Etogesic

Etodolac is a prescription medication used to treat pain, tenderness, swelling, and stiffness caused by osteoarthritis and rheumatoid arthritis. It is also used to relieve pain from other causes.

Etodolac belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking substances called prostaglandins that cause pain and inflammation.

Etodolac comes in tablet and capsule form. It is taken 2 or 3 times daily for arthritis and up to 4 times daily for other causes of pain. Once-daily extended-release tablets are also available.

Common side effects include stomach pain, constipation, and diarrhea. Etodolac may cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Etodolac is a prescription medication used to treat pain, tenderness, swelling, and stiffness caused by osteoarthritis and rheumatoid arthritis. It is also used to relieve pain from other causes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Boehringer Ingelheim Vetmedica, Inc.

Serious side effects have been reported. See "Precautions" section.

Common side effects include:

• constipation
• diarrhea
• stomach pain
• gas or bloating
• vomiting
• headache
• dizziness
• ringing in the ears
• runny nose
• sore throat
• blurred vision

This is not a complete list of etodolac side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ACE inhibitors such as lisinopril (Prinivil), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec) and others
• aspirin (Ecotrin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• diuretics, or water pills, such as thiazides (hydrochlorothiazide) and furosemide (Lasix)
• lithium (Eskalith, Lithobid, others)
• methotrexate (Rheumatrex, Trexall)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• warfarin (Coumadin)
• cholestyramine (Questran)
• cimetidine (Tagamet)
• digoxin (Digitek, Lanoxin)

This is not a complete list of etodolac drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with etodolac including:

• Cardiovascular thrombotic events. Etodolac can increase your risk of cardiovascular and heart diseases such as strokes and myocardial infarctions, which can lead to death. Tell your doctor if you have a history of heart disease.
• Gastrointestinal effects. Etodolac can cause digestive tract problems such as ulcers, bleeding, inflammation, and perforations (small holes). Tell your doctor if you have a history of digestive problems, or if you smoke or frequently drink alcohol. Alert your doctor if you take anticoagulants (blood-thinners) or corticosteroids such as prednisone.
• Hepatic events. Etodolac c­­an cause damage to the liver and increase liver tests. Tell your doctor if you have a history of liver disease.
• Hypertension. Etodolac may raise your blood pressure. Tell your doctor if you have a history of high blood pressure or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Congestive heart failure and edema. Etodolac can increase the chance of congestive heart failure, fluid retention, and weight gain.
• Renal effects. Kidney damage can result from the use of etodolac. Tell your doctor if you have a history of kidney disease or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Hypersensitivity reaction. An allergic reaction to etodolac can occur. Symptoms of a hypersensitivity reaction include:
  • hives
  • rash
  • difficulty breathing or swallowing
  • itching
  • swelling
• Adverse skin reactions. Etodolac can lead to dangerous skin reactions. Symptoms of a skin reaction include:
  • rash
  • red, itchy, or scaly skin
  • blisters
  • fever
• Pregnancy. Etodolac should not be taken past the 30th week of pregnancy.

Etodolac can cause dizziness. Do not drive or operate heavy machinery until you know how etodolac affects you.

Do not take etodolac if you:

• are allergic to etodolac
• will have or have recently had coronary (heart) surgery

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of etodolac, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking etodolac tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of heart, liver, or kidney disease
• have a history of gastrointestinal (digestive) problems
• have hypertension, or high blood pressure
• have a history of asthma
• take ACE inhibitors such as lisinopril (Prinivil) and enalapril (Vasotec)
• take aspirin (Ecotrin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• take diuretics, or water pills, such as thiazides (hydrochlorothiazide) and furosemide (Lasix)
• are allergic to etodolac
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Etodolac falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Etodolac is not recommended for women who are in the third trimester of pregnancy. It is possible this medication can harm or cause death to the unborn baby if taken during the third trimester.

It is not known if etodolac crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using etodolac.

• Etodolac comes in tablet and capsule forms.
• It is taken 2 or 3 times daily for arthritis and up to 4 times daily for other causes of pain.
• Once-daily extended-release tablets are also available.
• Take etodolac with water at around the same time(s) each day.

The recommended total daily dose of etodolac for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in well-controlled trials.

Osteoarthritis and Rheumatoid Arthritis

The recommended starting dose of etodolac for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg two or three times daily, or 400 mg twice daily, or 500 mg twice daily. A lower dose of 600 mg/day may suffice for long-term administration. Doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

If you take too much etodolac, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store etodolac at controlled room temperature 15 - 30°C (59 - 86°F).
• Keep etodolac and all medicines out of the reach of children.

Cardiovascular Risk:

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

Etodolac is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk:

NSAIDs 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 are at greater risk for serious gastrointestinal events.