Major Oral Rinse

Description

0.12% chlorhexidine gluconate (CHG) is an oral rinse that contains 1, 11-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate. The formulation is composed of a base that includes 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, and the product is characterized 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.

Limitations of Use: Chlorhexidine gluconate oral rinse 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.

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, administered twice daily. Patients should perform the rinsing for 30 seconds in the morning and evening, ideally after brushing their teeth.

It is essential to instruct patients not to rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using the chlorhexidine gluconate oral rinse. The solution is not intended for ingestion and must be expectorated following the rinsing procedure.

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 adverse reactions due to the potential for allergic responses.

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 remain vigilant for signs of these reactions and refer to the contraindications section for further guidance.

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, alterations in taste perception, and oral irritation along with local allergy-type symptoms.

In clinical trials, oral mucosal side effects were reported at a frequency of less than 1% among participants. These 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).

It is important to note that serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of dental products containing chlorhexidine. Furthermore, some patients may experience alterations in taste perception during treatment, with rare instances of permanent taste alteration documented 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 warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Major Oral Rinse (0.12% 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

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, 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. 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 of chlorhexidine gluconate oral rinse per day.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 symptoms resembling alcohol intoxication.

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 potential complications associated with overdosage.

Nonclinical Toxicology

No teratogenic effects were observed in the studies conducted. Additionally, there was no evidence of impaired fertility in rats at doses up to 100 mg/kg/day.

In a drinking water study involving rats, no carcinogenic effects were noted at doses up to 38 mg/kg/day. Furthermore, mutagenic effects were not detected in two mammalian in vivo mutagenesis studies utilizing 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.

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.

Among the oral mucosal symptoms frequently reported in association with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulceration, dry mouth, hypesthesia, glossal edema, and paresthesia. Additionally, minor irritation and superficial desquamation of the oral mucosa have been observed in some patients.

Cases of parotid gland swelling and inflammation of the salivary glands, known as sialadenitis, have also been reported in patients using chlorhexidine gluconate oral rinse. Furthermore, rare instances of permanent taste alteration following the use of this oral rinse have been noted through post-marketing 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 oral rinse regularly as directed, in conjunction with daily brushing. Patients must be advised to spit out the rinse after use and not to swallow 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. It is important to note that chlorhexidine gluconate oral rinse should not be used by individuals with 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 staining and tartar typically occur. Regular dental visits for the removal of any stain or tartar are recommended at least every six months, or more frequently if advised by their dentist. Both stain and tartar can be effectively removed by a dentist or hygienist. Additionally, patients should be informed 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 maintain a daily brushing and flossing routine, paying special attention to areas that begin to show discoloration. It is also important to communicate that chlorhexidine gluconate oral rinse may have a bitter taste and can alter the taste of foods and beverages, although this effect typically diminishes with continued use.

To reduce taste interference, patients should be advised to use chlorhexidine gluconate oral rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward. For any questions or concerns regarding chlorhexidine gluconate oral rinse, patients should be encouraged to contact their dentist or pharmacist. They should also be informed to call their healthcare provider for medical advice about side effects and that side effects can be reported to Xttrium Laboratories at 1-800-587-3721 or to the FDA at 1-800-FDA-1088.

Patients should be instructed to store chlorhexidine gluconate oral rinse at a temperature between 20ºC to 25ºC (68ºF to 77ºF) and to keep it out of reach of children.

Storage and Handling

The product is supplied in accordance with the following specifications: it should be stored at a temperature range of 20ºC to 25ºC (68ºF to 77ºF), with permissible excursions between 15ºC to 30ºC (59ºF to 86ºF) as defined by USP controlled room temperature guidelines.

It is essential to ensure that this product, along with all medications, is kept out of the reach of children to prevent accidental ingestion or misuse.

Additional Clinical Information

Patients using chlorhexidine gluconate oral rinse should be aware of several important counseling points. Immediate medical attention is necessary if allergic symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea occur. The rinse is contraindicated for individuals with a known sensitivity to chlorhexidine gluconate or its components.

Clinicians should inform patients that the use of chlorhexidine gluconate oral rinse may lead to tooth discoloration and an increase in tartar formation, particularly in areas prone to staining. Regular dental check-ups, at least every six months, are recommended for the removal of any stain or tartar. To minimize discoloration, patients should maintain a daily oral hygiene routine that includes brushing and flossing, focusing on areas that may begin to discolor. Additionally, the rinse may have a bitter taste that can alter the flavor of foods and beverages, although this effect typically diminishes with continued use. To mitigate taste interference, patients are advised to use the rinse after meals and to avoid rinsing with water or other mouthwashes immediately afterward.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Major Oral Rinse as submitted by Cardinal Health 107, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)