Betasept

Description

BETASEPT® is an antiseptic non-sterile surgical scrub containing 4% chlorhexidine gluconate. It is available in multiple formulations with net contents of 4 fl oz (118 mL), 8 fl oz (237 mL), 16 fl oz (473 mL), and 32 fl oz (946 mL). All formulations are distributed by Atlantis Consumer Healthcare Inc., located in Bridgewater, NJ 08807, USA.

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. It is also indicated for healthcare personnel handwashing, aiding in the reduction of bacteria that may potentially cause disease. Additionally, this drug is utilized for patient preoperative skin preparation, ensuring the skin is adequately prepared prior to surgery. Furthermore, it is indicated for skin wound care and general skin cleansing.

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

Dosage and Administration

Surgical hand scrub requires the operator to first wet their hands and forearms with water. Approximately 5 mL of the product should be used in conjunction with a wet brush to scrub for a duration of 3 minutes, ensuring meticulous attention is given to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, the hands and forearms must be rinsed thoroughly. The process should be completed with an additional wash using 5 mL of the product for another 3 minutes, followed by rinsing under running water. It is essential to dry the hands and forearms thoroughly after the final rinse.

For healthcare personnel handwashing, the hands should be wetted with water before dispensing approximately 5 mL of the product into cupped hands. The hands must be washed vigorously for a minimum of 15 seconds, followed by thorough rinsing and drying.

In the case of patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for at least 2 minutes and then dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with another sterile towel.

For skin wound and general skin cleansing, the area to be cleaned should first be thoroughly rinsed with water. The minimum amount of product necessary to cover the skin or wound area should then be applied, followed by gentle washing. A final thorough rinse is required to complete the cleansing process.

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.

Contact with the meninges is contraindicated, as it may lead to serious complications.

Application in the genital area is not recommended, as it may cause irritation or adverse effects.

Additionally, this product should not be used as a preoperative skin preparation for the head or face, to avoid potential complications associated with its use in these sensitive areas.

Warnings and Precautions

For external use only. Healthcare professionals should be aware that 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 without delay.

In cases where the product is ingested, emergency medical help should be sought promptly, or the Poison Control Center should be contacted for guidance.

Healthcare providers should advise patients to discontinue use and consult their physician if any signs of irritation, sensitization, or allergic reaction occur, as these symptoms may indicate a serious underlying condition. Monitoring for these adverse effects is essential to ensure patient safety and appropriate management.

Side Effects

Patients should be aware that this product is for external use only. There is a significant risk of severe allergic reactions associated with its use. Symptoms of such reactions may include 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.

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

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Betasept (antiseptic surgical scrub), the U.S. brand-name prescription product. 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 closely monitor these patients to mitigate potential risks associated with their use.

Geriatric Use

There is no specific information available 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, given the lack of targeted data for this population.

Pregnancy

The use of this medication during pregnancy has not been specifically addressed in the available data. There are no explicit safety concerns noted for pregnant patients, nor are there any dosage modifications recommended for this population. Additionally, the prescribing information does not indicate any special precautions that should be taken when administering this medication to pregnant individuals. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to women of childbearing potential and during pregnancy, as the absence of specific data does not imply safety or efficacy.

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 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, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that standard supportive measures be employed. This includes ensuring the patient's safety, providing symptomatic treatment, and considering consultation with a poison control center or a medical toxicologist for further guidance.

Healthcare providers should remain vigilant and document any observed symptoms or patient responses, as this information may be valuable for future assessments and recommendations.

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 cases of an allergic reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, users are cautioned to stop use and consult a healthcare professional if signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. The product should be used with caution in premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns.

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 crucial to inform patients to avoid contact with the eyes, ears, and mouth, as exposure to these areas may lead to serious and permanent eye injury or deafness, particularly if the solution is instilled in the middle ear through perforated eardrums.

In the event of accidental contact with the eyes, ears, or mouth, patients should be instructed to rinse the affected area promptly and thoroughly with water. Providers should also emphasize that wounds involving more than the superficial layers of the skin should not be routinely treated with this product.

Patients should be cautioned against repeated general skin cleansing of large body areas unless specifically advised by a healthcare provider. Additionally, they should be made aware of the potential for irritation, sensitization, or allergic reactions, which may indicate a serious condition requiring medical attention.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, as temperatures above 40°C (104°F) may compromise the integrity of the product. Proper storage conditions are essential to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Betasept as submitted by Xttrium Laboratories, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)