Trubrexa Dailymed

Trubrexa ^TM Transdermal Patch

Extended Time Release

Lidocaine 4.75%

Capsaicin 0.025%

Rx Only

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.

2. Dosage & 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:
  • oKeep Trubrexa ^TM Transdermal Patch in the sealed pouch until immediately before use.
  • oUse Trubrexa ^TM Transdermal Patch only on dry, intact (unbroken) skin.
  • oDuring administration, avoid unnecessary contact with any lis in the room, including lis that the patient may later have contact with, such as horizontal surfaces and bedsheets.
  • oImmediately after use, clean all areas of skin that had contact with Trubrexa ^TM Transdermal Patch.
  • oEnsure 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.

3. Dosage Forms & Strengths

Trubrexa ^TM Transdermal Patch contains 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. 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. 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.

5. Warnings, Precautions & 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 lis 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 bulers, 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.

5.5 Increase in Blood Pressure

Patient with unstable or poorly controlled hypertension, or a recent history of cardiovascular or cerebrovascular events, may be at increased risk of adverse cardiovascular effects. Consider these factors prior to initiating Trubrexa ^TM Transdermal Patch treatment. Monitor blood pressure periodically during and following the treatment procedure and provide adequate support for treatment-related pain.

5.6 Sensory Function

Decreases in sensory functions are generally minor and temporary (including to thermal and other harmful stimuli). All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory deterioration or loss prior to each prescription of Trubrexa ^TM Transdermal Patch. If sensory deterioration or loss is detected or pre-existing sensory deficit worsens, continued use of Trubrexa ^TM Transdermal Patch treatment should be reconsidered.

5.7 Precautions

Allergic Reactions

Allergic and anaphylactoid reactions associated with lidocaine can occur. They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, chock, and urticaria. If they occur, they should be managed by conventional means. Patients allergic to para-aminobenzoic acid derivates (procaine, tetracaine, benzocaine, etc.) have not shown cross-sensitivity to lidocaine. However, Trubrexa ^TM Transdermal Patch should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.

External Heat Sources

Placement of external heat sources, such as heating pads or electric blankets, over Trubrexa ^TM Transdermal Patch is not recommended.

Eye Exposure

The contact of Trubrexa ^TM Transdermal Patch with eyes should be avoided based on finding from previous studies with use of similar products. If eye contact occurs, immediately wash out the eye with water and saline and protect the eye until sensation returns.

Hepatic Disease

Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally.

Non-Intact Skin

Trubrexa ^TM Transdermal Patch is only recommended for use on intact skin. Application to broken or inflamed skin may result in increased irritation and/or increased absorption of ingredients.

5.8 Other Adverse Events

Due to the nature and limitation of spontaneous reports in postmarketing surveillance, causality has not been established for additional reported adverse events including: asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor.

5.9 Systemic (Dose-Related) Reactions

Systemic adverse reactions following appropriate use of Trubrexa ^TM Transdermal Patch are unlikely due to the small dose absorbed. Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold, or numbness, twitching tremors, convulsions, unconsciousness, respiratory depression, and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestations may include bradycardia, hypotension, and cardiovascular collapse leading to arrest.