Stopain Clinical

Description

No description information is available for the specified drug.

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 these practices may exacerbate adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent potential complications and ensure safety.

Warnings and Precautions

Contact with the eyes should be strictly avoided, as it may lead to irritation or injury. This product is intended for external use only; any internal application is contraindicated. Additionally, the formulation is flammable; therefore, it must be kept away from fire or flame to prevent potential hazards.

It is imperative that this 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 adverse effects. The product should not be applied to wounds or damaged skin to avoid 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. 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 irritation of the skin should prompt immediate discontinuation of the product and a consultation with a healthcare professional.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Stopain Clinical (menthol, unspecified form). 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; however, it should not exceed four times daily.

Geriatric Use

Elderly patients may not require specific recommendations or precautions based on the available data. However, healthcare providers should remain vigilant when prescribing to this population, considering the potential for altered pharmacokinetics and increased sensitivity to medications. Regular monitoring and assessment of therapeutic response and adverse effects are advisable to ensure the safety and efficacy of treatment in geriatric patients.

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 no specific data available 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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.

In all cases of suspected overdosage, the involvement of poison control experts is recommended to guide treatment decisions and ensure optimal patient care.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for healthcare providers 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 consult a healthcare professional if they notice any redness or if excessive skin irritation develops. When using this product, it is crucial to follow the directions provided and to avoid bandaging tightly or using a heating pad in conjunction with the product. Additionally, patients should be cautioned against applying the product to wounds or damaged skin to prevent adverse effects.

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 at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The product is administered topically, with the recommended application for adults and children over 12 years being directly onto the affected area. It may be reapplied as necessary, but should not exceed four applications per day.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Additionally, it is important to keep the product out of reach of children; if ingested, immediate medical assistance or contact with a Poison Control Center is advised.

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)