Stopain Clinical Continuous

Description

The product is identified by SPL code 34089-3. It 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 microcrystalline cellulose, magnesium stearate, and sodium starch glycolate.

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, the recommended application is to apply the product directly onto the affected area. It is important to note that there is no need to rub, massage, or bandage the area after application. If necessary, the application may be repeated; however, it should not exceed four times within a 24-hour period.

For children aged 12 years or younger, it is advised to consult a healthcare professional before use.

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 potential complications and ensure safety.

Warnings and Precautions

For external use only; direct contact with the eyes must be avoided to prevent irritation. The product is flammable; therefore, it should be kept away from fire or flame. The contents are under pressure; puncturing or incinerating the container is strictly prohibited. Additionally, it should not be stored at temperatures exceeding 120°F to maintain safety and efficacy.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Bandaging should not be applied tightly, nor should a heating pad be used in conjunction with the product. Application to wounds or damaged skin is contraindicated to prevent adverse effects.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens, symptoms persist beyond 7 days, symptoms resolve and then recur within a few days, redness appears, or excessive skin irritation develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to ensure prompt and appropriate care.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. The product is intended for external use only, and contact with the eyes should be avoided. It is flammable; therefore, it must be kept away from fire or flame. Additionally, the contents are under pressure, and users should not puncture or incinerate the container. It is advised not to store the product at temperatures exceeding 120°F.

When using this product, it is crucial to follow the directions provided. Users should refrain from bandaging tightly or using a heating pad in conjunction with the product. It should not be applied to wounds or damaged skin.

Patients are advised to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The presence of redness or excessive skin irritation also warrants cessation of use and medical consultation.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, 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 Continuous (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and younger may apply the medication directly onto the affected area without the need for rubbing, massaging, or bandaging. The application may be repeated as necessary; however, it should not exceed four times daily. For patients over 12 years of age, it is advised to consult a healthcare professional before 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 drug. 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 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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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

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, patients must be reminded to follow the directions provided and to avoid bandaging tightly or using a heating pad. Additionally, patients should not apply the product to wounds or damaged skin.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature, ensuring that the storage environment does not exceed 120°F.

To maintain safety and integrity, the product must be kept away from fire or flame. Additionally, it is important to note that the contents are under pressure; therefore, puncturing or incinerating the container is strictly prohibited. Proper handling and adherence to these storage conditions are vital for ensuring the product's efficacy and safety.

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 under 12 years, the product should be applied directly to 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 use. Additionally, it is important to keep the product out of reach of children; if ingested, 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 Continuous, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)