Piroxicam 20mg Capsules

Piroxicam is a non-selective nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis by reversibly inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes. This leads to a reduction in 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, difficulty 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 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.
Respiratory Issues: Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Chest pain or pressure.
Neurological Issues: Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
General Symptoms: Extreme fatigue or weakness, ringing in the ears, swelling, changes in vision, or flu-like symptoms.
Liver Problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. (Note: Liver problems can be life-threatening and have occurred with similar medications.)
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 experience minimal or no side effects. However, if you encounter any of the following side effects or any other unusual symptoms, consult your doctor or seek medical attention:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:

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.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you have ever experienced asthma triggered by a salicylate medication, such as aspirin, or an NSAID.
If you have a history of gastrointestinal (GI) bleeding or kidney problems.
If you have heart failure (a weak heart) or have recently had a heart attack.
If you are currently taking another NSAID, a salicylate drug like aspirin, or pemetrexed.
If you are having difficulty getting pregnant or are undergoing fertility testing.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This medication may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.

To ensure your safety, it is crucial to inform your doctor and pharmacist about:

All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have.

Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not 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.

If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.

There is a risk of developing high blood pressure while taking this medication. Follow your doctor's instructions for checking your blood pressure regularly.

Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions.

If you smoke, talk to your doctor about the potential effects on your health while taking this medication.

Adhere to the prescribed dosage and do not exceed the recommended amount. Taking more than directed may increase your risk of severe side effects. Additionally, do not take this medication for longer than your doctor has prescribed.

If you have asthma, consult with your doctor, as you may be more sensitive to this medication.

Be aware that this medication may increase your risk of bleeding easily. To minimize this risk, be cautious and avoid injury. Use a soft toothbrush and an electric razor for personal grooming.

The use of medications like this one may 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.

In people who have recently experienced a heart attack, the use of medications like this one may increase the risk of another heart attack and heart-related death. Additionally, people taking this type of medication after a first heart attack may have a higher risk of death within the following year compared to those not taking this medication. Talk to your doctor about these risks.

If you are taking aspirin to prevent a heart attack, consult with your doctor about potential interactions with this medication.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Medications like this one, known as NSAIDs, may affect ovulation, which could impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss this with your doctor if you have concerns.

If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• History of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs
• Advanced renal disease
• Severe hepatic impairment

• Anticoagulants (e.g., warfarin, heparin): Increased risk of bleeding
• Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding
• Corticosteroids: Increased risk of GI ulceration/bleeding
• SSRIs/SNRIs: Increased risk of GI bleeding
• Lithium: Increased lithium levels and toxicity
• Methotrexate: Increased methotrexate levels and toxicity
• Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced diuretic and antihypertensive effects, increased risk of renal impairment
• ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment and hyperkalemia
• Cyclosporine: Increased risk of nephrotoxicity
• Tacrolimus: Increased risk of nephrotoxicity
• Digoxin: May increase digoxin levels

• Beta-blockers: Reduced antihypertensive effect
• Hydantoins (e.g., phenytoin): May increase phenytoin levels
• Sulfonylureas: May increase hypoglycemic effect
• Cholestyramine: May reduce piroxicam absorption
• Alcohol: Increased risk of GI irritation/bleeding

• Antacids: May slightly delay absorption but no significant effect on bioavailability

• 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 reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Unexplained weight gain or edema
• Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)

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

Piroxicam is excreted into breast milk. Due to its long half-life and potential for serious adverse effects in the infant, use is generally not recommended during breastfeeding. If use is necessary, monitor the infant for adverse effects.

Not recommended for children under 12 years of age due to lack of established safety and efficacy data. Use in adolescents (12-18 years) should be with extreme caution and only if clearly indicated, considering the long half-life.

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

• Piroxicam has a very long half-life (around 50 hours), allowing for once-daily dosing, but also leading to a prolonged time to reach steady state (7-12 days) and a prolonged washout period.
• Due to its long half-life, piroxicam may accumulate in elderly patients or those with impaired renal/hepatic function, increasing the risk of adverse effects.
• Among NSAIDs, piroxicam is associated with a higher risk of serious GI adverse events compared to some other NSAIDs, especially at higher doses or in susceptible patients.
• Consider gastroprotective agents (e.g., proton pump inhibitors) for patients at high risk of GI complications.
• Patients should be advised to report any signs of bleeding, swelling, or changes in urine output immediately.
• The long half-life means that if adverse effects occur, they may persist for several days after discontinuation.

• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib, meloxicam)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Topical NSAIDs (e.g., diclofenac gel) for localized pain
• Corticosteroids (for severe inflammation, short-term use)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA
• Physical therapy, exercise, heat/cold therapy

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 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.