Fast Relief Artrosamin

Description

ARTROSAMIN is a pharmaceutical product with a net weight of 8 ounces (226 grams). It is manufactured in the USA.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including soreness and stiffness associated with simple backaches, strains, arthritis, and rheumatism.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should advise patients to discontinue use of the product if excessive irritation of the skin develops. It is important to avoid contact with the eyes and mucous membranes during application.

In cases where the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, or if redness is present, patients should be instructed to discontinue use and consult a physician immediately. Special caution should be exercised when treating conditions affecting children under 12 years of age, and in such cases, consultation with a physician is recommended.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only, this product should not be utilized if the safety seal is broken. It is essential to store the product at room temperature to maintain its efficacy.

This product is contraindicated for application on wounds or damaged skin. Caution is advised against applying it in large quantities, particularly on raw, irritated, or blistered areas. When using this product, it is critical to avoid contact with the eyes and mucous membranes. The product should be used strictly as directed, and it is important not to bandage the area tightly.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should stop use if excessive skin irritation occurs.

For individuals who are pregnant or breastfeeding, it is recommended to consult a healthcare professional prior to use. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be applied if the safety seal is broken. It is crucial to store the product at room temperature and avoid using it on wounds or damaged skin. Application in large quantities, particularly on raw, irritated, or blistered areas, is not recommended.

During use, patients should take care to avoid contact with the eyes or mucous membranes and should use the product only as directed. Tight bandaging of the area where the product is applied should also be avoided. If a patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to stop use and consult a healthcare professional. Additionally, if excessive skin irritation occurs, the patient should discontinue use immediately.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before using this product. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Fast Relief Artrosamin (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

It is important to discontinue use if the condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, or if redness is present. In any of these cases, or if the patient is under 12 years of age, a physician should be consulted immediately.

Additionally, this product should be kept out of reach of children to prevent accidental poisoning.

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 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 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 available data 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 lack of information necessitates careful clinical judgment and monitoring.

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

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent the risk of accidental poisoning. It is important for patients to understand the potential dangers associated with improper access to the medication by children. Providers should emphasize the necessity of safe storage practices to ensure the well-being of all household members.

Storage and Handling

The product is supplied in configurations that include 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. Additionally, healthcare professionals are advised not to use the product if the safety seal is broken, as this may indicate potential contamination or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for ensuring the product's quality and safety.

Additional Clinical Information

Patients should be advised that the medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children over 12 years of age. For children under 12, consultation with a physician is necessary prior to use.

Clinicians should counsel patients on several important points: if pregnant or breastfeeding, they should seek advice from a health professional before use. Patients must discontinue use and consult a doctor if the condition worsens, if symptoms persist beyond 7 days, or if excessive skin irritation occurs. It is crucial to keep the product out of reach of children to prevent accidental poisoning. Additionally, patients should avoid contact with eyes and mucous membranes, and seek medical attention if symptoms worsen or if redness develops.

Drug Information (PDF)

This file contains official product information for Fast Relief Artrosamin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)