Trivita Qpr

Description

TRIVITA QPR is a topical formulation designed for fast-acting temporary relief of minor aches and pains. This product features a menthol formula that provides a soothing effect upon application. Each 3 fluid ounce (88 ml) container contains 150 mg of broad-spectrum, THC-free hemp CBD. The easy roll-on applicator facilitates convenient application to affected areas.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, backache, and arthritis.

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

Dosage and Administration

The medication should be used strictly as directed. It is contraindicated for use in children under 12 years of age. For adults and adolescents, the recommended application involves rolling the product onto the affected area, with a maximum frequency of four times daily. Care should be taken to ensure that the application does not exceed this limit to avoid potential adverse effects.

Contraindications

Use is contraindicated in the following situations:

• Application with a heating pad or on heated skin is not recommended due to the potential for increased absorption and risk of adverse effects.

• Bandaging the area post-application is contraindicated as it may alter the intended effect and increase the risk of skin irritation.

• Application to wounds or damaged skin is prohibited to prevent further irritation or complications.

• It is essential to wash hands with cold water immediately after use and avoid contact with eyes or mucous membranes to prevent irritation or injury.

Warnings and Precautions

For external use only. This product is flammable and should be kept out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals are advised to recommend that patients contact a doctor prior to use if they have sensitive skin, are pregnant, breastfeeding, or are currently taking any medications. This precaution is essential to ensure the safety and appropriateness of the product for individual patients.

In the event of accidental ingestion, it is critical to seek medical assistance immediately or contact a poison control center. Prompt action is necessary to mitigate potential health risks associated with swallowing the product.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: redness or irritation at the application site, worsening of the condition, or if pain persists for more than 7 days or resolves only to reoccur. These symptoms may indicate an adverse reaction or the need for a different therapeutic approach.

Side Effects

Patients should be aware that the product is for external use only. It is flammable and should be kept out of reach of children. Prior to use, individuals are advised to contact a doctor if they have sensitive skin, are pregnant, breastfeeding, or are currently taking any medications.

In clinical practice, it is important to monitor for adverse reactions. Patients should discontinue use and consult a doctor if they experience redness or irritation. Additionally, if the condition worsens, or if pain persists for more than 7 days or resolves only to reoccur, medical advice should be sought immediately.

In the event of accidental ingestion, patients should seek medical help or contact a poison control center without delay.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Trivita Qpr (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use in this age group is contraindicated. Healthcare professionals are advised to consider alternative treatments for children in this age range.

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 should contact a healthcare professional before using this medication. It is important to discuss any current medications, as well as breastfeeding status, to ensure safety for both the mother and the fetus. The potential risks and benefits should be carefully evaluated in consultation with a healthcare provider.

Lactation

Lactating mothers are advised to contact a healthcare professional before using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Caution is recommended when administering this medication to lactating mothers, particularly if they are also taking other medications.

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 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, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a poison control center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate management strategy.

Healthcare providers should be prepared to implement supportive care and symptomatic treatment as necessary, based on the clinical presentation of the patient. Continuous monitoring and evaluation may be required to ensure patient safety and effective management of any complications arising from the 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that the product is flammable and must be kept out of reach of children to prevent accidental ingestion or exposure. Patients should be instructed to contact their doctor before using the product if they have sensitive skin, are pregnant, breastfeeding, or are currently taking any medications.

In the event of accidental ingestion, patients should seek medical help or contact a poison control center immediately. Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if any redness or irritation occurs, if the condition worsens, or if pain persists for more than 7 days or resolves only to reoccur.

Patients should be cautioned against using the product in conjunction with a heating pad or on heated skin. It is important to inform them not to bandage the area where the product is applied, and to avoid applying it to wounds or damaged skin. After application, patients should wash their hands with cold water immediately and refrain from touching their eyes or mucous membranes to prevent irritation.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the cap is tightly closed to maintain the integrity of the product. Proper storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended application of rolling onto the affected area no more than four times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)