Dyna-Hex

Description

DYNA-HEX 2® is an antiseptic foam handwash containing 2% Chlorhexidine Gluconate. It is distributed by Xttrium Laboratories, Inc., located in Mount Prospect, IL 60056. The product is available in various net weights: 8 fl oz (237 mL), 8.5 fl oz (251 mL), 16 fl oz (473 mL), 32 fl oz (946 mL), and 128 fl oz (1 gal). The National Drug Code (NDC) numbers for the product are 0116-1021-85, 0116-1021-16, 0116-1021-17, 0116-1021-32, and 0116-1021-01, respectively. This FDA-approved formula is intended for external use only and is designed to help reduce bacteria. It is fragrance-free and primarily used by healthcare personnel in hospital settings.

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 applications.

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

For healthcare personnel handwashing, the procedure begins with wetting the hands with water. Approximately 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for 15 seconds. After washing, hands should be rinsed and dried thoroughly.

In the case of skin wound and general skin cleaning, 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 thorough rinse should be performed again to ensure complete removal of the product.

Contraindications

Use of this product is contraindicated in the following situations:

• Known allergy to chlorhexidine gluconate or any other component of the formulation.

• Application in contact with the meninges, due to the risk of severe adverse effects.

• Use in the genital area, as it may lead to 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, 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. It is contraindicated for use in contact with the meninges and should not be applied to the genital area.

In cases of ingestion, immediate medical attention is required. 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 this product. Notably, there is a significant allergy alert, as the product may cause a severe allergic reaction. Symptoms of such reactions can 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.

Additionally, patients should 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

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dyna-Hex (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

There is no specific information regarding the use of Dyna-Hex 2 (chlorhexidine gluconate 2% solution) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this medication to elderly patients, as the absence of data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any comorbidities of geriatric patients prior to use, given the lack of established guidelines for this population.

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. Use during pregnancy should be approached with caution, and it is recommended that pregnant patients consult a healthcare provider before use.

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 in these patients to ensure safety and therapeutic effectiveness.

Overdosage

In the event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

Given the absence of detailed guidance, it is recommended that clinicians refer to established protocols for managing overdoses of similar pharmacological agents. Continuous assessment of the patient's clinical status is essential, and symptomatic treatment should be initiated as required.

In cases of suspected overdosage, contacting a poison control center or a medical toxicologist for further assistance may be prudent.

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 chlorhexidine gluconate. Reports include allergic reactions, such as anaphylaxis, as well as skin reactions, which encompass rash, pruritus, and urticaria. Additionally, serious skin reactions, including chemical burns and irritation, have been documented.

There have been cases of eye injury linked to chlorhexidine gluconate, particularly when the solution inadvertently contacts the eyes. Furthermore, instances of ototoxicity have been reported in cases where chlorhexidine gluconate is instilled into the middle ear through perforated eardrums.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

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

The product is administered topically and should be used with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. Clinicians should advise patients to avoid contact with the eyes, ears, and mouth, as exposure can lead to 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 essential to rinse thoroughly with water.

Patients should be informed that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Additionally, repeated cleansing of large body areas should only be performed under the guidance of a healthcare provider. If any signs of irritation, sensitization, or allergic reaction occur, patients should discontinue use and consult a doctor, as these may indicate a serious condition. The product should be kept out of reach of children, and in case of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)