Readyprep Chg

Description

The product consists of a combination of two cloths, identified by the label "Label V1 RK21MSC."

Uses and Indications

This drug is indicated for the reduction of bacteria that can potentially cause skin infections. It is also indicated for the preparation of the skin prior to surgical procedures.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals 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.

The product and packaging are not sterile; therefore, it is essential to adhere to hospital policies regarding skin preparation with non-sterile products.

To open the package, locate the tear notch labeled on the front. Grasp the package with both hands on either side of the tear notch and tear to expose the cloth. Transfer the contents onto a preparation table, ensuring that the cloth does not come into contact with the outside of the package to minimize the risk of contamination.

For skin preparation, utilize the first cloth to cleanse the designated area for either a moist or dry site, while keeping the remaining cloths uncontaminated. For dry surgical sites, such as the abdomen or arm, use one cloth to cleanse each area of 161 cm² (approximately 5 x 5 inches). Vigorously scrub the skin back and forth for 3 minutes, ensuring the treatment area is completely wet, then discard the cloth. Allow the area to dry for one minute without rinsing.

For moist surgical sites, such as the inguinal fold, use one cloth to cleanse each area of 65 cm² (approximately 2 x 5 inches). Again, scrub the skin back and forth for 3 minutes, ensuring complete wetting of the treatment area, then discard the cloth. Allow the area to dry for one minute without rinsing.

Each cloth is intended for single use only and must be discarded after use. Any unused cloths should be discarded after the package has been opened. Microwaving the product is strictly prohibited.

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 allergic reactions.

The product is contraindicated for use in lumbar punctures or in contact with the meninges, as it may pose a risk of serious complications.

Application on open skin wounds is not recommended, as it may lead to irritation or infection.

Additionally, this product should not be used as a general skin cleanser, as it is not formulated for that purpose.

Warnings and Precautions

For external use only. This product carries a significant risk of severe allergic reactions. Symptoms indicative of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

General precautions must be observed when administering this product. It is contraindicated in patients with known allergies to chlorhexidine gluconate or any other component of the formulation. The product should not be utilized for lumbar punctures or in any manner that may involve contact with the meninges. Additionally, it is not suitable for application on open skin wounds and should not be employed as a general skin cleanser.

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 underlying condition.

In cases of accidental ingestion, immediate medical attention is required. Contact a Poison Control Center without delay. While using this product, it is crucial to avoid contact with the eyes, ears, and mouth, as chlorhexidine can cause serious or permanent injury if it enters these areas. Should contact occur, the affected area should be rinsed thoroughly with cold water, and a physician should be contacted promptly.

Side Effects

Patients using this product should be aware that it is intended for external use only. There is a potential for severe allergic reactions, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

This product should not be used in patients with a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation. It is contraindicated for use in lumbar punctures, in contact with the meninges, on open skin wounds, or as a general skin cleanser.

Patients are instructed to stop using the product and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition.

While using this product, it is crucial to avoid contact with the eyes, ears, and mouth, as chlorhexidine can cause serious or permanent injury if it enters these areas. Should contact occur, patients should rinse the affected area with cold water immediately and seek medical advice.

Additionally, this product should be kept out of reach of children. If ingested, it is imperative to obtain medical help or contact a Poison Control Center without delay.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Readyprep Chg (chlorhexidine gluconate 2%). 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 or under 2 months of age, as these populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates careful consideration and management in these vulnerable groups.

Healthcare providers are advised to exercise caution and ensure appropriate monitoring when prescribing this medication to geriatric patients, taking into account their overall health status and any comorbid conditions that may affect treatment outcomes.

Pregnancy

The product has not been specifically studied in pregnant patients, and there are no detailed safety concerns regarding its use during pregnancy. Current data does not indicate any need for dosage modifications for pregnant individuals. Additionally, no special precautions are outlined for the use of this product in pregnant patients. Healthcare professionals should consider the available information and weigh the potential benefits against any unknown risks when prescribing this product to women of childbearing potential.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 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 through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to inform patients not to use this product if they are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. Additionally, patients should be cautioned against using the product for lumbar punctures or in contact with the meninges, as well as on open skin wounds. This product is not intended for use as a general skin cleanser.

Patients should be made aware that if they experience irritation, sensitization, or any signs of an allergic reaction while using the product, they should stop use and consult a doctor, as these symptoms may indicate a serious condition.

Furthermore, healthcare providers should emphasize the importance of avoiding contact with the eyes, ears, and mouth during use. Patients should be informed that chlorhexidine can cause serious or permanent injury if it enters these areas and remains. In the event of contact, patients should rinse the affected area with cold water immediately and seek medical attention.

Storage and Handling

The product is supplied in a configuration that requires careful storage to maintain its integrity. It should be stored flat to prevent any potential damage. The recommended storage temperature range is between 20-25°C (68-77°F). It is essential to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), as this may compromise the product's quality. Proper handling and adherence to these storage conditions are crucial for ensuring the product remains effective and safe for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)