Bactoshield Chg

Description

Bactoshield® is a surgical scrub containing 4% chlorhexidine gluconate (CHG) as its active ingredient. This solution antiseptic is formulated for antimicrobial use, providing effective skin cleansing prior to surgical procedures. The product is available in a net volume of 32 fluid ounces (946 mL). The National Drug Code (NDC) for Bactoshield® is 11084-039-24.

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 suitable for skin wound and general skin cleansing.

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

Dosage and Administration

Surgical hand scrubbing 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. An additional wash with 5 mL of the product is then required, lasting for another 3 minutes, after which the operator should rinse under running water and dry thoroughly.

For healthcare personnel handwashing, the process begins with wetting the hands with water. About 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for 15 seconds. After this, the hands must be rinsed and dried thoroughly.

In the case of skin wound and general skin cleansing, the area to be cleaned should be thoroughly rinsed with water. The minimum amount of product necessary to adequately cover the skin or wound area should then be applied, followed by gentle washing. A thorough rinse is required once again to ensure complete removal of the product.

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, as it may lead to severe allergic reactions.

The product must not be applied in contact with the meninges due to the risk of serious complications.

Additionally, use in the genital area is contraindicated to prevent potential adverse effects.

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.

This product should not be used by individuals who are allergic to chlorhexidine gluconate or any other component of the formulation. Additionally, it is contraindicated for use in contact with the meninges or in the genital area.

When utilizing this product, it is crucial to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it must be rinsed out promptly and thoroughly with 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 is discouraged unless specifically advised by a healthcare provider.

Users should discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. It is essential to keep this 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 recommended.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious. A severe allergic reaction is a notable concern, with symptoms that may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. It is imperative that individuals who are allergic to chlorhexidine gluconate or any other ingredient in this product refrain from its use.

In addition to allergic reactions, there are specific risks associated with the improper use of this product. If the product enters the eye, it may cause serious and permanent eye injury. Furthermore, 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 signs of an allergic reaction, 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 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 should be monitored closely when using this medication, particularly those who are premature infants or infants under 2 months of age. The formulation may pose a risk of irritation or chemical burns in this vulnerable population.

While specific dosage adjustments for geriatric patients are not provided, caution is advised due to the potential for increased sensitivity and adverse reactions in this age group. Healthcare providers are encouraged to assess the individual needs and health status of elderly patients to ensure safe and effective use of the medication. Regular monitoring for any signs of irritation or adverse effects is recommended to mitigate risks associated with treatment.

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, and no dosage modifications are recommended for this population. Additionally, there are no special precautions regarding the use of this medication during pregnancy. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to women of childbearing potential and during pregnancy, as individual circumstances may vary.

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 drug. 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, 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 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 these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of allergic reactions, including anaphylaxis, have been documented. Serious allergic reactions such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash have also been reported. Additionally, cases of chemical burns and irritation in premature infants and infants under 2 months of age have been noted. 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.

Patients should be informed to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these 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 or potential deafness if the solution enters the middle ear through perforated eardrums. If the solution comes into contact with these areas, patients should rinse thoroughly and promptly with water.

Additionally, patients should be cautioned that wounds involving more than the superficial layers of the skin should not be treated routinely with this product. Repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)