Bactoshield Chg

Description

Bactoshield® is a surgical scrub containing 2% chlorhexidine gluconate (CHG) as its active ingredient. This antiseptic solution exhibits antimicrobial properties, making it suitable for use in surgical settings. The product is presented in a net volume of 118 mL (4 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, aiding 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 is to 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.

2. Wet hands and forearms with water.

3. Apply 5 mL of the product.

4. Wash and scrub hands and forearms for 3 minutes, ensuring thorough attention to nails, cuticles, and interdigital spaces.

5. Rinse thoroughly with water.

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

7. Dry hands and forearms thoroughly.

For healthcare personnel handwashing, the procedure is as follows:

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 and dry hands thoroughly.

For skin wound cleansing and general skin cleansing, the following steps should be taken:

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 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 due to the risk of severe allergic reactions.

This product is not to be used as a preoperative skin preparation, particularly on the head or face, as it may pose risks associated with surgical procedures.

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

Additionally, the use of this preparation in the genital area is contraindicated due to potential adverse effects.

Warnings and Precautions

For external use only. This product carries an allergy alert, as it may induce a severe allergic reaction. Symptoms of such a 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.

This product should not be used in the following circumstances:

• In individuals with a known allergy to chlorhexidine gluconate or any other component of this formulation.

• As a preoperative skin preparation, particularly on the head or face.

• In contact with the meninges.

• In the genital area.

When utilizing this product, it is crucial 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 occur, it is essential to rinse the affected area with cold water immediately.

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 is discouraged unless necessitated by an underlying condition that requires a reduction in the bacterial population of the skin.

Users should discontinue use and consult a physician if irritation, sensitization, or an allergic reaction persists for 72 hours, as these may indicate a serious condition. It is also important to keep this product out of reach of children. In the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Side Effects

This product may cause a severe allergic reaction in some patients. Symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients should discontinue use immediately and seek medical assistance.

Patients should not use this product if they are allergic to chlorhexidine gluconate or any other ingredient in the formulation. Additionally, it is contraindicated for use as a preoperative skin preparation, particularly on the head or face, and should not come into contact with the meninges or be applied in the genital area.

When using this product, it is crucial to avoid contact with the eyes, ears, and mouth, as this may lead to serious and permanent eye injury if the product is placed or retained in the eye during surgical procedures. Furthermore, instillation in the middle ear through perforated eardrums may result in deafness. Should contact occur, patients are advised to rinse the affected area with cold water immediately. Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product, and repeated general skin cleansing of large body areas should be avoided unless necessary to reduce the bacterial population due to an underlying condition.

Patients should stop using the product and consult a healthcare professional if irritation, sensitization, or an allergic reaction occurs and persists for 72 hours, 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 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 should be monitored closely when using this medication, particularly those who are premature infants or infants under 2 months of age. The use of this product in these populations may lead to irritation or chemical burns. Caution is advised, and healthcare providers should consider the potential risks associated with its use in these vulnerable groups. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in 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 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 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

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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available 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, 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 effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

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

There have also been cases of eye injury associated with accidental introduction of the product into the eyes. Furthermore, instances of ototoxicity have been reported in patients with perforated eardrums following the use of the product.

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.

Patients should be informed to discontinue use and consult a doctor if they experience irritation, sensitization, or an allergic reaction that persists for 72 hours, as these symptoms may indicate a serious condition.

When using this product, it is crucial to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury if the product is placed or retained in the eye during surgical procedures, or may result in deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these areas, patients should rinse with cold water immediately.

Healthcare providers should also caution patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Additionally, repeated general skin cleansing of large body areas should be avoided unless an underlying condition necessitates a reduction in the bacterial population of the skin.

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 aware that the product must be used with caution in premature infants or those under 2 months of age, as it may cause irritation or chemical burns. It is important to use the product at full strength without dilution. For surgical hand scrubs, clinicians should instruct patients to remove jewelry, wet hands and forearms, apply 5 mL of the product, scrub for 3 minutes focusing on nails and interdigital spaces, rinse thoroughly, and repeat the process. For healthcare personnel handwashing, a vigorous wash for 30 seconds with 5 mL of the product is recommended, followed by thorough rinsing and drying. When used as a skin wound or general skin cleanser, the area should be rinsed with water, the minimum amount of product applied, gently washed, and rinsed thoroughly.

Patient counseling should emphasize the importance of keeping the product away from the eyes, ears, and mouth, as contact can lead to serious injuries, including permanent eye damage or deafness. Patients should be advised to discontinue use and consult a doctor if irritation, sensitization, or allergic reactions occur and persist for 72 hours, as these may indicate a serious condition. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

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.

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