Chlorhexidine gluconate

Description

The product is identified by the SPL code 34089-3. It is designated as 9705 IC and is also referred to as CHG 9705 IC. Further details regarding its molecular weight, chemical formula, dosage form, and appearance are not provided in the extracted facts.

Uses and Indications

This drug is indicated for the reduction of bacteria that can potentially cause skin infections. It is specifically used for the preparation of the skin prior to surgical procedures.

Dosage and Administration

Healthcare professionals should exercise caution when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. The product and packaging are not sterile; therefore, adherence to hospital policy for skin preparation with non-sterile products is essential.

To open the package, hold the top of the package in one hand while lifting the flap on the backside with the other hand. Grasp the flap at the top and pull down to tear it away, exposing the foam. Present the foam and cloths to the prep table while holding the outside of the package, ensuring that the cloths do not come into contact with the outside of the package to minimize the risk of contamination.

Using sterile scissors, cut off the end seal of the package and transfer the contents onto the prep table, again avoiding contact between the cloths and the outside of the package.

For skin preparation, utilize the first cloth to cleanse the indicated area for either a moist or dry surgical site, ensuring that the second cloth remains uncontaminated for later use.

For dry surgical sites (e.g., abdomen or arm), use one cloth to cleanse each 161 cm² area (approximately 5 x 5 inches). Vigorously scrub the skin back and forth for 3 minutes, ensuring the treatment area is completely wet, then discard the cloth. Allow the area to air dry for one minute without rinsing.

For moist surgical sites (e.g., inguinal fold), use one cloth to cleanse each 65 cm² area (approximately 2 x 5 inches). Similarly, scrub the skin back and forth for 3 minutes, ensuring complete wetting of the treatment area, then discard the cloth. Allow the area to air dry for one minute without rinsing.

Each cloth is for single use only and must be discarded after use. Any unused cloths should be discarded after the package has been opened. It is important to note that the product must not be microwaved.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. This product carries a significant risk of severe allergic reactions. Symptoms indicative of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product is contraindicated in patients with known allergies to chlorhexidine gluconate or any other components of the formulation. It should not be used for lumbar punctures or in contact with the meninges. Additionally, it is not intended for application on open skin wounds or as a general skin cleanser.

When utilizing this product, it is crucial to avoid contact with the eyes, ears, and mouth, as chlorhexidine may cause serious or permanent injury if it enters these areas. Should contact occur, rinse thoroughly with cold water and seek medical attention promptly.

Healthcare professionals should advise patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction manifest, as these may indicate a serious condition.

In cases of ingestion, immediate medical help should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious. A notable concern is the potential for severe allergic reactions, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

It is important to note that this product should not be used in patients with known allergies to chlorhexidine gluconate or any other ingredients contained within the formulation. Additionally, it is contraindicated for use in lumbar punctures, in contact with the meninges, or on open skin wounds, and should not be utilized as a general skin cleanser.

During the use of this product, patients should take care to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious or permanent injury if chlorhexidine is allowed to enter and remain in these areas. Should contact occur, it is imperative to rinse the affected area with cold water immediately and consult a physician.

Patients are also advised to stop using the product and consult a doctor if they experience any signs of irritation, sensitization, or allergic reaction, as these may indicate a serious condition requiring medical evaluation.

Drug Interactions

This product has the potential to induce a severe allergic reaction in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. It is imperative that healthcare providers assess patients for any history of hypersensitivity to these substances prior to administration.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not warranted based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Chlorhexidine Gluconate. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly premature infants and those under 2 months of age, should use this product with caution due to the potential for irritation or chemical burns. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature infants or infants under 2 months of age. The use of this product in these populations may lead to irritation or chemical burns. Caution is advised, and healthcare providers should consider the potential risks associated with its use in these vulnerable groups. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

The product has not been specifically studied in pregnant patients, and there are no available data regarding its use during pregnancy. Currently, there are no specific safety concerns associated with the use of this product in pregnant individuals. Additionally, no dosage modifications are recommended for pregnant patients, and no special precautions regarding its use during pregnancy have been indicated. Healthcare professionals should consider the lack of data and exercise clinical judgment when prescribing this product to women of childbearing potential.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants or those under 2 months of age. There is a risk that the product may cause irritation or chemical burns in breastfed infants. Therefore, careful consideration and monitoring are advised when administering this product to lactating mothers who are nursing young infants.

Renal Impairment

There is no specific information available 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

In the event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely and provide supportive care as needed.

Given the absence of detailed guidance, it is essential to assess the patient's clinical status and consider standard protocols for managing overdose situations. This may include symptomatic treatment and supportive measures tailored to the patient's needs.

Healthcare providers should remain vigilant for any potential symptoms that may arise and respond accordingly, ensuring that appropriate medical intervention is initiated as necessary.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified reports of severe allergic reactions, including wheezing or difficulty breathing, shock, facial swelling, hives, and rash. Additionally, cases of irritation, sensitization, or allergic reactions have been reported, which may indicate the presence of a serious condition. These events were reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This information is vital for ensuring patient safety and prompt intervention in case of an emergency.

Storage and Handling

The product is supplied in a configuration that requires careful storage to maintain its integrity. It should be stored flat to prevent any potential damage. The recommended storage temperature range is between 20-25°C (68-77°F). It is crucial to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), as this may compromise the product's quality. Proper handling and adherence to these storage conditions are essential for ensuring the product remains effective and safe for use.

Additional Clinical Information

The product is administered topically. Clinicians should exercise caution when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. It is important to note that the product and its packaging are not sterile, and healthcare providers should adhere to hospital policies regarding skin preparation with non-sterile products.

Patients should be advised not to microwave the product. In the event of an allergic reaction, use should be discontinued immediately, and medical assistance should be sought. Care should be taken to avoid contact with the eyes, ears, and mouth, as chlorhexidine can cause serious or permanent injury if it enters these areas; if contact occurs, the affected area should be rinsed with cold water, and a doctor should be contacted. Patients should also be instructed to stop use and consult a doctor if any irritation, sensitization, or allergic reaction occurs, as these may indicate a serious condition. If the product is ingested, immediate medical help or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Chlorhexidine Gluconate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)