Scrub-Stat

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for use as a surgical hand scrub, significantly reducing the number of microorganisms on the hands and forearms prior to surgical procedures or patient care. Additionally, it serves as a handwash for healthcare personnel, aiding in the reduction of bacteria that may potentially cause disease.

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

Dosage and Administration

Surgical hand scrubbing requires the following steps to ensure effective antisepsis. Healthcare professionals should first remove all jewelry. Hands and forearms must be wetted with water before dispensing 6 pumps (5 mL) of the product onto the hands. A thorough wash or scrub of the hands and forearms should be performed for a duration of 3 minutes, with particular attention given to the nails, cuticles, and interdigital spaces. Following this initial scrub, the hands and forearms should be rinsed thoroughly with water.

An additional wash is then required, utilizing another 6 pumps (5 mL) of the product. This second scrub should also last for 3 minutes, after which the hands and forearms must be rinsed under running water. Finally, it is essential to dry the hands and forearms thoroughly.

For healthcare personnel handwashing, the process begins with wetting the hands with water. After wetting, 6 pumps (5 mL) of the product should be dispensed into the hands. A vigorous wash should be conducted for 30 seconds, followed by a thorough rinse and drying of the hands.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other components of the formulation. Additionally, the product should not be used routinely in patients with wounds that extend beyond the superficial layers of the skin, due to the potential for adverse effects in deeper tissue.

Warnings and Precautions

For external use only. This product carries a significant risk of causing severe allergic reactions. Symptoms indicative of an allergic reaction 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 to ensure safe use. The product should be kept out of the eyes, ears, and mouth, as contact 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 essential to rinse the affected area with cold water without delay. Additionally, routine use is not recommended for individuals with wounds that extend beyond the superficial layers of the skin.

In cases of ingestion, immediate medical help should be sought, or the local Poison Control Center should be contacted.

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.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product.

Severe allergic reactions have been reported, which may manifest as symptoms including wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

It is important to note that this product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredients contained within the formulation.

During the use of this product, patients should take precautions 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. Should contact occur, it is recommended to rinse the affected area with cold water promptly.

Patients are also advised to discontinue use and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition. Additionally, routine use of this product is not recommended for wounds that extend beyond the superficial layers of the skin.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Scrub-Stat (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 be treated with caution. The use of these products in this population may lead to irritation or chemical burns. It is essential for healthcare professionals to monitor these patients closely to mitigate potential risks associated with their use.

Geriatric Use

There is no specific information regarding the use of SCRUB-STAT (chlorhexidine gluconate solution) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this medication to elderly patients, as the absence of data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any comorbidities of geriatric patients prior to use, given the lack of established guidelines for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy. Currently, there are no statements indicating contraindications or risks to the fetus associated with its use in pregnant patients. Additionally, no dosage modifications are recommended for individuals who are pregnant, and no special precautions have been noted for the use of this medication in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the 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 potential for severe allergic reactions associated with this product. Reported symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is advised to discontinue use immediately and seek medical assistance. Additionally, users are instructed to stop use and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition.

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.

When using this product, it is important to emphasize that patients must avoid contact with the eyes, ears, and mouth. Inform patients that exposure to the eyes may result in serious and permanent injury, and instillation in the middle ear through perforated eardrums may lead to deafness. If contact occurs, patients should rinse the affected area with cold water immediately.

Additionally, healthcare providers should caution patients against routine use of this product if they have wounds that extend beyond the superficial layers of the skin.

Patients should be advised to stop using the product and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these 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, defined as temperatures above 104°F (40°C). Additionally, the product must be protected from freezing to maintain its integrity and efficacy. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

The product is intended for topical administration only. Clinicians should counsel patients that it is for external use and may cause severe allergic reactions, which can manifest as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. Patients are advised to discontinue use and seek medical assistance immediately if any allergic reaction occurs.

It is crucial to instruct patients to avoid contact with the eyes, ears, and mouth, as this may lead to serious and permanent eye injury or deafness if introduced into the middle ear through perforated eardrums. In the event of contact, patients should rinse the affected area with cold water immediately. Additionally, the product should not be used on wounds that extend beyond the superficial layers of the skin. Patients should stop use and consult a doctor if they experience irritation, sensitization, or any allergic reactions, as these may indicate a serious condition. The product should be kept out of reach of children, and if ingested, medical help or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)