Etodolac 300mg 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, 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 immediately or seek emergency 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 enlarging bruises, 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, tingling, or shortness of breath.
High blood pressure: Severe headache, 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 attention 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 life-threatening. Seek medical help right away if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you notice any of the following side effects or any other symptoms that bother you or do not go away, 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 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 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. 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 lab personnel that you are taking this drug. There is a risk of developing high blood pressure with this type of medication, 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 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 increase your risk of bleeding, so be cautious and avoid injuries. To minimize this risk, use a soft toothbrush and an electric razor.

The use of this medication may increase the risk of heart failure, particularly in people with pre-existing heart failure. This may lead to a higher risk of heart attack, hospitalization for heart failure, and death. Discuss these risks with your doctor. Additionally, people who have had a recent heart attack may have a higher risk of heart attack and heart-related death when taking this medication. In fact, studies have shown that people 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.

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.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like this medication may affect ovulation, which can impact fertility. However, this effect is 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.

• Aspirin (high dose, due to increased GI risk)
• Other NSAIDs (due to increased GI and renal risk)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Heparin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Ticagrelor): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Lithium: Increased lithium levels and toxicity.
• Methotrexate: Increased methotrexate levels and toxicity.
• Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced natriuretic and antihypertensive effects, risk of renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment (especially in elderly or volume-depleted patients).

• Cyclosporine: Increased risk of nephrotoxicity.
• Digoxin: May increase digoxin levels.
• Corticosteroids: Increased risk of GI ulceration/bleeding.
• Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid in patients with CrCl < 45 mL/min).
• Beta-blockers: Reduced antihypertensive effect.
• Phenytoin: May increase phenytoin levels.

• Antacids: May delay absorption but not extent.

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

Avoid use after 20 weeks gestation due to risk of fetal renal dysfunction and oligohydramnios. Contraindicated in the third trimester (after 30 weeks gestation) due to risk of premature closure of the fetal ductus arteriosus.

Etodolac is excreted in breast milk in small amounts. Use with caution, especially with long-term use or high doses. Monitor infant for adverse effects (e.g., irritability, poor feeding). Other NSAIDs with shorter half-lives or lower milk transfer may be preferred.

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

Elderly patients are at greater risk for serious cardiovascular, gastrointestinal, and renal adverse events. Use the lowest effective dose for the shortest duration possible. Monitor renal function, GI bleeding, and blood pressure closely.

• Etodolac is considered a relatively COX-2 selective NSAID, which theoretically might offer a slightly better GI safety profile than non-selective NSAIDs, but it still carries significant GI and CV risks.
• Always prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Educate patients on the signs and symptoms of GI bleeding and cardiovascular 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 ulcers, concomitant corticosteroid/anticoagulant use, elderly).
• Monitor blood pressure regularly, especially in patients with pre-existing hypertension, as NSAIDs can elevate BP.
• Avoid in patients with severe heart failure or advanced kidney disease.

• 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)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA
• Physical therapy, heat/cold therapy, exercise

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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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 substance taken, the amount, and the time it occurred.