Trubrexa Patch Er
FDA Drug Information • Also known as: Trubrexa Patch Er
- Brand Names
- Trubrexa Patch Er
- Drug Class
- Amide Local Anesthetic [EPC], Antiarrhythmic [EPC]
- Route
- TRANSDERMAL
- Dosage Form
- PATCH
- Product Type
- HUMAN PRESCRIPTION DRUG
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 Trubrexa Patch Er Used For?
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.
Dosage and Administration
2.1 Important Dosage and Administration Instructions Unintended exposure to capsaicin can cause severe irritation of the eyes, mucous membranes, respiratory tract, and skin in healthcare providers and others. Because unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin, when administering Trubrexa TM Transdermal Patch it is important to follow these procedures: Keep Trubrexa TM Transdermal Patch in the sealed pouch until immediately before use. Use Trubrexa TM Transdermal Patch only on dry, intact (unbroken) skin. During administration, avoid unnecessary contact with any items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets. Immediately after use, clean all areas of skin that had contact with Trubrexa TM Transdermal Patch. Ensure all used and unused pieces Trubrexa TM Transdermal Patch are properly disposed of. 2.2 Dosing and Instructions for Use Tear open pouch bag and remove one patch. Place remaining patches back in pouch bag and seal the pouch bag closed. Peel the clear plastic film away and apply Trubrexa TM Transdermal Patch to intact skin to cover the most painful area. Apply one patch per day for up to 12 hours within a 24 hour period (12 on, 12 off). One single Trubrexa TM Transdermal Patch may be used twice per day. To re-use after first application, place the clear plastic film back on to medicated hydrogel pad. Clothing may be worn over the area of application. 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. When Trubrexa TM Transdermal Patch is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Side Effects (Adverse Reactions)
5.1 Risk of Methemoglobinemia Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; fatigue; or lightheadedness. Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Trubrexa TM Transdermal Patch and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration, etc. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. 5.2 Excessive Dosing Excessive dosing by applying Trubrexa TM Transdermal Patch to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and capsaicin and high blood concentrations. Lidocaine toxicity could b e expected at lidocaine blood concentrations above 5 mcg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine and capsaicin. 5.3 Severe Irritation with Unintended Capsaicin Exposure Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin. Eye and Mucous Membrane Exposure Do not apply Trubrexa TM Transdermal Patch to the face, eyes, mouth, nose, or scalp to avoid risk of exposure to eyes or mucous membranes. Accidental exposure to the eyes and mucous membranes can occur from touching Trubrexa TM Transdermal Patch or items exposed to capsaicin, then touching the eyes and mucous membranes. If irritation of eyes or mucous membranes occurs, remove the affected individual from the vicinity of Trubrexa TM Transdermal Patch and flush eyes and mucous membranes with cool water. Respiratory Tract Exposure Inhalation of airborne capsaicin can result in coughing or sneezing. If irritation of airways occurs, remove the affected individual from the vicinity of Trubrexa TM Transdermal Patch. Provide supportive medical care if shortness of breath develops. Skin Exposure Thoroughly clean all areas that had contact with Trubrexa TM Transdermal Patch and properly dispose of all patch components. 5.4 Application-Associated Pain During or immediately after treatment with Trubrexa TM Transdermal Patch, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours....
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
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
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
12.1 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 72189-541-11
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.