Diclofenac Epolamine 1.3% Top Patch

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its mechanism of action, like that of other NSAIDs, is believed to be due to inhibition of prostaglandin synthesis, primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. When applied topically, diclofenac epolamine delivers diclofenac locally to the affected tissues, reducing inflammation and pain.

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Skin irritation.
Chest pain or pressure, rapid heartbeat, or shortness of breath.
Sudden weight gain or swelling in the arms or legs.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness.
Flu-like symptoms.
Severe back pain.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These conditions can be life-threatening and may also affect internal organs. Seek medical help immediately if you experience:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor:

Dizziness or headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Gas
Heartburn

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate drugs, such as aspirin, or NSAIDs.
Presence of certain health conditions, including:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
Recent heart attack.
Concurrent use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Fertility issues or ongoing fertility evaluation.

Pregnancy and Fertility Considerations:

If you are trying to conceive, having fertility checked, or are pregnant, inform your doctor.
This medication may harm an unborn baby if taken after 20 weeks of pregnancy.
Between 20 to 30 weeks of pregnancy, only take this medication under your doctor's guidance.
Do not take this medication if you are more than 30 weeks pregnant.

Interactions with Other Medications and Health Conditions:

This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist.
Verify that it is safe to take this medication with your existing medications and health conditions.
Never start, stop, or adjust the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

As this medication can cause high blood pressure, your doctor will need to check your blood pressure regularly. If you smoke, it is crucial to discuss this with your doctor, as smoking may affect your treatment. Additionally, if you have asthma, you may be more sensitive to this medication, so be sure to talk to your doctor about any concerns.

Before consuming alcohol, consult with your doctor to discuss any potential risks. It is also important to use this medication only on healthy skin, avoiding any areas with skin problems. Do not exceed the recommended dosage, as this can lead to severe side effects. Furthermore, do not use this medication for longer than prescribed by your doctor.

It is crucial to be aware that medications like this one can increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss this with your doctor to understand the potential risks. Additionally, if you have recently had a heart attack, your risk of heart attack and heart-related death may be higher when taking this medication. In fact, people who took medications like this one after a first heart attack were more likely to die within the following year compared to those not taking this medication. If you are taking aspirin to prevent heart attacks, be sure to discuss this with your doctor.

Liver problems, including fatal cases, have been associated with medications like this one. If you experience any symptoms of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes, contact your doctor immediately.

This medication can be harmful if chewed or swallowed. If you or someone else has ingested this medication, call a doctor or poison control center right away. If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like this one may affect ovulation, which can impact fertility. However, this effect is reversible when the medication is stopped. Discuss any concerns with your doctor. If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Aspirin or other NSAIDs (history of asthma, urticaria, or other allergic-type reactions)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., warfarin, dabigatran): Increased risk of bleeding.
• Other NSAIDs (including aspirin): Increased risk of gastrointestinal adverse events and bleeding.
• Lithium: Increased lithium plasma concentrations.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Diuretics (e.g., furosemide, thiazide diuretics): Reduced natriuretic effect, potential for renal impairment.
• ACE inhibitors and Angiotensin Receptor Blockers (ARBs): Reduced antihypertensive effect, increased risk of renal impairment.
• Cyclosporine, Tacrolimus: Increased risk of nephrotoxicity.

• SSRIs/SNRIs: Increased risk of gastrointestinal bleeding.
• Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding.
• Digoxin: Increased digoxin plasma concentrations.
• Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid in patients with renal impairment).

• Not many specific minor interactions for topical diclofenac epolamine patch due to low systemic absorption, but general NSAID precautions apply.

• Pain level and characteristics
• Swelling or inflammation at the application site
• Redness, itching, rash, or blistering at the application site
• Signs of gastrointestinal upset (e.g., stomach pain, heartburn, black/tarry stools, vomiting blood)
• Unusual bleeding or bruising
• Swelling of ankles, feet, or hands (edema)
• Shortness of breath or chest pain
• Changes in urination (e.g., decreased urine output)
• Signs of allergic reaction (e.g., difficulty breathing, hives, swelling of face/throat)

Use of NSAIDs, including diclofenac epolamine topical patch, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus and renal dysfunction. Therefore, use is contraindicated in the third trimester. During the first and second trimesters, use only if the potential benefit justifies the potential risk to the fetus.

Diclofenac is excreted in human milk in low concentrations. While systemic exposure from topical application is low, caution should be exercised when diclofenac epolamine topical patch is administered to a nursing mother. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Not recommended for use in this population.

Elderly patients may be at greater risk for serious cardiovascular, gastrointestinal, and renal adverse events from NSAIDs. Use with caution, generally starting at the lower end of the dosing range, and monitor closely for adverse effects. While systemic exposure is low, the increased sensitivity of elderly patients to systemic NSAID effects should be considered.

• Ensure the skin is clean, dry, and free of cuts, rashes, or other damage before applying the patch.
• The patch should be applied to the most painful area. Do not apply to areas with open wounds or infections.
• Patients should be instructed not to cut the patch, as this may alter drug delivery.
• Advise patients to wash their hands thoroughly after applying or removing the patch.
• Local skin reactions (e.g., redness, itching, rash) are common but usually mild and transient. If severe or persistent, discontinue use and consult a healthcare provider.
• The patch should be removed before showering or bathing.
• Although systemic absorption is low, patients should be advised of the potential for systemic NSAID side effects, especially if they have pre-existing conditions (e.g., renal impairment, GI issues) or are on concomitant medications.

• Oral NSAIDs (e.g., ibuprofen, naproxen, oral diclofenac)
• Acetaminophen (for pain relief)
• Topical analgesics (e.g., capsaicin cream, lidocaine patch)
• RICE therapy (Rest, Ice, Compression, Elevation) for acute musculoskeletal injuries
• Physical therapy
• Corticosteroid injections (for localized inflammation)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.