Lodine 300mg Capsules

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
Category C (1st and 2nd trimester); Category D (3rd trimester)
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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 type of medicine called a nonsteroidal anti-inflammatory drug, or NSAID. 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.
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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. If it causes stomach upset, take it with food to help minimize discomfort. Be sure to take it with a full glass of water.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.

Missing a Dose

If you take this medication on a regular schedule, 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 dosing 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.
  • Avoid alcohol while taking this medication, 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) while taking etodolac, as this can increase side effects.
  • Stay hydrated, especially if you have kidney problems or are taking diuretics.

Dosing & Administration

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Adult Dosing

Standard Dose: Osteoarthritis/Rheumatoid Arthritis: 300 mg twice daily or three times daily, or 400-500 mg twice daily. Acute Pain: 200-400 mg every 6-8 hours as needed.
Dose Range: 200 - 1000 mg

Condition-Specific Dosing:

Osteoarthritis: 300 mg BID or TID, or 400-500 mg BID (max 1000 mg/day)
Rheumatoid Arthritis: 300 mg BID or TID, or 400-500 mg BID (max 1000 mg/day)
Acute Pain: 200-400 mg every 6-8 hours as needed (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 <18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor renal function.
Moderate: Use with caution; consider lower doses and monitor renal function closely. Not recommended in advanced renal disease.
Severe: Contraindicated in patients with advanced renal disease.
Dialysis: Not recommended in patients on dialysis due to high protein binding and risk of adverse effects.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution; consider lower doses and monitor liver function closely.
Severe: Not recommended 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 is considered a relatively COX-2 selective inhibitor at lower doses, but loses selectivity at higher doses.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 0.4 L/kg
ProteinBinding: >99%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 6-7 hours
Clearance: Not available
ExcretionRoute: Primarily renal (approximately 75% as metabolites), with about 20% excreted in feces.
Unchanged: <1% (in urine)
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Pharmacodynamics

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

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 medical attention immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of bleeding, including:
+ 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
+ Uncontrollable bleeding
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, including:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling faint
+ Numbness or tingling
+ Shortness of breath
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Chest pain or pressure, or rapid heartbeat
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Ringing in the ears
Flu-like symptoms
Liver problems, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be fatal. Seek medical help right away if you notice:
+ 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
+ Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. 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
Vomiting
Heartburn
Gas
Dizziness
Fatigue
Weakness
* Headache

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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:

  • Black, tarry, or bloody stools
  • Vomit that looks like coffee grounds
  • Severe stomach pain
  • Chest pain, shortness of breath, weakness on one side of the body, or slurred speech (signs of heart attack or stroke)
  • Swelling of the face, hands, or feet
  • Unusual weight gain
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine, pale stools
  • Persistent nausea or vomiting
  • Skin rash, blistering, or peeling
  • Decreased urination
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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 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.
If you have experienced nasal polyps, 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 pregnancy confirmation during treatment. 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. Verify that it is safe to take this medication with your existing treatments and health status. Never start, stop, or modify the dosage 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, be aware that drugs 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 may 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 drugs 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 drugs 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 a year compared to those not taking these medications. Talk to your doctor about these risks.

If you are taking aspirin to prevent a heart attack, consult with your doctor about potential interactions. 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 one may affect ovulation, which can impact fertility. However, this effect is reversible when the medication is stopped. Discuss any concerns about fertility with your doctor. If you are breastfeeding, inform your doctor, as you will need to discuss the 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. Call 911 or Poison Control at 1-800-222-1222. Management is primarily supportive; there is no specific antidote. Gastric decontamination (e.g., activated charcoal) may be considered if ingestion is recent and significant.

