Lodine XL 400mg 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 has been shown to be a preferential inhibitor of COX-2 over COX-1, particularly at lower doses, which may contribute to its gastrointestinal tolerability profile.

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 significant 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, significant weight gain, or swelling in the arms or legs.
Cardiovascular concerns: Chest pain or pressure, rapid heartbeat.
Neurological symptoms: Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
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, stomach pain or nausea, pale stools, vomiting, or yellowing of the skin or eyes.
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 notice 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 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, nausea, 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 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 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.
Use of phenylbutazone.
Fertility issues or ongoing fertility checks.
Pregnancy, planned pregnancy, or pregnancy during treatment. This medication 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 under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

This list is not exhaustive, and 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 treatments 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 taking this drug long-term, 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. There is a risk of developing high blood pressure with medications like this one, so your doctor may advise you to have your blood pressure checked regularly.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, talk to your doctor about the potential interactions between smoking and this medication. 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 may 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 medication may 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 medications like this one may increase the risk of heart failure, particularly in people who already have this condition. This may lead to a higher risk of heart attack, hospitalization for heart failure, and death. Discuss these potential risks with your doctor. Additionally, people who have had a recent heart attack may have a higher risk of heart attack and heart-related death when taking medications like this one. In fact, studies have shown that people taking these medications after a first heart attack were more likely to die within the following year compared to those not taking these medications.

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.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like this one may affect ovulation, which can impact fertility. However, this effect is reversible, and ovulation typically returns to normal once the medication is stopped. If you are trying to conceive, discuss the potential risks with your doctor.

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) or other NSAIDs (increased risk of GI adverse events)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Heparin) - increased bleeding risk
• Antiplatelet agents (e.g., Clopidogrel, Aspirin low dose) - increased bleeding risk
• SSRIs/SNRIs - increased risk of GI bleeding
• Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic and antihypertensive effect, increased risk of renal impairment
• ACE inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment
• Lithium - increased lithium plasma levels and toxicity
• Methotrexate - increased methotrexate toxicity
• Cyclosporine - increased nephrotoxicity
• Digoxin - increased digoxin plasma levels
• Pemetrexed (in patients with impaired renal function)

• Corticosteroids - increased risk of GI ulceration/bleeding
• Sulfonylureas - potential for altered glucose metabolism (rare)
• Phenytoin - potential for increased phenytoin levels (rare)
• Cholestyramine - may reduce etodolac absorption (separate administration)

• Antacids - may slightly delay absorption but not significantly affect bioavailability

• 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 the body, slurred speech)
• Signs of renal impairment (e.g., decreased urine output, swelling in ankles/feet)
• Signs of liver injury (e.g., fatigue, nausea, dark urine, jaundice, right upper quadrant tenderness)
• Unusual bruising or bleeding
• Skin rash or blistering
• Unexplained weight gain or edema
• Vision changes

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus. Use during 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. L3 (moderately safe) is often cited, but caution is advised.

Safety and effectiveness of Lodine XL (extended-release etodolac) in pediatric patients have not been established. Immediate-release etodolac is used in juvenile rheumatoid arthritis (JRA) in children 6 years and older, but specific dosing for the XL formulation is not available for pediatric use.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

• Etodolac XL is a once-daily formulation, improving patient adherence.
• While preferentially COX-2 selective, it still carries the class risks of NSAIDs, including GI and CV risks.
• Always counsel patients on the signs and symptoms of GI bleeding and cardiovascular events.
• Consider a proton pump inhibitor (PPI) or H2 blocker for patients at high risk of GI complications.
• Monitor blood pressure, renal function, and liver function, especially in long-term use or in patients with comorbidities.
• Avoid concomitant use with other NSAIDs or high-dose aspirin due to increased risk of adverse effects without added benefit.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Meloxicam, Diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Topical NSAIDs (e.g., Diclofenac gel)
• Corticosteroids (for severe inflammation, short-term use)
• Disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis (e.g., Methotrexate, Biologics)
• Physical therapy
• Heat/cold therapy
• 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 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 about the medication taken, the quantity, and the time it occurred.