Acclean Chlorhexidine Gluconate 0.12% Oral Rinse

Description

0.12% chlorhexidine gluconate (CHG) is an oral rinse formulated with 1,1'-hexamethylene bis 5-(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 administered twice daily. Patients should perform oral rinsing for 30 seconds in the morning and evening, ideally after tooth brushing.

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. Chlorhexidine gluconate oral rinse is not intended for ingestion; therefore, 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 components of 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. 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 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

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%.

Postmarketing reports have identified additional oral mucosal symptoms associated with chlorhexidine gluconate oral rinse, including stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have also been noted among patients using this rinse. Furthermore, there have been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients.

Serious adverse reactions, such as anaphylaxis and other serious allergic reactions, have been reported during postmarketing use of dental products containing chlorhexidine. Additionally, 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

Serious allergic reactions, including anaphylaxis, have been reported in postmarketing experiences with dental products containing chlorhexidine. Healthcare professionals should be vigilant for signs of hypersensitivity in patients using these products and take appropriate action if such reactions occur.

The impact of chlorhexidine gluconate oral rinse on periodontitis has not been established. Therefore, clinicians should exercise caution when considering its use for this indication and may need to monitor patients closely for any changes in their condition.

Packaging & NDC

The table below lists all NDC Code configurations of Acclean Chlorhexidine Gluconate 0.12% Oral Rinse (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

Elderly patients may require careful consideration 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 caution in geriatric populations, particularly those with complex health profiles.

Caution should also be exercised when administering chlorhexidine gluconate oral rinse to nursing women, as potential risks to both the mother and infant have not been fully characterized.

In clinical testing, an increase in supragingival calculus was observed among users of chlorhexidine gluconate oral rinse compared to control users. This finding may necessitate additional monitoring of oral health in elderly patients, who may already be at risk for dental issues.

Post-marketing surveillance has reported cases of anaphylaxis and serious allergic reactions associated with dental products containing chlorhexidine. Geriatric patients may have a higher susceptibility to such reactions, warranting careful observation for any signs of hypersensitivity.

Patients using chlorhexidine gluconate oral rinse may experience alterations in taste perception, with rare instances of permanent taste alteration reported. This side effect could significantly impact the quality of life in elderly patients, who may already face challenges related to nutrition and appetite.

Oral irritation and local allergy-type symptoms have been spontaneously reported, along with minor irritation and superficial desquamation of the oral mucosa. These effects may be more pronounced in geriatric patients, who often have more sensitive mucosal tissues.

Additionally, there have been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients using chlorhexidine gluconate oral rinse. Given the potential for these adverse effects, it is advisable for healthcare providers to monitor elderly patients closely during treatment and consider dose modifications as necessary to mitigate risks.

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, 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 of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 to seek medical attention promptly. Healthcare professionals should be prepared to assess the child’s condition and provide appropriate management to mitigate 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 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. Reports of anaphylaxis and serious allergic reactions have been documented. Additionally, rare cases of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been noted through post-marketing surveillance.

Among the most frequently reported oral mucosal symptoms linked to chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulceration, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have also been observed in patients using this product. Furthermore, instances of parotid gland swelling and inflammation of the salivary glands, known as sialadenitis, have been reported in association with the use of chlorhexidine gluconate oral rinse.

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, and to continue their daily brushing routine.

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 of the potential for allergic reactions, which may include symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. In such cases, patients should seek medical attention immediately.

It is important to inform patients that chlorhexidine gluconate oral rinse is contraindicated for individuals with a known sensitivity to it or its components. Patients should also be made aware that the rinse may cause tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where staining and tartar typically occur. Regular dental visits for the removal of any stain or tartar are crucial, with a recommendation to see their dentist at least every six months, or more frequently if advised.

Patients should be cautioned that chlorhexidine gluconate oral rinse may lead to permanent discoloration of some front-tooth fillings. To minimize discoloration, they should be encouraged to brush and floss daily, paying special attention to areas that begin to show discoloration. Additionally, patients may experience a bitter taste from the rinse, which can affect the taste of food and beverages; however, this effect typically diminishes with continued use. To mitigate 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 afterward.

Patients are encouraged to reach out to their dentist or pharmacist with any questions or comments regarding chlorhexidine gluconate oral rinse. They should also be instructed to contact their healthcare provider for medical advice concerning any side effects and to report side effects 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, both featuring child-resistant 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

Patients using chlorhexidine gluconate oral rinse should be aware of several important counseling points. Immediate medical attention is necessary if allergic symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea occur. The rinse is contraindicated for individuals with a known sensitivity to chlorhexidine or its components.

Chlorhexidine gluconate oral rinse may lead to tooth discoloration and an increase in tartar formation, particularly in areas prone to staining. Regular dental visits, at least every six months, are recommended for the removal of any stain or tartar. Both stain and tartar can be addressed by a dentist or hygienist. Additionally, the rinse may cause permanent discoloration of some front-tooth fillings. To minimize discoloration, patients should maintain a daily oral hygiene routine that includes brushing and flossing, particularly in areas that show signs of discoloration. Some patients may find the rinse has a bitter taste, which can alter the taste of food and beverages; however, this effect typically diminishes with continued use. To reduce taste interference, it is advisable to use the rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward.

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)