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.

This product 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.

No teratogenic or nonteratogenic effects have been reported.

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 use the rinse twice daily, specifically in the morning and evening, for a duration of 30 seconds each time, 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 oral rinse. Additionally, 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 severe allergic 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. Not all patients will experience a significant increase in tooth staining; however, 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 stain, in contrast to 1% of control users.

Staining is more pronounced in patients with higher accumulations of unremoved plaque. 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, alterations in taste perception, and oral irritation along with local allergy-type symptoms.

In clinical trials, participants reported less common adverse reactions, including aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each of these events 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.

Other notable adverse reactions include minor irritation and superficial desquamation of the oral mucosa. There have also been reports of cases involving parotid gland swelling and inflammation of the salivary glands (sialadenitis).

Serious allergic reactions, including anaphylaxis, have been documented during postmarketing use of dental products containing chlorhexidine. Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been reported through post-marketing product surveillance.

Drug Interactions

Anaphylaxis and serious allergic reactions have been reported in postmarketing experiences associated with dental products containing chlorhexidine. Healthcare professionals should remain vigilant for signs of hypersensitivity in patients using these products.

Currently, there are no specific drug or laboratory test interactions identified in the available data. Monitoring for any unexpected reactions or changes in laboratory results is advisable, although no direct interactions have been documented.

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, caution is advised when considering its use in this population.

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

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 response, chlorhexidine gluconate should be used during pregnancy only if clearly needed. This medication is classified as Pregnancy Category B. 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. Given that many drugs can 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. 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 may be advisable in 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 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

Reproduction studies conducted in rats and rabbits at doses of chlorhexidine gluconate up to 300 mg/kg/day and 40 mg/kg/day, respectively, did not reveal evidence of teratogenic effects on 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 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 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. Anaphylaxis and serious allergic reactions have been reported. Among the oral mucosal symptoms frequently noted are stomatitis, gingivitis, glossitis, ulcers, 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) in patients utilizing chlorhexidine gluconate oral 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.

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. While not all patients will experience a visually significant increase in tooth staining, clinical testing has shown that 56% of 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. Staining may be more pronounced in patients with heavier accumulations of unremoved plaque.

It should be noted that staining resulting from the use of 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 to complete the prophylaxis. Discretion 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 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 its use have been reported through post-marketing product surveillance. It is advisable for healthcare providers to reevaluate patients and provide a thorough prophylaxis at intervals no longer than six months.

The recommended usage is twice daily 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. To minimize the medicinal taste, patients should be advised not to rinse with water immediately after use.

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

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

Clinicians should counsel patients about potential side effects, including staining of oral surfaces such as teeth and the tongue, which does not negatively impact the health of the gingivae or other oral tissues. Some patients may also experience changes in taste perception. Postmarketing reports have indicated serious allergic reactions, including anaphylaxis, as well as oral mucosal symptoms like stomatitis, gingivitis, and glossitis. Additionally, cases 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 Dentsply LLC. Professional Division Trading as "DENTSPLY Professional". It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)