Dyna-Hex 4

Description

DYNA-HEX 4® is a 4% Chlorhexidine Gluconate solution formulated as an antiseptic. It is presented in a foam pump dosage form, ensuring effective application. The product is distributed by Xttrium Laboratories, Inc., located in Mount Prospect, IL 60056. Each container holds a net volume of 18 fluid ounces (532 mL). The National Drug Code (NDC) for this product is 0116-1060-18.

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 following procedure: Healthcare professionals should begin by wetting their hands and forearms with water. They should then dispense 3 full pumps (5 grams) of the product and scrub for a duration of 3 minutes using a wet brush, ensuring to pay close attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, hands and forearms must be rinsed thoroughly. This should be followed by an additional wash for 3 minutes with another 3 full pumps (5 grams) of the product, which should also be rinsed under running water. Finally, hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the process begins with wetting the hands with water. The individual should then dispense 3 full pumps (5 grams) of the product into cupped hands and wash vigorously for 15 seconds. After washing, hands must be rinsed and dried thoroughly.

In the case of skin wound and general skin cleansing, the area to be cleaned should first be thoroughly rinsed with water. The minimum amount of product necessary to cover the skin or wound area should then be applied, followed by gentle washing. The area must be rinsed again thoroughly to ensure complete cleansing.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation.

Additionally, the product should not be used routinely in patients with wounds that extend beyond the superficial layers of the skin due to the potential for adverse effects.

Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these areas, it is imperative to rinse thoroughly with water.

Warnings and Precautions

For external use only. This product carries a significant risk of severe allergic reactions. Healthcare professionals should be vigilant for symptoms such as wheezing, difficulty breathing, shock, facial swelling, hives, or 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 with a known allergy to chlorhexidine gluconate or any other component of the formulation.

When administering this product, it is crucial to avoid contact with the eyes, ears, and mouth. Exposure to these areas may result in serious and permanent eye injury if the solution is introduced into the eye during surgical procedures, or it may lead to deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it must be rinsed out promptly and thoroughly with water. Additionally, routine use is not recommended for wounds that extend beyond the superficial layers of the skin.

Healthcare professionals should advise patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious 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 the use of this product.

Severe allergic reactions have been reported, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

It is contraindicated for use in individuals with a known allergy to chlorhexidine gluconate or any other ingredient contained in this product.

During the use of this product, it is crucial to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these areas, it is recommended to rinse thoroughly with water.

Patients should also refrain from routine use of this product on wounds that extend beyond the superficial layers of the skin.

If irritation, sensitization, or any signs of an allergic reaction occur, patients should stop using the product and consult a healthcare professional, as these symptoms may indicate a serious condition.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical help should be sought or contact with a Poison Control Center is recommended.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach. The combination of these agents can lead to staining of the skin. To mitigate this risk, it is advised to rinse the skin thoroughly after using chlorhexidine gluconate and to utilize only non-chlorine detergents for cleaning purposes.

Packaging & NDC

Below are the non-prescription pack sizes of Dyna-Hex 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 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. It is essential to assess the individual patient's condition and adjust the treatment approach accordingly to ensure safety and efficacy.

Pregnancy

There are no specific statements regarding the use of Dyna-Hex (chlorhexidine gluconate liquid) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered if necessary.

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 not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 include allergic reactions, which encompass severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, cases of irritation, sensitization, or allergic reactions have been documented, which may suggest the potential for serious conditions. These events have been reported voluntarily or through surveillance programs, contributing to the ongoing assessment of the product's safety profile.

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 not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation. It is important to counsel patients to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When discussing the proper use of this product, healthcare providers should emphasize the importance of avoiding contact with the eyes, ears, and mouth. Patients should be made aware that exposure to these areas may result in serious and permanent eye injury if the product is placed or retained in the eye during surgical procedures, or may lead to deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these areas, patients should rinse thoroughly and promptly with water.

Additionally, healthcare providers should caution patients against routine use of the product on wounds that extend beyond the superficial layers of the skin, as this may pose additional risks.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. 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), to maintain product integrity. Proper container requirements should be adhered to, ensuring that the product is kept in suitable conditions to prevent degradation. Special handling needs should be observed to ensure the product remains within the recommended temperature range throughout its storage and handling processes.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dyna-Hex 4, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)