Lodine 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.

Urgent Side Effects: Seek Medical Help Immediately

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 medical attention right away:

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 uncontrolled 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 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 can occur, potentially affecting internal organs and being life-threatening. 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 no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects or if they persist or bother you, contact your doctor or seek medical attention:

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

This is not an exhaustive list of potential 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 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 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 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 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 laboratory personnel that you are taking this drug. Additionally, be aware that medications 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 prescribed by your doctor.

If you have asthma, consult with 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 medications 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 medications like this one after a recent heart attack may have 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 the year following the heart attack compared to those not taking these medications. Talk to your doctor about these potential risks.

If you are taking aspirin to prevent a heart attack, consult with your doctor about the 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 and typically returns to normal once 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.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Advanced renal disease
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI ulceration and 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 and antihypertensive effects; increased 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 plasma concentrations.

• Beta-blockers: Reduced antihypertensive effect.
• Phenytoin: May increase phenytoin levels.
• Sulfonylureas: May enhance hypoglycemic effect.
• Cholestyramine: May reduce etodolac absorption (separate administration).

• Antacids: May decrease peak plasma concentrations but not overall absorption.

• Abdominal pain
• Indigestion
• Heartburn
• Nausea
• Vomiting
• Black, tarry stools
• Coffee-ground vomit
• Unusual bruising or bleeding
• Swelling of ankles, feet, or hands (edema)
• Unexplained weight gain
• Shortness of breath
• Chest pain
• Weakness or numbness on one side of the body
• Slurred speech
• Skin rash or blistering
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Flu-like symptoms

Use of NSAIDs, including Etodolac, is not recommended in pregnant women at 20 weeks gestation and later due to the risk of oligohydramnios and fetal renal dysfunction. If NSAID treatment is necessary between 20 and 30 weeks gestation, limit use to the lowest effective dose and shortest duration possible, and consider ultrasound monitoring of amniotic fluid. Contraindicated from 30 weeks gestation due to risk of premature closure of the fetal ductus arteriosus.

Etodolac is excreted in breast milk in very low concentrations. Generally considered compatible with breastfeeding, but use with caution, especially in preterm infants or those with underlying conditions. Monitor infant for adverse effects (e.g., irritability, poor feeding).

Safety and efficacy 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 cardiovascular, gastrointestinal, and renal adverse events with NSAID use. 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 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.
• Avoid concomitant use with other NSAIDs, including aspirin (unless low-dose aspirin for cardioprotection, in which case administer aspirin at least 30 minutes before or 8 hours after etodolac immediate-release).
• Monitor blood pressure regularly, especially in patients with pre-existing hypertension.

• 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)
• Corticosteroids (for severe inflammation, with different side effect profile)
• Non-pharmacologic therapies (e.g., RICE - Rest, Ice, Compression, Elevation; physical therapy, acupuncture, massage)

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, and do not take medication prescribed for someone else. This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is important to 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 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 substance taken, the amount, and the time it occurred.