Feldene 10mg Capsules

Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its mechanism of action is believed to be due to the inhibition of prostaglandin synthesis, primarily through the non-selective inhibition of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes. This 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 immediate medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
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.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden significant weight gain.
High Potassium Levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Shortness of Breath, Weight Gain, or Swelling: Sudden onset of shortness of breath, significant weight gain, or swelling in the arms or legs.
Chest Pain or Pressure: Discomfort or tightness in the chest.
Neurological Symptoms: 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: Feeling extremely tired or weak.
Ringing in the Ears: Tinnitus or ringing sounds in the ears.
Swelling: Unexplained swelling or edema.
Vision Changes: Changes in eyesight or vision.
Flu-like Symptoms: Fever, chills, or body aches.
Liver Problems: Dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or eyes. Liver problems can be life-threatening, so seek medical help immediately if you experience any of these symptoms.
Severe Skin Reactions: 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. These reactions can be life-threatening and may affect internal organs.

Other Possible Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Gastrointestinal Symptoms: Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite.
Gas: Bloating or gas.
Dizziness or Headache: Feeling lightheaded or experiencing headaches.

This is not an exhaustive list of possible side effects. If you have 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 drugs, such as aspirin, or NSAIDs.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding or kidney problems.
+ Heart failure (weak heart) or a recent heart attack.
Concurrent use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Fertility issues or ongoing fertility evaluation.
Pregnancy, planned pregnancy, or suspected pregnancy. 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 of the following to your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications.
Natural products and vitamins.
Existing health problems.

Verify with your doctor that it is safe to take this medication with your current medications and health conditions. Do not initiate, 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 long-term, 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 a longer period than specified by your doctor.

If you have asthma, consult your doctor, as you may be more sensitive to this medication. You may also experience easier bleeding, so it is crucial to be cautious and avoid injuries. To reduce the risk of bleeding, 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 medications like this one. In fact, studies have shown that individuals taking this type of medication after a first heart attack were more likely to die within the following year compared to those not taking the medication. 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 and 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 reversible, and ovulation typically returns to normal once the medication is stopped. If you are trying to conceive, discuss this with your doctor.

Finally, if you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby.

• Aspirin (high dose, due to increased GI risk)
• Other NSAIDs (due to increased GI and renal risk)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Heparin) - increased bleeding risk
• Antiplatelet agents (e.g., Clopidogrel) - increased bleeding risk
• SSRIs/SNRIs - increased GI bleeding risk
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• ACE Inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment
• Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic and antihypertensive effect, increased risk of renal impairment
• Corticosteroids - increased GI ulceration/bleeding risk
• Cyclosporine - increased nephrotoxicity
• Tacrolimus - increased nephrotoxicity
• Digoxin - increased digoxin levels (less common but possible)

• Beta-blockers - reduced antihypertensive effect
• Hydantoins (e.g., Phenytoin) - increased phenytoin levels
• Sulfonylureas - altered blood glucose control
• Cholestyramine - reduced piroxicam absorption
• Alcohol - increased risk of GI irritation/bleeding

• Antacids - may slightly delay absorption but not clinically significant

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal dysfunction (decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of allergic reactions/skin reactions (rash, hives, itching, swelling of face/throat, difficulty breathing)
• Unusual bruising or bleeding
• Sudden weight gain or swelling (edema)

Use should be avoided during pregnancy, especially in the third trimester due to potential for premature closure of the fetal ductus arteriosus and renal dysfunction in the fetus. Category C in first and second trimesters, Category D in third trimester.

Piroxicam is excreted into breast milk in low concentrations. While the amount is small, due to the long half-life and potential for serious adverse effects in infants (e.g., cardiovascular, renal), it is generally recommended to use with caution or consider an alternative NSAID with a shorter half-life. Monitor infant for adverse effects.

Safety and efficacy have not been established in pediatric patients. Generally not recommended for routine use in children due to potential for serious adverse effects and lack of data.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, including gastrointestinal bleeding, ulceration, perforation, renal toxicity, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects, especially renal function and GI symptoms.

• Piroxicam has a very long half-life (approximately 50 hours), allowing for once-daily dosing, but also means that steady-state concentrations are reached slowly (7-12 days) and adverse effects can persist for an extended period after discontinuation.
• Due to its long half-life and higher risk of GI adverse events compared to other NSAIDs, piroxicam is generally not considered a first-line NSAID for chronic conditions, especially in the elderly.
• Always advise patients to take piroxicam with food or milk to minimize GI upset.
• Patients should be educated on the signs and symptoms of serious GI and cardiovascular adverse events and instructed to seek immediate medical attention if they occur.
• Hydration status should be assessed, especially in patients at risk for renal impairment, as NSAIDs can exacerbate dehydration-induced renal dysfunction.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Diclofenac, Celecoxib)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, different mechanism, higher risk of dependence)
• Corticosteroids (for severe inflammation, different mechanism, different side effect profile)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA
• Topical NSAIDs (e.g., Diclofenac gel) for localized pain

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, which provides crucial information for patients. 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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.