Fisico Arthrozene Pain Cream

Description

The drug is identified by the 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 lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of the muscles and joints associated with conditions such as arthritis, simple backache, sprains, bruises, and strains.

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

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Use is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, bandaging should not be performed tightly, as this may compromise circulation. Contact with the eyes must be avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that symptoms persist for more than seven days, the product should be discontinued, and a physician should be consulted for further evaluation and management.

In cases of accidental ingestion, immediate medical attention is necessary. Healthcare professionals should advise patients to seek emergency medical help if the product is swallowed.

Monitoring for persistent symptoms is crucial; if symptoms do not resolve within the specified timeframe, patients are advised to stop using the product and contact their healthcare provider for further guidance. No specific laboratory tests are required for the safe use of this product.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes during application. In clinical practice, if symptoms persist for more than seven days, patients are advised to discontinue use and consult a physician for further evaluation.

Additionally, the product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to consult a physician immediately.

Patients are cautioned against using this product on wounds or damaged skin, and it is recommended not to bandage the area tightly after application.

For pregnant or breastfeeding individuals, it is essential to contact a physician prior to use to ensure safety for both the patient and the child.

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 Fisico Arthrozene Pain Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

Geriatric Use

There is no specific information regarding the use of FISICO Arthrozene Pain Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and potential comorbidities of geriatric patients prior to initiating treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should contact their physician prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare professionals are advised to consider the individual circumstances of each patient when discussing treatment options in this population.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

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 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, it is imperative that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and management.

Potential symptoms of overdosage may vary depending on the specific circumstances and the individual’s health status. Therefore, a thorough assessment by a healthcare provider is essential to determine the appropriate course of action.

Management of overdosage should be guided by the physician's recommendations, which may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is advised to address any emerging complications promptly.

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 consult a physician immediately if the product is swallowed. It is important to emphasize the need to avoid contact with the eyes, as this may lead to irritation or other adverse effects. Additionally, patients should be informed that if their symptoms persist for more than seven days, they should discontinue use of the product and seek medical advice. This guidance is crucial for ensuring patient safety and effective management of their condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of three to four times daily for adults and children aged two years and older. For children under two years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Fisico Arthrozene Pain Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)