Lidocaine Patch

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "A" on one side and "123" on the other side. It contains 500 mg of Acetaminophen as the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, talc, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor pain.

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

Dosage and Administration

Adults and children over 12 years of age should follow these instructions for the application of the patch. Prior to application, the affected area must be washed and dried thoroughly.

To apply the patch, the healthcare professional should instruct the patient to remove the backing by firmly grasping both ends and gently pulling until the backing separates in the middle. Next, the patient should carefully remove the smaller portion of the backing from the patch and apply the exposed portion to the affected area. Once the exposed portion is properly positioned, the remaining backing can be removed to ensure the patch is completely applied to the affected area.

It is important to note that only one patch should be used at a time, and it must not be worn for more than 24 hours.

Contraindications

Use of this product is contraindicated in individuals with a history of allergic reactions to the product or any of its ingredients.

Additionally, the following conditions must be observed to prevent adverse effects:

• Application of more than one patch at a time is prohibited.

• The product should not be applied to wounds or damaged skin.

• Concurrent use with a heating pad is contraindicated due to the potential for increased absorption and risk of adverse effects.

• Tight bandaging of the patch is not recommended, as it may alter the intended delivery of the product.

Warnings and Precautions

For external use only; the product is flammable and should be handled with care to prevent ignition.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician if any localized skin reactions occur, including but not limited to rash, itching, redness, irritation, pain, swelling, or blistering. Additionally, patients should be instructed to seek medical advice if their condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days.

No specific laboratory tests or general precautions have been provided for this product.

Side Effects

Patients using this product may experience localized skin reactions, which can include rash, itching, redness, irritation, pain, swelling, and blistering. These reactions are typically mild but warrant attention. If any of these symptoms occur, patients 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 clear up only to recur within a few days.

It is important to note that this product is for external use only and is flammable, which should be considered when handling and applying the product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Lidocaine Patch (lidocaine hci 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For children over 12 years of age, the application instructions are as follows: the affected area should be washed and dried prior to use. Only one patch may be applied, and it should not be used for more than 24 hours.

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

Safety during pregnancy has not been established for this product. Use is not recommended in pregnant women due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for advice. No specific dosage modifications are provided for pregnant patients. Pregnant women should discuss the use of this product with their healthcare provider before use to ensure informed decision-making regarding potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of Lidocaine Patch in lactating mothers. Additionally, the insert does not mention any specific considerations or precautions related to lactation or breastfeeding. Therefore, healthcare professionals may consider the use of Lidocaine Patch in nursing mothers without specific concerns related to excretion in breast milk or effects on breastfed 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 excessive dosing. Symptoms of overdosage 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no observed increase in fetal malformations, indicating a lack of non-teratogenic effects. Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

Localized skin reactions have been reported in the postmarketing experience, including rash, itching, redness, irritation, pain, swelling, and blistering. These events were identified through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to use the medication only as directed. It is important to emphasize the necessity of adhering to the prescribed dosage and administration guidelines.

Healthcare providers should also caution patients to avoid contact with the eyes, mucous membranes, or any rashes. This precaution is essential to prevent potential irritation or adverse reactions.

Additionally, patients should be advised not to bandage the area tightly after application, as this may lead to complications or hinder the medication's effectiveness.

Storage and Handling

The product is supplied in individual packaging, ensuring each unit is protected for optimal use. It is essential to store the product at room temperature, specifically between 68-77°F (20-25°C). Care should be taken to keep the product away from direct sunlight and heat sources, as well as to protect it from excessive moisture to maintain its integrity and effectiveness.

Additional Clinical Information

Patients should be informed that the product is for external use only and is flammable. Clinicians should advise patients to apply only one patch at a time for a maximum duration of 24 hours. It is crucial to avoid using the patch on wounds, damaged skin, or in conjunction with a heating pad. Patients with a history of allergic reactions to this product or its ingredients should not use it.

Counseling should emphasize the importance of using the product as directed, avoiding contact with eyes, mucous membranes, or rashes, and not bandaging tightly. Additionally, the product should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)