Drug Interactions

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Contraindicated Interactions

  • Aspirin (high dose, due to increased GI risk)
  • Other NSAIDs (due to increased GI risk)
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Major Interactions

  • Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
  • Antiplatelet agents (e.g., Clopidogrel, Aspirin low dose): Increased risk of GI bleeding.
  • Corticosteroids: Increased risk of GI ulceration/bleeding.
  • Diuretics (e.g., Furosemide, Thiazides): Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
  • ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
  • Lithium: Increased lithium plasma concentrations and toxicity.
  • Methotrexate: Increased methotrexate plasma concentrations and toxicity.
  • SSRIs/SNRIs: Increased risk of GI bleeding.
  • Cyclosporine/Tacrolimus: Increased risk of nephrotoxicity.
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Moderate Interactions

  • Beta-blockers: Reduced antihypertensive effect.
  • Digoxin: Possible increased digoxin levels.
  • Phenytoin: Possible increased phenytoin levels.
  • Cholestyramine: May reduce etodolac absorption.
  • Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid concomitant use in patients with creatinine clearance <80 mL/min).
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline hematologic parameters and detect pre-existing anemia or bleeding disorders.

Timing: Prior to initiation of long-term therapy.

Renal Function (BUN, Serum Creatinine)

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

Timing: Prior to initiation of therapy.

Liver Function Tests (ALT, AST)

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

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: NSAIDs can cause new onset hypertension or worsen pre-existing hypertension.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Renal Function (BUN, Serum Creatinine)

Frequency: Periodically, especially in patients with risk factors for renal impairment (e.g., elderly, heart failure, diuretic use) or on long-term therapy.

Target: Within normal limits for patient's age and baseline.

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

Liver Function Tests (ALT, AST)

Frequency: Periodically, especially with long-term therapy.

Target: Within normal limits.

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

Blood Pressure

Frequency: Regularly, especially at the start of treatment and during dose adjustments.

Target: Individualized based on patient's target BP.

Action Threshold: Sustained elevation; consider alternative therapy or antihypertensive adjustment.

Complete Blood Count (CBC)

Frequency: Periodically, especially with long-term therapy.

Target: Within normal limits.

Action Threshold: Significant drop in hemoglobin/hematocrit, or signs of bleeding; investigate and discontinue if necessary.

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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 the body, slurred speech)
  • Signs of renal dysfunction (e.g., decreased urine output, edema, unusual fatigue)
  • Signs of liver injury (e.g., jaundice, dark urine, persistent nausea/vomiting, abdominal pain)
  • Skin reactions (e.g., rash, blistering, peeling skin)
  • Unexplained weight gain or swelling (edema)
  • Vision changes

Special Patient Groups

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Pregnancy

Use during pregnancy should be avoided, especially during the third trimester, due to potential risks to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for increased risk of miscarriage and cardiac malformations. Use only if clearly needed and benefits outweigh risks.
Second Trimester: Limited data, but generally considered safer than third trimester. Use lowest effective dose for shortest duration.
Third Trimester: Contraindicated. NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
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Lactation

Etodolac is excreted in breast milk. Use with caution; consider potential risks to the infant versus benefits to the mother. Other NSAIDs with better safety profiles in lactation may be preferred.

Infant Risk: Low to moderate risk. Potential for adverse effects on infant's cardiovascular or renal system, though unlikely with typical doses. Monitor infant for adverse effects.
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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 to NSAIDs, particularly gastrointestinal bleeding and perforation, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Etodolac is considered to have some COX-2 selectivity, which theoretically might lead to a slightly lower GI risk compared to non-selective NSAIDs, but this benefit is dose-dependent and does not eliminate the risk.
  • Always advise patients to take etodolac with food or milk to minimize gastrointestinal upset.
  • Educate patients about the signs and symptoms of serious GI and cardiovascular adverse events, and when to seek immediate medical attention.
  • For chronic conditions, consider the lowest effective dose and periodically reassess the need for continued therapy.
  • Be mindful of concomitant medications, especially those that increase bleeding risk or affect renal function.
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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, with higher risk of side effects and dependence)
  • Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine patches)
  • Non-pharmacological therapies (e.g., physical therapy, heat/cold therapy, exercise, acupuncture)
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Cost & Coverage

Average Cost: Varies widely per 30 capsules
Generic Available: Yes
Insurance Coverage: Generally Tier 1 or Tier 2 for generic formulations, Tier 3 or higher for brand names if available.
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General Drug Facts

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 provides crucial information for patients. Please read this guide carefully and review it again whenever your prescription is refilled. 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. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.