Dyna-Hex 2

Description

DYNA-HEX 2® is a chlorhexidine gluconate 2% solution formulated as an antiseptic for external use only. Each bottle contains 18 fluid ounces (532 mL) of the solution, which is dispensed via a foaming pump. The product is distributed by Xttrium Laboratories, Inc., located in Mount Prospect, IL 60056. The National Drug Code (NDC) for this product is 0116-1022-18.

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

Healthcare professionals are advised to follow the outlined procedures for the effective use of the product in various settings.

For surgical hand scrubbing, healthcare personnel should begin by wetting their hands and forearms under running water for 30 seconds. It is essential to clean the fingernails using a nailstick or a similar cleaner. Following this, a total of 8 mL of the product (equivalent to 6 full pumps) should be applied, with or without a wet brush, and scrubbed for 1.5 minutes, ensuring thorough attention to the nails, cuticles, and the skin between the fingers. After scrubbing, the hands and forearms must be rinsed thoroughly under running water for an additional 30 seconds. This process should be repeated with another 8 mL of the product (6 full pumps), followed by another 30-second rinse under running water. Finally, hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the procedure begins with wetting the hands with water. Then, 5 mL of the product (4 full pumps) should be dispensed into cupped hands. The hands must be washed vigorously for 15 seconds, followed by a thorough rinse and drying.

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. A final thorough rinse is required to complete the cleansing process.

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 applied in contact with the meninges due to the potential for serious adverse effects. It is also contraindicated for use in the genital area to prevent irritation or other complications.

Warnings and Precautions

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

Caution is advised for individuals with known allergies to chlorhexidine gluconate or any other components of this product. The product should not be applied in contact with the meninges or used in the genital area, as these applications may pose additional risks.

In cases of ingestion, immediate medical attention is required. If swallowed, it is essential to contact a Poison Control Center or seek emergency medical help without delay.

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.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Notably, there is a potential for severe allergic reactions, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, it is imperative that patients discontinue use immediately and seek medical assistance.

The product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other ingredient contained within the formulation. Additionally, it should not be used in contact with the meninges or in the genital area.

Patients are advised to stop using the product and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 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.

Pregnancy

There are no specific statements regarding the use of Dyna-Hex (chlorhexidine gluconate 2% solution) during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the available data does not provide sufficient information to assess the potential risks or benefits of this medication in pregnant patients. Healthcare professionals should consider the lack of specific guidance and weigh the potential risks versus benefits when prescribing this medication to women of childbearing potential. It is advisable to monitor any emerging data related to the use of chlorhexidine gluconate in pregnant patients and to counsel patients accordingly.

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 specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability.

Healthcare professionals should also consider contacting a poison control center for guidance on specific interventions and antidotes that may be appropriate based on the clinical scenario. Continuous monitoring and supportive measures should be implemented until the patient is stabilized and further evaluation can be conducted.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is crucial for ongoing management and treatment decisions.

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 reported voluntarily or through surveillance programs. Notably, allergic reactions have been documented, including severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, cases of irritation, sensitization, or allergic reactions have been reported, which may indicate the potential for serious conditions.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

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 storage conditions are essential to ensure 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)