Dash Chlorhexidine Gluconate 0.12% Oral Rinse

Description

This product is an oral rinse formulated with 0.12% chlorhexidine gluconate (1,1'-hexamethylene bis 5-(p-chlorophenyl) biguanidedi-0-gluconate). The base of the solution consists of water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, peppermint oil, saccharin sodium, and FD&C Blue #1. The pH of the solution is near-neutral, ranging from 5 to 7, and may be adjusted using hydrochloric acid or sodium hydroxide. Chlorhexidine gluconate is a salt derived from chlorhexidine and gluconic acid, with a molecular formula of C22H30Cl2N10•2C6H12O7 and a molecular weight of 897.77. The structural formula is provided as part of the product specifications.

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.

Limitations of Use: Chlorhexidine gluconate has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG).

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 administered twice daily. Patients are advised to perform oral rinsing for 30 seconds in the morning and evening, following tooth brushing.

It is essential that patients do not 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, it should be expectorated after rinsing.

Contraindications

Use of this product is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation. Due to the potential for severe allergic reactions, such patients should avoid this product.

Warnings and Precautions

An increase in supragingival calculus has been observed in clinical studies involving users of chlorhexidine gluconate oral rinse compared to control groups. While the impact of chlorhexidine gluconate on subgingival calculus remains undetermined, it is essential for healthcare professionals to monitor patients for any signs of calculus accumulation.

To manage calculus deposits effectively, it is recommended that dental prophylaxis be performed at intervals not exceeding six months. This proactive approach will help mitigate any potential complications associated with calculus buildup.

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. Immediate medical attention is warranted in the event of such reactions to ensure patient safety.

Side Effects

Patients using chlorhexidine gluconate oral rinse may experience a range of adverse reactions. 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 1.0% of participants and included aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Postmarketing reports have identified additional adverse reactions such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. Other observed effects include minor irritation and superficial desquamation of the oral mucosa, parotid gland swelling, and inflammation of the salivary glands (sialadenitis).

Serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of dental products containing chlorhexidine. It is important for patients to be aware that chlorhexidine gluconate oral rinse can cause staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue. Some patients may also experience alterations in taste perception, with rare instances of permanent taste alteration following use.

Drug Interactions

Serious allergic reactions, including anaphylaxis, have been reported in postmarketing experiences with dental products containing chlorhexidine. Healthcare professionals should remain vigilant for signs of hypersensitivity in patients using these products.

Chlorhexidine gluconate oral rinse may lead to staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. Patients should be informed about this potential effect to manage expectations regarding oral hygiene and aesthetics.

Additionally, some patients may experience alterations in taste perception during treatment with chlorhexidine gluconate oral rinse. There have been rare reports of permanent taste alteration following its use, which should be considered when prescribing this treatment. Monitoring for changes in taste perception may be advisable during the course of therapy.

Packaging & NDC

The table below lists all NDC Code configurations of Dash 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 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 special consideration when using chlorhexidine gluconate. The clinical effectiveness and safety of chlorhexidine gluconate have not been established in individuals under the age of 18, which underscores the need for caution in geriatric populations, particularly those with unique health profiles.

When administering chlorhexidine gluconate to elderly patients, especially nursing women, caution is advised due to potential risks. It is important to monitor for an increase in supragingival calculus, which has been observed in users of chlorhexidine gluconate oral rinse compared to control groups. While staining from the oral rinse does not adversely affect the health of the gingivae or other oral tissues, it remains a consideration for patient management.

Discretion should be exercised when prescribing chlorhexidine gluconate to geriatric patients with anterior facial restorations that have rough surfaces or margins, as this may influence treatment outcomes. Additionally, some elderly patients may experience alterations in taste perception during treatment, with rare instances of permanent taste alteration reported through postmarketing surveillance.

To ensure optimal oral health, it is recommended that patients using chlorhexidine gluconate be reevaluated and provided with thorough prophylaxis at intervals no longer than six months. This approach will help to mitigate potential adverse effects and enhance the overall safety and efficacy of treatment in the geriatric population.

Pregnancy

Pregnancy category B indicates that 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 fetal harm. 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 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 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 chlorhexidine gluconate 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 that medical attention is sought immediately. Prompt evaluation and management by healthcare professionals are essential to address potential complications associated with overdosage.

Nonclinical Toxicology

Pregnancy category B has been assigned to this drug based on nonclinical studies. Reproduction studies conducted in rats and rabbits at chlorhexidine gluconate doses of up to 300 mg/kg/day and 40 mg/kg/day, respectively, did not reveal 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. Given that animal reproduction studies may not always predict human responses, this drug should be used during pregnancy only if clearly needed.

In terms of non-teratogenic effects, no evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.

Carcinogenic effects were not observed in a drinking water study in rats 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.

No specific details regarding animal pharmacology and toxicology beyond those mentioned in the nonclinical toxicology section are available.

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, ulcers, 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) in patients utilizing chlorhexidine gluconate oral rinse. Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been documented through postmarketing product surveillance.

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 rinse regularly as directed by their dentist, in conjunction with daily brushing. Patients should be advised to spit out the rinse after use and to avoid swallowing it.

Healthcare providers should alert patients to the potential for allergic reactions. If patients experience symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea, they should seek medical attention immediately. Additionally, patients with a known sensitivity to Chlorhexidine Gluconate or its components should not use this oral rinse.

Patients should be made aware that Chlorhexidine Gluconate Oral Rinse may lead to tooth discoloration and an increase in tartar formation, particularly in areas where stains and tartar typically accumulate. Regular dental visits for the removal of stains and tartar are recommended at least every six months, or more frequently if advised by their dentist. Both stains and tartar can be effectively removed by a dentist or hygienist. It is important to note that the rinse may cause permanent discoloration of some front-tooth fillings.

To minimize the risk of discoloration, patients should be encouraged to maintain a daily brushing and flossing routine, paying special attention to areas that begin to show discoloration. Patients may also find that the rinse has a bitter taste and can alter the taste of foods and beverages; however, this effect typically diminishes with continued use. To mitigate taste interference, it is advisable for patients to rinse with Chlorhexidine Gluconate Oral Rinse after meals and to refrain from rinsing with water or other mouthwashes immediately afterward.

Patients should be encouraged to reach out to their dentist or pharmacist with any questions or concerns regarding Chlorhexidine Gluconate Oral Rinse. They should also be informed to contact their healthcare provider for medical advice about any side effects experienced. Side effects can be reported to the FDA at 1-800-FDA-1088. Lastly, patients should be reminded to keep this and all medications out of the reach of children.

Storage and Handling

The product is supplied in its original container or in amber glass bottles. It should be stored at a temperature range of 20°-25°C (68°-77°F), with permissible excursions between 15°-30°C (59°-86°F) as defined by USP Controlled Room Temperature guidelines. Proper adherence to these storage conditions is 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 Dash Chlorhexidine Gluconate 0.12% Oral Rinse as submitted by Natco Pharma USA LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)