Lodine XL 500mg 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 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 immediately or seek emergency 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 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, 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 issues: Chest pain or pressure, rapid heartbeat.
Neurological issues: Weakness on one side of the body, speech or thinking difficulties, balance changes, facial drooping, or blurred vision.
Other symptoms: 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 can occur, potentially affecting internal organs and being life-threatening. 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 people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms or if they persist or bother you, contact your doctor:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting.
Heartburn.
Gas.
Dizziness, tiredness, or weakness.
Headache.

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.
A history of nasal polyps or 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.
Concurrent use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Use of phenylbutazone.
Fertility issues or ongoing fertility checks.
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.

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 to ensure safe use. 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 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, medications like this one have been associated with high blood pressure, 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, you should also talk to your doctor about the potential interactions between smoking and this medication.

To minimize the risk of severe side effects, it is vital to adhere to the dosage instructions provided by your doctor. Do not take more than the prescribed amount, and do not take this medication for longer than recommended.

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

The use of medications like this one has been linked to an increased risk of heart failure. If you already have heart failure, this medication may increase your risk of heart attack, hospitalization for heart failure, and death. Discuss these risks with your doctor.

In people who have recently experienced a heart attack, medications like this one have been associated with an increased risk of heart attack and heart-related death. Furthermore, research has shown that people taking medications like this one after a first heart attack were more likely to die within a year compared to those not taking these medications. Talk to your doctor about these potential risks.

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

Medications like this one, which are classified as NSAIDs, may affect ovulation (egg release) and potentially impact fertility. However, this effect is reversible, and ovulation typically returns to normal once the medication is stopped. Discuss these potential effects with your doctor.

If you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby and provide guidance on the safe use of this medication.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Advanced renal disease

• Anticoagulants (e.g., Warfarin, Heparin): Increased risk of bleeding
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding
• Corticosteroids: Increased risk of GI ulceration and 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, potential for renal impairment
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment
• Cyclosporine: Increased risk of nephrotoxicity
• Digoxin: Increased digoxin plasma concentrations

• Beta-blockers: Reduced antihypertensive effect
• Hydantoins (e.g., Phenytoin): Increased phenytoin levels
• Sulfonylureas: Potential for altered glucose metabolism
• Cholestyramine: May reduce Etodolac absorption (separate administration times)
• Alcohol: Increased risk of GI irritation/bleeding

• Antacids: May slightly delay absorption but not significantly affect bioavailability

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal dysfunction (decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, severe abdominal pain)
• Signs of allergic reactions (rash, hives, itching, swelling of face/lips/tongue, difficulty breathing)
• Unexplained weight gain or edema
• Severe skin reactions (rash, blistering, peeling skin)

Use should be avoided 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.

Etodolac is excreted in breast milk in small amounts. While the risk to a nursing infant appears low, caution is advised. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Etodolac, and any potential adverse effects on the breastfed infant from Etodolac or from the underlying maternal condition.

Safety and efficacy of Etodolac extended-release have not been established in pediatric patients. Use is generally not recommended.

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

• Etodolac ER offers once-daily dosing, which can improve patient adherence.
• While Etodolac is considered to have some COX-2 selectivity, it is not a highly selective COX-2 inhibitor like celecoxib, and still carries significant GI and CV risks common to all NSAIDs.
• Always advise patients to take with food or milk to minimize GI upset.
• Educate patients on the signs and symptoms of serious adverse events (GI bleeding, CV events, renal dysfunction) and when to seek immediate medical attention.
• Consider a proton pump inhibitor (PPI) or H2-blocker for patients at high risk of GI complications.
• Avoid concomitant use with other NSAIDs, including over-the-counter products, to prevent additive toxicity.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Meloxicam, Diclofenac)
• 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)
• Non-pharmacological therapies (e.g., physical therapy, heat/cold therapy, exercise, acupuncture)

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, a patient fact sheet that provides crucial information. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.