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 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 (1 tablespoon) of undiluted chlorhexidine gluconate oral rinse, 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; 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 during clinical testing. 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 during postmarketing surveillance of dental products containing chlorhexidine. For further details regarding contraindications, please refer to the relevant 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, each occurring at a frequency of less than 1%. These included aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Postmarketing reports have identified additional oral mucosal symptoms frequently associated with chlorhexidine gluconate oral rinse, such as 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 product. Furthermore, there have been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients utilizing chlorhexidine gluconate oral rinse.

Serious allergic reactions, including anaphylaxis, 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 documented through post-marketing product surveillance.

Drug Interactions

No specific drug interactions or laboratory test interactions are documented in the provided information. Therefore, there are no recommendations for dosage adjustments or monitoring related to drug interactions.

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, 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.

Caution is advised when administering chlorhexidine gluconate oral rinse to nursing women, as potential risks may be present. In elderly patients, there is a noted increase in the likelihood of staining of teeth and other oral surfaces, as well as an increase in calculus formation, particularly in those with heavier accumulations of unremoved plaque.

Additionally, some elderly patients may experience alterations in taste perception during treatment. It is important to note that rare instances of permanent taste alteration have been reported through post-marketing surveillance, which may be of particular concern in this age group.

Prescribers should exercise discretion when considering chlorhexidine gluconate oral rinse for patients with anterior facial restorations that have rough surfaces or margins. Staining resulting from the use of this rinse may be difficult to remove and could necessitate the replacement of restorations, which is a significant consideration for geriatric patients who may already have complex dental needs.

Finally, it is recommended that elderly patients be reevaluated and provided with a thorough prophylaxis at intervals no longer than six months to ensure ongoing oral health and to monitor for any adverse effects associated with the 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 teratogenic effects on the fetus. However, there is a lack of adequate and well-controlled studies in pregnant women. Given that animal reproduction studies may not reliably predict human outcomes, this drug should be administered 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 of the oral rinse per day.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

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, particularly 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 resembling alcohol intoxication due to the formulation of the rinse.

It is imperative that medical attention is sought if a small child ingests more than 4 ounces of chlorhexidine gluconate oral rinse. The development of symptoms indicative of alcohol intoxication further necessitates immediate medical evaluation and intervention. Healthcare professionals should be prepared to manage these cases promptly 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 these studies included 1000 mg/kg/day in a mouse dominant-lethal assay and 250 mg/kg/day in a hamster cytogenetics test. Furthermore, there was no evidence of impaired fertility in rats at doses up to 100 mg/kg/day. No information is available regarding teratogenic effects or additional animal pharmacology and toxicology data.

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 (sialadenitis) have been reported.

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 of potential allergic reactions, including symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea, and instructed to seek medical attention immediately if these occur. Additionally, patients with a known sensitivity to chlorhexidine gluconate or its components should not use this product.

Healthcare providers should discuss the possibility of tooth discoloration and increased tartar formation associated with the use of chlorhexidine gluconate oral rinse, particularly in areas where stains and tartar typically accumulate. Patients should be encouraged to visit their dentist for the removal of any stain or tartar at least every six months, or more frequently if advised by their dentist. It is important to note that chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings.

To minimize the risk of discoloration, patients should be advised to brush and floss daily, paying special attention to areas that begin to show discoloration. They 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 encouraged to rinse with chlorhexidine gluconate oral rinse after meals and to avoid rinsing with water or other mouthwashes immediately after using the rinse.

Patients should feel free to reach out to their dentist or pharmacist with any questions or comments regarding chlorhexidine gluconate oral rinse. They should also be informed to contact their healthcare provider for medical advice about any side effects and that side effects can be reported to the FDA at 1-800-FDA-1088.

For proper use, patients should be instructed to swish 1 tablespoon (15ml) of the rinse undiluted in their mouth for 30 seconds before spitting it out, ideally after breakfast and before bedtime, or as prescribed. To minimize the medicinal taste, patients should be reminded not to rinse with water immediately after use.

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

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)