Nabumetone 750mg 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 nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Chest pain or pressure.
Neurological symptoms: Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness.
Ringing in the ears.
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, which can affect internal organs and be fatal. 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

Most medications can cause side effects, but many people experience none or only mild symptoms. If you experience any of the following side effects or any other symptoms that bother you or do not subside, contact your doctor or seek medical attention:

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

This is not an exhaustive list of potential 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 use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. 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 medications 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or modify 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 on long-term treatment with this drug, your doctor may recommend regular blood tests to monitor your condition.

You should be aware that medications like this one can cause high blood pressure. Therefore, it is crucial to have your blood pressure checked as directed by your doctor. Additionally, discuss your alcohol consumption with your doctor before drinking, as it may interact with this medication.

If you are a smoker, have asthma, or have any other health concerns, consult with your doctor to determine the best course of treatment. It is vital to follow your doctor's instructions regarding dosage and treatment duration. Taking more than the prescribed amount or using this medication for longer than recommended can increase your risk of severe side effects.

Be cautious when taking this medication, as it may affect your blood's ability to clot, making you more prone to bleeding. To minimize this risk, use a soft toothbrush and an electric razor, and avoid injuries. If you are taking aspirin to prevent heart attacks, inform your doctor, as this medication may interact with aspirin.

This medication can also 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 any unusual sunburns.

The use of medications like this one can increase the risk of heart failure, particularly in individuals who already have heart failure. This can lead to a higher risk of heart attacks, hospitalization, and death. Discuss these risks with your doctor to determine the best treatment plan.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age should be aware that NSAIDs like this medication can affect ovulation, potentially impacting fertility. However, this effect is reversible once the medication is stopped. Consult with your doctor to discuss any concerns.

If you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby and determine the best course of action.

• Aspirin (for patients with aspirin-sensitive asthma)
• Other NSAIDs (concurrent use)

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel): Increased risk of 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 antihypertensive effects.
• ACE Inhibitors/ARBs: Increased risk of renal impairment, especially in elderly or volume-depleted patients.
• Cyclosporine: Increased risk of nephrotoxicity.
• Digoxin: Increased digoxin plasma concentrations.
• Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid in patients with CrCl < 45 mL/min).

• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Beta-blockers: Reduced antihypertensive effect.
• Cholestyramine: May reduce absorption of nabumetone.
• Phenytoin: May increase phenytoin levels.
• Sulfonylureas: May enhance hypoglycemic effect.

• 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)
• Symptoms 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 or blurred vision (rare, but reported with NSAIDs)

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. 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 (6-MNA) are excreted in human milk in small amounts. While generally considered low risk, caution should be exercised. Monitor the infant for adverse effects (e.g., irritability, poor feeding).

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

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

• Nabumetone is a prodrug, meaning it needs to be metabolized by the liver to become active. This may lead to a slightly slower onset of full anti-inflammatory effect compared to some other NSAIDs.
• It has a long half-life (24 hours), allowing for once-daily dosing, which can improve patient adherence.
• While often considered 'GI-sparing' compared to some older NSAIDs, it still carries the class-wide Black Box Warning for GI bleeding and cardiovascular events. Patients should be counseled on these risks.
• Take with food to minimize GI upset and enhance absorption.
• Due to its long half-life, it takes several days to reach steady-state concentrations, and similarly, effects (and side effects) may persist for a few days after discontinuation.

• Acetaminophen (for pain/fever, no anti-inflammatory effect)
• Corticosteroids (for severe inflammation, short-term use)
• Disease-Modifying Antirheumatic Drugs (DMARDs) for rheumatoid arthritis (e.g., Methotrexate, biologics)
• Physical therapy
• Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine patches)
• Opioid analgesics (for severe pain, short-term, with caution)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, 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 safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact 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, to facilitate prompt and appropriate treatment.