Elevate Cooling Therapy Twist up

Description

Elevate Twist Up is a topical formulation presented in a 2 oz stick format. The product is designed for localized application, providing a convenient delivery method for its active ingredients. The packaging is optimized for ease of use, allowing for precise application to targeted areas.

Uses and Indications

This drug is indicated for external use on muscles and joints to relieve soreness. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

Healthcare professionals should instruct patients to massage the desired amount of the medication into the affected skin area. This application should not exceed 10 times daily unless otherwise directed by a physician.

For pediatric patients, specifically those under 12 years of age, it is essential to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

The product should not be used in the following situations:

• Do not bandage tightly, as this may impede circulation.

• Avoid contact with eyes to prevent irritation or injury.

• Do not apply to wounds or damaged skin to avoid exacerbating the condition.

• The use of heating pads or other heating devices in conjunction with this product is contraindicated due to the risk of increased irritation or adverse effects.

If symptoms worsen or persist for more than 7 days, or if symptoms clear up and then recur within a few days, discontinue use and consult a healthcare professional.

Warnings and Precautions

The product is intended for external use only. It is imperative that users do not apply a tight bandage when using this product, as this may lead to adverse effects. Care should be taken to avoid contact with the eyes, as this may result in irritation or injury. The product must not be applied to wounds or damaged skin, as this could exacerbate the condition or lead to complications. Additionally, the use of heating pads or other heating devices in conjunction with this product is contraindicated, as it may increase the risk of adverse reactions.

In the event of accidental ingestion, immediate medical assistance should be sought, or the user should contact a Poison Control Center without delay.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring of the condition is essential to ensure appropriate management and to prevent potential complications.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid bandaging tightly when using this product, as well as to prevent contact with the eyes. The product should not be applied to wounds or damaged skin, and it is contraindicated for use with heating pads or other heating devices.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are advised to stop use and consult a doctor.

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 specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Elevate Cooling Therapy Twist up (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult their physician prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in efficacy and safety profiles compared to older populations.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for safety during pregnancy. There are no specific contraindications for use during pregnancy, and the insert does not provide any specific safety concerns or risks to the fetus associated with the use of this product during this period. Additionally, no dosage modifications for pregnant individuals are mentioned, nor does the insert specify any special precautions regarding use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk. Caution is advised due to the lack of studies on the effects of this product on nursing infants.

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, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, ensuring that appropriate interventions are undertaken 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the 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.

Patients should be informed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, patients must be cautioned against bandaging tightly, as this may lead to complications. They should also be advised to avoid contact with the eyes and not to apply the product to wounds or damaged skin. Additionally, patients should refrain from using the product in conjunction with heating pads or other heating devices to prevent adverse effects.

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 in a manner that protects it from direct sunlight to maintain its integrity and efficacy.

For optimal storage conditions, it is recommended to keep the product in a cool, dry place, away from sources of heat and moisture. Special handling precautions should be observed to ensure that the product remains within the specified temperature range and is not exposed to adverse environmental conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Elevate Cooling Therapy Twist up, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)