Chlorhexidine gluconate

Description

Chlorhexidine Gluconate is a 0.75% antimicrobial skin soap solution intended for external use only. It provides up to 6 hours of protection against a broad spectrum of microorganisms. The product is distributed by USA Medical Supply, located in Northbrook, IL 60062, and is available in multiple National Drug Code (NDC) formats: 81657-001-01, 81657-001-02, 81657-001-03, and 81657-001-04. Chlorhexidine Gluconate is manufactured in the USA and is FDA approved. Users should be aware of the California Proposition 65 warning and are advised to keep the product from freezing. For more information, visit www.usamedicalsupply.com.

Uses and Indications

This drug is indicated for use as a healthcare personnel handwash to help reduce bacteria that potentially can cause disease.

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

Dosage and Administration

Healthcare professionals should exercise caution when administering this product to premature infants and infants under 2 months of age, as it may cause irritation or chemical burns.

For hand hygiene, healthcare personnel should follow these steps:

1. Wet hands with water.

2. Dispense approximately 5 mL of the product into cupped hands.

3. Wash hands vigorously for a duration of 30 seconds.

4. Rinse hands thoroughly and dry completely.

Adhering to these guidelines will help ensure effective hand hygiene while minimizing the risk of adverse effects in vulnerable populations.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, it should not be used routinely in patients with wounds that extend beyond the superficial layers of the skin due to the potential for adverse effects.

Contact with the eyes, ears, or mouth is also contraindicated, as exposure may lead to serious and permanent eye injury or deafness if introduced into the middle ear through perforated eardrums. In the event of contact with these areas, it is imperative to rinse thoroughly with water.

Warnings and Precautions

For external use only. This product carries a significant risk of causing severe allergic reactions. Symptoms indicative of an allergic response 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 out of 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 come into contact with these sensitive areas, it is essential to rinse thoroughly and promptly with water. Additionally, this product should not be used routinely on wounds that extend beyond the superficial layers of the skin.

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

In cases of ingestion, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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. This product is contraindicated in individuals with known allergies to chlorhexidine gluconate or any other ingredient contained in the formulation.

Common adverse reactions include irritation, sensitization, or allergic reactions. Should any of these symptoms occur, patients are instructed to stop using the product and consult a healthcare professional, as these may indicate a serious condition.

Patients should be aware that this product is for external use only. It is crucial 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 the solution is instilled in the middle ear through perforated eardrums. If contact occurs, the affected area should be rinsed promptly and thoroughly with water.

Additionally, the product should not be used routinely on wounds that extend beyond the superficial layers of the skin. It is important to keep this product out of reach of children, as ingestion may necessitate immediate medical attention or contact with a Poison Control Center.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Chlorhexidine Gluconate Solution 0.75% Antiseptic. 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 to prevent accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients should be monitored closely when using this product, particularly those who are premature or under 2 months of age, as there is a risk of irritation or chemical burns associated with its use. Caution is advised in this population, and healthcare providers should consider the potential for increased sensitivity and adverse reactions. It is essential to evaluate the benefits and risks before prescribing this product to geriatric patients, ensuring appropriate dosage adjustments and safety measures are in place.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in premature infants and infants under 2 months of age. There is a potential risk of irritation or chemical burns associated with the use of this product in these populations. Healthcare professionals are encouraged to weigh the benefits against the risks when considering the use of this product in pregnant patients, especially those who may be caring for infants in the specified age group.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants and those under 2 months of age. There is a risk that these products 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 infants in these vulnerable age groups.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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 available 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 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 the potential for severe allergic reactions associated with this product. Reported symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, users are cautioned to stop use and consult a healthcare professional if signs of irritation, sensitization, or allergic reactions occur, as these may indicate a serious condition. Special care should be taken when using this product in premature infants and infants under 2 months of age, as it may lead to irritation or chemical burns.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation. It is important to counsel patients to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When using this product, healthcare providers should emphasize the importance of avoiding contact with the eyes, ears, and mouth. Patients should be made aware that exposure to these areas may result in serious and permanent eye injury or deafness if the solution is instilled in the middle ear through perforated eardrums. In the event of contact with these areas, patients should rinse thoroughly with water.

Additionally, healthcare providers should advise patients against routine use of the product if they have wounds that extend beyond the superficial layers of the skin, as this may pose additional risks.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, particularly temperatures exceeding 40°C (104°F). Additionally, the product must be protected from freezing to maintain its integrity and efficacy. Proper storage conditions are essential to ensure the product remains safe and effective for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Chlorhexidine Gluconate Solution 0.75% Antiseptic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)