tooth brushing. Patients are advised not to rinse with water, use other mouthwashes, brush their teeth, or eat immediately after using the rinse.

Clinicians should inform patients that chlorhexidine gluconate oral rinse may cause staining of oral surfaces, including teeth, restorations, and the tongue, as well as potential alterations in taste perception during treatment. Caution is advised when administering this rinse to nursing women. Postmarketing experiences have reported serious allergic reactions, including anaphylaxis, and rare cases of permanent taste alteration. Common oral mucosal symptoms associated with the rinse 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 Nupro 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)