Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%

Description

No description information is available for the specified drug.

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

For surgical hand scrubbing, the following procedure should be followed:

1. Remove all jewelry.

2. Wet hands and forearms with water.

3. Apply 5 mL of the product and scrub hands and forearms for 3 minutes, ensuring to pay particular attention to the nails, cuticles, and interdigital spaces.

4. Rinse thoroughly with water.

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

6. 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.

When using the product as a skin wound and general skin cleanser, the following steps should be adhered to:

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, to avoid potential complications associated with surgical procedures.

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

Additionally, the use of this preparation in the genital area is contraindicated to prevent irritation or other adverse reactions.

Warnings and Precautions

For external use only. This product carries a significant risk of causing 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.

Individuals with known allergies to chlorhexidine gluconate or any other component of this formulation should refrain from using this product. It 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. Additionally, this product is not intended for use in the genital area.

Healthcare professionals should advise patients to discontinue use and consult a physician if any irritation, sensitization, or allergic reaction occurs and persists for 72 hours, as these symptoms may indicate a serious underlying condition.

In cases of ingestion, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Notably, there is a significant allergy alert, as the product has the potential to cause severe allergic reactions. 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.

In addition to the severe allergic reactions, patients should also be aware of the possibility of irritation, sensitization, or allergic reactions that persist for 72 hours. The persistence of these symptoms may indicate a serious condition, and patients are encouraged to consult a healthcare professional if such reactions occur.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (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 not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 caring for infants in the specified age group.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which may include severe manifestations such as wheezing or difficulty breathing, shock, facial swelling, hives, and rash.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they have a known allergy to chlorhexidine gluconate or any other ingredient in the formulation. It is crucial to emphasize that this product should not be used 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.

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

While using this product, patients should be cautioned 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, or may lead to deafness if instilled in the middle ear through perforated eardrums. In case of contact with these areas, patients should rinse with cold water immediately.

Healthcare providers should also inform 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 necessary to reduce the bacterial population of the skin due to an underlying condition.

Storage and Handling

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

Additional Clinical Information

The product is administered topically. Clinicians should counsel patients to discontinue use and seek immediate medical assistance if an allergic reaction occurs. It is crucial to keep the product out of reach of children; if ingested, medical help or contact with a Poison Control Center should be sought immediately. Caution is advised when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns.

Drug Information (PDF)

This file contains official product information for Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)