Dyna-Hex

Description

DYNA-HEX 2® is a topical antiseptic solution containing 2% Chlorhexidine Gluconate. It is intended for external use only and is provided in a single-use format. The product is packaged in a net volume of 4 fluid ounces (118 mL). DYNA-HEX 2® is distributed by Xttrium Laboratories, Inc., located in Mount Prospect, IL 60056, under NDA 0116-1021-04.

Uses and Indications

This drug is indicated for use in healthcare personnel handwashing to help reduce bacteria that may potentially cause disease. It is also indicated for patient preoperative skin preparation, ensuring the patient's skin is adequately prepared prior to surgical procedures. Additionally, this drug is suitable for skin wound cleansing and general skin cleansing purposes.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare personnel should initiate hand hygiene by wetting hands with water. Approximately 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for a duration of 15 seconds. Hands must then be rinsed thoroughly and dried.

For patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for a minimum of 2 minutes, after which it should be dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with another sterile towel.

In the case of skin wound and general skin cleaning, the area intended for cleaning should first be thoroughly rinsed with water. The minimum amount of product necessary to adequately cover the skin or wound area should then be applied, followed by gentle washing. A thorough rinse is required once again to ensure complete removal of the product.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other ingredient in this formulation should not use this product, due to the risk of severe allergic reactions.

Contact with the meninges is contraindicated, as it may lead to serious complications.

Application in the genital area is not recommended, as it may cause irritation or adverse effects.

Additionally, this product should not be used as a preoperative skin preparation for the head or face, to avoid potential complications associated with its use in these sensitive areas.

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.

In cases where the product is ingested, emergency medical help should be sought without delay. Contacting a Poison Control Center is also recommended to ensure appropriate management.

Healthcare providers should advise patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may signify a serious underlying condition. Monitoring for these adverse effects is essential to ensure patient safety and well-being.

Side Effects

Patients using this product should be aware that it is for external use only. There is a potential risk of severe allergic reactions, which may manifest as symptoms including 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

Individuals with a known allergy to chlorhexidine gluconate or any other component of this product may experience a severe allergic reaction. It is imperative that healthcare providers assess patient history for such allergies prior to administration.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

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 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 to prevent accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients may not have specific information regarding the use of Dyna-Hex 2 (Chlorhexidine Gluconate 2% Solution) in this population. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions that should be considered when administering this medication to geriatric patients.

Healthcare providers should exercise caution and consider individual patient factors when prescribing Dyna-Hex 2 to elderly patients, as the absence of specific data necessitates careful monitoring and assessment of treatment outcomes in this demographic.

Pregnancy

The product has not been specifically studied in pregnant patients, and there are no detailed safety concerns regarding its use during pregnancy provided in the prescribing information. Additionally, there are no dosage modifications recommended for pregnant individuals. As such, healthcare professionals should consider the absence of specific data when prescribing this product to women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for Dyna-Hex 2 (chlorhexidine gluconate liquid). Therefore, the effects on breastfed infants and the excretion of the drug in breast milk remain undetermined. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

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 relation to the use of this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

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, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. 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 reported due to improper use of the product, resulting in serious and permanent damage. Furthermore, instances of ototoxicity have been noted when the solution was instilled in the middle ear through perforated eardrums.

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 against using the product in contact with the meninges, the genital area, or as a preoperative skin preparation for the head or face. Providers should emphasize the importance of discontinuing use and consulting a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

When instructing patients on the application of this product, healthcare providers should stress the necessity of keeping the solution away from the eyes, ears, and mouth. Patients should be made aware that contact with these areas may result in serious and permanent eye injury or deafness if the solution is instilled in the middle ear through perforated eardrums. In the event of accidental contact, patients should rinse the affected area promptly and thoroughly with water.

Providers should also inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Additionally, repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

Storage and Handling

The product is supplied in a single-use configuration. It should be stored at a controlled room temperature of 20-25ºC (68-77ºF). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

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)