Chlorhexidine gluconate

Description

No description information is available for the specified drug.

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 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 this initial scrub, the hands and forearms must be rinsed thoroughly with water. Following the rinse, an additional wash for 3 minutes using another 5 mL of the product is necessary, followed by 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 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. It is essential to rinse thoroughly with water, and a second thorough rinse is recommended 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 components of this formulation should not use this product.

This preparation is not to be utilized 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, the use of this product in the genital area is not recommended, as it may cause irritation or other adverse effects.

Warnings and Precautions

For external use only, this product carries the risk of causing a severe allergic reaction. Symptoms indicative of such a reaction 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 without delay.

General precautions must be observed to ensure safe application. The product should be kept out of the eyes, ears, and mouth, as contact may result in 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. Should contact occur, it is essential to rinse the affected area with cold water immediately.

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 be avoided unless necessitated by an underlying condition that requires a reduction in the bacterial population of the skin.

In cases of ingestion, immediate medical help should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if irritation, sensitization, or allergic reactions occur and persist for 72 hours, as these may indicate a serious condition.

Side Effects

This product may cause a severe allergic reaction in some patients. Symptoms of such reactions can include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product if they are allergic to chlorhexidine gluconate or any other ingredients contained in the formulation. Additionally, it is contraindicated for use as a preoperative skin preparation, particularly on the head or face, and should not come into contact with the meninges or be applied in the genital area.

When using this product, it is crucial to avoid contact with the eyes, ears, and mouth, as this may lead to serious and permanent eye injury if the product is introduced into the eye during surgical procedures. Furthermore, instillation in the middle ear through perforated eardrums may result in deafness. Should contact occur, patients should rinse the affected area with cold water immediately. 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 be avoided unless 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 irritation, sensitization, or an allergic reaction occurs and persists for 72 hours, as these may indicate a serious condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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. 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 may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised against the use of this preparation if they have a known allergy to chlorhexidine gluconate or any other ingredients contained within the formulation. Caution is warranted when considering the use of this product in premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns. The product is intended for external use only, and healthcare professionals should ensure that pregnant patients are aware of these precautions to mitigate potential risks to both the mother and the fetus.

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 reactions 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.

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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of allergic reactions, including anaphylaxis, have been documented. Additionally, skin reactions such as rash, pruritus, and urticaria have been reported. Serious skin reactions, including chemical burns and skin irritation, have also been noted.

Furthermore, cases of ototoxicity have been observed when the product was utilized in the middle ear. Instances of eye injury have been reported following accidental introduction of the product into the eyes.

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 essential to inform patients not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredients contained in the preparation.

Patients should be cautioned against using this product as a preoperative skin preparation, particularly on the head or face, and should not apply it in contact with the meninges or in the genital area. Providers must emphasize the importance of keeping the product away from 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. In the event of contact with these areas, patients should rinse immediately with cold water.

Healthcare providers should also inform 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 be avoided unless necessary to reduce the bacterial population due to an underlying condition.

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

Storage and Handling

This product is available in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product under controlled conditions to maintain its integrity and efficacy.

The recommended storage temperature range is between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). The product should be kept in its original container to protect it from light and moisture.

Healthcare professionals should handle this product with care, as it may cause a severe allergic reaction in susceptible individuals. Proper precautions should be taken to avoid exposure, and any unused product should be disposed of in accordance with local regulations.

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.

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