Flector 1.3% 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 the inhibition of prostaglandin synthesis, primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. When applied topically, diclofenac penetrates the skin and accumulates in underlying tissues, providing localized pain relief and anti-inflammatory effects with minimal systemic exposure.

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, redness, swelling, blistering, 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, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding 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: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, numbness or tingling, or shortness of breath.
Skin irritation, chest pain or pressure, rapid heartbeat, shortness of breath, significant weight gain, or swelling in the arms or legs.
Weakness on one side of the body, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness, flu-like symptoms, or 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, which can be life-threatening. If you experience any of the following symptoms, seek medical help immediately:

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, or 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 symptoms that bother you or persist, contact your doctor:

Dizziness or headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
* Gas or 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 essential 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 medications, such as aspirin, or NSAIDs.
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 medications like aspirin, or pemetrexed
Fertility issues or ongoing fertility evaluation

Pregnancy and Fertility Considerations:

If you are trying to conceive, having fertility issues, or undergoing fertility evaluation, inform your doctor.
If you are pregnant or plan to become pregnant, discuss the risks with 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 if your doctor recommends it.
Do not take this medication if you are more than 30 weeks pregnant.

Additional Safety Precautions:

Provide your doctor and pharmacist with a comprehensive list of all medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Ensure that it is safe to take this medication with all your other medications and health conditions.
Never start, stop, or change the dose 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.

High blood pressure is a potential side effect of this medication. Your doctor will advise you on how often to have your blood pressure checked. If you smoke, it is crucial to discuss this with your doctor, as it may impact 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. When using this medication, avoid applying it to skin with any problems or irritations. Do not exceed the recommended dosage, as this may lead to unsafe side effects. Use this medication only for the duration prescribed by your doctor.

There is an increased risk of heart failure associated with this medication. 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. Furthermore, people who have had a recent heart attack may have a higher risk of heart attack and heart-related death when taking this medication. In fact, studies have shown that people taking this medication after a first heart attack were more likely to die in the following year compared to those not taking this medication. If you are taking aspirin to prevent a heart attack, be sure to discuss this with your doctor.

Liver problems, including fatal cases, have been reported with medications like this one. If you experience any symptoms of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or 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 medication 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, consult with your doctor to discuss any potential risks to your baby.

• Other NSAIDs (including aspirin >325 mg/day or other diclofenac formulations): Increased risk of GI bleeding, ulceration, or perforation.
• Anticoagulants (e.g., warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., clopidogrel): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI adverse events.

• ACE Inhibitors/ARBs: May diminish antihypertensive effect and increase risk of renal impairment.
• Diuretics (e.g., furosemide, hydrochlorothiazide): May reduce natriuretic effect and increase risk of renal impairment.
• Methotrexate: May increase methotrexate levels and toxicity.
• Lithium: May increase lithium plasma concentrations and toxicity.
• Cyclosporine: May increase nephrotoxicity of cyclosporine.
• Digoxin: May increase serum digoxin levels.

• SSRIs/SNRIs: Increased risk of GI bleeding.

• Skin irritation, redness, itching, rash, blistering at application site
• Abdominal pain, indigestion, heartburn, nausea, vomiting
• Black, tarry stools or blood in vomit (signs of GI bleeding)
• Unusual bruising or bleeding
• Swelling of hands, feet, or ankles (fluid retention)
• Unexplained weight gain
• Shortness of breath, chest pain (cardiovascular events)
• Changes in urination (renal impairment)
• Yellowing of skin or eyes, dark urine (liver problems)

Use of NSAIDs, including Flector Patch, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Therefore, Flector Patch is contraindicated in the third trimester of pregnancy. Use during the first and second trimesters should be avoided unless the potential benefit outweighs the potential risk to the fetus, and only if clearly needed.

Diclofenac is excreted in human milk. While systemic absorption from topical application is low, caution should be exercised when Flector Patch is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Flector Patch, and any potential adverse effects on the breastfed infant from Flector Patch or from the underlying maternal condition.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is not recommended.

Elderly patients may be at greater risk for serious cardiovascular, gastrointestinal, and renal adverse events associated with NSAID use. While systemic exposure from topical diclofenac is low, caution is advised. Use the lowest effective dose for the shortest duration possible. Monitor for signs of adverse effects, especially GI bleeding and renal impairment.

• Flector Patch is designed for localized pain relief, offering an alternative to oral NSAIDs for patients who may be sensitive to systemic side effects or prefer topical treatment.
• Ensure patients understand proper application technique: apply to clean, dry, intact skin, and do not cut the patch.
• Emphasize the importance of avoiding heat sources (e.g., heating pads) and direct sunlight on the treated area to prevent severe skin reactions.
• Although systemic absorption is low, remind patients and prescribers that Flector Patch carries the same Black Box Warnings as oral NSAIDs regarding cardiovascular and gastrointestinal risks, especially with prolonged use or in high-risk individuals.
• Advise patients to remove the patch before bathing or showering and apply a new one after, as water can affect adhesion and drug delivery.
• Consider this option for patients with localized musculoskeletal pain who have contraindications or poor tolerance to oral NSAIDs, but still monitor for systemic effects.

• Other topical NSAIDs (e.g., diclofenac gel, Pennsaid solution)
• Oral NSAIDs (e.g., ibuprofen, naproxen, oral diclofenac)
• Topical analgesics (e.g., capsaicin cream, lidocaine patch)
• Acetaminophen
• Physical therapy
• Ice/Heat therapy
• Corticosteroid injections (for localized inflammation)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.