Relafen 750mg Tablets

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 non-selective inhibitor of cyclooxygenase (COX-1 and COX-2) enzymes, thereby inhibiting prostaglandin synthesis. This inhibition reduces 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 reactions: Rash, hives, itching, redness, swelling, blistering, or peeling skin with or without fever; wheezing; tightness in the chest or throat; difficulty breathing, swallowing, or speaking; 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; coffee ground-like vomit; blood in the urine; black, red, or tarry stools; gum bleeding; abnormal vaginal bleeding; unexplained bruises or bruises that enlarge; or uncontrolled 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, fainting, numbness, tingling, or shortness of breath.
High blood pressure: Severe headache, 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, speech or thinking difficulties, balance changes, facial drooping, or blurred vision.
General weakness: Feeling extremely tired or weak.
Other symptoms: Ringing in the ears, flu-like symptoms.

Liver Problems: This medication can cause liver damage, which may be fatal. Seek immediate medical attention if you experience:
Dark urine
Fatigue
Decreased appetite
Nausea or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes

Severe Skin Reactions: This medication can cause life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions. Seek immediate medical attention 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
Swollen glands

Other Side Effects

Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness or headache
Constipation, diarrhea, stomach pain, nausea, or vomiting
Heartburn
* Gas

This is not an exhaustive list of possible 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 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.
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.
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 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. Be sure to discuss this with your doctor.

Drugs similar to this one have been associated with high blood pressure. Follow your doctor's instructions for monitoring your blood pressure.

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

If you smoke, talk to your doctor about the potential effects of this medication.

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

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

This medication may affect your blood's ability to clot, making you more prone to bleeding. Be cautious and take steps to avoid injury, such as using a soft toothbrush and an electric razor.

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

This drug may increase your sensitivity to the sun, making you more susceptible to sunburn. Take necessary precautions when exposed to the sun, and inform your doctor if you experience frequent sunburns while taking this medication.

The use of drugs like this one may increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization due to heart failure, and death may be higher. Discuss this with your doctor.

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 reversible when the medication is stopped. Consult with your doctor if you have concerns about fertility.

If you are breastfeeding, inform your doctor to discuss any 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 risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Aspirin low dose): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced natriuretic effect, increased risk of renal impairment.
• ACE Inhibitors (e.g., Lisinopril) / Angiotensin Receptor Blockers (ARBs, e.g., Valsartan): Reduced antihypertensive effect, increased risk of renal impairment (especially in elderly or volume-depleted patients).
• Lithium: Increased plasma lithium levels, leading to toxicity.
• Methotrexate: Increased methotrexate levels, leading to toxicity.
• SSRIs/SNRIs: Increased risk of GI bleeding.

• Cyclosporine: Increased risk of nephrotoxicity.
• Digoxin: May increase serum digoxin levels.
• Phenytoin: May increase serum phenytoin levels.
• Oral Hypoglycemics (Sulfonylureas): May enhance hypoglycemic effect.
• Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid in patients with creatinine clearance <45 mL/min).

• Alcohol: Increased risk of GI irritation/bleeding.
• Ginkgo Biloba: Theoretical increased bleeding risk.

• 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 body, slurred speech)
• Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet)
• Signs of liver injury (e.g., fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, flu-like symptoms)
• Signs of allergic reactions/skin reactions (e.g., rash, hives, blistering, swelling of face/throat)
• Unusual bruising or bleeding
• Vision changes (rare, but reported with NSAIDs)

Avoid use at 20 weeks gestation and later. NSAID use at 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Avoid use in the third trimester (after 30 weeks gestation) due to the risk of premature closure of the fetal ductus arteriosus.

Low levels of the active metabolite (6-MNA) are excreted into breast milk. Generally considered compatible with breastfeeding, but use with caution and monitor the infant for adverse effects (e.g., irritability, rash, GI upset).

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 to NSAIDs, including gastrointestinal bleeding, ulceration, perforation, cardiovascular thrombotic events, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor renal function, GI symptoms, and blood pressure closely.

• Nabumetone is a prodrug, meaning it needs to be metabolized by the liver to become active. Its active metabolite (6-MNA) has a long half-life, allowing for once-daily dosing.
• Due to its long half-life, it may take several days to weeks to reach full therapeutic effect and steady-state concentrations.
• While often considered 'GI-friendly' among non-selective NSAIDs due to its prodrug nature and less direct gastric irritation, it still carries the class-wide Black Box Warning for serious GI and cardiovascular risks.
• Always advise patients to take with food or milk to minimize GI upset.
• Educate patients on the signs of serious adverse events (GI bleeding, cardiovascular events, renal dysfunction) and when to seek immediate medical attention.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Diclofenac, Celecoxib)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, with caution)
• Topical NSAIDs (e.g., Diclofenac gel)
• Corticosteroids (for severe inflammation, short-term)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., Methotrexate, Biologics)
• Physical therapy, exercise, heat/cold therapy

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 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.