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Nabumetone is a prodrug that is rapidly metabolized in the liver to its principal active metabolite, 6-methoxy-2-naphthylacetic acid (6-MNA). 6-MNA is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic properties. Its mechanism of action, like that of other NSAIDs, is believed to be due to the inhibition of prostaglandin synthesis through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes.

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 reactions: 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. In rare cases, allergic reactions can be fatal.
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 concerns: Chest pain or pressure.
Neurological symptoms: Weakness on one side of the body, speech or thinking difficulties, balance changes, facial drooping, or blurred vision.
General concerns: Extreme fatigue or weakness, ringing in the ears, 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 fatal, so seek medical attention immediately if you experience any of these symptoms.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur, potentially affecting internal organs and being life-threatening. Seek medical help right away if you experience 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

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:

Dizziness or headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
* Gas

If any of these side effects or other concerns bother you or persist, contact your doctor for guidance. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide medical advice on managing side effects.

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 experienced nasal polyps, swelling of the mouth, face, lips, tongue, or throat, unusual hoarseness, or breathing difficulties after taking 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 another NSAID, a salicylate drug (such as aspirin), or pemetrexed.
If you are having trouble conceiving or undergoing fertility testing.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This drug 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 inform your doctor and pharmacist about all the medications you are taking (prescription, over-the-counter, natural products, and vitamins) and any health problems you have. This will help ensure your safety while taking this medication. 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 for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.

Drugs similar to this one have been associated with increased blood pressure. 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 of this medication on your health.

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

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

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 consider using an electric razor.

If you are taking aspirin to help prevent heart attacks, inform your doctor, as this medication may interact with aspirin.

This medication may also increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when spending time outdoors, and inform your doctor if you experience excessive sunburn.

The use of medications like this one has been linked to an increased 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 to understand the potential risks.

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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like this one may affect ovulation, potentially impacting fertility. However, this effect is typically reversible once the medication is stopped. Consult with your doctor to discuss any concerns.

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

• Aspirin (concomitant use with other NSAIDs, including nabumetone, increases risk of GI bleeding)
• Other NSAIDs (increased risk of GI and renal adverse effects)
• Coronary Artery Bypass Graft (CABG) surgery (contraindicated for 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.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced natriuretic effect, increased risk of renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• Lithium: Increased plasma lithium levels, leading to toxicity.
• Methotrexate: Increased methotrexate levels, leading to toxicity.
• Cyclosporine: Increased risk of nephrotoxicity.
• Tacrolimus: Increased risk of nephrotoxicity.

• Digoxin: May increase serum digoxin levels.
• Beta-blockers: May reduce antihypertensive effect.
• Phenytoin: May increase phenytoin levels.
• Sulfonylureas: May enhance hypoglycemic effect.
• Cholestyramine: May reduce absorption of nabumetone.

• Antacids: May slightly reduce absorption, but generally not clinically significant.

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Symptoms 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 reaction (e.g., rash, hives, itching, swelling of face/lips/tongue/throat, difficulty breathing)
• Unexplained weight gain or edema
• Vision changes (rare, but reported with NSAIDs)

Use during the first and second trimesters should be avoided unless the potential benefit outweighs the potential risk to the fetus (Category C). Contraindicated during the third trimester of pregnancy (Category D) due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn. May also inhibit uterine contractions and prolong labor.

Nabumetone and its active metabolite (6-MNA) are excreted into breast milk in small amounts. Due to the potential for serious adverse reactions in nursing infants (e.g., cardiovascular, renal, GI effects), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Generally, not recommended.

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

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

• Nabumetone is a prodrug; its active metabolite (6-MNA) has a long half-life (~24 hours), allowing for once-daily dosing.
• While often considered 'GI-sparing' compared to some other NSAIDs, it still carries a significant risk of GI adverse events, including serious bleeding, ulceration, and perforation, especially with long-term use or in high-risk patients.
• Always advise patients to take with food or milk to minimize GI upset.
• Due to the long half-life, it may take several days to reach steady-state concentrations and for the full therapeutic effect to be observed.
• Patients should be educated on the signs and symptoms of GI bleeding and cardiovascular events and advised to seek immediate medical attention if they occur.
• Regular monitoring of renal function, liver function, and blood pressure is crucial, especially in elderly patients or those with comorbidities.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Diclofenac, Celecoxib)
• 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 rheumatoid arthritis (e.g., Methotrexate, Biologics)
• Physical therapy
• Heat/cold therapy

If your symptoms or health issues persist or worsen, it is 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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you 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 detailed information, including the substance taken, the amount, and the time it occurred.