Hibiclens

Description

Hibiclens is a topical antiseptic solution that contains chlorhexidine gluconate as the active ingredient, available in a concentration of 4%. The solution is characterized as a clear, colorless to pale yellow liquid. Inactive ingredients include water, cocamidopropyl betaine, glycerin, sodium chloride, citric acid, tromethamine, and may contain fragrance. Hibiclens is packaged in various sizes, including 4 oz and 8 oz bottles.

Uses and Indications

This drug is indicated as an antimicrobial skin cleanser to reduce bacteria that potentially can cause disease. It is suitable for use in skin wound and general skin cleansing applications. Additionally, this drug serves as a surgical hand scrub and is intended for healthcare personnel handwashing.

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 the 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 a surgical hand scrub, healthcare professionals should wet their hands and forearms with water. Approximately 5 mL (equivalent to 4 pumps) of the product should be used for scrubbing with a brush for a duration of 3 minutes. Following the scrub, 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 (4 pumps) of the product into cupped hands. A vigorous washing action should be performed for 15 seconds, followed by rinsing and thorough drying of the hands.

Contraindications

Use of this product is contraindicated in the following situations:

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

The product must not be applied in contact with the meninges, as this may lead to serious complications.

Additionally, use in the genital area is contraindicated to prevent potential adverse effects.

Warnings and Precautions

For external use only. It is imperative that this product is not ingested; if swallowed, immediate medical assistance should be sought or a Poison Control Center contacted.

Patients should not use this product if they have a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, this product must not be applied in contact with the meninges or used in the genital area.

When using this product, care must be taken to avoid contact with the eyes, ears, and mouth. Exposure to these areas may result in serious and permanent eye injury or potential deafness if the product is instilled in the middle ear through perforated eardrums. In the event of contact with any of these sensitive areas, it is crucial to rinse thoroughly with cold water immediately.

Wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Furthermore, repeated general cleansing of large body areas is discouraged unless specifically advised by a healthcare provider.

In case of ingestion, it is essential to seek emergency medical help or contact a Poison Control Center without delay.

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

Side Effects

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

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 should be monitored closely when using this medication, particularly those who are premature infants or infants under 2 months of age. The use of this product in these populations may lead to irritation or chemical burns. Caution is advised, and healthcare providers should consider the potential risks associated with its use in these vulnerable groups. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

There are no specific statements regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. It is advisable to monitor fetal outcomes in women of childbearing potential who are exposed to this medication 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 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

There is no specific information 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific guidelines.

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

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 ingredient contained in the formulation.

Patients should be cautioned against using the product in contact with the meninges or in the genital area. When using this product, it is critical to keep it away from the eyes, ears, and mouth, as contact with these areas may lead to serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. In the event of contact with any of these sensitive areas, patients should rinse thoroughly with cold water immediately.

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 cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

Patients should be instructed to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition requiring medical attention.

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). 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 Hibiclens, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)