Lodine 500mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
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.
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.
Minor Interactions
- Antacids: May delay absorption but not significantly affect extent.
Monitoring
Baseline Monitoring
Rationale: To establish baseline and monitor for anemia or other hematologic abnormalities, especially with long-term use.
Timing: Before initiating therapy.
Rationale: To assess baseline renal function, as NSAIDs can cause renal impairment.
Timing: Before initiating therapy.
Rationale: To assess baseline hepatic function, as NSAIDs can cause liver enzyme elevations.
Timing: Before initiating therapy.
Rationale: To establish baseline, as NSAIDs can cause new onset hypertension or worsen existing hypertension.
Timing: Before initiating therapy.
Routine Monitoring
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.
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.
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.
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.
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
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:
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.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age. Use is generally not recommended.
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
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.
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)
Cost & Coverage
General Drug Facts
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.