Denti-Care Denti-Rinse

Description

Chlorhexidine gluconate is an oral rinse formulated with 0.12% chlorhexidine gluconate, which is chemically defined as 1,11-hexamethylene bis5-(p-chlorophenyl) biguanide di-D-gluconate. This formulation includes a base composed of water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavoring agents, sodium saccharin, and FD and C Blue No.1. Chlorhexidine gluconate is classified as a salt of 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.

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 marked in the cap. Patients are advised to use the rinse twice daily, specifically in the morning and evening, for a duration of 30 seconds 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 chlorhexidine gluconate oral rinse. Additionally, healthcare professionals should emphasize that the rinse is not intended for ingestion and must be expectorated following use.

Contraindications

Chlorhexidine gluconate oral rinse is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other components of 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. Clinically, an increase in supragingival calculus has been observed in users of chlorhexidine gluconate oral rinse compared to control users. The potential impact of chlorhexidine gluconate oral rinse on subgingival calculus remains undetermined. It is essential that calculus deposits be removed through dental prophylaxis at intervals not exceeding six months to maintain oral health.

Healthcare professionals should be aware that hypersensitivity and generalized allergic reactions have been reported in some patients. For further details, please refer to the contraindications section.

No specific general precautions or laboratory tests have been identified for chlorhexidine gluconate oral rinse. It is advisable for healthcare providers to remain vigilant and monitor patients for any adverse reactions or changes in oral health status during treatment.

Side Effects

The most common adverse reactions associated with chlorhexidine gluconate oral rinses include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and an alteration in taste perception. Oral irritation and local allergy-type symptoms have also been spontaneously reported by patients using this rinse.

In placebo-controlled adult clinical trials, several oral mucosal side effects were observed, including aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each of these side effects occurred at a frequency of less than 1.0%.

Postmarketing experience has revealed additional oral mucosal symptoms frequently reported by patients, such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse. Furthermore, there have been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients utilizing this rinse.

Patients should be aware of the potential for hypersensitivity and generalized allergic reactions, which have been documented. It is important to note that some patients may experience an alteration in taste perception during treatment, with rare instances of permanent taste alteration reported through post-marketing product surveillance.

Drug Interactions

Chlorhexidine gluconate oral rinse is contraindicated in individuals with known hypersensitivity to chlorhexidine or its components. The use of this rinse may lead to hypersensitivity reactions, including generalized allergic responses.

In terms of drug and laboratory test interactions, the impact of chlorhexidine gluconate oral rinse on periodontitis remains undetermined. Clinical studies have indicated an increase in supragingival calculus among users of chlorhexidine gluconate oral rinse compared to control groups; however, it is currently unclear whether this rinse contributes to an increase in subgingival calculus. Monitoring for these effects may be warranted in patients using the rinse, although specific dosage adjustments are not indicated based on the available data.

Packaging & NDC

The table below lists all NDC Code configurations of Denti-Care Denti-Rinse (chlorhexidine gluconante), 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. Caution is advised when administering this product to children, as ingestion of 1 or 2 ounces by a small child (approximately 10 kg body weight) may lead to gastric distress, including nausea, or signs of alcohol intoxication. If a small child ingests more than 4 ounces of chlorhexidine gluconate oral rinse or exhibits signs of alcohol intoxication, medical attention should be sought immediately.

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, it is important to consider that the absence of established safety and efficacy data in this population necessitates caution when prescribing this medication to elderly patients.

Healthcare providers should monitor geriatric patients closely for any adverse effects or complications that may arise during treatment, given the lack of targeted studies in this demographic. Additionally, although no dosage adjustments are specified, clinicians should exercise clinical judgment and consider individual patient factors when determining the appropriateness of chlorhexidine gluconate oral rinse for elderly patients.

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, there is a lack of adequate and well-controlled studies in pregnant women. Due to the limitations of animal reproduction studies in predicting human response, this drug 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 medication 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 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 in small children can lead to significant adverse effects. 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 reveal any 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 studies assessing 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 person ingesting 30 mL (2 capfuls) of chlorhexidine gluconate oral rinse daily.

Carcinogenic effects were not observed in a drinking water study in rats at doses up to 38 mg/kg/day. Additionally, mutagenic effects were not detected in two mammalian in vivo mutagenesis studies involving chlorhexidine gluconate, with the highest doses tested being 1000 mg/kg/day in a mouse dominant-lethal assay and 250 mg/kg/day in a hamster cytogenetics test. Furthermore, no evidence of impaired fertility was noted in rats at doses up to 100 mg/kg/day.

Postmarketing Experience

Local hypersensitivity and generalized allergic reactions have been reported following the use of chlorhexidine gluconate oral rinse. Additionally, there are reports of permanent discoloration of some front-tooth fillings associated with its use. Rare instances of permanent taste alteration have also been documented through post-marketing product surveillance.

Among the oral mucosal symptoms frequently reported are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been observed in patients using the rinse. Furthermore, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have been noted in this patient population.

Patient Counseling

Patients should be informed that chlorhexidine gluconate oral rinse has been prescribed by their dentist to treat gingivitis, aiming to reduce gum redness and swelling while helping to control gum bleeding. It is essential for patients to use the oral rinse regularly as directed by their dentist, in conjunction with daily brushing.

Patients must be advised to spit out the rinse after use, as chlorhexidine gluconate oral rinse should not be swallowed. They should be made aware that the rinse may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where stains and tartar typically accumulate. Regular dental visits for the removal of any stain or tartar are important, with a recommendation to see the dentist at least every six months or more frequently if advised.

It is crucial to inform patients that both stains and tartar can be effectively removed by their dentist or hygienist. Additionally, patients should be cautioned that chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. To minimize the risk of discoloration, patients should be encouraged to maintain a daily brushing and flossing routine, paying special attention to areas that may begin to discolor.

Patients should also be made aware of the potential for local hypersensitivity and generalized allergic reactions, and that chlorhexidine gluconate oral rinse should not be used by individuals with a known sensitivity to it or its components. The rinse may have a bitter taste, which can affect the taste of foods and beverages; however, this effect typically diminishes with continued use. To mitigate taste interference, patients are advised to rinse with chlorhexidine gluconate oral rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward.

For any questions or concerns regarding chlorhexidine gluconate oral rinse, patients should be encouraged to contact their dentist or pharmacist. Lastly, it is important to instruct patients on the proper storage of the rinse at USP Controlled Room Temperature (20°C - 25°C or 68°F - 77°F).

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 USP Controlled Room Temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to ensure that the containers are kept in a secure location to prevent unauthorized access, particularly due to the child-resistant features of the packaging.

Additional Clinical Information

Patients are advised to use chlorhexidine gluconate oral rinse twice daily, rinsing for 30 seconds after brushing their teeth, specifically after breakfast and before bedtime. To minimize the medicinal taste, it is recommended not to rinse with water immediately after use. Patients should avoid swallowing the rinse and are encouraged to visit their dentist for the removal of any stains or tartar at least every six months, or more frequently if advised.

Post-marketing surveillance has reported rare cases of permanent taste alteration associated with the use of chlorhexidine gluconate oral rinse. Commonly reported oral mucosal symptoms include stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Additionally, instances of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have been documented. For any questions or concerns regarding the use of this rinse, patients should consult their dentist or pharmacist.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Denti-Care Denti-Rinse as submitted by Xttrium Laboratories, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)