Stopain Clinical

Description

The product is a topical analgesic gel identified by SPL Code 34089-3. It contains menthol as the active ingredient and is characterized by its clear and colorless appearance. The formulation includes several inactive ingredients: carbomer, triethanolamine, purified water, propylene glycol, methylparaben, propylparaben, and sodium hydroxide.

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

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

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; ingestion is not permitted.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center for guidance.

No specific instructions regarding discontinuation of use or additional precautions have been provided. As such, healthcare professionals should exercise standard clinical judgment when advising patients on the use of this product.

Side Effects

Patients should be advised to avoid contact with eyes when using this product, as it is intended for external use only. Adverse reactions associated with the use of this product may occur, and it is important for patients to be aware of these potential effects.

In clinical trials and postmarketing experiences, the safety profile of the product has been evaluated, although specific adverse reactions were not detailed in the provided data. It is essential for healthcare providers to monitor patients for any unexpected reactions and to provide guidance on the appropriate use of the product to minimize risks.

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 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

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, given the lack of targeted data.

Pregnancy

There is no specific information regarding the use of STOPAIN CLINICAL (menthol, unspecified form gel) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant individuals, as the potential effects on fetal outcomes are not established. It is advisable to weigh the benefits against any potential risks when recommending this product to women of childbearing potential.

Lactation

There are no specific statements or considerations regarding nursing mothers or lactation in the provided text. Therefore, the effects of the medication on breastfed infants and the excretion of the drug in breast milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers.

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 the use of 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 available information.

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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 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 medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication 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. It may be reapplied as necessary, but should not exceed four applications per day.

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

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)