Hibiclens

Description

Hibiclens is a topical antiseptic solution available in multiple sizes, including 4 oz, 8 oz, 16 oz, 32 oz, and 1 gallon. The product is packaged in bottles and cartons, ensuring a variety of options for different usage needs. The packaging includes images of the product in various formats, such as the Hibiclens 4 oz Bottle and Carton, 8 oz Bottle and Carton, 16 oz Bottle and Carton, as well as the 32 oz and 1 gallon formats.

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 care and general skin cleansing. 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 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 for 15 seconds is recommended, 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.

Application in contact with the meninges is contraindicated, as it may lead to serious complications.

Additionally, the product should not be used in the genital area to avoid potential irritation or 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 the local Poison Control Center contacted.

Caution is advised for individuals with known allergies. This product should not be used by anyone who is allergic to chlorhexidine gluconate or any other component of the formulation. Additionally, it is contraindicated for use in contact with the meninges and should not be applied to the genital area.

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

In the event of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

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 that patients stop using the product and consult a healthcare professional. These reactions may indicate a serious condition that requires medical attention.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. 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 to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects, necessitating careful use of this medication in this population. While no specific dosage adjustments or age considerations are indicated for geriatric use, it is essential to monitor these patients closely for any signs of irritation, sensitization, or allergic reactions, as such effects may be more pronounced in elderly individuals. Regular assessment and vigilance are recommended to ensure the safety and well-being of geriatric patients receiving this treatment.

Pregnancy

There are no specific statements regarding the use of Hibiclens (chlorhexidine gluconate solution) during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the available data does not provide sufficient information to assess the potential risks or benefits of this product in pregnant patients. Healthcare professionals should consider the lack of established safety data when prescribing this medication to women of childbearing potential and weigh the potential risks against the clinical need for treatment.

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

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. A reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min.

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 consider general principles of management for suspected cases of overdose.

It is essential to monitor patients 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, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved in the overdose.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose situation effectively.

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 product. Reports include allergic reactions, such as anaphylaxis, as well as skin reactions, which encompass rash, pruritus, and urticaria. Additionally, serious skin reactions, including chemical burns and irritation, have been documented.

There have also been cases of eye injury resulting from improper use of the product, leading to serious and permanent damage. Furthermore, instances of ototoxicity have been reported 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 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 healthcare professional if they experience any irritation, sensitization, or allergic reactions, as these symptoms 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). 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

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 exposure may lead to serious and permanent eye injury or deafness if introduced into the middle ear through perforated eardrums. If contact occurs, rinsing with cold water is recommended. Additionally, wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Repeated cleansing of large body areas should only occur under the guidance of a healthcare provider. Patients should discontinue use and consult a doctor if they experience irritation, sensitization, or any allergic reactions, as these may indicate a serious condition. It is also 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)