Lexilido

Lexilido

Lexilido Recall

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Questions & Answers

Side Effects & Adverse Reactions

Excessive dosage, or short interval between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs.

  1. Do not use:
       On wounds, cuts, damaged or infected skin
       On eyes, mouth, genitals, or other mucous membranes
  2. Consult physician for children under 12 years of age
  3. Stop and consult your prescriber if pain worsens

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

  • Shortness of breath
  • Swelling or numbness of the tongue or throat
  • Severe headache or vomiting
  • Dizziness or faintness
  • Changes in vision or speech

DIRECTIONS FOR USE

Adults and children 12 years and over:

Apply 1 to 2 patches to the affected area of intact skin. LexiLido Patch® should be removed after 12 hours of continuous use and remain off for at least 12 hours.  

  1. Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors. Safely discard the remaining unused pieces of cut patches where children and pets cannot reach. 
  2. Remove the transparent release liner (clear plastic backing) before application of patches to the skin. Apply immediately after removal from the protective envelope.
  3. Apply 1 patch to the affected area so that the patch covers most of the painful area. Apply patch only once during each 24-hr period (12 hours on / 12 hours off).
  4. Remove patch if irritation occurs.

Children under 12 years of age:

Consult a doctor

General information about the safe and effective use LexiLido Patch®

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use this product for another indication. Do not give this drug to anyone else, even if they have the same condition.

How should I store LexiLido Patch®

Store product at room temperature at 68°F to 77°F (20°C to 25°C). Keep away from heat or sunlight. Protect from excessive moisture. Discard product after expiration date posted on the product label.

DO NOT use the product after the expiration date printed on the box.

This leaflet provides the most important information about LexiLido Patch®. If you would like more information, talk with your healthcare provider or pharmacist. There is additional information in the following sections intended for healthcare professionals

What are the active ingredients in LexiLido Patch® ?

The patch consists of 5% menthol and 4% lidocaine. .

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

LexiLido Patch® is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to musculoligamentous strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact. If consulted by your physician.

Other uses may be considered if deemed clinically relevant

History

There is currently no drug history available for this drug.

Other Information

LexiLido Patch® is a prescription topical patch containing 15 articulated patches (5 per resealable pouch x 3 pouches). Lidocaine is present in a 4% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C14H22N2O. The molecular weight of lidocaine is 234.34 g/mol. Menthol is present in a 5% concentration (w/w). The chemical name is (1R,2S,5R)-2-isopropyl-5-methylcyclohexanol. The empirical formula for menthol is C10H20O with a molecular weight of 156.27 g/mol. 

The structural formulas are:

** Menthol **

The structural formula of Menthol.

** Lidocaine**

The structural formula of Lidocaine.

Lexilido Manufacturers


  • Alexso, Inc.
    Lexilido (Levomenthol And Lidocaine) Patch [Alexso, Inc.]

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