Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

Description

ACCCLEAN is an oral rinse formulation that contains 0.12% chlorhexidine gluconate, chemically defined as 1,1’-hexamethylene bis 5-(p-chlorphenyl) biguanidedi-D-gluconate. The product is presented in a base comprising water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavoring agents, sodium saccharin, and FD&C Blue No. 1. The chlorhexidine gluconate solution is characterized by a near-neutral pH, ranging from 5 to 7. Chlorhexidine gluconate itself is a salt formed 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 (1 tablespoon) of undiluted chlorhexidine gluconate oral rinse, 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 or beverages immediately after using the chlorhexidine gluconate oral rinse. The rinse is not intended for ingestion and should be expectorated following the rinsing procedure.

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. Clinicians should be aware that an increase in supragingival calculus has been observed in users of chlorhexidine gluconate oral rinse compared to control groups. However, it remains undetermined whether the use of this oral rinse leads to an increase in subgingival calculus.

To mitigate the accumulation of calculus, it is recommended that calculus deposits be removed through dental prophylaxis at intervals not exceeding six months.

Healthcare professionals should also be vigilant for the potential occurrence of anaphylaxis and serious allergic reactions, which have been reported during postmarketing surveillance of dental products containing chlorhexidine. For further details, please refer to the contraindications section.

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, oral irritation, and local allergy-type symptoms.

In clinical trials, specifically placebo-controlled adult studies, several oral mucosal side effects were reported, 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.

Other notable adverse reactions include minor irritation and superficial desquamation of the oral mucosa, cases of parotid gland swelling, and inflammation of the salivary glands (sialadenitis). Serious allergic reactions, including anaphylaxis, have been reported in association with dental products containing chlorhexidine. Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through post-marketing product surveillance.

Drug Interactions

Chlorhexidine gluconate oral rinse is contraindicated in individuals with known hypersensitivity to chlorhexidine gluconate or any of its components.

In terms of drug and laboratory test interactions, the efficacy of chlorhexidine gluconate oral rinse in treating periodontitis has not been established. The use of this oral rinse may lead to staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. It is important to note that such staining does not negatively impact the health of the gingivae or other oral tissues.

Prescribers should exercise caution when recommending 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, patients may need to be excluded from treatment with chlorhexidine gluconate oral rinse if they find permanent discoloration unacceptable.

Additionally, some patients may experience changes in taste perception during treatment. There have been rare reports of permanent alterations in taste following the use of chlorhexidine gluconate oral rinse, as noted in post-marketing surveillance. Monitoring for these effects is advisable during the course of treatment.

Packaging & NDC

The table below lists all NDC Code configurations of Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (chlorhexidine gluconate 0.12% oral rinse), 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

Elderly patients may experience specific considerations 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 underscores the need for careful evaluation in geriatric populations.

When prescribing chlorhexidine gluconate oral rinse to elderly patients, discretion is advised, particularly for those with anterior facial restorations that have rough surfaces or margins. The use of this oral rinse may lead to tooth discoloration and an increase in tartar (calculus) formation, especially in areas prone to staining and tartar accumulation. Clinical testing has indicated a notable increase in supragingival calculus among users of chlorhexidine gluconate oral rinse compared to control users.

While staining from the rinse does not adversely affect the health of the gingivae or other oral tissues, some elderly patients may experience alterations in taste perception during treatment. There have been rare reports of permanent taste alteration following the use of chlorhexidine gluconate oral rinse, which should be considered when discussing treatment options with geriatric patients.

Additionally, oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of this rinse. Minor irritation and superficial desquamation of the oral mucosa have also been observed in some patients. Furthermore, there have been instances of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.

Given these potential effects, healthcare providers should monitor elderly patients closely for any adverse reactions and consider dose modifications as necessary to ensure safe and effective use of chlorhexidine gluconate oral rinse.

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 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 of chlorhexidine gluconate 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 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 that medical attention is sought immediately. Prompt evaluation and management by healthcare professionals are essential to address potential complications associated with overdosage.

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, 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.

In placebo-controlled adult clinical trials, the following oral mucosal side effects were reported: aphthous ulcer, 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%.

Patient Counseling

Advise patients that ACCLEAN chlorhexidine gluconate oral rinse has been prescribed by their dentist to treat gingivitis, aiming to reduce gum redness and swelling, as well as to help 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 should be instructed to spit out the rinse after use and to avoid swallowing it.

Inform patients to seek immediate medical attention if they experience any allergic symptoms, which may include skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. Emphasize that chlorhexidine gluconate oral rinse should not be used by individuals who have a known sensitivity to it or its components.

Patients should be made aware that the use of chlorhexidine gluconate oral rinse may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where stains and tartar typically accumulate. It is important for patients to visit their dentist for the removal of any stains or tartar at least every six months, or more frequently if advised by their dentist. Both stains and tartar can be effectively removed by a dentist or hygienist.

Additionally, inform patients 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 brush and floss daily, paying special attention to areas that begin to show discoloration.

Patients may find that chlorhexidine gluconate oral rinse has a bitter taste and can alter the taste of food and beverages. This taste alteration typically diminishes with continued use. To reduce taste interference, patients should be advised to rinse with chlorhexidine gluconate oral rinse after meals and to avoid rinsing with water or other mouthwashes immediately after using the oral rinse.

Encourage patients to reach out to their dentist or pharmacist if they have any questions or comments regarding chlorhexidine gluconate oral rinse. Remind them to contact their healthcare provider for medical advice concerning any side effects they may experience, and inform them that side effects can also be reported to the FDA at 1-800-FDA-1088.

Storage and Handling

Chlorhexidine gluconate oral rinse is available in two package configurations: 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles, both 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. Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Acclean Chlorhexidine Gluconate 0.12% Oral Rinse as submitted by Xttrium Laboratories, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)