Etodolac 400mg Tablets

Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its mechanism of action is believed to be due to the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes, which leads to a reduction in the synthesis of prostaglandins, key mediators of inflammation, pain, and fever. Etodolac is considered relatively COX-2 selective 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 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 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, fainting, 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 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 life-threatening. Seek medical help right away if you experience 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 people experience few or no side effects. However, if you notice 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, tiredness, 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.
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.
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 pregnancy occurrence while taking this medication. This drug may harm an unborn baby if taken at 20 weeks or later in pregnancy. If you are between 20 to 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. Verify that it is safe to take this medication with your existing treatments and health issues. 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. It is vital to follow your doctor's instructions regarding dosage and duration of treatment. 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 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 this risk, 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. Furthermore, people who have had a recent heart attack may have a higher risk of heart attack and heart-related death when taking medications like this one. In fact, studies have shown that individuals taking these medications after a first heart attack were more likely to die within the following year compared to those not taking these medications.

If you are taking aspirin to prevent heart attacks, consult your doctor about potential interactions. 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 typically reversible when the medication is stopped. If you are trying to conceive, discuss these potential risks with your doctor.

Finally, if you are breastfeeding, you should consult your doctor about the potential risks to your baby. Your doctor will help you weigh the benefits and risks of using this medication while breastfeeding.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of GI bleeding.
• Other NSAIDs (including COX-2 inhibitors): Increased risk of GI and renal adverse effects.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced natriuretic and antihypertensive effects.
• ACE inhibitors/ARBs: Reduced antihypertensive effect and increased risk of renal impairment.

• SSRIs/SNRIs: Increased risk of GI bleeding.
• Cyclosporine: Increased risk of nephrotoxicity.
• Digoxin: Possible increase in digoxin levels.
• Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid in patients with CrCl <45 mL/min).
• Tacrolimus: Increased risk of nephrotoxicity.

• Antacids: May delay absorption but not extent.
• Alcohol: Increased risk of GI irritation/bleeding.

• 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)
• Symptoms of liver injury (e.g., fatigue, nausea, dark urine, jaundice, right upper quadrant tenderness)
• Signs of allergic reactions or severe skin reactions (e.g., rash, blistering, itching, swelling of face/throat)
• Unusual bruising or bleeding
• Persistent headache or vision changes

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. 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. Use with caution during breastfeeding. Monitor the infant for adverse effects such as drowsiness, poor feeding, or unusual irritability.

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 cardiovascular, gastrointestinal, and renal events. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

• Always advise patients to take Etodolac with food, milk, or an antacid to minimize gastrointestinal upset.
• Etodolac is not a substitute for aspirin for cardiovascular prophylaxis; it may actually interfere with aspirin's antiplatelet effect.
• Educate patients on the signs and symptoms of GI bleeding and cardiovascular events, emphasizing the importance of immediate medical attention if they occur.
• Consider alternative pain management strategies in patients with significant cardiovascular or gastrointestinal risk factors.
• For chronic use, periodic monitoring of renal function, liver enzymes, and blood pressure is crucial.

• 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 side effect profile)
• Topical NSAIDs (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, 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, 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.