Etodolac 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 demonstrates some selectivity for COX-2 inhibition at therapeutic doses, though it is not as selective as celecoxib.

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, 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 urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruises or enlarging bruises, or uncontrolled bleeding.
Kidney problems: Inability to urinate, changes in urine output, blood in urine, or sudden significant weight gain.
High potassium levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, fainting, numbness, tingling, or shortness of breath.
High blood pressure: Severe headache, dizziness, fainting, or changes in vision.
Respiratory issues: Shortness of breath, sudden significant weight gain, or swelling in arms or legs.
Cardiovascular concerns: Chest pain, pressure, or rapid heartbeat.
Neurological symptoms: Weakness on one side of the body, speech or thinking difficulties, balance changes, facial drooping, or blurred vision.
Other severe reactions: Ringing in 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), or other serious reactions, which can affect internal organs and be life-threatening. Seek medical help right away if you notice red, swollen, blistered, or peeling skin; red or irritated eyes; mouth, throat, nose, eye, genital, or skin sores; fever; chills; body aches; shortness of breath; or swollen glands.

Common 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 concerns, 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 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 and situations to ensure safe treatment:

Any known allergies to this medication, its components, or other substances, including foods and 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 breathing difficulties after taking aspirin or NSAIDs.
Presence of 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 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 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 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, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount can increase your chances of experiencing adverse effects. Furthermore, do not take this medication for a longer period than prescribed by your doctor.

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, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss these potential risks with your doctor.

In people who have recently experienced a heart attack, the use of medications like this one has been associated with an increased risk of heart attack and heart-related death. Additionally, 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 a heart attack, consult your doctor about the potential interactions between aspirin and 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) and potentially impact fertility. However, this effect is reversible and typically returns to normal when the medication is stopped. Discuss these 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.

• Other NSAIDs (including aspirin > low dose)
• Ketorolac

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of gastrointestinal 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; increased risk of renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect; increased risk of renal impairment, especially in dehydrated or elderly patients.
• Corticosteroids: Increased risk of gastrointestinal ulceration and bleeding.
• Cyclosporine: Increased risk of nephrotoxicity.
• Digoxin: May increase digoxin levels.

• Beta-blockers: Reduced antihypertensive effect.
• Hydantoins (e.g., Phenytoin): May increase phenytoin levels.
• Sulfonylureas: May enhance hypoglycemic effect.
• Cholestyramine: May reduce etodolac absorption.

• Not available

• 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, unusual weight gain)
• Signs of liver injury (e.g., fatigue, nausea, dark urine, jaundice, flu-like symptoms)
• Skin reactions (e.g., rash, blistering, peeling)
• Unexplained weight gain or edema

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn. Use during the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Use with caution. Etodolac is excreted in breast milk in small amounts. Weigh the potential benefits of breastfeeding against the potential risks to the infant.

Safety and effectiveness have not been established in pediatric patients under 18 years of age. Use is generally not recommended.

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

• Etodolac has some COX-2 selectivity, which may theoretically lead to a lower risk of GI side effects compared to non-selective NSAIDs, but this benefit is not consistently demonstrated in all studies and does not eliminate the GI risk.
• Always prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Educate patients on the signs and symptoms of serious cardiovascular and gastrointestinal adverse events and advise them to seek immediate medical attention if these occur.
• Consider gastroprotective agents (e.g., PPIs) for patients at high risk of GI complications (e.g., history of ulcer, concomitant corticosteroids/anticoagulants, elderly).
• Monitor blood pressure regularly, as NSAIDs can cause new-onset hypertension or worsen existing hypertension.
• Avoid use in patients with severe heart failure or advanced renal disease.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Diclofenac)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, different mechanism and risk profile)
• Topical NSAIDs (e.g., Diclofenac gel, for localized pain)
• Corticosteroids (for severe inflammation, different mechanism and side effect profile)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again each time your prescription is refilled. 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 medication taken, the amount, and the time it occurred.