Therapain Plus

Description

The product is presented in a roll-on dosage form, designed for topical application. This formulation allows for targeted delivery and ease of use. The roll-on mechanism facilitates precise application to the desired area, enhancing user convenience and effectiveness.

Uses and Indications

This drug is indicated for the relief of temporary pain associated with various conditions, including arthritis, stiffness, sprains and strains, neck and backaches, muscle soreness, and cramps.

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

Dosage and Administration

The product should be shaken well before use. It is to be applied liberally to the affected area, not exceeding 3 to 4 applications per day. After each application, hands should be washed thoroughly with soap and water to prevent unintended contact with other areas.

For pediatric patients under 12 years of age, it is recommended to consult a physician prior to use. Following the initial application, once the first coat has been absorbed into the skin, 1 to 3 additional coats may be reapplied to enhance effectiveness.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional under the following circumstances:

• If excessive skin irritation develops.

• If the condition worsens.

• If symptoms persist for more than 7 days.

In these cases, medical advice should be sought to ensure appropriate management.

Warnings and Precautions

This product is intended for external use only. It is flammable; therefore, it is imperative to avoid exposure to heat, sparks, and open flames during use.

When utilizing this product, healthcare professionals should advise patients to take precautions to prevent contact with sensitive areas, including the eyes, mouth, genitalia, mucous membranes, and any irritated or very sensitive skin. Application to open wounds or damaged skin is contraindicated. Additionally, patients should be instructed not to apply the product with tight bandaging.

This product is not recommended for individuals with diabetes or those who have impaired circulation, as these conditions may increase the risk of adverse effects.

Patients should be advised to discontinue use and consult a healthcare professional if excessive skin irritation develops, if the condition worsens, or if symptoms persist for more than 7 days. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is for external use only and is flammable; therefore, it is crucial to avoid exposure to heat, sparks, and open flames.

When using this product, patients should take care to avoid contact with the eyes, mouth, genitalia, mucous membranes, and areas of irritated or very sensitive skin. It is advised not to apply the product to open wounds or damaged skin, and bandaging should not be done tightly. Additionally, individuals who are diabetic or have impaired circulation should refrain from using this product.

Patients are instructed to stop use and consult a doctor if excessive skin irritation develops, if the condition worsens, or if symptoms persist for more than 7 days.

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 Therapain Plus (menthol roll-on). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should be evaluated by a physician prior to use. It is important to consider the specific needs and potential risks associated with this age group when determining treatment options.

Geriatric Use

There is no specific information regarding the use of Therapain Plus in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors, including comorbidities and concurrent medications. Monitoring for potential adverse effects is advisable in this population, given the general increased sensitivity of elderly patients to medications.

Pregnancy

There is currently no information available regarding the use of Therapain Plus during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of information related to the use of Therapain Plus during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. Further clinical judgment should be applied based on individual patient circumstances.

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 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.

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 and the individual patient's response. 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. 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 if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, while specific overdosage information is not available, the emphasis remains on vigilant monitoring and supportive care to mitigate potential risks associated with overdose situations.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion or misuse.

Patients should be instructed to stop using the product and consult a doctor if they experience excessive skin irritation, if their condition worsens, or if symptoms persist for more than 7 days. In such cases, it is important for patients to discontinue use and seek medical advice to ensure appropriate management of their condition.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure. The container must be kept tightly closed to maintain the integrity of the product. Freezing is not permitted, as it may compromise the quality. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

Patients should apply the product liberally to the affected area no more than 3 to 4 times daily. Clinicians should advise patients to avoid contact with the eyes, mouth, genitalia, mucous membranes, and any irritated or very sensitive skin. The product should not be applied to open wounds or damaged skin, and it should not be bandaged tightly. Additionally, consultation with a physician is recommended for children under 12 years of age.

Drug Information (PDF)

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

View product document (PDF)