Etodolac tablets

What is this medicine?

Etodolac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac works by reducing hormones that cause inflammation and pain in the body.

Etodolac is used to relieve the inflammation, swelling, stiffness, and joint pain of osteoarthritis (the most common form of arthritis) and rheumatoid arthritis. It is also used to relieve pain in other situations.

Etodolac may also be used for other purposes not listed in this medication guide.

What should I tell my health care provider before I take this medicine?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use Etodolac if you are allergic to etodolac, or if you have a history of allergic reaction to aspirin or other NSAIDs.

Before taking Etodolac, tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart attack, stroke, or blood clot;

• heart disease, congestive heart failure, high blood pressure;

• a history of stomach ulcers or bleeding;

• liver or kidney disease,

• asthma;

• polyps in your nose;

• a bleeding or blood clotting disorder; or

• if you smoke.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Etodolac.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Etodolac during the last 3 months of pregnancy may harm the unborn baby. Do not take Etodolac during pregnancy unless your doctor has told you to. It is not known whether Etodolac passes into breast milk or if it could harm a nursing baby. Do not use Etodolac without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 6 years old without the advice of a doctor.

How should I use this medicine?

Take Etodolac exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve.

If you take Etodolac for a long period of time, your doctor may want to check you on a regular basis to make sure Etodolac is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Etodolac can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Etodolac.

Store Etodolac at room temperature away from moisture and heat.

What if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I watch for while using this medicine?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Etodolac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking Etodolac. Alcohol can increase the risk of stomach bleeding caused by Etodolac. Avoid prolonged exposure to sunlight. Etodolac may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

What side effects may I notice from this medicine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Etodolac and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• swelling or rapid weight gain;

• urinating less than usual or not at all;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• bruising, severe tingling, numbness, pain, muscle weakness; or

• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious Etodolac side effects may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation;

• bloating, gas;

• dizziness, headache, nervousness;

• skin itching or rash;

• sore throat, stuffy nose;

• blurred vision; or

• ringing in your ears.

This is not a complete list of side effects and others may occur.

What may interact with this medicine?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with Etodolac may cause you to bruise or bleed easily.

Before taking Etodolac, tell your doctor if you are taking any of the following drugs:

• a blood thinner such as warfarin (Coumadin);

• cyclosporine (Gengraf, Neoral, Sandimmune);

• digoxin (digitalis, Lanoxin);

• lithium (Eskalith, Lithobid);

• methotrexate (Rheumatrex, Trexall);

• a diuretic (water pills) such as furosemide (Lasix);

• steroids (prednisone and others);

• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Cataflam, Voltaren), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or

• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

This list is not complete and there may be other drugs that can interact with Etodolac. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.