Chlorhexidine gluconate

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 formulation has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG).

For patients with coexisting gingivitis and periodontitis, it is advised to refer to the precautions section for further guidance.

Limitations of Use

Chlorhexidine gluconate oral rinse is not indicated for the treatment of ANUG, and its efficacy in this condition has not been established.

Dosage and Administration

Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. The recommended dosage is 15 mL (½ fl. oz. or 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.

Patients must be instructed not to rinse with water or other mouthwashes, brush their teeth, or eat immediately after using the oral rinse. It is important to note that chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.

For ongoing patient care, those using chlorhexidine gluconate oral rinse should be reevaluated and provided with a thorough prophylaxis at intervals no longer than six months.

Contraindications

Chlorhexidine gluconate oral rinse is contraindicated in individuals who are known to be hypersensitive to chlorhexidine gluconate or any other ingredients in the formulation. Additionally, the use of chlorhexidine gluconate oral rinse should be avoided in patients for whom permanent discoloration of anterior facial restorations is unacceptable, particularly those with rough surfaces or margins.

Chlorhexidine gluconate should not be used in contact with the meninges, in the genital area, or as a preoperative skin preparation of the head or face. The use of PerioChip is contraindicated in patients with known sensitivity to chlorhexidine.

Warnings and Precautions

Warnings

The effect of chlorhexidine gluconate oral rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate oral rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine.

General Precautions

For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate oral rinse should not be used as a major indicator of underlying periodontitis. Chlorhexidine gluconate oral rinse can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in tooth staining. In clinical testing, 56% of chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of chlorhexidine gluconate oral rinse users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from use of chlorhexidine gluconate oral rinse does not adversely affect the health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis. Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from chlorhexidine gluconate oral rinse treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations. Some patients may experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post-marketing product surveillance.

Laboratory Tests

No specific laboratory tests are mentioned in the provided text.

Get Emergency Medical Help Instructions

No specific instructions for getting emergency medical help are mentioned in the provided text.

Stop Taking and Call Your Doctor Instructions

No specific instructions to stop taking and call your doctor are mentioned in the provided text.

Side Effects

• The most common side effects associated with chlorhexidine gluconate oral rinses include:

  • An increase in staining of teeth and other oral surfaces

  • An increase in calculus formation

  • An alteration in taste perception

  • Oral irritation and local allergy-type symptoms

• Oral Mucosal Side Effects (reported during placebo-controlled adult clinical trials, frequency < 1%):

  • Aphthous ulcer

  • Grossly obvious gingivitis

  • Trauma

  • Ulceration

  • Erythema

  • Desquamation

  • Coated tongue

  • Keratinization

  • Geographic tongue

  • Mucocele

  • Short frenum

• Postmarketing Experience:

  • Stomatitis

  • Gingivitis

  • Glossitis

  • Ulcer

  • Dry mouth

  • Hypesthesia

  • Glossal edema

  • Paresthesia

  • Minor irritation and superficial desquamation of the oral mucosa

  • Parotid gland swelling

  • Inflammation of the salivary glands (sialadenitis)

• Warnings:

  • Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine.

• Precautions:

  • Some patients may experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post-marketing product surveillance.

Drug Interactions

The available data for various formulations of Chlorhexidine Gluconate, including oral rinses and solutions, indicates that there are no reported drug interactions associated with these products. This includes the following formulations:

• Dash Chlorhexidine Gluconate 0.12% Oral Rinse (Liquid)

• Cleancare Chlorhexidine Gluconate 0.12% Oral Rinse (Solution)

• Chlorhexidine Gluconate 0.12% Oral Rinse (Liquid)

• Major Oral Rinse (Rinse)

• Chlorhexidine Gluconate (Rinse)

• Chlorhexidine Gluconate Oral Rinse (Solution)

• Periogard Alcohol Free (Rinse)

For all listed products, there is no information regarding interactions with other drugs or laboratory tests. Therefore, healthcare professionals may consider these formulations to have a low potential for drug interactions based on the current data.

