Chlorhexidine gluconate

Uses and Indications

This drug is indicated for skin antisepsis, oral cleansing, and nasal antisepsis. It helps reduce the chance of infection in minor oral irritation and aids in the removal of dental plaque, debris, and secretions. Additionally, it 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 also helps reduce bacteria that can potentially cause skin infections and is indicated for the preparation of skin prior to surgery.

Limitations of Use: Chlorhexidine Gluconate Oral Rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, refer to the precautions section.

Dosage and Administration

Chlorhexidine Gluconate Oral Rinse therapy should be initiated directly following dental prophylaxis. The recommended dosage for oral rinsing is 15 mL of undiluted Chlorhexidine Gluconate Oral Rinse, to be used twice daily for 30 seconds, in the morning and evening after tooth brushing. Patients must be instructed not to rinse with water, other mouthwashes, brush teeth, or eat immediately after using the rinse. It is important to note that Chlorhexidine Gluconate Oral Rinse is not intended for ingestion and should be expectorated after rinsing.

For skin antisepsis, the 2% Chlorhexidine Gluconate Cloth should be used with caution in premature infants or infants under 2 months of age due to the risk of irritation or chemical burns. The product and packaging are not sterile; therefore, healthcare professionals should adhere to hospital policies regarding skin preparation with non-sterile products.

To prepare the skin, the first cloth should be used to cleanse the indicated area, while the second cloth should be kept uncontaminated for larger areas. For dry surgical sites, one cloth should be used to cleanse each 161 cm² area (approximately 5 x 5 inches) of skin for 3 minutes, ensuring the area is completely wet before discarding. The area should then be allowed to air dry for one minute without rinsing. For moist surgical sites, one cloth should be used to cleanse each 65 cm² area (approximately 2 x 5 inches) of skin for the same duration and method.

Each cloth is for single use only and should be discarded after use. Any unused cloths should be discarded after the package has been opened.

For skin application using the 3M Skin and Nasal Antiseptic, the solution should be applied to clean, dry skin. A swab should be dipped into the solution and stirred vigorously for 10 seconds before being used to scrub the prep site for 2 minutes, working from clean to dirty, using both sides of the swab. This process should be repeated with a second swab, and the prep solution should be allowed to dry without blotting.

For nasal application, the inside of both nostrils should be cleaned with a tissue before using a swab dipped in the solution. The swab should be inserted into one nostril and rotated for 15 seconds, covering all surfaces, followed by a focus on the inside tip of the nostril for an additional 15 seconds. This process should be repeated for the other nostril using a fresh swab each time, and the application should be repeated in both nostrils with new swabs. Patients should be advised not to blow their nose, and any solution that drips out can be lightly dabbed with a tissue.

Contraindications

Use is contraindicated in patients with known hypersensitivity to chlorhexidine gluconate or any other ingredients in the product. It should not be used for lumbar punctures or in contact with the meninges. The product is also contraindicated for application on open skin wounds or as a general skin cleanser. Additionally, it should not be used in individuals with known sensitivity to iodine or any other ingredient in the formulation. The product must not be applied to the eyes; in case of contact, immediate flushing with water is required. Furthermore, it is contraindicated for use in infants less than 2 months old due to the risk of increased blood iodine levels. If more than the recommended amount is accidentally swallowed, medical help or contact with a Poison Control Center is advised.

Warnings and Precautions

Serious Warnings

• For external use only.

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

• If swallowed, get medical help or contact a Poison Control Center right away.

General Precautions

• Do not use on patients with known allergies to chlorhexidine gluconate or any other ingredients in this product.

• Do not use for lumbar punctures or in contact with the meninges.

• Do not use on open skin wounds or as a general skin cleanser.

• Keep out of eyes, ears, and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

• Do not use if there is a known sensitivity to iodine or any other ingredient in this product.

• Do not use on infants less than 2 months old due to the risk of increased blood iodine levels.

Monitoring Requirements

• For patients with 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. In clinical testing, 56% of users exhibited a measurable increase in facial anterior stain after six months. Stain can be removed by conventional professional prophylactic techniques, but additional time may be required. Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins.

• Some patients may experience an alteration in taste perception while undergoing treatment. Rare instances of permanent taste alteration have been reported.

