Piroxicam 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 inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition reduces the formation of prostaglandin precursors from arachidonic acid, thereby reducing 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:

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.
Respiratory Issues: Shortness of breath, sudden significant 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 changes, 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. Liver problems can be life-threatening, so seek medical help immediately if you experience any of these symptoms.
Severe Skin Reactions: These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can affect body organs and be life-threatening. Seek medical help right away if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most people do not experience severe side effects, but some may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

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

This is not an exhaustive list of possible 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:

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 salicylate medications, such as aspirin, or NSAIDs.
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 any other NSAID, a salicylate medication like aspirin, or pemetrexed.
If you are having difficulty getting pregnant or are undergoing fertility testing.
If you are pregnant, planning 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.

Additionally, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

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, and 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. You may also experience easier bleeding, so it is crucial to be cautious and avoid injury. 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. Moreover, 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 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 potential risks.

If you are taking aspirin to prevent heart attacks, consult your doctor about the potential interactions. Additionally, if you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

It is also important to note that NSAIDs, like this medication, may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss any concerns about fertility with your doctor.

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

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Severe renal impairment
• Severe hepatic impairment
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Late pregnancy (third trimester)

• Anticoagulants (e.g., Warfarin, Heparin, Dabigatran, Rivaroxaban): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI ulceration and 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, increased risk of renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• Cyclosporine: Increased risk of nephrotoxicity.
• Tacrolimus: Increased risk of nephrotoxicity.

• Beta-blockers: Reduced antihypertensive effect.
• Digoxin: May increase digoxin levels.
• Phenytoin: May increase phenytoin levels.
• Oral Hypoglycemics (Sulfonylureas): May enhance hypoglycemic effect.
• Cholestyramine: May reduce piroxicam absorption (separate administration).

• Antacids: May slightly delay absorption but not clinically significant.

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of cardiovascular events (e.g., chest pain, shortness of breath, sudden weakness or numbness)
• Signs of liver injury (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Unexplained weight gain or edema
• Severe skin reactions (e.g., blistering, peeling skin)

Piroxicam is classified as Pregnancy Category C during the first and second trimesters and Category D during the third trimester. Use should be avoided in the third trimester due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction.

Piroxicam is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding, but caution is advised due to its long half-life and potential for accumulation in the infant. Monitor the infant for adverse effects.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended due to potential for serious adverse effects, including GI bleeding and renal impairment. In specific cases (e.g., juvenile idiopathic arthritis), use may be considered under specialist supervision with careful monitoring, but other NSAIDs are often preferred.

Elderly patients are at increased risk for serious adverse reactions, including gastrointestinal bleeding, ulceration, perforation, renal impairment, and cardiovascular 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, allowing for once-daily dosing, but this also means it takes longer to reach steady-state and clear from the body, increasing the risk of accumulation and adverse effects, especially in vulnerable populations.
• Due to its long half-life and higher risk of GI and skin adverse events compared to other NSAIDs, piroxicam is often considered a second-line NSAID for chronic conditions.
• Always advise patients to take piroxicam with food or milk to minimize GI upset.
• Educate patients on the signs of GI bleeding and renal impairment, and to seek immediate medical attention if these occur.
• Avoid concomitant use with other NSAIDs, including aspirin (unless low-dose aspirin for cardioprotection, in which case separate dosing may be considered, but still with increased GI risk).

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

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about its use. 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 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 quantity, and the time it occurred.