Halyard Chlorhexidine Gluconate

Description

Chlorhexidine Gluconate 4% Solution is an antiseptic formulation presented as a liquid foaming solution. It is packaged in a foam pump for ease of application. This product is non-sterile and intended for external use only. Each container holds 4 fluid ounces (118 mL) of the solution. Chlorhexidine Gluconate 4% Solution is manufactured for O&M Halyard, Inc., located at 9120 Lockwood Blvd., VA 23116, USA, and is produced in the United States.

Uses and Indications

This drug is indicated for use as a surgical hand scrub, significantly reducing the number of microorganisms on the hands and forearms prior to surgical procedures or patient care. It is also indicated for healthcare personnel handwashing, assisting in the reduction of bacteria that may potentially cause disease. Additionally, this drug serves as a skin wound and general skin cleanser, helping to reduce bacteria on the skin.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Surgical hand scrubs require the removal of all jewelry prior to the procedure. Healthcare professionals should begin by wetting their hands and forearms with water, followed by the application of 5 mL (approximately 4 pumps) of the product. A thorough wash or scrub of the hands and forearms should be performed for a duration of 3 minutes, with particular attention given to the nails, cuticles, and interdigital spaces. After this initial scrub, the hands and forearms must be rinsed thoroughly with water. A second application of 5 mL (4 pumps) of the product is then required, followed by an additional wash for another 3 minutes, concluding with a thorough rinse under running water. Finally, hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the process begins with wetting the hands with water. Approximately 5 mL (4 pumps) of the product should be dispensed into cupped hands, followed by vigorous washing for 30 seconds. After washing, hands must be rinsed and dried thoroughly.

When cleansing skin wounds or for general skin cleansing, the area to be treated should first be thoroughly rinsed with water. The minimum amount of product necessary to cover the skin or wound area should then be applied, followed by gentle washing. It is essential to rinse thoroughly with water, and a second thorough rinse is recommended to ensure complete removal of the product.

Contraindications

Use of this preparation is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other component of this formulation should not use this product due to the risk of severe allergic reactions.

This product is not to be used as a preoperative skin preparation, particularly on the head or face, to avoid potential complications associated with surgical procedures.

Contact with the meninges is contraindicated, as it may lead to serious adverse effects.

Additionally, the use of this preparation in the genital area is contraindicated to prevent irritation or other adverse reactions.

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.

Caution is advised for individuals with known allergies to chlorhexidine gluconate or any other components of this formulation. This product is contraindicated for use as a patient preoperative skin preparation, particularly on the head or face, and should not be applied in contact with the meninges or used in the genital area.

When utilizing this product, it is essential to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. Should contact occur, it is crucial to rinse the affected area with cold water immediately. Additionally, wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product. Repeated cleansing of large body areas is discouraged unless necessitated by an underlying condition that requires a reduction in the bacterial population of the skin.

In the event of accidental ingestion, immediate medical attention should be sought, or contact should be made with a Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction persist for 72 hours, as these may indicate a serious condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Notably, there is a potential for severe allergic reactions, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. Individuals with a known allergy to chlorhexidine gluconate or any other ingredient in this preparation should not use this product.

In clinical settings, it is critical to avoid using this product as a preoperative skin preparation, particularly on the head or face, and it should not come into contact with the meninges or be applied in the genital area. During use, care must be taken to prevent contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. Should contact occur, it is advised to rinse the affected area with cold water immediately.

Patients should refrain from using this product on wounds that extend beyond the superficial layers of the skin, and repeated general skin cleansing of large body areas should only be performed when necessary to reduce the bacterial population due to an underlying condition.

If irritation, sensitization, or an allergic reaction occurs and persists for 72 hours, patients are advised to discontinue use and consult a healthcare professional, as these symptoms may indicate a serious condition.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach. The combination of these agents can lead to staining. To mitigate this interaction, it is advised to rinse the skin thoroughly after using chlorhexidine gluconate and to utilize only non-chlorine detergents for cleaning purposes.

Packaging & NDC

Below are the non-prescription pack sizes of Halyard Chlorhexidine Gluconate (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. It is essential to assess the individual patient's condition and adjust the treatment approach accordingly to ensure safety and efficacy.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no explicit statements regarding safety concerns or dosage modifications for pregnant individuals. Additionally, the prescribing information does not indicate any special precautions that need to be taken when considering the use of this medication in pregnant patients. Healthcare professionals should weigh the potential benefits against any unknown risks when prescribing this medication 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 these vulnerable populations. It is advisable for healthcare professionals to closely monitor breastfed infants for any adverse effects when this product is used by lactating mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay. It is recommended to reach out to a Poison Control Center for expert guidance on managing the situation effectively.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, reports include allergic reactions, which encompass severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash.

Additionally, there have been observations of irritation, sensitization, or allergic reactions that persist for up to 72 hours, which may indicate the presence of a serious condition. These events have been reported voluntarily or through surveillance programs, contributing to the ongoing assessment of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for reference. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, defined as temperatures above 104°F (40°C), and to prevent freezing, as these conditions may compromise the product's integrity.

For further details regarding safety and handling, healthcare professionals are encouraged to consult the Safety Data Sheet (SDS). Additionally, it is important to note that chlorhexidine gluconate skin cleansers may cause staining when used in conjunction with chlorine-releasing products, such as chlorine bleach. Therefore, it is recommended to rinse thoroughly and utilize only non-chlorine detergents for laundering or cleaning purposes.

Additional Clinical Information

Patients should be advised to use the product with caution in premature infants or those under 2 months of age, as it may cause irritation or chemical burns. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

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