Dyna-Hex 4

Description

DYNA-HEX 4® is a chlorhexidine gluconate 4% solution, classified as an antiseptic. Each formulation contains 4% chlorhexidine gluconate as the active ingredient. The product is distributed by Xttrium Laboratories, Inc., located in Mount Prospect, IL 60056. The net contents of each container are 32 fluid ounces (1 quart) or 946 milliliters. The product is identified by the National Drug Code (NDC) 0116-1060-32 and 0116-1060-33.

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. Additionally, it is indicated for healthcare personnel handwashing, aiding in the reduction of bacteria that may potentially cause disease.

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 apply approximately 2.0 cubic inches of the product and scrub for a duration of 3 minutes, ensuring to focus on the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following this initial scrub, hands should be rinsed thoroughly. An additional scrub is then performed using another 2.0 cubic inches of the product for an additional 3 minutes, after which hands should be rinsed under running water. It is essential to dry hands thoroughly after completing the procedure.

For healthcare personnel handwashing, the process begins with wetting the hands with water. Approximately 1.5 cubic inches of the product should be dispensed into cupped hands, followed by vigorous washing for 15 seconds. After washing, hands must be rinsed and dried thoroughly to ensure proper hygiene.

Contraindications

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

Warnings and Precautions

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

When utilizing 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 or potential deafness if the solution is instilled into 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, wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product.

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.

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

Side Effects

Patients using this product should be aware that it is for external use only. There is a significant allergy alert associated with this product, as it may cause 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, patients are advised to stop use immediately and seek medical assistance.

Patients should not use this product if they are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. Caution is advised during use, as the product should be kept out of the eyes, ears, and mouth. Contact with these areas may result in serious and permanent eye injury or potential deafness if the solution is instilled in the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it is imperative to rinse thoroughly with water.

Patients are also advised to refrain from using 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 discontinue use and consult a healthcare professional, as these may indicate a serious condition.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach, leading to staining. To mitigate this interaction, 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 be treated with caution. The use of these products in this population may lead to irritation or chemical burns. It is essential for healthcare professionals to monitor these patients closely to mitigate potential risks associated with their use.

Geriatric Use

There is no specific information regarding the use of Dyna-Hex (chlorhexidine gluconate 4% solution) in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions that may be necessary for elderly patients.

Healthcare providers should exercise caution when administering this medication to geriatric patients, considering the lack of data on its use in this population. Monitoring for any adverse effects or unusual responses may be prudent, given the absence of established guidelines for elderly patients.

Pregnancy

The safety of chlorhexidine gluconate during pregnancy has not been established. Due to potential risks to the fetus, chlorhexidine gluconate is contraindicated in pregnancy. Pregnant patients should use this medication with caution and are advised to consult a healthcare provider before use to discuss potential risks and benefits.

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.

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 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.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, which may manifest as severe symptoms such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, instances of irritation, sensitization, or allergic reactions have been noted, which could indicate the presence of a serious condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential to inform patients not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation.

Patients should be cautioned to keep the solution away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these sensitive areas, patients should rinse thoroughly and promptly with water.

Healthcare providers should also inform patients that wounds involving more than the superficial layers of the skin should not be treated routinely with this product. Patients should be instructed to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition.

Storage and Handling

The product is supplied in a single-use container, which must be discarded when empty. It should be stored at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F).

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)