Stop Use and Consult a Doctor

• Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if swelling, rash, or fever develops.

• If irritation, sensitization, or allergic reaction occurs, these may be signs of a serious condition.

Side Effects

Patients using the Skin Antisepsis, Oral Cleansing, and Nasal Antisepsis System may experience a range of adverse reactions, which can be categorized by frequency and seriousness.

Common Side Effects

• An increase in staining of teeth and other oral surfaces

• An increase in calculus formation

• An alteration in taste perception

Oral Mucosal Side Effects

Reported during placebo-controlled adult clinical trials, the following oral mucosal side effects occurred at a frequency of less than 1%:

• Aphthous ulcer

• Grossly obvious gingivitis

• Trauma

• Ulceration

• Erythema

• Desquamation

• Coated tongue

• Keratinization

• Geographic tongue

• Mucocele

• Short frenum

Postmarketing Reports

Additional adverse reactions reported postmarketing include:

• 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)

Serious Reactions

Anaphylaxis and serious allergic reactions have been reported during postmarketing use of dental products containing chlorhexidine.

Warnings

Patients are advised to stop use and consult a doctor if:

• Sore mouth symptoms do not improve within 7 days

• Swelling, rash, or fever develops

• Irritation, pain, or redness persists or worsens

General Precautions

Chlorhexidine Gluconate Oral Rinse can cause staining of oral surfaces, with clinical testing indicating that 56% of users exhibited a measurable increase in facial anterior stain after six months. Additionally, 15% of users developed what was judged to be heavy stain. Rare instances of permanent taste alteration following use have also been reported.

Contraindications

The product should not be used on patients with known allergies to chlorhexidine gluconate or any other ingredients in this product, for lumbar punctures, in contact with the meninges, or on open skin wounds.

Drug Interactions

This product may cause severe allergic reactions in patients with known hypersensitivity to chlorhexidine gluconate or any other ingredients contained within. Anaphylaxis and serious allergic reactions have been reported during postmarketing use of dental products containing chlorhexidine. Therefore, it is advised that individuals with such allergies refrain from using this product.

In terms of drug interactions, no specific interactions have been identified in the provided data. However, it is important to note that the use of chlorhexidine gluconate oral rinse can lead to staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. The effect of chlorhexidine gluconate oral rinse on periodontitis has not been determined.

Additionally, caution is advised for patients with known sensitivities to iodine or other ingredients in this product, as adverse reactions may occur. No specific laboratory test interactions have been mentioned in the available information.

Pediatric Use

Children under 12 years of age should be supervised during the use of skin antisepsis, oral cleansing, and nasal antisepsis products. For children under 3 years of age, it is recommended to consult a dentist or doctor prior to use.

Caution is advised when using these products in premature infants or infants under 2 months of age, as they may cause irritation or chemical burns. Additionally, these products should not be used on infants less than 2 months old due to the risk of increased blood iodine levels.

Ingestion of 1 or 2 ounces of Chlorhexidine Gluconate Oral Rinse by a small child (approximately 10 kg body weight) may lead to 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.

It is crucial to keep these products out of reach of children. If swallowed, immediate medical help should be sought or contact a Poison Control Center.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects when using the Skin Antisepsis, Oral Cleansing, and Nasal Antisepsis System. While no specific geriatric use information or dosage adjustments are explicitly provided in the product labeling, it is important to consider the potential for reduced kidney function in this population, which may necessitate careful monitoring and possible dosage modifications.

Healthcare professionals should monitor elderly patients for signs of irritation, sensitization, or allergic reactions, as these effects may be more pronounced. Special precautions are advised for elderly patients with known allergies or sensitivities to chlorhexidine gluconate or iodine. Overall, while no specific age considerations are outlined, caution is warranted when administering these products to geriatric patients.

Pregnancy

There are no specific statements regarding the use of chlorhexidine gluconate during pregnancy in the available data. The safety profile does not indicate any contraindications or risks associated with the use of chlorhexidine gluconate for pregnant patients. Additionally, no dosage modifications for pregnant individuals are suggested.

While the data does not provide specific warnings or special precautions related to pregnancy, it is important to note that chlorhexidine gluconate should not be used by individuals who are hypersensitive to it or its ingredients. Anaphylaxis and serious allergic reactions have been reported in postmarketing experiences with dental products containing chlorhexidine. Furthermore, chlorhexidine gluconate may cause staining of oral surfaces and could lead to tooth discoloration or increased tartar formation.

