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. The product is presented as a near-neutral solution with a 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 of undiluted chlorhexidine gluconate oral rinse, which should be measured using the cap provided. Patients are advised to perform oral rinsing twice daily for 30 seconds, specifically 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 chlorhexidine gluconate oral rinse. Additionally, this product is not intended for ingestion; patients should expectorate the rinse after use to ensure proper administration and effectiveness.

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. 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 contributes 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. Healthcare providers should monitor patients for any signs of hypersensitivity and be prepared to manage such reactions promptly.

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 been noted in patients using the rinse. Furthermore, there have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported among users.

Serious allergic reactions, including anaphylaxis, have been documented during postmarketing use of dental products containing chlorhexidine. Some patients may experience an alteration in taste perception while undergoing 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 is not recommended. Healthcare professionals should exercise caution when considering this treatment for children and adolescents, as the lack of data limits the ability to assess potential risks and benefits.

Geriatric Use

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

Healthcare providers should exercise caution when considering the use of chlorhexidine gluconate oral rinse in geriatric patients, given the lack of established data. Monitoring for any adverse effects or complications is advisable, as the absence of specific guidelines necessitates a careful assessment of individual patient needs and responses.

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. Due to the limitations of animal reproduction studies in predicting human outcomes, chlorhexidine gluconate 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 drug 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

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 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. 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 rinse. 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 instructed not to rinse with water or other mouthwashes, brush their teeth, or eat immediately after using chlorhexidine gluconate oral rinse. It is important to emphasize that chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing. The recommended usage is twice daily oral rinsing for 30 seconds, both in the morning and evening, following tooth brushing. The usual dosage is 15 ml, as marked in the cap, of undiluted chlorhexidine gluconate oral rinse.

To minimize the medicinal taste, patients should be advised against rinsing with water immediately after use. Healthcare providers should ensure that patients are reevaluated and receive a thorough prophylaxis at intervals no longer than six months. It is important to inform patients that staining resulting from the use of chlorhexidine gluconate oral rinse does not adversely affect the health of the gingivae or other oral tissues, and that stains can typically be removed from most tooth surfaces through conventional professional prophylactic techniques.

Discretion should be exercised when prescribing chlorhexidine gluconate oral rinse to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed from these surfaces by dental prophylaxis, patients should be excluded from treatment with chlorhexidine gluconate oral rinse if permanent discoloration is deemed unacceptable.

Patients may experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse, and rare instances of permanent taste alteration have been reported through post-marketing product surveillance. Additionally, healthcare providers should inform patients that ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse by a small child (approximately 10 kg body weight) could result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of chlorhexidine gluconate oral rinse is ingested by a small child or if signs of alcohol intoxication develop.

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.

The 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 handling and storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

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)