Cleancare Chlorhexidine Gluconate 0.12% Oral Rinse

Description

0.12% chlorhexidine gluconate (CHG) is an oral rinse that contains 1,1'-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate. The formulation includes a base composed of water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Chlorhexidine gluconate is a salt formed from chlorhexidine and gluconic acid, and the solution is near-neutral with a pH range of 5-7.

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 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 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. Healthcare professionals should be aware that clinical testing has indicated an increase in supragingival calculus among users of chlorhexidine gluconate oral rinse compared to control users. 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.

Additionally, there have been reports of anaphylaxis and serious allergic reactions associated with the use of dental products containing chlorhexidine during postmarketing surveillance. Healthcare providers should remain vigilant for signs of these adverse reactions in patients.

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, 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. Furthermore, there have been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients using this rinse.

Serious adverse reactions, including 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

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Cleancare 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

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

Healthcare providers should exercise clinical judgment when considering the use of chlorhexidine gluconate oral rinse in geriatric patients, as individual patient factors may influence treatment decisions. Monitoring for any adverse effects or changes in efficacy is advisable when administering this product to elderly patients.

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 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 these patients to ensure safety and efficacy.

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 to seek medical attention promptly. Healthcare professionals should be prepared to assess the child for potential complications 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 during postmarketing use. Additionally, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through product surveillance.

Among the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have also been noted in patients using this rinse. Furthermore, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have been reported.

Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects related to the use of chlorhexidine gluconate rinse.

Patient Counseling

Advise patients 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 should be instructed to spit out the rinse after use and not to swallow 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 staining and tartar typically occur. It is important for patients 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. Both stain 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 the rinse has a bitter taste and can alter the taste of food and beverages; however, 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.

Patients should be reminded that if they have any questions or concerns regarding chlorhexidine gluconate oral rinse, they can contact their dentist, pharmacist, or Safco Dental at 1-800-621-2178. Additionally, advise patients to call their healthcare provider for medical advice regarding 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 in the following configurations: a 1-pint (473 ml) amber plastic bottle with a child-resistant dispensing closure, a 4-ounce (118 ml) amber plastic bottle with a child-resistant closure, a 64-ounce (1893 ml) white plastic bottle with a foam-lined closure, and a 15 ml unit-dose cup.

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 prescribed chlorhexidine gluconate oral rinse for the treatment of gingivitis should use the rinse regularly as directed by their dentist, in conjunction with daily brushing. It is important to spit out the rinse after use and not to swallow it. Patients should be aware of potential allergic reactions, including skin rash, itching, swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea, and seek immediate medical attention if these occur. Individuals with a known sensitivity to chlorhexidine gluconate or its components should avoid its use.

Chlorhexidine gluconate oral rinse may lead to tooth discoloration and increased tartar formation, particularly in areas prone to staining. Regular dental visits for the removal of stains and tartar are recommended, ideally every six months or more frequently if advised by a dentist. To minimize discoloration, patients should maintain a diligent oral hygiene routine, including daily brushing and flossing. The rinse may have a bitter taste that can affect the flavor of food and beverages, although this 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 Cleancare Chlorhexidine Gluconate 0.12% Oral Rinse as submitted by Safco Dental Supply LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)