Stopain Clinical Roll-on

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The product is packaged in bottles containing 100 tablets.

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 guidance.

For children aged 12 years or younger, the product should be applied directly to the affected area. It is important to roll the applicator onto the skin without rubbing, massaging, or bandaging the area. The application may be repeated as necessary; however, it should not exceed four applications within a 24-hour period.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, it is contraindicated to bandage tightly or use a heating pad, as this may lead to increased risk of adverse effects.

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; it is imperative that it not be ingested or applied internally. Additionally, the product is flammable; therefore, it must be kept away from fire or flame to prevent any hazardous incidents.

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 resolve and then recur within a few days, redness is observed, or excessive skin irritation develops. These signs may indicate a need for reevaluation of the treatment plan.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay to ensure appropriate management of the situation.

No specific general precautions or laboratory tests have been identified for this product; however, ongoing monitoring of the patient's response to treatment is recommended to ensure safety and efficacy.

Side Effects

Patients should be advised to avoid contact with the eyes when using this product, as it is intended for external use only. The formulation is flammable; therefore, it is essential to keep it away from fire or flame.

In clinical practice, patients are instructed to discontinue use and consult a healthcare professional 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 seek medical advice if they experience redness or excessive irritation of the skin during use.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. 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 Roll-on (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years or younger should apply the product directly onto the affected area without rubbing, massaging, or bandaging. The application may be repeated as necessary, but it is important not to exceed four applications in a 24-hour period. For patients over 12 years of age, it is recommended to consult a healthcare professional before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

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

Patients should be instructed to stop using the product 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 discontinue use and seek medical advice if they notice any redness or if excessive irritation of the skin 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, they should not 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. Additionally, it is crucial to keep the product out of reach of children to ensure safety. Once opened, the product should be discarded to avoid any potential risks associated with prolonged exposure to air or contamination.

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 rolled directly onto the affected area without rubbing, massaging, or bandaging, and may be reapplied as necessary, not exceeding four applications per day.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before using the product. 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 Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)