Stopain Clinical

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to apply the product directly onto the affected area. This should not exceed 3 to 4 times daily. It is important to wash hands thoroughly after each use to prevent unintentional contact with other areas of the body or surfaces.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may exacerbate adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent irritation or further complications.

Warnings and Precautions

For external use only; contact with eyes should be avoided to prevent irritation. The product is flammable; therefore, it must be kept away from fire or flame to ensure safety.

It is imperative that the product is used only as directed. Users should refrain from tightly bandaging the area of application or using a heating pad, as these practices may exacerbate potential adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent further complications.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. The presence of redness or excessive skin irritation also warrants immediate consultation with a healthcare provider.

In the event of accidental ingestion, it is crucial to obtain emergency medical assistance or contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only, and contact with the eyes should be avoided to prevent irritation. Additionally, the product is flammable; therefore, it should be kept away from fire or flame.

Patients are advised to stop using the product and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness is present, or excessive irritation of the skin develops. These reactions may indicate a need for further evaluation or a change in treatment strategy.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger may apply the medication directly onto the affected area without the need for a bandage. The application may be repeated if necessary, but it should not exceed four times daily. For patients over 12 years of age, including adults, it is advised to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Patients should also be informed to stop using the product and seek medical advice if they notice any redness or if excessive skin irritation develops. Emphasizing the importance of using the product only as directed is crucial for patient safety.

Additionally, healthcare providers should counsel patients against tightly bandaging the area where the product is applied or using a heating pad during treatment. Patients must be reminded not to apply the product to wounds or damaged skin to avoid potential complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The product is administered topically. For adults and children over 12 years, it is recommended to consult a doctor prior to use. For children aged 12 years or younger, the product should be applied directly to the affected area without the need for bandaging, with a maximum of four applications per day as necessary.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)