Chlorhexidine gluconate

Description

Chlorhexidine Gluconate Solution is an antiseptic formulation containing 0.75% chlorhexidine gluconate, intended for external use only. It is manufactured by Bajaj Medical, located in Chicago, IL 60609, and is FDA approved. The solution is available in multiple sizes: 4 fl oz (118 mL) with NDC 61037-414-01, 8 fl oz (236 mL) with NDC 61037-414-02, 16 fl oz (473 mL) with NDC 61037-414-05, 32 fl oz (946 mL) with NDC 61037-414-06, 128 fl oz (3785 mL) with NDC 61037-414-07, and additional 8 fl oz (236 mL) options with NDCs 61037-414-03 and 61037-414-04, as well as a 40.6 fl oz (1.2 L) size with NDC 61037-414-08. All formulations are made in the USA.

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 use while minimizing the risk of adverse effects.

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 result in 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 away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury or potential deafness if introduced into the middle ear through a perforated eardrum. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly and promptly with water. Additionally, the product should not be used routinely on wounds that extend beyond the superficial layers of the skin.

Healthcare professionals should advise patients to stop using the product 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 may experience a range of adverse reactions associated with the use of this product.

Severe allergic reactions have been reported, which may manifest as symptoms including 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.

It is contraindicated for use in individuals with a known allergy to chlorhexidine gluconate or any other ingredient contained in this product.

During the use of 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 potential deafness if the solution is instilled in the middle ear through perforated eardrums. Should the solution come into contact with these areas, it is recommended to rinse thoroughly with water.

Patients should also refrain from routine use of this product on wounds that extend beyond the superficial layers of the skin.

If irritation, sensitization, or any signs of an allergic reaction occur, patients should stop using the product and consult a healthcare professional, as these symptoms may indicate a serious condition.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical help should be sought or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

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 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 caution in administration. It is advisable to consider dose adjustments and to ensure that appropriate safety measures are in place when treating geriatric patients. Regular assessment of the patient's response to therapy is recommended to mitigate any adverse effects.

Pregnancy

There is no specific information regarding the use of chlorhexidine gluconate solution during pregnancy. The prescribing information does not mention any contraindications or risks associated with its use in pregnant patients. Additionally, there are no dosage modifications indicated for individuals who are pregnant. The insert also does not specify any special precautions for the use of this solution during pregnancy. As such, healthcare professionals should consider the absence of data when advising pregnant patients on the use of chlorhexidine gluconate solution.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. 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 and monitoring of these patients.

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 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 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 an allergic reaction 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 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

The product is administered topically. Clinicians should advise patients to use the product with caution in premature infants and infants under 2 months of age, as it may cause irritation or chemical burns. It is crucial to avoid contact with the eyes, ears, and mouth, as exposure can lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these areas, patients should rinse thoroughly with water.

Patients are also cautioned against routine use on wounds that extend beyond the superficial layers of the skin. They should discontinue use and consult a healthcare professional if any irritation, sensitization, or allergic reaction occurs, as these may indicate a serious condition. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

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.

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