Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

Description

ACCCLEAN is an oral rinse formulated with 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis 5-(p-chlorphenyl) biguanide di-D-gluconate). The product's base consists of water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Chlorhexidine gluconate is a salt derived from chlorhexidine and gluconic acid, and the solution is characterized by a near-neutral pH range of 5 to 7.

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 immediately after using the chlorhexidine gluconate oral rinse. The rinse is not intended for ingestion and must 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 severe allergic reactions.

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 during clinical trials. However, it remains unclear whether the use of this oral rinse leads to an increase in subgingival calculus.

To mitigate the potential 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 occurrence of anaphylaxis and other serious allergic reactions, which have been reported in postmarketing experiences with dental products containing chlorhexidine. For further details, please refer to the contraindications section.

Side Effects

Patients may experience a range of adverse reactions associated with the use of the product. 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, 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 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. Minor irritation and superficial desquamation of the oral mucosa have also been noted.

Serious adverse reactions include cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis). Anaphylaxis and other serious allergic reactions have been reported during postmarketing use. Furthermore, there have been rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse.

Drug Interactions

Chlorhexidine gluconate oral rinse is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any of its components. The use of this product has been associated with reports of anaphylaxis and other serious allergic reactions during postmarketing surveillance, indicating a need for caution in susceptible populations.

In terms of drug and laboratory test interactions, the efficacy of chlorhexidine gluconate oral rinse in treating periodontitis has not been established. Additionally, it is important to note that chlorhexidine gluconate oral rinse may lead to staining of oral surfaces, including teeth, dental restorations, and the dorsum of the tongue. Regular monitoring of oral health and aesthetic considerations may be warranted for patients using this rinse.

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 importance of careful evaluation in geriatric populations.

There have been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) associated with the use of chlorhexidine gluconate oral rinse. Additionally, an increase in supragingival calculus has been observed in users of the rinse compared to control groups. While staining from the rinse does not adversely affect the health of the gingivae or other oral tissues, clinicians should exercise discretion when prescribing this product to elderly patients with anterior facial restorations that have rough surfaces or margins.

Elderly patients may also experience alterations in taste perception during treatment, with rare instances of permanent taste alteration reported through post-marketing surveillance. Given these potential side effects, it is advisable for healthcare providers to monitor geriatric patients closely and to conduct a thorough prophylaxis evaluation at intervals no longer than six months. This approach will help ensure the safety and efficacy of chlorhexidine gluconate oral rinse in the elderly population.

Pregnancy

Reproduction studies have been conducted in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, without revealing 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, 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

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 symptoms resembling alcohol intoxication.

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’s condition 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 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 noted oral mucosal symptoms linked to chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulceration, 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). 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

Advise patients that ACCLEAN 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.

Instruct patients to spit out the rinse after use, emphasizing that chlorhexidine gluconate oral rinse should not be swallowed. Patients should be made aware of the potential for allergic reactions; they must seek immediate medical attention if they experience symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea.

Inform patients that chlorhexidine gluconate oral rinse is contraindicated for individuals with a known sensitivity to it or its components. Additionally, patients should be counseled about the possibility of tooth discoloration or increased tartar formation, particularly in areas prone to staining. It is important for patients to visit their dentist for professional removal of any stain or tartar at least every six months, or more frequently if advised.

Patients should be cautioned that chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. To minimize discoloration, they should be encouraged to maintain a diligent oral hygiene routine, including daily brushing and flossing, with particular attention to areas that begin to discolor.

Discuss with patients that the rinse may have a bitter taste and can alter the taste of food and beverages, although this effect typically diminishes with continued use. To mitigate taste interference, recommend that patients rinse with chlorhexidine gluconate oral rinse after meals and avoid rinsing with water or other mouthwashes immediately afterward.

Encourage patients to reach out to their dentist or pharmacist with any questions or comments regarding chlorhexidine gluconate oral rinse. Remind them to contact their healthcare provider for medical advice concerning any side effects 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 supplied as a blue liquid in two package configurations: 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles, each equipped with child-resistant dispensing closures.

This product should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 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

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 Henry Schein, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)