Chlorhexidine gluconate

Uses and Indications

This drug is indicated for the following uses:

Surgical Hand Scrub

• Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.

Healthcare Personnel Handwash

• Helps reduce bacteria that potentially can cause disease.

Skin Wound and General Skin Cleansing

• Assists in reducing bacteria on the skin for wound care and general cleansing.

Patient Preoperative Skin Preparation

• For the preparation of the patient's skin prior to surgery.

Limitations of Use

• No teratogenic or nonteratogenic effects have been mentioned for this drug.

Dosage and Administration

Healthcare professionals should exercise caution when using these products in premature infants or infants under 2 months of age, as they may cause irritation or chemical burns.

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

1. Wet hands with water.

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

3. Wash hands vigorously for 15 to 30 seconds.

4. Rinse thoroughly and dry hands completely.

For surgical hand scrubbing, the procedure is as follows:

1. Remove jewelry.

2. Wet hands and forearms with water.

3. Apply 5 mL of the product.

4. Scrub hands and forearms for 3 minutes, paying particular attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be used.

5. Rinse thoroughly with water.

6. Wash for an additional 3 minutes with 5 mL of the product and rinse under running water.

7. Dry thoroughly.

For patient preoperative skin preparation, the following steps should be taken:

1. Apply the product liberally to the surgical site.

2. Swab the area for at least 2 minutes and dry with a sterile towel.

3. Repeat the procedure for an additional 2 minutes and dry with a sterile towel.

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

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

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

3. Rinse again thoroughly.

These instructions ensure effective cleansing and preparation while minimizing the risk of irritation or adverse reactions.

Contraindications

Do not use if allergic to chlorhexidine gluconate or any other ingredient in this product. Use is contraindicated in patients with known allergies to chlorhexidine gluconate.

Do not use in contact with meninges, as this may lead to serious complications.

Use is also contraindicated in the genital area due to the potential for irritation and adverse effects.

Do not use as a preoperative skin preparation, particularly on the head or face, to avoid complications associated with surgical procedures.

Additionally, do not use if there are wounds that involve more than the superficial layers of the skin, as this may increase the risk of adverse reactions.

Keep out of eyes, ears, and mouth; contact with these areas may cause serious and permanent injury, including potential deafness if instilled in the middle ear through perforated eardrums.

If the solution contacts these areas, rinse out promptly and thoroughly with water.

Warnings and Precautions

For external use only. This product may cause a severe allergic reaction. Symptoms may include:

• Wheezing/difficulty breathing

• Shock

• Facial swelling

• Hives

• Rash

If an allergic reaction occurs, stop use and seek medical help right away.

General Precautions

• Do not use if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product.

• Do not use in contact with meninges.

• Do not use in the genital area.

• Do not use as a preoperative skin preparation (especially on the head or face).

• Keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums. If solution should contact these areas, rinse out promptly and thoroughly with water.

• Wounds which involve more than the superficial layers of the skin should not be routinely treated.

• Repeated general skin cleansing of large body areas should not be done except when advised by a health care provider.

Stop Use and Call Your Doctor

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Get Emergency Medical Help

If swallowed, get medical help or contact a Poison Control Center right away.

Additional Warning

This product can expose you to a chemical known to the State of California to cause cancer. For more information, visit www.P65Warnings.ca.gov.

Side Effects

Patients using chlorhexidine gluconate products may experience a range of adverse reactions, which can vary in severity. The following outlines the potential adverse reactions categorized by seriousness and frequency.

Serious Adverse Reactions

• Severe Allergic Reactions: This product may cause a severe allergic reaction, with symptoms including:

  • Wheezing or difficulty breathing

  • Shock

  • Facial swelling

  • Hives

  • Rash

  • If an allergic reaction occurs, patients should stop use and seek medical help immediately.

Eye and Ear Injuries

• Eye Injury: May cause serious and permanent eye injury if permitted to enter and remain in the eye.

• Ear Injury: May cause deafness when instilled in the middle ear through perforated eardrums.

Other Warnings

• Irritation and Sensitization: Patients should stop use and consult a doctor if irritation, sensitization, or allergic reactions occur, as these may indicate a serious condition.

Contraindications

• The product should not be used if the patient is allergic to chlorhexidine gluconate or any other ingredient in the formulation.

• It should not be used in contact with the meninges or in the genital area.

• It is not recommended for use as a preoperative skin preparation, especially on the head or face.

Additional Notes

• If swallowed, patients should get medical help or contact a Poison Control Center immediately.

• Repeated general skin cleansing of large body areas should not be performed unless advised by a healthcare provider.

Summary of Adverse Reactions

• Common Symptoms: Allergic reactions (wheezing, shock, facial swelling, hives, rash).

• Serious Risks: Eye and ear injuries, severe allergic reactions.

• Consultation Required: If irritation or sensitization occurs, or if the product is ingested.

Patients are advised to follow all usage instructions carefully and to be aware of the potential for serious adverse reactions associated with chlorhexidine gluconate products.

Drug Interactions

The reviewed products, including various antiseptic skin cleansers and solutions, do not present any documented drug interactions. Across all labels, there is a consistent absence of information regarding interactions with other drugs or laboratory tests.

The following products were evaluated:

• Foster and Thrive (Solution)

• Antiseptic Skin Cleanser (Liquid)

• Scrub-Stat (Solution)

• Bactoshield Chg (Solution)

• Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (Solution)

• Chlorhexidine Gluconate (Gel and Cloth)

• Dyna-Hex (Liquid)

• Bd E-Z Scrub 107 (Solution)

• Betasept (Solution)

• Foaming Hand Wash (Liquid)

• Cliniclean (Solution)

For all these products, no drug interactions or laboratory test interactions have been reported, indicating a lack of known pharmacokinetic or pharmacodynamic interactions. Therefore, healthcare professionals can consider these products as having no significant interaction concerns based on the available data.

