Etodolac 500mg 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 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 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 concerns: Chest pain or pressure, rapid heartbeat.
Neurological symptoms: Weakness on one side of the body, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
Other severe reactions: 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 help 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 your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Common 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 or seek medical help:

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

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 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 use of this medication. 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, 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, as you may be more sensitive to this medication. This drug may also affect your blood's ability to clot, making you more prone to bleeding. To minimize this risk, be cautious and avoid injuries, use a soft toothbrush, and consider using 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 due to heart failure, and death. Discuss these risks with your doctor. Furthermore, people who have had a recent heart attack may be at a higher risk of heart attack and heart-related death when taking this medication. In fact, studies have shown that individuals taking this type of medication after a first heart attack were more likely to die within a year compared to those not taking this medication. Talk to your doctor about these potential risks.

If you are taking aspirin to prevent heart attacks, consult your doctor about the potential interactions with this medication. Older adults (65 years and 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) in women, potentially impacting fertility. However, this effect is typically reversible when the medication is stopped. If you are concerned about fertility, discuss this 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.

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

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding
• Corticosteroids: Increased risk of GI ulceration/bleeding
• SSRIs/SNRIs: Increased risk of GI bleeding
• Lithium: Increased lithium levels and toxicity
• Methotrexate: Increased methotrexate levels and toxicity
• 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
• Cyclosporine: Increased nephrotoxicity
• Digoxin: Increased digoxin levels

• Beta-blockers: Reduced antihypertensive effect
• Hydantoins (e.g., Phenytoin): Increased phenytoin levels
• Sulfonylureas: Increased hypoglycemic effect
• Quinolone antibiotics: Increased risk of CNS stimulation/seizures
• Pemetrexed: Increased myelosuppression, renal, and GI toxicity (avoid in patients with renal impairment)

• Alcohol: Increased risk of GI irritation

• 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 (e.g., rash, hives, itching, difficulty breathing, swelling of face/lips/tongue/throat)
• Unexplained weight gain or edema
• Vision changes

Use should be avoided during pregnancy, especially in the third trimester due to the risk of premature closure of the fetal ductus arteriosus and renal dysfunction in the fetus. Category C in first and second trimesters (animal studies show adverse effects, no adequate human studies), Category D in third trimester (positive evidence of human fetal risk).

Etodolac is excreted in breast milk in small amounts. While generally considered low risk for healthy, full-term infants, caution is advised. Monitor infant for adverse effects such as drowsiness or GI upset.

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

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

• Etodolac ER is a once-daily NSAID, which can improve patient adherence compared to multiple daily dosing.
• While Etodolac is considered to have some COX-2 selectivity, it still carries the class warnings for cardiovascular and gastrointestinal risks common to all NSAIDs.
• Always advise patients to take with food or milk to minimize GI upset, even with the ER formulation.
• Educate patients on the signs and symptoms of serious adverse events (GI bleeding, cardiovascular events, renal impairment) and when to seek immediate medical attention.
• Consider baseline and periodic monitoring of renal function, liver function, and blood pressure, especially in patients on long-term therapy or with pre-existing conditions.
• Avoid concomitant use with other NSAIDs, including over-the-counter products, to prevent additive toxicity.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, with higher risk of side effects and dependence)
• Disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis
• Corticosteroids (for severe inflammation, short-term use)
• Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine patches)
• Non-pharmacological therapies (e.g., physical therapy, exercise, heat/cold therapy, acupuncture)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial resource 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 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it occurred.