Cardinal Health

Description

Chlorhexidine Gluconate 4% Solution is a non-sterile antiseptic formulation available in two sizes: 4 fluid ounces (118 mL) and 8 fluid ounces (237 mL). This solution is intended for single-use applications and serves as an effective antiseptic agent.

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, aiding in the reduction of bacteria that may potentially cause disease. Additionally, this drug is indicated for patient preoperative skin preparation, ensuring the skin is adequately prepared prior to surgery. Furthermore, it is suitable for skin wound and general cleansing.

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

Dosage and Administration

Surgical hand scrubbing requires the operator to first wet their hands and forearms with water. Approximately 5 mL of the product should be used in conjunction with a wet brush to scrub for a duration of 3 minutes, ensuring meticulous attention is given to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, the hands and forearms must be rinsed thoroughly. The procedure should then be repeated with an additional 5 mL of product, scrubbed for another 3 minutes, and rinsed under running water. It is essential to dry the hands and forearms thoroughly after completion.

For healthcare personnel handwashing, the individual should wet their hands with water and dispense approximately 5 mL of the product into cupped hands. A vigorous washing technique should be employed for a minimum of 15 seconds, followed by thorough rinsing and drying of the hands.

In the context of patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for at least 2 minutes and then dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with a sterile towel to ensure optimal preparation.

For skin wound and general skin cleansing, the area to be cleaned should first be thoroughly rinsed with water. The minimum amount of product necessary to adequately cover the skin or wound area should then be applied, followed by gentle washing. A thorough rinse is required to complete the cleansing process.

Contraindications

Use of this product is contraindicated in the following situations:

• Known allergy to chlorhexidine gluconate or any other component of the formulation.

• Contact with the meninges, due to the potential for serious adverse effects.

• Application in the genital area, as it may lead to irritation or other complications.

• Use as a preoperative skin preparation on the head or face, which may pose risks of 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.

General precautions must be observed to ensure safe application. The product should be kept away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly and promptly with water.

Wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Additionally, repeated cleansing of large body areas should only be performed under the guidance of a healthcare provider to avoid unnecessary irritation or damage to the skin.

In cases of accidental ingestion, immediate medical help should be sought, or a Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, 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 crucial to note that this product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation.

In clinical settings, caution is advised when using this product, particularly in specific anatomical areas. The product should not be applied in contact with the meninges or in the genital area. Additionally, it is contraindicated for use as a preoperative skin preparation on the head or face.

During application, care must be taken to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is recommended to rinse thoroughly with water.

Patients should also be aware that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Furthermore, repeated general skin cleansing of large body areas should only be performed under the guidance of a healthcare provider.

If any signs of irritation, sensitization, or allergic reaction occur, patients should stop using the product 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, leading to staining. It is advised to rinse the skin thoroughly after use and to utilize only non-chlorine detergents to prevent this interaction.

Packaging & NDC

Below are the non-prescription pack sizes of Cardinal Health (chlorhexidine gluconate 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly premature infants and those under 2 months of age, should be treated with caution. The use of these products in this population may lead to irritation or chemical burns. It is essential for healthcare professionals to closely monitor these patients to mitigate potential risks associated with their use.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature or under 2 months of age, as these populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates careful consideration and management in these vulnerable groups.

Healthcare providers are advised to exercise caution and ensure appropriate monitoring when prescribing this medication to geriatric patients, taking into account their overall health status and any comorbid conditions that may influence treatment outcomes.

Pregnancy

There are no specific statements regarding the use of chlorhexidine gluconate 4% during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are indicated. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention 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 effects have been identified in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Serious side effects have been reported voluntarily or identified through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated contact number, 1-877-227-3642. This information contributes to the ongoing monitoring of the safety profile of the product.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is crucial to inform patients to avoid contact with the eyes, ears, and mouth, as exposure to these areas may lead to serious and permanent eye injury if the product is placed or retained in the eye during surgical procedures, or may result in deafness if instilled in the middle ear through perforated eardrums.

In the event of accidental contact with these sensitive areas, patients should be instructed to rinse thoroughly and promptly with water. Providers should also counsel patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product.

Additionally, repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider. Patients should be made aware of the potential for irritation, sensitization, or allergic reactions, and they should be encouraged to report any such occurrences, as these may indicate a serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)