Etodolac ER 400mg 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, particularly COX-2, reducing the formation of prostaglandin precursors.

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 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; mouth, throat, nose, eye, genital, or skin sores; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:

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

This is not an exhaustive list of possible 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 checks.
Pregnancy, planned pregnancy, or potential pregnancy. This medication 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 status. Never start, stop, or adjust 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 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 possible effects on your health. 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, 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 careful to avoid injury, 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, 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 this type of medication. In fact, studies have shown that individuals taking drugs like this one 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 help prevent a heart attack, 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.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like this one may affect ovulation, which could impact fertility. However, this effect is typically reversible when the medication is stopped. If you are trying to conceive, discuss the 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.

• Aspirin (high dose, due to increased GI risk)
• Other NSAIDs (due to increased GI and renal risk)

• Anticoagulants (e.g., Warfarin, Heparin) - increased bleeding risk
• Antiplatelet agents (e.g., Clopidogrel) - increased bleeding risk
• SSRIs/SNRIs - increased bleeding risk
• Corticosteroids - increased GI ulceration/bleeding risk
• ACE Inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment
• Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic/antihypertensive effect, increased risk of renal impairment
• Lithium - increased lithium plasma levels and toxicity
• Methotrexate - increased methotrexate plasma levels and toxicity
• Cyclosporine - increased nephrotoxicity
• Tacrolimus - increased nephrotoxicity

• Beta-blockers - reduced antihypertensive effect
• Digoxin - increased digoxin plasma levels
• Phenytoin - increased phenytoin plasma levels
• Sulfonylureas - increased hypoglycemic effect
• Cholestyramine - reduced etodolac absorption

• Antacids - may delay absorption but not significantly affect AUC

• 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, unusual fatigue)
• Symptoms of liver injury (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, severe abdominal pain)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Unexplained weight gain or edema (fluid retention)
• Vision changes or blurred vision (rare, but reported with NSAIDs)

Use during pregnancy should be avoided, especially during the third trimester, due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus. Use in 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. While generally considered compatible with breastfeeding for short-term use, caution is advised. Monitor the infant for adverse effects (e.g., drowsiness, poor feeding, irritability). Consider alternative NSAIDs with better safety profiles in lactation or use the lowest effective dose for the shortest duration.

Safety and efficacy of Etodolac ER have not been established in pediatric patients. Use is generally not recommended.

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

• Always advise patients to take Etodolac ER with food or milk to minimize GI upset, even though it's an ER formulation.
• Emphasize the importance of swallowing the ER tablet whole; crushing or chewing can lead to rapid release and potentially higher peak plasma levels, increasing side effect risk.
• Educate patients about the black box warnings for cardiovascular and GI risks, and instruct them on symptoms requiring immediate medical attention.
• For long-term use, periodic monitoring of renal function, liver enzymes, and CBC is crucial, especially in elderly patients or those with comorbidities.
• Remind patients to inform all healthcare providers (including dentists) about their Etodolac use due to potential drug interactions and bleeding risks.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Meloxicam)
• Acetaminophen (for pain and fever, without anti-inflammatory effect)
• Opioid analgesics (for severe pain, with different risk profile)
• Topical NSAIDs (e.g., Diclofenac gel, 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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.