Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

Description

The formulation contains 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis 5-(p-chlorphenyl) biguanidedi-D-gluconate) in a base comprising water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. This chlorhexidine gluconate product is presented as a near neutral solution with a pH range of 5 to 7. Chlorhexidine gluconate is a salt derived from chlorhexidine and gluconic acid. The chemical structure of chlorhexidine gluconate is as follows:

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 a dental prophylaxis. The recommended dosage for adults and children over the age of 12 is 15 ml of undiluted chlorhexidine gluconate oral rinse, which is marked in the cap. Patients should perform rinsing twice daily for 30 seconds, ideally in the morning and evening after tooth brushing.

It is essential that patients do not rinse with water, use other mouthwashes, brush their teeth, or consume food immediately after using the oral rinse. The solution is not intended for ingestion and must be expectorated following the rinsing procedure.

Patients utilizing chlorhexidine gluconate oral rinse should be reevaluated and provided with a thorough dental prophylaxis at intervals not exceeding six months to ensure continued oral health and effective use of the rinse.

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 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 this product. Common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and alterations in taste perception.

In clinical trials, oral mucosal side effects were reported in less than 1% of participants and included aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Postmarketing experiences have revealed additional adverse reactions, such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Other side effects noted include oral irritation, local allergy-type symptoms, minor irritation and superficial desquamation of the oral mucosa, parotid gland swelling, and inflammation of the salivary glands (sialadenitis).

It is important to note that serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of dental products containing chlorhexidine.

Drug Interactions

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

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 the use of this oral rinse leads to an increase in subgingival calculus.

No specific dosage adjustments or monitoring recommendations are provided based on the available data.

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

Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18. However, there is no specific information provided regarding dosage adjustments or safety concerns for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the absence of established safety and efficacy data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any comorbidities of elderly patients prior to initiating treatment with 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, 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 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 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 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 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 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 oral mucosal symptoms frequently noted 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

Patients should be informed 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. Patients should be advised to spit out the rinse after use and not to swallow it.

Healthcare providers should counsel 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. It is important to note 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. Regular dental visits for the removal of any stain or tartar are crucial, with a recommendation to see the dentist at least every six months, or more frequently if advised. Both stains and tartar can be effectively removed by a dentist or hygienist.

Additionally, patients should be informed 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 interference is generally less noticeable with continued use. To mitigate this effect, 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.

For any questions or concerns regarding chlorhexidine gluconate oral rinse, patients should be encouraged to contact their dentist or pharmacist. They should also be informed to call their healthcare provider for medical advice about any side effects experienced. Side effects can be reported to the FDA at 1-800-FDA-1088.

Finally, patients should be instructed to store the oral rinse at a temperature between 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

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

View full prescribing information (PDF)