Chlorhexidine gluconate

Description

Chlorhexidine Gluconate 0.12% Oral Rinse, USP is an oral rinse that contains 0.12% chlorhexidine gluconate (1, 11-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate). The formulation includes water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, peppermint flavor, sodium saccharin, and FD&C Blue No. 1 as inactive ingredients. Chlorhexidine gluconate oral solution is characterized as a near-neutral solution with a pH range of 5-7. Chlorhexidine gluconate is a salt formed from chlorhexidine and gluconic acid, with a molecular formula of C22H30Cl2N10·2C6H12O7 and a molecular weight of 897.

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 additional guidance.

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 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 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. This proactive approach is essential for maintaining oral health and preventing complications associated with calculus buildup.

Additionally, healthcare providers should be vigilant for signs of anaphylaxis and other serious allergic reactions, which have been reported during postmarketing surveillance of dental products containing chlorhexidine. Prompt recognition and management of these adverse reactions are critical to ensuring 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% 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, paresthesia, minor irritation, 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. Patients should 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 reported through post-marketing 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 necessary at this time.

Packaging & NDC

The table below lists all NDC Code configurations of 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 oral rinse have not been established in pediatric patients under the age of 18. Caution is advised when administering this product to children, as ingestion of 1 or 2 ounces by a small child (approximately 10 kg body weight) may lead to gastric distress, including nausea, or signs of alcohol intoxication. If a small child ingests more than 4 ounces of chlorhexidine gluconate oral rinse or exhibits signs of alcohol intoxication, medical attention should be sought immediately.

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 outcomes. Monitoring for any adverse effects is advisable, given the lack of established data in this population.

Pregnancy

Reproduction studies have been conducted in rats and rabbits with chlorhexidine gluconate at doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and 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 tablespoons) of the oral rinse per day.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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. For instance, a child weighing approximately 10 kg may experience gastric distress, which can manifest as nausea, following the ingestion of 1 or 2 ounces of the solution. Additionally, there may be signs resembling 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 any potential complications arising from the overdosage.

Nonclinical Toxicology

Reproduction studies conducted in rats and rabbits with chlorhexidine gluconate at doses of up to 300 mg/kg/day and 40 mg/kg/day, respectively, did not demonstrate any evidence of teratogenic effects on the fetus. 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 responses, the use of this drug during pregnancy should be considered only when clearly necessary.

In studies assessing parturition and lactation in 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 tablespoons) of chlorhexidine gluconate oral rinse daily.

In a drinking water study involving 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 tested 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.

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

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, ulcer, 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 post-marketing product surveillance.

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. Healthcare providers should advise patients that therapy with chlorhexidine gluconate oral rinse should be initiated directly following a dental prophylaxis.

Patients using chlorhexidine gluconate oral rinse should be reevaluated and provided with a thorough prophylaxis at intervals no longer than six months. The recommended usage is twice daily oral rinsing for 30 seconds, both in the morning and evening after tooth brushing, with a usual dosage of 15 ml (1 tablespoon) of undiluted rinse.

Patients should be made aware that an increase in staining of teeth and other oral surfaces may occur, as well as an increase in calculus formation. Some patients may experience alterations in taste perception during treatment, and rare instances of permanent taste alteration have been reported. It is important to note 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 stains can typically be removed from most tooth surfaces through conventional professional prophylactic techniques.

Healthcare providers should exercise discretion 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 if permanent discoloration is deemed unacceptable. Additionally, some patients may experience oral irritation and local allergy-type symptoms associated with the use of chlorhexidine gluconate rinse, which should be communicated to them.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It 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). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

Chlorhexidine gluconate oral rinse may lead to staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. While this staining does not negatively impact the health of the gingivae or other oral tissues, it can be removed from most tooth surfaces through standard professional prophylactic techniques. Clinicians should exercise caution when prescribing this rinse to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed by dental prophylaxis and permanent discoloration is a concern, patients should be advised against using chlorhexidine gluconate oral rinse.

Additionally, some patients may experience alterations in taste perception during treatment. Post-marketing surveillance has reported rare cases of permanent taste alteration associated with the use of chlorhexidine gluconate oral rinse.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Chlorhexidine Gluconate 0.12% Oral Rinse as submitted by Chartwell Governmental & Specialty RX, LLC.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)