Lodine XL 600mg Tablets

Etodolac 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, primarily through the inhibition of cyclooxygenase (COX) enzymes. Etodolac shows some selectivity for COX-2 inhibition over COX-1 at therapeutic doses, which may contribute to a potentially lower incidence of gastrointestinal side effects compared to non-selective NSAIDs, though it still carries significant GI risks.

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 problems: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological issues: Trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Other symptoms: Ringing in the ears, flu-like symptoms, or liver problems (which can be fatal). If you experience dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes, contact your doctor immediately.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur, potentially affecting internal organs and being 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

Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical attention:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
Dizziness, fatigue, or weakness
* Headache

This is not an exhaustive list of potential side effects. If you have questions or concerns, 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.
Use of phenylbutazone.
Fertility issues or attempts to conceive, as this medication may affect fertility.
Pregnancy or plans to become pregnant. 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. Your doctor and pharmacist will help you determine whether it is safe to take this medication with your other medications 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.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and lab personnel that you are taking this drug. Additionally, be aware that drugs like this one can cause high blood pressure. Your doctor will likely advise you to have your blood pressure checked regularly.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, you should also talk to your doctor about the potential interactions. It is vital to follow your doctor's instructions regarding dosage and treatment duration. Taking more than the prescribed amount or using the medication for longer than recommended can increase your risk of severe side effects.

If you have asthma, consult your doctor before taking this medication, as you may be more sensitive to its effects. This drug can also increase your risk of bleeding, so be cautious and avoid injuries. To minimize this risk, use a soft toothbrush and an electric razor.

The use of drugs 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. Furthermore, 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 people taking drugs like this one after a first heart attack were more likely to die within a year compared to those not taking this type of medication.

If you are taking aspirin to prevent heart attacks, consult your doctor about potential interactions. Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.

Women of childbearing age should be aware that NSAIDs like this drug can affect ovulation, which may impact fertility. However, this effect is reversible when the medication is stopped. If you are trying to conceive, discuss the potential risks with your doctor.

Finally, if you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby and discuss alternative options with you.

• Aspirin (high dose)
• Other NSAIDs (concurrent use)
• Coronary Artery Bypass Graft (CABG) surgery (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
• Lithium: Increased lithium levels and toxicity
• Methotrexate: Increased methotrexate levels and toxicity
• Cyclosporine: Increased nephrotoxicity
• Diuretics (e.g., Furosemide, Thiazides): Reduced diuretic and antihypertensive effects, increased risk of renal impairment
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment
• Corticosteroids: Increased risk of GI ulceration and bleeding

• Beta-blockers: Reduced antihypertensive effect
• Digoxin: Increased digoxin levels
• Phenytoin: Increased phenytoin levels
• Oral hypoglycemics: Potential for altered glucose control
• Cholestyramine: May reduce etodolac absorption

• Antacids: May delay absorption but not significantly affect bioavailability

• 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 reactions or severe skin reactions (e.g., rash, hives, blistering, peeling skin, facial swelling, difficulty breathing)
• Unexplained weight gain or edema
• Vision changes or blurred vision (rare, but reported with NSAIDs)

Use should be avoided in the third trimester due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Etodolac is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

Elderly patients are at increased risk for serious adverse reactions (especially GI bleeding and cardiovascular events) due to age-related decreases in renal function and increased comorbidities. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

• Lodine XL is an extended-release formulation, designed for once-daily dosing, which can improve patient adherence.
• Despite some COX-2 selectivity, etodolac still carries significant GI and cardiovascular risks, similar to other NSAIDs. Patients should be educated on warning signs.
• Always prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Concomitant use with aspirin (even low-dose for cardioprotection) should be approached with caution due to increased GI risk, and etodolac may interfere with aspirin's antiplatelet effect.
• Monitor blood pressure regularly, as NSAIDs can cause new-onset hypertension or worsen pre-existing hypertension.
• Hydration is important, especially in patients at risk for renal impairment, to minimize kidney effects.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Diclofenac)
• Acetaminophen (for pain/fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, different mechanism, higher risk profile)
• Disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (e.g., Methotrexate, biologics)
• Corticosteroids (for severe inflammation, short-term use)
• Topical NSAIDs (e.g., Diclofenac gel, for localized pain)

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. 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.