Lodine 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, particularly COX-2, which reduces 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 Reaction: 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 Issues: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Issues: Trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Other Symptoms: Ringing in the 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), and other serious reactions can occur, potentially affecting internal organs and being fatal. Seek medical help immediately 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

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:

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

If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide medical advice on managing side effects.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Describe the allergic reaction and its symptoms.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you have experienced any of the following reactions after taking aspirin or NSAIDs:
+ Nasal polyps
+ Swelling of the mouth, face, lips, tongue, or throat
+ Unusual hoarseness
+ Trouble breathing
If you have a history of certain health conditions, including:
+ Gastrointestinal (GI) bleeding
+ Kidney problems
+ Heart failure (weak heart)
+ Recent heart attack
If you are currently taking any other NSAID, a salicylate drug like aspirin, or pemetrexed.
If you are taking phenylbutazone.
If you are having difficulty getting pregnant or undergoing fertility testing.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This drug may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.

Additional Important Considerations

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins. You must verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change 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 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. 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 this medication. In fact, studies have shown that 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. Your doctor can help you understand these risks and make informed decisions about your treatment.

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

Medications like this one, known as NSAIDs, may affect ovulation (egg release) in women, potentially impacting fertility. However, this effect is reversible, and ovulation typically returns to normal once the medication is stopped. If you are concerned about fertility, discuss this with your doctor.

Finally, if you are breastfeeding, you should consult your doctor to discuss any potential risks to your baby.

• Other NSAIDs (increased risk of GI adverse events)
• Aspirin (concomitant use with analgesic doses of aspirin increases risk of GI adverse events; concomitant use with low-dose aspirin for cardioprotection may reduce its antiplatelet effect)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Diuretics (e.g., Furosemide, Thiazides): Reduced natriuretic effect, potential for renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• Cyclosporine: Increased nephrotoxicity.
• Digoxin: Increased digoxin plasma concentrations.

• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid in patients with CrCl < 80 mL/min).
• Tacrolimus: Increased nephrotoxicity.
• Cholestyramine: May reduce etodolac absorption (separate administration).

• Antacids: May delay absorption but not significantly affect extent.

• 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 dysfunction (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (e.g., nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, flu-like symptoms)
• Signs of allergic reactions or serious skin reactions (e.g., rash, hives, blistering, swelling of face/lips/tongue/throat, difficulty breathing)
• Unusual bruising or bleeding
• Fluid retention and edema

Contraindicated after 20 weeks gestation due to risk of fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal pulmonary hypertension due to premature closure of the ductus arteriosus. Avoid use during the third trimester. 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 human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. L3 (Moderate risk).

Safety and effectiveness 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 adverse events from NSAIDs, including gastrointestinal bleeding, ulceration, perforation, cardiovascular thrombotic events, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

• Etodolac is considered a relatively COX-2 selective NSAID, which may theoretically offer a slightly lower risk of GI side effects compared to non-selective NSAIDs, but it still carries significant GI and cardiovascular risks.
• Always prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Advise patients to take with food or milk to minimize GI upset.
• Educate patients on the signs and symptoms of serious GI and cardiovascular adverse events and to seek immediate medical attention if they occur.
• Consider a proton pump inhibitor (PPI) or H2-blocker for patients at high risk of GI complications (e.g., history of ulcer, concomitant corticosteroids, anticoagulants, elderly).
• Monitor blood pressure regularly, especially in patients with pre-existing hypertension.
• Avoid in patients with severe heart failure, advanced renal disease, or severe hepatic impairment.

• 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, with different side effect profile)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and avoid taking medication prescribed to someone else. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. 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 medication taken, the amount, and the time it occurred.