Lidocaine And Capsaicin
FDA Drug Information • Also known as: Trubrexa
- Brand Names
- Trubrexa
- Drug Class
- Amide Local Anesthetic [EPC], Antiarrhythmic [EPC]
- Route
- TRANSDERMAL
- Dosage Form
- PATCH
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
9. DESCRIPTION Trubrexa TM Transdermal Patch is comprised of an adhesive material containing 4.75% lidocaine and 0.025% capsaicin. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer with breathable fabric. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TM Transdermal Patch logo. 4 patches are included in each pouch bag. The inactive ingredients include: Arnica, Magnesium, Polyacrylate, Vegan Glycerol, and Water. Trubrexa TM Transdermal Patch is Latex Free, Paraben Free, and Vegan.
What Is Lidocaine And Capsaicin Used For?
1. INDICATIONS & USAGE Trubrexa TM Transdermal Patch is indicated in adults over the age of 12 years old for the treatment of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.
Drug Interactions
6. DRUG INTERACTIONS Antiarrhythmic Drugs Trubrexa TM Transdermal Patch should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics When Trubrexa TM Transdermal Patch is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Drugs That May Cause Methemoglobinemia Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Nitrates/Nitrites (nitric oxide, nitroglycerin, nitroprusside, nitrous oxide) Local anesthetics (benzocaine, bupivacaine, lidocaine, prilocaine, procaine, tetracaine) Antineoplastic Agents (cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase) Antibiotics (dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides) Antimalarials (chloroquine, primaquine) Anticonvulsants (Phenobarbital, phenytoin, sodium valproate) Other Drugs (acetaminophen, metoclopramide, quinine, sulfasalazine)
Contraindications
4. CONTRAINDICATIONS Trubrexa TM Transdermal Patch is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.
Overdosage
8. OVERDOSAGE Lidocaine overdose from cutaneous absorption is rare but could occur. If there is any suspicion of lidocaine overdose, drug blood concentration should be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdose with lidocaine. In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics. There is no specific antidote for overdose with capsaicin. In case of suspected overdose, remove Trubrexa TM Transdermal Patch and gently wash the area with soap and water. Use supportive measures and treat symptoms as clinically warranted.
How Supplied
12. HOW SUPPLIED / STORAGE & HANDLING 12.1 How Supplied Trubrexa TM Transdermal Patch comes in a sealed pouch bag. Each patch is 2 in x 2 in (5.08 cm x 5.08 cm) and consists of an adhesive side containing the active/inactive ingredients and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, plastic film. The outer surface of the backing layer is imprinted with the Trubrexa TM Transdermal Patch logo. Trubrexa TM Transdermal Patch is available as a unit box containing 32 patches (8 pouch bags). NDC 83295-4000-1 12.2 Storage Store unit box between 68 o -77 o F (20 o -25 o C). Excursions between 15 o -30 o C (59 o -86 o F) are allowed. Keep Trubrexa TM Transdermal Patch in the sealed pouch bags until immediately before use. 12.3 Handling and Disposal Unintended exposure to capsaicin can cause severe irritation of eyes, skin, respiratory tract, and mucous membranes. Avoid contact with your eyes, nose, or mouth. Keep used and unused patches out of the reach of children and pets. Pouch bags are not child resistant. Wash hands with soap and water after handling the patch. If irritation or a burning sensation occurs during application, remove the patch and do not reapply until the irritation subsides. After use, fold patches so that the adhesive side sticks to itself, then safely discard used patches where children and pets cannot get to them.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.