Caution is advised when using chlorhexidine products in premature infants or infants under 2 months of age due to the potential for irritation or chemical burns. As such, healthcare providers should consider these factors when advising pregnant patients on the use of chlorhexidine gluconate.

Lactation

Lactating mothers should exercise caution when using products containing chlorhexidine gluconate, as the effects on nursing mothers and lactation have not been specifically studied. It is currently unknown whether chlorhexidine gluconate is excreted in human milk.

Additionally, care should be taken when administering these products to premature infants or those under 2 months of age, as they may cause irritation or chemical burns. Chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.

Given the lack of specific data regarding the safety of chlorhexidine gluconate in breastfeeding, healthcare professionals are advised to monitor for any adverse effects in breastfed infants when these products are used.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available labeling for the Skin Antisepsis, Oral Cleansing, and Nasal Antisepsis System. The provided information does not include any recommendations regarding dosage adjustments, special monitoring, or safety considerations for individuals with reduced kidney function. As such, healthcare professionals should exercise caution and consider the lack of data when administering this product to patients with renal impairment. Further clinical judgment may be necessary in these cases.

Hepatic Impairment

Patients with hepatic impairment have no specific information regarding dosage adjustments, special monitoring, or precautions provided in the product inserts for the Skin Antisepsis, Oral Cleansing, and Nasal Antisepsis systems. Therefore, the safety and efficacy of these products in this population remain undetermined. It is advisable for healthcare providers to exercise caution and consider individual patient factors when administering these products to patients with liver problems.

Overdosage

In the event of an overdose involving Chlorhexidine Gluconate Oral Rinse, particularly in small children, ingestion of 1 or 2 ounces may lead to gastric distress, which can manifest as nausea or symptoms resembling alcohol intoxication. If a small child, approximately 10 kg in body weight, ingests more than 4 ounces, or if any signs of alcohol intoxication are observed, it is imperative to seek medical attention promptly.

Monitoring for symptoms of gastric distress and alcohol intoxication is recommended following any significant ingestion. While specific information regarding overdosage is limited in other contexts, the potential for adverse effects necessitates caution and appropriate medical intervention when overdose is suspected.

Nonclinical Toxicology

Teratogenic Effects

No relevant information regarding teratogenic effects has been provided in the available data.

Non-Teratogenic Effects

Chlorhexidine Gluconate Oral Rinse has been associated with certain non-teratogenic effects. Notably, it can cause staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue. Clinical testing indicated that 56% of users exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Additionally, 15% of users developed what was classified as heavy stain, in contrast to 1% of control users. It is important to note that the staining does not adversely affect the health of the gingivae or other oral tissues. Some patients may experience alterations in taste perception during treatment, with rare instances of permanent taste alteration reported through post-marketing surveillance.

Furthermore, caution is advised when using these products on infants less than 2 months old due to the potential risk of increased blood iodine levels. Use in premature infants or infants under 2 months of age should be approached with care, as these products may cause irritation or chemical burns.

Nonclinical Toxicology Section

No specific information regarding nonclinical toxicology has been provided in the available data.

Animal Pharmacology and Toxicology

No relevant information regarding animal pharmacology and toxicology has been found in the available data.

Storage and Handling

The product is supplied in single-dose 0.5 fluid ounce (15 mL) amber plastic bottles with child-resistant dispensing closures. Each cloth is designed for skin antisepsis, oral cleansing, and nasal antisepsis.

The product should be stored flat and maintained at a temperature between 20-25°C (68-77°F). Excursions in temperature are permitted between 15°C to 30°C (59°F to 86°F) in accordance with USP controlled room temperature guidelines. It is essential to avoid excessive heat above 40°C (104°F).

The product and packaging are not sterile; therefore, it is important to follow hospital policy for skin preparation with non-sterile products. Each cloth should be discarded after a single use, and any unused cloths should be discarded after the package has been opened. The cloths should be applied to clean, dry skin, and the prep solution should be allowed to dry without blotting. If the solution drips out of the nose, it can be lightly dabbed with a tissue. Microwaving the product is not recommended.