Pediatric Use

Clinical effectiveness and safety of chlorhexidine gluconate oral rinse, including formulations such as Paroex®, Dash Chlorhexidine Gluconate 0.12%, Acclean Chlorhexidine Gluconate 0.12%, Cleancare Chlorhexidine Gluconate 0.12%, PerioGard®, and Peridex™, have not been established in pediatric patients under the age of 18.

Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse by a small child (approximately 10 kg body weight) may result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces is ingested or if signs of alcohol intoxication develop.

Geriatric Use

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

Caution should be exercised when prescribing chlorhexidine gluconate oral rinse to patients with anterior facial restorations that have rough surfaces or margins, as staining may occur, which could be difficult to remove. Some patients may experience alterations in taste perception during treatment, with rare instances of permanent taste alteration reported. Additionally, oral irritation and local allergy-type symptoms have been spontaneously reported, along with minor irritation and superficial desquamation of the oral mucosa.

Patients using chlorhexidine gluconate oral rinse should be reevaluated and provided with thorough prophylaxis at intervals no longer than six months.

Pregnancy

Reproduction studies have been conducted in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to the fetus. Chlorhexidine gluconate is classified as a Pregnancy Category B medication. 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, 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 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 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 (approximately 2 capfuls) of the oral rinse per day. This suggests a favorable safety profile in terms of maternal dosing, but the implications for breastfed infants remain unclear due to the lack of specific data on excretion and effects in human milk.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available labeling for Chlorhexidine Gluconate products. Across multiple formulations, including various oral rinses and solutions, there is a consistent absence of information regarding dosage adjustments, special monitoring, or safety considerations for individuals with reduced kidney function.

Given this lack of guidance, healthcare providers should exercise caution when considering the use of Chlorhexidine Gluconate in patients with renal impairment. It is advisable to monitor these patients closely for any potential adverse effects, as the pharmacokinetics of the drug in this population remain undefined. Further clinical judgment may be necessary to determine the appropriateness of use in such cases.

Hepatic Impairment

Patients with hepatic impairment have no specific dosage adjustments, special monitoring requirements, or precautions outlined for the use of chlorhexidine gluconate products, including various oral rinses and solutions. The available insert texts do not provide information regarding the effects of hepatic impairment on the pharmacokinetics or safety of these products. Therefore, healthcare providers should exercise caution and consider individual patient circumstances when prescribing these products to patients with liver problems.

Overdosage

Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse by a small child weighing approximately 10 kg may lead to gastric distress, which can include symptoms such as nausea. Additionally, there may be signs of alcohol intoxication associated with the ingestion of this product.

If a small child ingests more than 4 ounces of chlorhexidine gluconate oral rinse, or if any signs of alcohol intoxication develop, it is imperative that medical attention is sought immediately. Monitoring for symptoms of gastric distress and alcohol intoxication is recommended in such cases.

Nonclinical Toxicology

Teratogenic Effects

Reproduction studies conducted in rats and rabbits at chlorhexidine gluconate doses of 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 responses, chlorhexidine gluconate should be used during pregnancy only if clearly needed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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. 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.

Animal Toxicology

The nonclinical toxicology data indicate that chlorhexidine gluconate does not exhibit carcinogenic or mutagenic potential at the tested doses, and it does not impair fertility in animal models. These findings support the safety profile of chlorhexidine gluconate in the context of its intended use.

Storage and Handling

Chlorhexidine Gluconate oral rinse is supplied as a blue liquid in various packaging configurations, including 4-ounce (118 mL) and 1-pint (473 mL) amber plastic bottles with child-resistant closures. Some formulations are also available in single-dose 0.5 fluid ounce (15 mL) amber plastic bottles.

The product should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F) as per USP controlled room temperature guidelines. It is essential to keep this and all medications out of the reach of children.

For optimal handling, the bottles should be dispensed in their original containers or in amber glass bottles to protect the integrity of the solution.