Hibiclens for Georgia Pacific

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated as an antimicrobial skin cleanser to reduce bacteria that may potentially cause disease. It is specifically formulated for use as a surgical hand scrub and is also suitable for healthcare personnel handwashing.

Limitations of Use: This product is intended for external use only and should not be used on broken or irritated skin.

Dosage and Administration

Healthcare professionals are advised to follow the specified procedures for the effective use of the product in both surgical and healthcare personnel hand hygiene.

For surgical hand scrubbing, the following steps should be adhered to: First, wet the hands and forearms with water. Then, dispense approximately 5 mL (equivalent to 8 pumps) of the product and scrub for a duration of 3 minutes using a brush. It is essential to rinse thoroughly under running water and repeat the scrubbing process. Finally, ensure that hands and forearms are dried thoroughly.

In the case of healthcare personnel handwashing, begin by wetting the hands with water. Dispense about 5 mL (8 pumps) of the product into cupped hands and wash vigorously for 15 seconds. After washing, rinse the hands thoroughly and dry completely.

Adhering to these protocols will help maintain optimal hand hygiene in clinical settings.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation.

Additionally, the product should not be applied to the eyes, ears, or mouth, as it may cause serious and permanent eye injury if it enters the eye, or may lead to deafness if instilled in the middle ear through perforated eardrums.

Routine use is also contraindicated in patients with wounds that extend beyond the superficial layers of the skin.

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. Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums. Should contact occur, it is imperative to rinse the affected area with cold water immediately.

Routine use of this product is not recommended for patients with wounds that extend beyond the superficial layers of the skin. Healthcare professionals should advise patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction develop, as these symptoms may indicate a serious underlying condition.

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 indicate a serious condition.

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 for Georgia Pacific (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 ensure that the product is kept out of reach of children to prevent accidental exposure.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in the context of premature infants or infants under 2 months of age. There is a potential risk of irritation or chemical burns associated with the use of this product in these vulnerable populations. Healthcare professionals are encouraged to weigh the benefits against the risks when considering the use of this product in pregnant patients, especially those who may be at risk of exposure to premature or very young infants.

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

There is no specific information available 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 context of overdosage, it is important to note that there is no specific information available regarding overdosage in the current drug insert. Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose, even in the absence of detailed guidance.

In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any adverse effects or symptoms that may arise. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

Given the lack of specific overdosage information, healthcare professionals are encouraged to consult local poison control centers or relevant medical authorities for guidance on management strategies tailored to the individual case. Continuous assessment and appropriate interventions are essential to ensure patient safety and mitigate any potential risks associated with overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which may 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 the Poison Control Center if the product is swallowed. It is essential to inquire whether the patient has a known allergy to chlorhexidine gluconate or any other ingredients contained in the product.

Patients should be informed to keep the product away from the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these sensitive areas, patients should rinse thoroughly with cold water without delay.

Healthcare providers should caution patients against routine use of the product if they have wounds that extend beyond the superficial layers of the skin. Additionally, patients should be instructed to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition.

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 exercise caution when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. Patients should be advised to discontinue use and seek medical assistance immediately if an allergic reaction occurs. Additionally, it is important to keep the product out of reach of children; if ingested, medical help or contact with a Poison Control Center should be sought promptly.

Drug Information (PDF)

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

View product document (PDF)