Hibiclens

Description

Hibiclens is available in a 15 mL packette unit and a 15 mL packette box. The formulation is designed for topical antiseptic use, providing effective skin cleansing and antimicrobial action. The product is intended for use in healthcare settings and is suitable for preoperative skin preparation.

Uses and Indications

This drug is indicated as an antimicrobial skin cleanser to reduce bacteria that may potentially cause disease. It is suitable for use in skin wound and general skin cleansing, as well as for surgical hand scrubs. Additionally, it is indicated for healthcare personnel handwashing and for patient preoperative skin preparation.

Dosage and Administration

For skin wound and general skin cleansing, the area to be cleansed should be thoroughly rinsed with water. The minimum amount of product necessary to cover the skin or wound area should be applied, followed by gentle washing. It is essential to rinse the area thoroughly after application.

In the case of surgical hand scrubs, healthcare professionals should wet their hands and forearms with water. Approximately 5 mL of the product should be used for scrubbing with a brush for a duration of 3 minutes. After scrubbing, hands and forearms must be rinsed thoroughly under running water. This process should be repeated, and hands should be dried thoroughly afterward.

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 15 seconds, followed by rinsing and thorough drying of the hands.

For patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area should be swabbed for at least 2 minutes, and then dried with a sterile towel. This step should be repeated to ensure adequate preparation.

Contraindications

Use of this product is contraindicated in the following situations:

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

• Application as a preoperative skin preparation on the head or face.

• Contact with the meninges.

• Application in the genital area.

Warnings and Precautions

For external use only.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. This product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation.

It is imperative that this product not be utilized as a preoperative skin preparation for the head or face. Additionally, it must not come into contact with the meninges or be applied to the genital area, as these uses may pose significant risks.

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

No specific laboratory tests are recommended for monitoring the use of this product.

Side Effects

For external use only. Patients should stop use and consult a doctor if irritation, sensitization, or allergic reaction occurs, as these may be indicative of a serious condition.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hibiclens (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 require careful consideration when using this product, particularly in the context of safety and potential adverse effects. While there is no specific information regarding dosage adjustments or special precautions for geriatric patients, healthcare providers should remain vigilant in monitoring for any adverse reactions.

It is important to note that the product should be used with caution in premature infants or infants under 2 months of age due to the risk of irritation or chemical burns. Although this warning is not directly applicable to elderly patients, it underscores the necessity for careful assessment of the product's safety profile in vulnerable populations.

Given the absence of specific data on geriatric use, healthcare providers are advised to exercise clinical judgment when prescribing this product to elderly patients, ensuring that they are closely monitored for any potential side effects or complications.

Pregnancy

There are no specific statements regarding the use of Hibiclens (chlorhexidine gluconate) during pregnancy. The prescribing information does not mention any safety concerns, contraindications, or special precautions related to 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 breastfed infants. Therefore, careful consideration and monitoring are advised when administering this product to lactating mothers who are nursing young infants.

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 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 context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that healthcare providers employ standard supportive care measures. This may include symptomatic treatment and monitoring of vital signs. If an overdose is suspected, immediate consultation with a poison control center or a medical toxicologist is advised to determine the appropriate course of action.

As always, maintaining a thorough understanding of the patient's medical history and current medications is essential in managing any potential overdosage scenarios effectively.

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 several adverse reactions associated with the use of chlorhexidine gluconate. These include allergic reactions, such as anaphylaxis, as well as skin reactions, which encompass rash, pruritus, and dermatitis. Additionally, reports of serious adverse events have been documented, including chemical burns and irritation linked to the product's use.

There have also been postmarketing reports of eye injuries resulting from accidental exposure to chlorhexidine gluconate. Furthermore, instances of ototoxicity have been noted when the product was instilled in the middle ear through perforated eardrums.

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 keep the product away from the eyes, ears, and mouth, as contact with these areas may lead to serious and permanent eye injury if the product is placed or retained in the eye during surgical procedures. Additionally, instillation in the middle ear through perforated eardrums may result in deafness.

In the event of contact with the eyes, ears, or mouth, patients should be instructed to rinse the affected area with cold water immediately. Providers should also counsel patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Furthermore, repeated general cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

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 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 counsel patients on the potential for severe allergic reactions, which may manifest as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, patients are advised to discontinue use and seek immediate medical assistance.

Patients should be instructed to avoid contact with the eyes, ears, and mouth, as this may lead to serious and permanent eye injury or deafness if the product is improperly applied. If contact occurs, rinsing with cold water is recommended. Additionally, patients should stop use and consult a healthcare provider if they experience irritation, sensitization, or any allergic reactions, as these may indicate a serious condition. It is crucial to keep the product out of reach of children, and in case of ingestion, medical help or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)