Etodolac 600mg ER 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 at lower doses, but inhibits both COX-1 and COX-2 at higher therapeutic doses.

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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, 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 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: 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 life-threatening. Seek medical help right away if you experience 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.

Common Side Effects

Most people do not experience severe side effects, but some may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor or seek medical help if they bother you or persist:

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 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 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.

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 co-administration. Never start, stop, or modify 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 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 laboratory 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 by your doctor.

If you have asthma, you may be more sensitive to this medication, so it is essential to discuss your condition with your doctor. This medication may also increase your risk of bleeding, so it is crucial 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 associated with 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. Your doctor can help you understand these risks and determine the best course of treatment.

People who have had a recent heart attack may be at a higher risk of heart attack and heart-related death when taking medications like this one. Additionally, studies have shown that people taking medications like this one after a first heart attack were more likely to die in the year following the heart attack compared to those not taking these medications. Your doctor can help you understand these risks and determine the best treatment plan.

If you are taking aspirin to help prevent a heart attack, you should discuss the potential interactions with your doctor. 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 typically reversible when the medication is stopped. If you are trying to conceive, you should discuss the potential risks with your doctor.

Finally, if you are breastfeeding, you should inform your doctor, as they will need to assess the potential risks to your baby and determine the best course of treatment.

• Aspirin (high-dose, for anti-inflammatory effect)
• Other NSAIDs (concurrent use increases risk of adverse effects)
• 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 plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations 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, especially in elderly or volume-depleted patients.

• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Digoxin: May increase digoxin plasma concentrations.
• Phenytoin: May increase phenytoin plasma concentrations.
• Sulfonylureas: May enhance hypoglycemic effect.
• Cholestyramine: May reduce etodolac absorption.

• Antacids: May delay absorption but not significantly affect extent.

• 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 impairment (e.g., decreased urine output, swelling in ankles/feet)
• Signs of liver injury (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Unexplained weight gain or edema
• Skin rash or allergic reactions
• Vision changes

Use during pregnancy should be avoided, especially in the third trimester. NSAIDs can cause premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn. Use in early pregnancy should only be considered 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 with short-term use, caution is advised. Monitor the infant for adverse effects such as drowsiness, poor feeding, or gastrointestinal upset.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established for the extended-release formulation. Use is generally not recommended.

Elderly patients are at increased risk for serious adverse reactions, including gastrointestinal bleeding, ulceration, perforation, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor renal function, GI symptoms, and blood pressure closely.

• Always take Etodolac ER with food or milk to minimize GI upset.
• Remind patients that this is an extended-release formulation and should not be crushed or chewed.
• Educate patients on the signs and symptoms of serious GI and cardiovascular adverse events, and when to seek immediate medical attention.
• Consider a proton pump inhibitor (PPI) or H2 blocker for patients at high risk of GI complications (e.g., history of ulcers, concomitant corticosteroid or anticoagulant use).
• Monitor renal function, especially in elderly patients, those with pre-existing renal impairment, heart failure, or those on diuretics/ACE inhibitors/ARBs.
• Avoid concomitant use with other NSAIDs, including over-the-counter products, to prevent additive toxicity.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib)
• 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 chronic inflammatory conditions (e.g., Methotrexate, biologics)
• Physical therapy, exercise, heat/cold therapy (non-pharmacological)

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 use. It is essential to read this guide carefully and review it again whenever you receive a refill of the medication. 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. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.