Hibiclens

Description

The product is identified by SPL code 34089-3 and is formulated as a topical antiseptic solution. It contains chlorhexidine gluconate as the active ingredient. The solution appears as a clear, colorless to pale yellow liquid. Inactive ingredients include water, sodium chloride, citric acid, sodium citrate, fragrance, and other excipients as necessary.

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 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.

For 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, the 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 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 healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended ingestion or exposure.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare providers should also counsel patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur. These symptoms may indicate a serious underlying condition that requires further evaluation and management.

Side Effects

Patients should be aware that the product is intended for external use only. In clinical use, some participants may experience side effects that warrant caution.

In the event of irritation, sensitization, or an allergic reaction, it is advised to stop use immediately and consult a healthcare professional. These reactions may indicate a serious condition that requires medical attention.

Drug Interactions

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

There is no specific information 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. It is advisable to monitor these patients closely for any adverse effects or changes in 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 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are critical in managing cases of suspected overdose to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include severe manifestations such as wheezing or difficulty breathing, shock, facial swelling, hives, and rash.

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. They must be instructed to discontinue use and consult a physician if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When using this product, patients should be reminded to avoid contact with the eyes, ears, and mouth, as exposure 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 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 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) to maintain its integrity. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), as this may compromise the product's quality. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

Patients should be advised to use the product with caution, particularly in premature infants or those under 2 months of age, as it may cause irritation or chemical burns. For skin wound and general skin cleansing, it is important to thoroughly rinse the area with water, apply the minimum amount necessary to cover the skin or wound, and wash gently before rinsing thoroughly. In the case of surgical hand scrubs, hands and forearms should be wet with water, scrubbed for 3 minutes with approximately 5 mL of the product using a brush, and rinsed thoroughly under running water, repeating the process. For healthcare personnel handwashing, hands should be wet, about 5 mL of the product dispensed into cupped hands, and washed vigorously for 15 seconds before rinsing and drying thoroughly.

Clinicians should counsel patients on the potential for severe allergic reactions, which may manifest as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. Patients should be instructed to discontinue use and seek medical assistance immediately if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. Additionally, the product should be kept out of reach of children, and in the event 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)