Dyna-Hex 2

Description

NDC 0116-1022-32, DYNA-HEX 2® is a chlorhexidine gluconate 2% solution antiseptic. It contains 2% chlorhexidine gluconate as the active ingredient. The product is distributed by Xttrium Laboratories, Inc., located in Mount Prospect, IL 60056. The net contents of the solution are 32 fluid ounces (1 quart) or 946 milliliters.

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

Healthcare professionals are advised to follow the outlined procedures for the surgical hand scrub and healthcare personnel handwash to ensure optimal hygiene and infection control.

For the surgical hand scrub, the following steps should be adhered to:

1. Begin by wetting hands and forearms with water.

2. Dispense 5 mL of the solution into the hands and scrub for 3 minutes using a wet brush, ensuring to perform 4 full strokes while paying particular attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary.

3. Rinse hands and forearms thoroughly under running water.

4. Repeat the process by washing for an additional 3 minutes with another 5 mL of the solution, again using 4 full strokes, followed by a thorough rinse under running water.

5. Finally, dry hands and forearms thoroughly.

For the healthcare personnel handwash, the following procedure is recommended:

1. Wet hands with water.

2. Dispense 5 mL of the solution into cupped hands and wash vigorously for 15 seconds.

3. Rinse hands thoroughly and dry completely.

Adhering to these protocols is essential for maintaining hand hygiene in clinical settings.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. Due to the potential for severe allergic reactions, it is essential to assess patient history for such allergies prior to administration.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should be aware of the potential for severe allergic reactions associated with its use. Symptoms indicative of an allergic reaction 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.

Caution is advised for individuals with known allergies to chlorhexidine gluconate or any other components of this product.

When administering this product, it is essential 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 a perforated eardrum. Should the solution inadvertently contact these areas, it must be rinsed out promptly and thoroughly with water.

This product should not be used on wounds that extend beyond the superficial layers of the skin, as such applications may not be appropriate.

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

In cases of accidental ingestion, immediate medical attention 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. In the event of an allergic reaction, it is imperative to discontinue 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.

When using this product, there is a risk of serious and permanent eye injury if the solution enters the eye and remains there. Additionally, instillation in the middle ear through perforated eardrums may lead to deafness. Should the solution come into contact with these sensitive areas, it is crucial to rinse thoroughly with water as soon as possible. Furthermore, wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product.

Patients are advised to stop 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.

In cases 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 2 (chlorhexidine gluconate 2%). 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Dyna-Hex 2% (chlorhexidine gluconate) during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions related to the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are indicated. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

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 patients with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

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.

In all cases of suspected overdosage, the involvement of poison control experts is recommended to guide treatment decisions and ensure optimal patient care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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.

It is important to inform patients not to use this product if they are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. When using the product, patients should be cautioned to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums.

Should the solution come into contact with the eyes, ears, or mouth, patients must rinse the affected area promptly and thoroughly with water. Additionally, healthcare providers should advise patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product.

Patients should be instructed to stop using the product and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious 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 range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dyna-Hex 2, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)