Chlorhexidine gluconate

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no specific indications or usage details provided.

Healthcare professionals should be aware that there are no reported teratogenic or nonteratogenic effects associated with this drug. Further information regarding its use in particular conditions or populations may be obtained from clinical studies or prescribing information as it becomes available.

Dosage and Administration

Chlorhexidine gluconate oral rinse therapy should be initiated immediately following a dental prophylaxis. The recommended dosage for adults and children over the age of 12 is 15 mL of undiluted chlorhexidine gluconate oral rinse, which should be measured using the cap provided. Patients are advised to perform rinsing twice daily for 30 seconds, ideally in the morning and evening after brushing their teeth.

It is essential that patients do not rinse with water or other mouthwashes, brush their teeth, or consume food or beverages immediately after using the oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion; patients should expectorate the solution after rinsing.

Patients utilizing chlorhexidine gluconate oral rinse should be reevaluated and receive a thorough dental prophylaxis at intervals not exceeding six months to ensure continued oral health and effective use of the rinse.

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. Clinical studies have indicated an increase in supragingival calculus among users of chlorhexidine gluconate oral rinse compared to control groups. The impact of this rinse on subgingival calculus remains undetermined. It is recommended that calculus deposits be removed through dental prophylaxis at intervals not exceeding six months. Additionally, anaphylaxis and serious allergic reactions have been reported in postmarketing experiences with dental products containing chlorhexidine; therefore, healthcare professionals should refer to the contraindications section for further guidance.

For patients with coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate oral rinse should not be relied upon as a primary indicator of underlying periodontitis.

Chlorhexidine gluconate oral rinse may lead to staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. While not all patients will experience significant staining, clinical data show that 56% of users exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Furthermore, 15% of chlorhexidine gluconate oral rinse users developed what was classified as heavy staining, in contrast to 1% of control users. Staining is more pronounced in individuals with substantial plaque accumulation. Importantly, staining does not adversely affect the health of the gingivae or other oral tissues and can typically be removed through standard professional prophylactic techniques, although additional time may be required.

Healthcare professionals should exercise caution 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 during dental prophylaxis, patients may need to be excluded from treatment with chlorhexidine gluconate oral rinse if they find permanent discoloration unacceptable. In some cases, stain removal may be challenging and could necessitate the replacement of restorations.

Patients may also experience alterations in taste perception while using chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration have been reported through post-marketing surveillance, warranting attention from healthcare providers.

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

Serious adverse reactions, including anaphylaxis and other serious allergic reactions, have been reported during postmarketing use of dental products containing chlorhexidine. 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

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

The table below lists all NDC Code configurations of 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 outcomes. Monitoring for any adverse effects is advisable, given the lack of established data in this 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 harm to 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 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 (2 capfuls) of the oral rinse per day.

Renal Impairment

There is no specific information 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 ingestion 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.

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 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.

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 post-marketing 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. Furthermore, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have also been reported in patients using this oral 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 stains and tartar typically accumulate. It is important for patients to visit their dentist for the removal of any stains or tartar 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. 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 foods and beverages; however, this effect typically diminishes with continued use. To reduce taste interference, recommend that patients rinse with chlorhexidine gluconate oral rinse after meals and avoid rinsing with water or other mouthwashes immediately afterward.

Encourage patients to reach out to their dentist, pharmacist, or the toll-free number 1-800-361-2862 if they have any questions or comments regarding chlorhexidine gluconate oral rinse. Additionally, advise patients to contact their healthcare provider for medical advice about any side effects they may experience, and inform them that side effects can be reported to the FDA at 1-800-332-1088.

Storage and Handling

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 mL) amber plastic bottles equipped with child-resistant dispensing closures. The product should be stored at a temperature range of 20ºC to 25ºC (68ºF to 77ºF), with permissible excursions between 15ºC to 30ºC (59ºF to 86ºF) in accordance with USP controlled room temperature guidelines.

It is essential to keep this product out of reach of children. For proper usage, to open the bottle, one should squeeze the smooth areas near the bottom of the cap while turning. To securely close the bottle, turn the cap until it locks in place.

Additional Clinical Information

Clinicians should exercise caution when prescribing chlorhexidine gluconate oral rinse to patients with anterior facial restorations that have rough surfaces or margins. If natural stains on these surfaces cannot be removed through dental prophylaxis, patients may need to be excluded from treatment if they find permanent discoloration unacceptable.

Postmarketing surveillance has revealed cases of anaphylaxis and serious allergic reactions associated with dental products containing chlorhexidine. Additionally, there have been rare reports of permanent taste alteration following the use of chlorhexidine gluconate oral rinse.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Chlorhexidine Gluconate as submitted by Darby Dental Supply, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)