Feldene 20mg Capsules

Piroxicam 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 non-selective inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition reduces the formation of prostaglandin precursors, which are involved in inflammation, pain, and fever.

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

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 kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Shortness of breath, significant weight gain, or swelling in the arms or legs.
Chest pain or pressure.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Feeling extremely tired or weak.
Ringing in the ears.
Swelling.
Changes in vision.
Flu-like symptoms.

Liver Problems and Severe Skin Reactions

In rare cases, this medication can cause liver problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor immediately: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. These reactions can affect other organs and be life-threatening. Seek medical help right away if you notice: 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 Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or if they bother you or persist, contact your doctor:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Gas.
Dizziness or headache.

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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.
Presence of gastrointestinal (GI) bleeding or kidney problems.
Heart conditions, including heart failure (weak heart) or a recent heart attack.
Concurrent use of other NSAIDs, salicylate medications like aspirin, or pemetrexed.
Fertility issues, including difficulty getting pregnant or ongoing fertility evaluations.
Pregnancy, planned pregnancy, or pregnancy confirmation during treatment. This medication may harm an unborn baby if taken after 20 weeks of gestation. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

To ensure your safety, it is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments 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. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.

You should also have your blood pressure checked regularly, as directed by your doctor, since medications like this one can cause high blood pressure. Additionally, discuss your alcohol consumption with your doctor before drinking. If you smoke, talk to your doctor about the potential risks.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount can increase your chances of experiencing adverse effects. Furthermore, do not take this medication for longer than your doctor has advised.

If you have asthma, consult your doctor, as you may be more sensitive to this medication. Be cautious and avoid injuries, as this drug can increase your risk of bleeding. To reduce this risk, use a soft toothbrush and an electric razor.

The use of 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 these risks with your doctor. Additionally, 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 type of medication after a first heart attack were more likely to die within the following year compared to those not taking it. Talk to your doctor about these risks.

If you are taking aspirin to prevent heart attacks, consult your doctor about potential interactions. Older adults (65 years or older) should use this medication with caution, as they may be more susceptible to side effects.

It is also important to note that NSAIDs, like this medication, can affect ovulation, which may impact fertility. However, this effect is typically reversible when the medication is stopped. If you are trying to conceive, discuss this with your doctor. Finally, if you are breastfeeding, consult your doctor to discuss any potential risks to your baby.

• Aspirin (high dose)
• Other NSAIDs (concurrent use)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Diuretics (e.g., Furosemide, Thiazides): Reduced natriuretic and diuretic effects, potential for renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment (especially in elderly or volume-depleted patients).
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Cyclosporine/Tacrolimus: Increased risk of nephrotoxicity.
• Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid in patients with renal impairment).

• Beta-blockers: Reduced antihypertensive effect.
• Hydantoins (e.g., Phenytoin): Increased phenytoin levels.
• Sulfonylureas: Potential for altered glycemic control.
• Digoxin: Possible increased digoxin levels.
• Cholestyramine: May reduce piroxicam absorption (separate administration).

• Antacids: May slightly delay absorption but no significant clinical effect.

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (e.g., nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, flu-like symptoms)
• Signs of allergic reactions or skin reactions (e.g., rash, hives, blistering, swelling of face/throat)
• Unusual bruising or bleeding
• Vision changes or blurred vision
• Fluid retention or swelling (edema)

Use should be avoided during pregnancy, especially in the third trimester due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Piroxicam is excreted in breast milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Use with caution.

Safety and effectiveness in pediatric patients have not been established. Not recommended for chronic use in children due to potential for serious adverse effects and lack of data.

Elderly patients are at greater risk for serious cardiovascular, gastrointestinal, and renal adverse events. Use the lowest effective dose for the shortest duration possible. Monitor renal function, GI bleeding, and blood pressure closely.

• Piroxicam has a very long half-life (around 50 hours), allowing for once-daily dosing, but also means it takes longer to reach steady state and clear from the body, increasing the risk of accumulation and adverse effects, especially in elderly or renally impaired patients.
• Due to its long half-life and higher risk of GI and cardiovascular adverse events compared to some other NSAIDs, piroxicam is generally not considered a first-line NSAID for chronic conditions, especially in the elderly.
• Always prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Educate patients on the signs and symptoms of serious GI and cardiovascular adverse events and advise them to seek immediate medical attention if these occur.
• Consider gastroprotective agents (e.g., PPIs) for patients at high risk of GI complications, especially with long-term use.
• Monitor blood pressure regularly, as NSAIDs can cause new-onset hypertension or worsen existing hypertension.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, with higher risk of side effects and dependence)
• Corticosteroids (for severe inflammation, with different side effect profile)
• Disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (e.g., Methotrexate, Hydroxychloroquine)
• Physical therapy
• Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine patches)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. 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 incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.