Relafen DS 1000mg Tablets

Nabumetone is a non-acidic prodrug that is rapidly metabolized in the liver to its principal active metabolite, 6-methoxy-2-naphthylacetic acid (6-MNA). 6-MNA is a potent inhibitor of cyclooxygenase (COX) activity, 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 immediately or seek emergency medical attention:

Signs of an 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. In rare cases, allergic reactions can be fatal.
Signs of 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.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden significant weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Shortness of breath, sudden significant weight gain, or swelling in the arms or legs.
Chest pain or pressure.
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.
Ringing in the ears.
Flu-like symptoms.
Liver problems, which can be life-threatening, may occur with this medication. Seek immediate medical attention if you experience dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions, may occur. These reactions can affect internal organs and be fatal. Seek medical help right away if you notice 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

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:

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

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 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 trouble breathing after taking aspirin or NSAIDs.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding or kidney problems.
+ Heart failure (weak heart) or a recent heart attack.
If you are taking other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
If you are having difficulty getting pregnant 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 at 20 weeks or later in pregnancy. Only take this medication between 20 to 30 weeks of pregnancy if your doctor advises 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 disclose all of the following to your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
All your health problems.

Verify with your doctor that it is safe to take this medication with your existing 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 long-term, your doctor may recommend regular blood tests to monitor your condition.

You should also have your blood pressure checked regularly, as medications like this one can cause high blood pressure. Your doctor will advise you on how often to have your blood pressure checked.

Before consuming alcohol, discuss it with your doctor. If you smoke, talk to your doctor about the potential risks. Additionally, if you have asthma, consult with your doctor, as you may be more sensitive to this medication.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Take this medication only for the duration recommended by your doctor.

Be aware that this medication may increase your risk of bleeding easily. To reduce this risk, be careful to avoid injuries, use a soft toothbrush, and consider using an electric razor.

If you are taking aspirin to prevent heart attacks, inform your doctor, as this medication may interact with aspirin. This drug can also increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to the sun, and inform your doctor if you experience easy sunburning while taking this medication.

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 due to heart failure, and death may be higher. Discuss these risks 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 can affect ovulation, which may impact your ability to get pregnant. 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, as you will need to discuss the potential risks to your baby.

• Aspirin (high-dose, for anti-inflammatory effect)
• Other NSAIDs (concurrent use increases risk of adverse events)
• 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
• Corticosteroids - increased GI ulceration/bleeding risk
• SSRIs/SNRIs - increased GI bleeding risk
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate toxicity
• Cyclosporine - increased nephrotoxicity
• Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic and antihypertensive effects, increased nephrotoxicity risk
• ACE Inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment
• 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 nabumetone absorption
• Alcohol - increased risk of GI irritation/bleeding

• 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)
• Symptoms of liver injury (e.g., fatigue, nausea, dark urine, yellowing of skin/eyes)
• Signs of allergic reaction (e.g., rash, itching, swelling of face/throat, difficulty breathing)
• Unusual bruising or bleeding
• Severe skin reactions (e.g., rash, blistering, peeling skin)

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

Nabumetone and its active metabolite are excreted in breast milk in small amounts. Use with caution; monitor the infant for adverse effects such as drowsiness, poor feeding, or rash. Consider alternative agents, especially for long-term use.

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 cardiovascular, gastrointestinal, and renal events associated with NSAID use. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects, especially GI bleeding and renal impairment.

• Nabumetone is a prodrug, converted to its active metabolite 6-MNA, which has a long half-life allowing for once-daily dosing.
• It is a non-acidic NSAID, which theoretically may cause less direct gastric irritation, but still carries the same systemic GI bleeding risk as other NSAIDs due to COX inhibition.
• Always advise patients to take with food or milk to minimize GI upset.
• Due to the long half-life of 6-MNA, it may take several days to reach steady-state concentrations and for full therapeutic effect.
• Emphasize the Black Box Warnings for cardiovascular and gastrointestinal risks, especially in high-risk patients.
• Monitor renal function, liver function, and blood pressure regularly, particularly in elderly patients or those with comorbidities.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, with higher risk of side effects and dependence)
• Topical NSAIDs (e.g., Diclofenac gel, for localized pain)
• Corticosteroids (for severe inflammation, short-term use due to side effects)
• Disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis
• 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 your doctor, pharmacist, or other healthcare provider for guidance. 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.