Lodine 500mg Tablets

Manufacturer WYETH-AYERST Active Ingredient Etodolac Capsules and Tablets(ee toe DOE lak) Pronunciation ee toe DOE lak
WARNING: This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. @ COMMON USES: It is used to treat some types of arthritis.It is used to manage pain.
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Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID)
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Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
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Pregnancy Category
Not applicable (risk summary)
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FDA Approved
Aug 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Etodolac is a medicine called an NSAID (nonsteroidal anti-inflammatory drug). It works by reducing substances in the body that cause pain, fever, and inflammation (swelling and redness). It's used to treat pain, and conditions like arthritis that cause joint pain and swelling.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. Always take it with a full glass of water.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on proper disposal. You may also have access to local drug take-back programs.

Missing a Dose

If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Do not lie down for at least 10 minutes after taking to prevent esophageal irritation.
  • Avoid alcohol, as it can increase the risk of stomach bleeding.
  • Do not take other NSAIDs (like ibuprofen or naproxen) or aspirin unless directed by your doctor.
  • Stay well-hydrated, especially if you have kidney problems.
  • Be aware that this medication may increase your risk of heart attack or stroke, especially with long-term use or high doses. Do not use before or after heart bypass surgery.
  • Be aware of the risk of stomach bleeding, especially if you have a history of ulcers or bleeding problems.

Dosing & Administration

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Adult Dosing

Standard Dose: Osteoarthritis/Rheumatoid Arthritis: 300 mg two or three times daily, or 400-500 mg two times daily. Acute Pain: 200-400 mg every 6-8 hours as needed.
Dose Range: 200 - 1200 mg

Condition-Specific Dosing:

Osteoarthritis: 300-500 mg BID or TID (IR); 400-1000 mg once daily (ER). Max 1200 mg/day.
Rheumatoid Arthritis: 300-500 mg BID or TID (IR); 400-1000 mg once daily (ER). Max 1200 mg/day.
Acute Pain: 200-400 mg every 6-8 hours. Max 1000 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (safety and efficacy not established for patients under 18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but use with caution.
Moderate: Use with caution, consider lower doses and close monitoring. Avoid in advanced renal disease.
Severe: Contraindicated in patients with advanced renal disease.
Dialysis: Not recommended; Etodolac is not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: Use with caution, consider lower doses.
Moderate: Use with caution, consider lower doses and close monitoring. Avoid in severe hepatic impairment.
Severe: Avoid use in patients with severe hepatic impairment.

Pharmacology

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Mechanism of Action

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. Etodolac demonstrates some COX-2 selectivity in vitro, but its clinical significance is debated.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 100%
Tmax: 1-2 hours (for immediate-release tablets)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 0.4 L/kg
ProteinBinding: >99% (primarily to albumin)
CnssPenetration: Limited (low levels detected in CSF)

Elimination:

HalfLife: Approximately 7 hours
Clearance: Approximately 49 mL/min
ExcretionRoute: Renal (approximately 70%), Fecal (approximately 30%)
Unchanged: <1% (renal)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes to 1 hour (for analgesia)
PeakEffect: 1-2 hours (for analgesia)
DurationOfAction: 6-8 hours (for analgesia)

Safety & Warnings

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BLACK BOX WARNING

CARDIOVASCULAR THROMBOTIC EVENTS: NSAIDs, including etodolac, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Etodolac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. GASTROINTESTINAL RISK: NSAIDs, including etodolac, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
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Side Effects

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, 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, speech or thinking difficulties, balance changes, 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 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; 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 many people may not experience any or may only have mild symptoms. If you are concerned about any of the following side effects or if they persist, contact your doctor:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
Dizziness, fatigue, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, black/tarry stools, vomit that looks like coffee grounds (signs of stomach bleeding)
  • Chest pain, shortness of breath, sudden weakness on one side of the body, slurred speech (signs of heart attack/stroke)
  • Swelling in your hands or feet, sudden weight gain (signs of fluid retention or kidney problems)
  • Yellowing of skin or eyes, dark urine, nausea, unusual tiredness (signs of liver problems)
  • Skin rash, blistering, peeling skin, or swelling of the face/throat (signs of severe allergic reaction)
  • Unusual bruising or bleeding
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Before Using This Medicine

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 medication, its components, or other substances, such as foods or drugs. 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. It is crucial to note that 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 if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

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. It is vital to follow your doctor's instructions regarding the 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. You may experience easier bleeding while taking this drug, so it is essential to be cautious and avoid injuries. To minimize the risk of bleeding, 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 people taking these medications after a first heart attack were more likely to die within a year compared to those not taking these medications. Your doctor can help you understand these risks.

