Coralite Extra Strength Pain Relief Sleeve Knee

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older. Patients are advised to apply one sleeve to the affected area no more than three times daily. The sleeve should fit snugly but not tightly and must not be worn for more than eight hours at a time.

For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

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

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

Use is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition and potential for infection.

• The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

General precautions must be observed when using this product. It should not be applied to wounds or damaged skin. Additionally, it is contraindicated for use in children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if redness, irritation, or rash develops.

In cases of accidental ingestion, it is crucial to seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, or if redness, irritation, or rash develops, medical advice should be sought.

Before using the product, patients should ask a doctor if there is redness over the affected area, as this may indicate a more serious condition that requires professional evaluation.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Coralite Extra Strength Pain Relief Sleeve Knee (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients with arthritis-like conditions should not be treated with this medication if they are under 12 years of age. For children in this age group, it is essential 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 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 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Management of overdosage should be tailored to the individual patient, taking into account the specific circumstances and any co-administered medications. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on further management strategies.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply standard overdosage management protocols and remain observant for any adverse effects in patients.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use the product on wounds or damaged skin. It is also important to caution against using the product on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should instruct patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if symptoms resolve and then recur within a few days, or if they experience redness, irritation, or rash after using the product.

When discussing the use of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be reminded to avoid contact with the eyes, mucous membranes, or rashes while using the product. They should also be informed not to bandage tightly over the sleeve or use it in conjunction with a heating pad.

Furthermore, patients should be advised to discontinue use at least 1 hour before taking a bath or shower and to avoid using the product immediately after bathing. Lastly, healthcare providers should recommend that patients consult a doctor if there is any redness over the affected area before using the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The product is administered topically, with a recommended application of one sleeve to the affected area no more than three times daily. It is important that the sleeve is not worn for more than eight hours at a time.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Additionally, patients should be advised to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) if the product is swallowed.

Drug Information (PDF)

This file contains official product information for Coralite Extra Strength Pain Relief Sleeve Knee, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)