Etodolac

Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat osteoarthritis, rheumatoid arthritis, and acute pain.

• Etodolac is available under the following different brand names: Lodine.

Dosage Forms and Strengths

Tablet (adult only)

• 400 mg
• 500 mg

Capsule (adult only)

• 200 mg
• 300 mg

Tablet, extended-release (adult and pediatric)

• 400 mg
• 500 mg
• 600 mg

Dosage Considerations – Should be Given as Follows:

Pain

• Immediate release: 200-400 mg orally every 6-8 hours; not to exceed 1000 mg/day (not evaluated)

Osteoarthritis

• Immediate release: 600-1000 mg/day orally divided every 8-12 hours or 900 mg/day orally divided every 8 hours; doses greater than 1000 mg/day not evaluated
• Extended-release: 400-1000 mg orally once daily; not to exceed 1200 mg/day (not evaluated)

Rheumatoid Arthritis

• Immediate release: 600-1000 mg/day orally divided every 8-12 hours or 900 mg/day orally divided every 8 hours; doses greater than 1000 mg/day not evaluated
• Extended-release: 400-1000 mg orally once daily; not to exceed 1200 mg/day (not evaluated)

Juvenile Rheumatoid Arthritis

Children under 6 years

• Safety and efficacy not established

Children 6-16 years

• 20-30 kg (extended-release): 400 mg orally once daily
• 31-45 kg (extended-release): 600 mg orally once daily
• 46-60 kg (extended-release): 800 mg orally once daily
• Over 60 kg (extended-release): 1000 mg orally once daily

Dosing considerations

• The safety and effectiveness of conventional tablets for juvenile rheumatoid arthritis have not been established
• Take with food or 8-12 oz of water to avoid gastrointestinal (GI) effects
• Less than 60 kg: Not to exceed 20 mg/kg orally
• Mild-to-moderate renal impairment: Dose adjustment not necessary
• Severe renal impairment; Not recommended
• Hepatic impairment: Dose adjustment not necessary

Common side effects of etodolac include:

• Indigestion
• Dizziness
• Nervousness
• Skin itching
• Blurred vision
• Depression
• Chills/fever
• Vomiting
• Diarrhea
• Constipation
• Upset stomach
• Stomach pain
• Heartburn
• Bloating
• Gas
• Headache
• Sore throat
• Stuffy nose

Less common side effects of etodolac include:

• Weakness/lack of energy
• Feeling unwell (malaise)
• Bronchospasm
• Difficult or painful urination
• Urinary frequency
• Swelling (edema)
• Dark, tarry stools
• Rash
• Ringing in the ears (tinnitus)

Serious side effects of etodolac include:

• Heart attack
• Stroke
• Coma
• Skin changes (paleness, blisters, and hives)
• Weight gain
• Shortness of breath
• Fast heart rate
• Unusual bleeding (including GI bleeding)
• Yelling skin and eyes (jaundice)
• Bloody urine
• Back pain

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Etodolac has no known severe interactions with other drugs.
• Serious interactions of etodolac include:
  • apixaban
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • ketorolac
  • ketorolac intranasal
  • lisinopril
  • methotrexate
  • moexipril
  • pemetrexed
  • perindopril
  • quinapril
  • ramipril
  • tacrolimus
  • trandolapril
• Etodolac has moderate interactions with at least 227 different drugs.
• Etodolac has mild interactions with at least 79 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

Cardiovascular risk:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
• The risk may increase with duration of use
• Patients with risk factors for or existing cardiovascular disease may be at greater risk
• NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery

Gastrointestinal risk:

• NSAIDs increase the risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
• GI adverse events may occur at any time during use and without warning symptoms
• Elderly patients are at greater risk for serious GI events

This medication contains etodolac. Do not take Lodine if you are allergic to etodolac or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Absolute

• Aspirin allergy
• Perioperative pain associated with coronary artery bypass graft
• Previous allergic reactions or asthma after taking aspirin or other NSAIDs

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Etodolac?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Etodolac?"

Cautions

• Use caution in patients with a history of asthma (bronchial).
• Caution in bleeding disorder, duodenal/gastric/peptic ulcer, stomatitis, systemic lupus erythematosus, ulcerative colitis, upper gastrointestinal (GI) disease, late pregnancy (may cause premature closure of ductus arteriosus).
• Use with caution in cardiac disease, hepatic and renal impairment.
• Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injuries; patients at greatest risk include elderly individuals; those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion; and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers.
• Advanced renal disease: Monitor closely.
• Risk of severe gastrointestinal (GI) toxicities, including inflammation, ulcers, bleeding, and perforation.
• Increased risk of serious cardiovascular thrombotic events, heart attack (myocardial infarction [MI]), and stroke.
• Heart Failure risk:
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to trigger heart failure by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
  • NSAIDs should be avoided or withdrawn whenever possible
  • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134

Pregnancy and Lactation

• Use etodolac with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done. Avoid the use of etodolac in late pregnancy (may cause premature closure of ductus arteriosus).
• Quebec Pregnancy Registry identified 4705 women who had a spontaneous abortion by 20 weeks gestation; each case was matched to 10 control subjects (n=47,050) who had not had a spontaneous abortion; exposure to non-aspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortion and approximately 2.6% of controls.
• It is unknown whether etodolac is excreted in breast milk; it is not recommended for use while breastfeeding.