Stopain Clinical

Description

The product is identified by the SPL Code 34089-3 and is presented in a bottle.

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 over 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing instructions.

For children aged 12 years or younger, the medication should be applied directly to the affected area. There is no requirement to bandage the area after application. The application may be repeated as necessary; however, it is important not to exceed four applications within a 24-hour period.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of heating pads 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

Contact with the eyes should be strictly avoided, as this product is intended for external use only. It is important to note that the product is flammable; therefore, it must be kept away from fire or flame to prevent any hazardous situations.

Healthcare professionals should advise patients to discontinue use and seek medical attention 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 appears, or excessive skin irritation develops. These signs may indicate a need for further evaluation and management.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers are advised to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. It is crucial to avoid contact with the eyes, as this may lead to irritation or other complications. The product is intended for external use only, and users should exercise caution, as it is flammable; it must be kept away from fire or flame.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. Additionally, the presence of redness or excessive skin irritation should prompt immediate discontinuation of the product and a consultation with a healthcare professional.

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 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 pediatric patients over 12 years, it is advised to consult a healthcare professional before use.

It is important to keep the medication 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 recommended.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 drug 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 drug insert 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be informed to stop using the product and seek medical advice if they notice any redness or if excessive skin irritation develops.

It is important for healthcare providers to emphasize that patients should use the product only as directed. Patients should also be cautioned against bandaging the area tightly or using a heating pad while using the product. Furthermore, patients should be advised not to apply the product to wounds or damaged skin to avoid potential complications.

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 to maintain its integrity and effectiveness.

Due to its flammable nature, the product must be kept away from fire or flame to prevent any hazardous situations. Care should be taken to avoid tightly bandaging the area where the product is applied, and the use of heating pads is not recommended. Additionally, the product should not be applied to wounds or damaged skin to ensure safety and efficacy.

Once opened, the product should be discarded to prevent any potential risks associated with prolonged exposure to air or contamination.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years should consult a doctor before use, while children 12 years or younger can apply the product directly to the affected area without the need for bandaging. It is recommended to repeat the application if necessary, but not to exceed four times daily.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, 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)