Avedana Pain Relief

Description

This product is formulated using all-natural botanical ingredients. The composition emphasizes the use of plant-derived components, ensuring a formulation that aligns with natural product standards.

Uses and Indications

This drug is indicated for the topical relief of pain in localized areas. It is recommended to spray the formulation to completely cover the painful area. For enhanced relief, application after a warm shower or bath is advised. The formulation may be reapplied as needed to maintain comfort.

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

Dosage and Administration

The medication should be administered as a spray, ensuring that the painful area is completely covered. For enhanced relief, it is recommended to apply the spray following a warm shower or bath. The spray may be reapplied as needed to maintain comfort and alleviate pain.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with eyes and mucous membranes should be avoided due to the potential for irritation. Additionally, the product should not be applied to wounds, damaged, or irritated skin, as this may exacerbate irritation or lead to adverse effects. If excessive irritation develops, discontinuation of use is advised.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds, damaged, or irritated skin. If excessive irritation develops, discontinuation of use is advised.

In the event of ingestion, immediate medical assistance should be sought, and the poison control center must be contacted without delay.

Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin, are pregnant, or are breastfeeding.

Side Effects

For external use only. Patients should consult a doctor prior to use if they have sensitive skin, are pregnant, or are breastfeeding.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be monitored closely to ensure that the medication is kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought, and the poison control center should be contacted without delay.

Geriatric Use

There is no specific information available 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

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 healthcare professional prior to 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. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients regularly. For those with a creatinine clearance below a specified threshold, a reduced dose should be considered. Additionally, special monitoring is required for patients with severe renal impairment to mitigate potential risks associated with altered pharmacokinetics.

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, it is important for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected drug overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved. Common symptoms may include, but are not limited to, altered mental status, respiratory depression, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate assessment of the patient's airway, breathing, and circulation is crucial. Supportive care should be initiated as necessary, and specific antidotes should be administered if available and indicated.

Healthcare professionals are advised to consult local poison control centers or relevant clinical guidelines for further management strategies tailored to the specific substance involved in the overdose. Continuous monitoring and supportive care are essential components of effective management in these situations.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is critical for ongoing patient care and potential reporting requirements.

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

Postmarketing experience has revealed reports of skin irritation and allergic reactions associated with the use of Avedana Pain Relief Spray. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of ingestion, patients should seek medical help and contact a poison control center immediately.

When using this product, patients should be instructed to avoid contact with the eyes and mucous membranes. They should not apply the product to wounds, damaged, or irritated skin, and should discontinue use if excessive irritation develops.

Additionally, healthcare providers should encourage patients to consult a doctor before using this product if they have sensitive skin, are pregnant, or are breastfeeding.

Storage and Handling

The product is supplied in a configuration that includes a spray cap. It is essential to store the product in a cool, dry place, ensuring that the spray cap is screwed tightly to maintain integrity. Care should be taken to keep the product away from excessive heat and open flames to prevent any potential hazards.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)