Etodolac 200mg Capsules

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 is considered a relatively COX-2 selective inhibitor at lower doses, but loses selectivity at higher doses.

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, 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, difficulty speaking or thinking, balance problems, 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 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 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 few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor if they bother you or persist:

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 potential 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 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 when 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 potential 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 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, be aware that drugs like this one can cause high blood pressure. Follow your doctor's instructions for monitoring your blood pressure.

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 adhere to the prescribed dosage and not exceed the recommended amount, as taking more than directed can increase the risk of severe side effects. Do not take this medication for longer than your doctor has prescribed.

If you have asthma, consult your doctor, as you may be more sensitive to this medication. Be cautious and avoid injuries, as this drug can increase the risk of bleeding. To minimize this risk, use a soft toothbrush and an electric razor.

The use of drugs like this one can increase the risk of heart failure. If you already have heart failure, the risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss these risks with your doctor. Furthermore, people taking drugs like this one after a recent heart attack are at a higher risk of heart attack and heart-related death. In fact, studies have shown that individuals taking these medications 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 risks.

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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like this one can affect ovulation, which may impact fertility. However, this effect is reversible when the medication is stopped. Discuss any concerns about fertility with your doctor. If you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby.

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

• Anticoagulants (e.g., Warfarin, Heparin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Cyclosporine: Increased nephrotoxicity.
• Digoxin: Increased digoxin plasma concentrations.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.

• Diuretics (e.g., Furosemide, Thiazides): Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Beta-blockers: Reduced antihypertensive effect.
• Pemetrexed: Increased myelosuppression, renal, and GI toxicity (avoid in patients with renal impairment).

• Antacids: May delay absorption but not significantly affect bioavailability.
• Cholestyramine: May reduce absorption.

• 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, unusual fatigue)
• Signs of allergic reaction/skin reactions (rash, hives, itching, swelling of face/lips/tongue, difficulty breathing)
• Unusual bruising or bleeding
• Sudden weight gain or swelling (fluid retention)

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

Etodolac is excreted into breast milk in small amounts. Generally considered to be of low risk for the infant, especially with short-term use. Monitor infant for adverse effects.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

Elderly patients are at greater risk for serious adverse events, 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 is considered to have relatively less GI toxicity compared to non-selective NSAIDs at lower doses, but this selectivity is lost at higher doses.
• Always use the lowest effective dose for the shortest duration consistent with individual patient treatment goals to minimize risks.
• Advise patients to take with food or milk to minimize GI upset.
• Patients with a history of GI bleeding or cardiovascular disease should generally avoid NSAIDs or use them with extreme caution and appropriate gastroprotective agents (e.g., PPIs).
• Monitor blood pressure regularly, especially in hypertensive patients, as NSAIDs can elevate BP.
• Educate patients on the signs and symptoms of serious adverse events (GI bleeding, cardiovascular events, renal impairment) and when to seek immediate medical attention.

• 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)
• Topical NSAIDs (e.g., Diclofenac gel, for localized pain)
• Corticosteroids (for severe inflammation, short-term use due to side effects)
• 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 for further guidance. 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 provides crucial information 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, 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.