If you are taking aspirin to prevent a heart attack, inform your doctor, as this may affect your treatment plan. Older adults (65 years or 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. Finally, if you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Lethargy
  • Drowsiness
  • Nausea
  • Vomiting
  • Epigastric pain
  • GI bleeding
  • Rarely: hypertension, acute renal failure, respiratory depression, coma

What to Do:

Seek immediate medical attention. There is no specific antidote. Treatment is supportive and symptomatic. May include gastric lavage, activated charcoal, and supportive care for vital functions. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

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

  • Anticoagulants (e.g., Warfarin, Dabigatran, Apixaban, Rivaroxaban): Increased risk of bleeding.
  • Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
  • Corticosteroids: Increased risk of GI ulceration and bleeding.
  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced natriuretic and antihypertensive effects, potential for renal impairment.
  • ACE Inhibitors (e.g., Lisinopril, Enalapril): Reduced antihypertensive effect, increased risk of renal impairment.
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan): Reduced antihypertensive effect, increased risk of renal impairment.
  • Lithium: Increased plasma lithium levels and potential for toxicity.
  • Methotrexate: Increased methotrexate levels and toxicity.
  • Cyclosporine: Increased nephrotoxicity.
  • SSRIs/SNRIs: Increased risk of GI bleeding.
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Moderate Interactions

  • Beta-blockers: Reduced antihypertensive effect.
  • Digoxin: Possible increase in digoxin levels.
  • Phenytoin: Possible increase in phenytoin levels.
  • Oral Hypoglycemics (Sulfonylureas): Enhanced hypoglycemic effect.
  • Cholestyramine: May reduce etodolac absorption.
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Minor Interactions

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

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline and monitor for anemia or other hematologic abnormalities, especially with long-term use.

Timing: Before initiating therapy.

Renal Function (BUN, Serum Creatinine)

Rationale: To assess baseline renal function, as NSAIDs can cause renal impairment.

Timing: Before initiating therapy.

Liver Function Tests (ALT, AST)

Rationale: To assess baseline hepatic function, as NSAIDs can cause liver enzyme elevations.

Timing: Before initiating therapy.

Blood Pressure (BP)

Rationale: To establish baseline, as NSAIDs can cause new onset hypertension or worsen existing hypertension.

Timing: Before initiating therapy.

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Routine Monitoring

Renal Function (BUN, Serum Creatinine)

Frequency: Periodically, especially with long-term use, in elderly patients, or those with risk factors for renal impairment.

Target: Within normal limits or stable from baseline.

Action Threshold: Significant increase in BUN/creatinine; consider dose reduction or discontinuation.

Liver Function Tests (ALT, AST)

Frequency: Periodically, especially with long-term use.

Target: Within normal limits or stable from baseline.

Action Threshold: Significant elevation (e.g., >3x ULN); discontinue therapy.

Blood Pressure (BP)

Frequency: Regularly, especially at initiation and with dose changes.

Target: Maintain within target range for patient.

Action Threshold: Significant increase in BP; consider antihypertensive adjustment or NSAID discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically with long-term use (e.g., annually or as clinically indicated).

Target: Within normal limits.

Action Threshold: Significant decrease in hemoglobin/hematocrit or other abnormalities; investigate for GI bleeding or other causes.

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Symptom Monitoring

  • 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 body, slurred speech)
  • Signs of renal impairment (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/skin reactions (e.g., rash, hives, blistering, swelling of face/throat, difficulty breathing)
  • Unexplained weight gain or edema

Special Patient Groups

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Pregnancy

Contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use during the first and second trimesters should only be considered if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential increased risk of miscarriage and cardiac malformations (limited data, conflicting studies).
Second Trimester: Potential for oligohydramnios and fetal renal dysfunction, especially with prolonged use.
Third Trimester: Contraindicated due to risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and impaired renal function in the fetus leading to oligohydramnios.
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Lactation

Low levels of etodolac are excreted in breast milk. Generally considered compatible with breastfeeding with caution, especially for short-term use. Monitor infant for adverse effects.

Infant Risk: Low risk; potential for GI upset or other NSAID-related effects in the infant, but generally not expected with typical doses.
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Pediatric Use

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

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Geriatric Use

Elderly patients are at increased risk for serious adverse reactions, particularly gastrointestinal bleeding, ulceration, perforation, and renal impairment. Use the lowest effective dose for the shortest duration possible. Close monitoring of renal function and GI symptoms is crucial.

Clinical Information

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Clinical Pearls

  • Etodolac is considered to have some COX-2 selectivity, which theoretically might reduce GI side effects compared to non-selective NSAIDs, but this benefit is not consistently demonstrated in clinical practice and does not eliminate the GI risk.
  • Always advise patients to take etodolac with food or milk to minimize GI upset.
  • Educate patients on the signs and symptoms of serious cardiovascular and GI adverse events, and when to seek immediate medical attention.
  • For chronic conditions like arthritis, consider the lowest effective dose for the shortest duration to minimize risks.
  • Regular monitoring of blood pressure, renal function, and liver enzymes is important, especially in patients on long-term therapy or with underlying risk factors.
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Alternative Therapies

  • 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 risk profile)
  • Topical NSAIDs (e.g., Diclofenac gel, for localized pain)
  • Non-pharmacological therapies (e.g., physical therapy, heat/cold therapy, exercise, lifestyle modifications)
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Cost & Coverage

Average Cost: Varies widely, typically low for generic per 30 tablets (e.g., $10-$50 for generic 500mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to 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. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.