Bactoshield Chg

Description

Bactoshield® is a surgical scrub containing 4% chlorhexidine gluconate (CHG) as its active ingredient. This solution serves as an antiseptic with antimicrobial properties, designed for use in surgical settings. The product is presented in a net volume of 946 mL (32 fl oz).

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, assisting in the reduction of bacteria that may potentially cause disease. Additionally, this drug serves as a skin wound and general skin cleanser, helping to reduce bacteria on the skin.

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 should be used at full strength and must not be diluted.

For surgical hand scrubbing, the following procedure should be adhered to:

1. Remove all jewelry prior to the procedure.

2. Wet hands and forearms with water.

3. Apply 5 mL of the product to the hands and forearms.

4. Scrub hands and forearms for a duration of 3 minutes, ensuring thorough attention to the nails, cuticles, and interdigital spaces.

5. Rinse thoroughly with water.

6. Repeat the scrubbing process with an additional 5 mL of the product for another 3 minutes, followed by rinsing under running water.

7. Dry hands and forearms thoroughly.

For healthcare personnel handwashing, the following steps should be followed:

1. Wet hands with water.

2. Dispense approximately 5 mL of the product into cupped hands.

3. Wash hands vigorously for 30 seconds.

4. Rinse hands thoroughly and dry completely.

For skin wound cleansing and general skin cleansing, the procedure is as follows:

1. Thoroughly rinse the area to be cleansed with water.

2. Apply the minimum amount of product necessary to cover the skin or wound area and wash gently.

3. Rinse thoroughly with water.

4. Rinse the area again thoroughly to ensure complete removal of the product.

Contraindications

Use of this preparation 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. Additionally, it is contraindicated for use as a preoperative skin preparation, particularly on the head or face, due to the risk of adverse reactions. Contact with the meninges is also contraindicated, as it may lead to serious complications. Furthermore, application in the genital area is not recommended.

Warnings and Precautions

For external use only, this product carries the potential 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 using this product. It should not be utilized by individuals with known allergies to chlorhexidine gluconate or any other components of the formulation. The product is contraindicated for use as a patient preoperative skin preparation, particularly on the head or face, and should not come into contact with the meninges or be applied to the genital area.

When applying this product, care must be taken to avoid contact with the eyes, ears, and mouth, as it may cause serious and permanent eye injury if introduced into the eye during surgical procedures. Additionally, instillation into the middle ear through perforated eardrums may result in deafness. Should contact with these areas occur, it is essential to rinse immediately with cold water. Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product. Furthermore, repeated general skin cleansing of large body areas should be avoided unless necessitated by an underlying condition that requires a reduction in the bacterial population of the skin.

In cases of ingestion, immediate medical help should be sought, or contact with a Poison Control Center is advised. Users should discontinue use and consult a physician if irritation, sensitization, or allergic reactions occur and persist for 72 hours, as these may indicate a serious condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Notably, there is a risk of severe allergic reactions, which can manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. Individuals with a known allergy to chlorhexidine gluconate or any other ingredient in this preparation should not use this product.

During the use of this product, there is a potential for serious and permanent eye injury if the product is placed or retained in the eye during surgical procedures. Additionally, instillation in the middle ear through perforated eardrums may lead to deafness.

Patients are advised to discontinue use and consult a healthcare professional if they experience irritation, sensitization, or any allergic reaction that persists for 72 hours, as these symptoms may indicate a serious condition.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Bactoshield Chg (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. 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 may exhibit increased sensitivity to side effects when using this medication, necessitating careful consideration during treatment. Although no specific dosage adjustments are recommended for geriatric patients, it is essential to monitor this population closely for any signs of irritation, sensitization, or allergic reactions, as these adverse effects may be more pronounced in elderly individuals. Regular assessment and vigilance are advised to ensure the safety and well-being of geriatric patients receiving this therapy.

Pregnancy

The safety of this product during pregnancy has not been established. While there are no specific contraindications for use in pregnant patients, caution is advised. It is recommended that pregnant individuals consult a healthcare provider before using this product to ensure that potential risks are adequately assessed and managed.

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 these vulnerable populations. It is advisable for healthcare professionals to closely monitor breastfed infants for any adverse effects when this product is used by lactating mothers.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis, and various skin reactions, including rash, pruritus, and dermatitis. Additionally, reports of serious skin reactions, including chemical burns and irritation, have been documented.

Hypersensitivity reactions have also been noted, with cases of angioedema and urticaria reported. Furthermore, instances of eye injury have occurred when the product was used improperly, resulting in serious and permanent damage. There are also reports suggesting that the product may cause ototoxicity when administered in the middle ear through perforated eardrums.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, defined as temperatures above 104°F (40°C). For further details regarding safety and handling, please refer to the Safety Data Sheet (SDS).

Additional Clinical Information

Patients should be advised to discontinue use and seek medical assistance immediately if an allergic reaction occurs. Additionally, if irritation, sensitization, or an allergic reaction persists for 72 hours, patients are encouraged to consult a healthcare professional, as these symptoms may indicate a serious condition. In the event of accidental ingestion, it is crucial to obtain medical help or contact a Poison Control Center without delay.

Drug Information (PDF)

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

View product document (PDF)