Thritex

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and muscle pains associated with conditions such as arthritis, simple backache, strains, muscle soreness, and stiffness.

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

Dosage and Administration

Adults and children aged 12 years and older should apply the patch to the affected area, with a recommended frequency of 1 to 2 times daily.

Application Instructions:

1. Clean and dry the affected area thoroughly before application.

2. Cut open the pouch and remove the patch.

3. Carefully remove the protective film from the patch and apply it directly to the area of pain.

4. The patch should not be applied to the affected area more than 3 times daily.

5. After applying the patch, wash hands with soap to prevent accidental contact with other areas of the body.

6. Reseal the pouch containing any unused patches to maintain their integrity.

Healthcare professionals should ensure that patients are aware of these instructions to optimize the effectiveness of the treatment.

Contraindications

Use of this product is contraindicated in children under 12 years of age unless directed by a physician.

Warnings and Precautions

For external use only, this product should not be applied to wounds or damaged skin. It is contraindicated in individuals with a known allergy to Menthol. When utilizing this product, it is imperative to avoid covering the area with a bandage and to adhere strictly to the directions provided. Care should be taken to prevent contact with the eyes and mucous membranes.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve only to recur within a few days. Additionally, patients should be instructed to stop using the product if they experience rash, itching, or excessive skin irritation.

Emergency medical assistance should be sought if severe reactions occur, although specific instructions for such situations are not detailed in the provided information.

No general precautions or laboratory tests have been specified; however, practitioners should remain vigilant for any adverse effects and monitor patients accordingly.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for use on wounds or damaged skin and should not be used by individuals with a known allergy to Menthol.

During the use of this product, patients are advised not to cover the treated area with a bandage and to apply the product only as directed. Care should be taken to avoid contact with the eyes and mucous membranes.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, persistence of symptoms for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if a rash, itching, or excessive skin irritation develops, it is important to stop use and seek medical advice.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Thritex (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. For children under 12 years of age, consultation with a physician is advised prior to use.

For adolescents aged 12 years and older, the recommended application involves placing the patch on the affected area, with a frequency of changing the patch 1 to 2 times daily.

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

The use of THRITEX (menthol patch) during pregnancy has not been specifically addressed in the available prescribing information. There are no stated contraindications for its use in pregnant patients, nor are there any identified risks to the fetus associated with the product. Additionally, the prescribing information does not indicate the need for dosage modifications or special precautions for individuals who are pregnant. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of THRITEX in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of the THRITEX menthol patch in lactating mothers. Additionally, there is no information available about the potential for excretion of THRITEX in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. 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 available information.

Overdosage

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

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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

No postmarketing experience details are available for the product associated with SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to consult a physician before administering this medication to children under the age of 12, ensuring that appropriate guidance and safety measures are followed.

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 below 25°C (77°F) to maintain its integrity and efficacy. Care should be taken to avoid exposure to direct sunlight during storage. Proper handling practices should be followed to ensure the product remains within the recommended temperature range.

Additional Clinical Information

The product is administered topically, with specific directions for use in adults and children aged 12 years and older. Patients are instructed to apply the patch to the affected area, with a recommended frequency of changing the patch 1 to 2 times daily, and not to exceed application to the affected area more than 3 times daily.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)