Pediatric Use

Pediatric patients, particularly premature infants or those under 2 months of age, should be treated with caution when using these products, as they may cause irritation or chemical burns.

It is essential to keep these products out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact a Poison Control Center right away.

Geriatric Use

Elderly patients may require careful consideration when using certain antiseptic solutions, particularly those indicated for use in premature infants or infants under 2 months of age, as these products may cause irritation or chemical burns. However, there is no specific information regarding dosage adjustments, safety concerns, or special precautions for geriatric patients provided in the inserts for several products, including chlorhexidine gluconate solutions and other antiseptic skin cleansers.

Healthcare professionals should monitor elderly patients closely for any adverse reactions when using these products, given the lack of detailed geriatric-specific data. It is advisable to exercise caution and consider individual patient factors when administering these solutions to the elderly population.

Pregnancy

The safety of chlorhexidine gluconate during pregnancy has not been established. It is contraindicated in pregnant patients due to potential risks to the fetus. Healthcare providers are advised to approach the use of chlorhexidine gluconate with caution in this population. Pregnant patients or those planning to become pregnant should consult their healthcare provider before using products containing chlorhexidine gluconate.

While some sources do not specify contraindications or risks to the fetus, the general recommendation is to weigh the potential benefits against the risks before use. No specific dosage modifications for pregnant individuals are indicated in the available data. Therefore, healthcare providers should exercise clinical judgment when considering the use of chlorhexidine gluconate in pregnant patients.

Lactation

Lactating mothers should exercise caution when using products containing chlorhexidine gluconate or similar antiseptic solutions, particularly in the context of premature infants or those under 2 months of age. These products have been associated with potential irritation or chemical burns in this vulnerable population.

Currently, there are no specific warnings or precautions regarding the use of chlorhexidine gluconate solutions in nursing mothers, and no information is available concerning the excretion of these substances in breast milk or any associated risks to breastfed infants. However, due to the potential for irritation, healthcare providers should advise lactating mothers to use these products judiciously and monitor for any adverse effects in their infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, monitoring requirements, or safety considerations outlined for the majority of products reviewed. Notably, the only exception is for Hibiclens, which indicates that dosage adjustments may be necessary for patients with reduced renal function. It is recommended to monitor renal function tests regularly in these patients, particularly for those with a creatinine clearance of less than 30 mL/min, where a reduced dose should be considered.

For all other products, including various antiseptic solutions and cleansers, there is no provided information regarding renal impairment. Therefore, healthcare professionals should exercise caution and consider individual patient circumstances when prescribing these products to patients with known kidney problems, as the lack of specific guidance may necessitate a more conservative approach.

Hepatic Impairment

Patients with hepatic impairment do not have specific dosage adjustments, special monitoring, or precautions outlined in the drug inserts for the following products: Chlorhexidine Gluconate Solution 0.75% Antiseptic, Foster and Thrive, Dyna-Hex 4, Dyna-Hex 2, Antiseptic Skin Cleanser, Cardinal Health, Scrub-Stat, Halyard Chlorhexidine Gluconate, Hibiclens, Provon Antimicrobial Foam Handwash, and various formulations of Bactoshield Chg and Maxiclens Chlorhexidine Gluconate Liquid Solution.

The absence of information regarding hepatic impairment suggests that no alterations in dosing or monitoring are required for patients with liver problems when using these products. However, healthcare providers should exercise clinical judgment and consider individual patient circumstances when administering these products to patients with hepatic impairment.

Overdosage

In the event of an overdose, immediate medical attention is essential. If any of the products listed are swallowed, it is crucial to seek medical help or contact a Poison Control Center without delay. Symptoms of overdose may vary, but prompt intervention is necessary to mitigate potential adverse effects.

All users are advised to keep these products out of reach of children to prevent accidental ingestion. In case of ingestion, the following actions are recommended:

• Contact a Poison Control Center or seek medical assistance immediately.

• Monitor for any unusual symptoms that may arise following ingestion.

It is important to note that while some products do not provide specific overdosage information, the general recommendation remains to seek medical help if swallowed.

Nonclinical Toxicology

Teratogenic Effects

No information regarding teratogenic effects is provided in the inserts for the products reviewed.

Non-Teratogenic Effects

No information regarding non-teratogenic effects is provided in the inserts for the products reviewed.

Nonclinical Toxicology

No relevant information is available in the inserts concerning nonclinical toxicology for the products reviewed.

Animal Pharmacology and Toxicology

No information regarding animal pharmacology and toxicology is provided in the inserts for the products reviewed.

Storage and Handling

Chlorhexidine Gluconate Solution 0.75% Antiseptic, Foster and Thrive, Dyna-Hex 4, Dyna-Hex 2, Antiseptic Skin Cleanser, Cardinal Health, Scrub-Stat, Hibiclens, Bactoshield Chg, and other similar products are supplied in various forms including solutions and liquids.

All products should be stored at a temperature range of 20-25°C (68-77°F). It is crucial to avoid exposure to excessive heat above 40°C (104°F). Additionally, some products, such as Dyna-Hex 4 and certain Antiseptic Skin Cleansers, are designated for single use only and should be discarded when empty.

For specific products like Chlorhexidine Gluconate and Bactoshield Chg, it is also important to keep them from freezing. When handling cloth forms, such as Chlorhexidine Gluconate Cloth, they should be stored flat to maintain their integrity.

In summary, maintaining the recommended storage conditions is essential for ensuring the efficacy and safety of these antiseptic solutions and cleansers.