Cannarelief 2000mg, Earthmed Sport 2000mg

Description

CannaRelief 2000mg CBD is a liquid formulation containing cannabidiol (CBD) derived from hemp. Each 1 mL of the product delivers 2000 mg of CBD. The inactive ingredients consist of medium-chain triglyceride (MCT) oil and natural flavoring. The product is packaged in a 30 mL bottle. The SPL Code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains.

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

Dosage and Administration

Adults and children aged 12 years and older should apply the medication to the affected area one to four times daily, depending on the severity of the condition. For children under 12 years of age, it is recommended to consult a physician for appropriate dosing and administration guidance.

Contraindications

The product should not be applied to wounds or irritated skin, as this may exacerbate the condition or lead to adverse effects. Additionally, contact with the eyes must be avoided to prevent potential irritation or injury.

Warnings and Precautions

The product is intended for external use only and is designed to provide penetrating pain relief. Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, if the condition resolves but recurs within a few days, or if any rash or irritation develops.

It is crucial to emphasize that the product should not be applied to open wounds or irritated skin. Additionally, patients should be instructed to avoid contact with the eyes to prevent potential adverse effects.

While no specific laboratory tests are recommended for monitoring, healthcare providers should remain vigilant for any signs of adverse reactions or complications associated with the use of this product.

Side Effects

Patients using this product should be aware that it is intended for external use only and is designed to provide penetrating pain relief.

In clinical practice, patients are advised to stop use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, the condition resolves but recurs within a few days, or if a rash or irritation develops.

Additional adverse reactions noted include the worsening of the condition, prolonged symptoms lasting beyond 7 days, recurrence of the condition after initial improvement, and the occurrence of rash or irritation. These reactions should be monitored closely, and appropriate medical advice should be sought if they arise.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this drug and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cannarelief 2000mg, Earthmed Sport 2000mg (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years and younger should consult a healthcare professional before use. For patients aged 12 years and older, the recommended application is to the affected area one to four times daily. It is important to keep this product out of reach of children to prevent accidental ingestion or misuse.

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 before 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 discuss their individual circumstances with their healthcare provider 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 drug in human breast milk or its effects on breastfed infants. Therefore, healthcare providers should carefully evaluate the potential risks and benefits when considering treatment for lactating patients.

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 patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

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, it is imperative to seek immediate medical assistance or contact a poison control center. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdosage.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of overdosage typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and act swiftly to ensure the safety and well-being of the patient experiencing an overdosage.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse.

Patients should be instructed not to apply the medication to wounds or irritated skin, and to avoid contact with the eyes to prevent potential adverse effects.

It is important for healthcare providers to inform patients to seek medical advice if their condition worsens, if symptoms persist for more than 7 days, if the condition appears to clear but recurs within a few days, or if any rash or irritation develops. This guidance will help ensure the safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 68 to 77 degrees Fahrenheit. Care should be taken to avoid direct sunlight during storage to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Cannarelief 2000mg, Earthmed Sport 2000mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)