Chlorhexidine Gluconate

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for surgical hand scrubs, significantly reducing the number of microorganisms on the hands and forearms prior to surgery 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, facilitating the preparation of the patient's skin prior to surgery, as well as for skin wound and general skin cleansing.

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

Dosage and Administration

Surgical hand scrubs should begin with wetting the 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 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. An additional wash with 5 mL of the product is required for another 3 minutes, after which the hands should be rinsed under running water and dried thoroughly.

For healthcare personnel handwashing, hands should be wetted with water before dispensing about 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.

For skin wound and general skin cleaning, 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 once again to complete the cleaning process.

Contraindications

Use of this product is contraindicated in the following situations:

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

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

Application in the genital area is not recommended, as it may cause irritation or adverse effects.

Additionally, this product should not be used as a preoperative skin preparation for the head or face to avoid potential complications associated with its use in these sensitive areas.

Warnings and Precautions

For external use only. This product carries a significant risk of causing severe allergic reactions. Symptoms indicative of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. Healthcare professionals should be vigilant for these signs and advise patients to discontinue use immediately and seek medical assistance if any of these symptoms occur.

This product contains coconut oil diethanolamine condensate (cocamide diethanolamine), which is recognized by the State of California as a potential carcinogen. For further information, refer to www.P65Warnings.ca.gov.

General precautions must be observed when using this product. It is contraindicated for individuals with known allergies to chlorhexidine gluconate or any other components of the formulation. The product should not be applied in contact with the meninges or used in the genital area. Additionally, it is not recommended for preoperative skin preparation of the head or face.

Care should 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 deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these sensitive areas, the solution should be rinsed out promptly and thoroughly with water.

Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product. Furthermore, repeated general skin cleansing of large body areas should be avoided unless necessary to reduce the bacterial population due to an underlying condition.

In case of ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Patients should be advised to discontinue use and consult a healthcare provider if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition requiring further evaluation.

Side Effects

Patients using this product should be aware that it is for external use only. There is a significant risk of 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.

This product contains coconut oil diethanolamine condensate (cocamide diethanolamine), which is recognized by the State of California as a substance that may cause cancer. For further information, patients can visit www.P65Warnings.ca.gov.

Patients should not use this product if they have a known allergy to chlorhexidine gluconate or any other ingredients contained within. Additionally, it should not be applied in contact with the meninges, in the genital area, or as a preoperative skin preparation for the head or face.

While using this product, it is crucial to avoid 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 the solution come into contact with these areas, it is imperative to rinse thoroughly with water. Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product, 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.

Patients are advised to stop using the product and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Chlorhexidine Gluconate (antiseptic skin cleanser). 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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in the context of premature infants or 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 vulnerable 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 at risk of delivering prematurely or who have recently given birth to infants in the specified age group.

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

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 these patients to ensure safety and efficacy.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on managing overdose cases.

In summary, while no specific overdosage information is available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

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

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 of the potential for allergic reactions. They must be advised to discontinue use and seek medical assistance right away if they experience any signs of an allergic reaction. It is crucial to emphasize that this product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredients contained in the formulation.

Healthcare providers should caution patients against using this product in contact with the meninges or in the genital area. Additionally, it should not be used as a preoperative skin preparation for the head or face.

When using this product, patients must be instructed to avoid contact with the eyes, ears, and mouth, as it may cause serious and permanent eye injury if introduced into the eye during surgical procedures, or may lead to deafness if instilled in the middle ear through perforated eardrums. If the solution comes into contact with these areas, patients should rinse thoroughly and promptly with water.

Providers should inform patients 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 be avoided unless necessary to reduce the bacterial population due to an underlying condition.

Patients should be advised to stop using the product and consult their doctor if they experience irritation, sensitization, or any allergic reactions, 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 temperature range of 68-77ºF (20-25°C). Care should be taken to avoid exposure to excessive heat, which should not exceed 104°F (40°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

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)