Halyard Chlorhexidine Gluconate

Description

Chlorhexidine Gluconate 4% Solution is a non-sterile antiseptic liquid formulation intended for external use only. The product is packaged in a flip-top container for ease of application. It is manufactured for O&M Halyard, Inc., located at 9120 Lockwood Blvd., VA 23116, USA, and is produced in the United States. Care should be taken to keep the solution from freezing.

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 scrub requires the removal of all jewelry prior to use. Healthcare professionals should wet their hands and forearms with water, then apply 5 mL of the product. A thorough wash or scrub of the hands and forearms should be performed for 3 minutes, with particular attention given to the nails, cuticles, and interdigital spaces. After scrubbing, hands and forearms must be rinsed thoroughly with water. This process should be followed by an additional wash for 3 minutes using another 5 mL of the product, followed by rinsing under running water. Finally, hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the procedure begins with wetting the hands with water. Approximately 5 mL 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 using the product as a skin wound and general skin cleanser, the area to be cleansed 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. The area must be rinsed thoroughly with water, and this rinsing should be repeated to ensure complete cleansing.

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.

It is contraindicated for use as a preoperative skin preparation, particularly on the head or face, due to the potential for adverse reactions in these sensitive areas.

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

Additionally, this product should not be applied in the genital area to avoid irritation or other adverse effects.

Warnings and Precautions

For external use only. This product carries a significant risk of severe allergic reactions. Healthcare professionals should be vigilant for symptoms such as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

General precautions must be observed when administering this product. It is contraindicated in individuals with known allergies to chlorhexidine gluconate or any other components of the formulation. Additionally, this product should not be utilized as a preoperative skin preparation, particularly on the head or face, nor should it come into contact with the meninges. The genital area is also a prohibited site for application.

In cases of ingestion, immediate medical attention is required. Healthcare providers should advise patients to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be instructed 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 underlying condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product.

Severe allergic reactions have been reported, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. Due to the potential for these serious reactions, individuals with known allergies to chlorhexidine gluconate or any other ingredient in this preparation should not use the 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.

When using this product, there is a risk of serious and permanent eye injury if it is placed or retained in the eye during surgical procedures. Additionally, instillation in the middle ear through perforated eardrums may lead to deafness. In the event of contact with the eyes, immediate rinsing with cold water is advised.

Patients are instructed to discontinue use and consult a healthcare professional if they experience irritation, sensitization, or an allergic reaction that persists for 72 hours, as these symptoms may indicate a serious condition.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach, leading 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 treated with caution due to the potential for reduced kidney function and increased sensitivity to side effects. While the prescribing information does not specify any dosage adjustments or particular age considerations for geriatric use, healthcare providers are advised to closely monitor this population for any adverse reactions or complications that may arise during treatment. It is essential to assess renal function and consider individual patient factors when prescribing to elderly patients to ensure safety and efficacy.

Pregnancy

Pregnant patients should be aware that there are no specific safety concerns or special precautions associated with the use of this medication during pregnancy. Additionally, there are no dosage modifications indicated for pregnant individuals. While the prescribing information does not provide explicit data regarding the effects on fetal outcomes, healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks when making treatment decisions for pregnant patients.

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

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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, which may manifest as severe symptoms such as wheezing or difficulty breathing, shock, facial swelling, hives, and rash. Additionally, cases of irritation, sensitization, or allergic reactions have been noted, particularly those that persist for 72 hours, which may indicate a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep the 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 identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity. 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 efficacy.

For cleaning and laundering, it is important to note that chlorhexidine gluconate skin cleansers can cause staining when used in conjunction with chlorine-releasing products, such as chlorine bleach. Therefore, it is recommended to rinse the product thoroughly and to utilize only non-chlorine detergents to avoid any adverse effects.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to use the product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. In the event of accidental ingestion, patients should 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.

View product document (PDF)