Tolmetin is a nonsteroidal anti-inflammatory drug (NSAID).

Tolmetin is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis. Tolmetin is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old.

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

Tolmetin can increase your risk of fatal heart attack or stroke. Do not use tolmetin just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Tolmetin may also cause stomach or intestinal bleeding, which can be fatal.

Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Use the lowest dose that is effective in treating your condition.

Take tolmetin on an empty stomach, at least 1 hour before or 2 hours after a meal.

It may take up to 1 week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

If you use tolmetin long-term, you may need frequent medical tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using tolmetin.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Rheumatoid Arthritis:

Initial dose: 400 mg orally 3 times a day
Maintenance dose: 600 to 1800 mg orally in 3 divided doses
Maximum dose: 1800 mg orally per day

Comments:
-It is recommended to include a dose upon awaking and a dose at bedtime.
-Doses should be adjusted according to response to treatment after 1 or 2 weeks.
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.

Use: For the relief of signs and symptoms of rheumatoid arthritis, including acute flares and long term management of chronic disease.

Usual Adult Dose for Osteoarthritis:

Initial dose: 400 mg orally 3 times a day
Maintenance dose: 600 to 1800 mg orally in 3 divided doses
Maximum dose: 1800 mg orally per day

Comments:
-It is recommended to include a dose upon awaking and a dose at bedtime.
-Doses should be adjusted according to response to treatment after 1 or 2 weeks.
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.

Use: For the relief of signs and symptoms of osteoarthritis, including acute flares and long term management of chronic disease.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

2 years or older:
Initial dose: 20 mg/kg/day orally in 3 to 4 divided doses
Maintenance dose: 15 to 30 mg/kg/day orally in 3 to 4 divided doses
Maximum dose: 30 mg/kg/day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.

Use: For the relief of signs and symptoms of juvenile rheumatoid arthritis, including acute flares and long term management of chronic disease.

Tolmetin can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Tolmetin may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using tolmetin, especially in older adults.

You should not use tolmetin if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

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

• a history of stomach ulcers or bleeding;

• asthma;

• fluid retention;

• liver or kidney disease; or

• if you take aspirin to prevent heart attack or stroke.

If you are pregnant, you should not take tolmetin unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

You should not breastfeed while using this medicine.

Tolmetin is not approved for use by anyone younger than 2 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin unless your doctor tells you to.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to tolmetin (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Tolmetin may cause serious side effects. Stop using tolmetin and call your doctor at once if you have:

• changes in your vision;

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• any skin rash, no matter how mild;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of tolmetin may include:

• indigestion, stomach pain, nausea, vomiting;

• diarrhea, gas;

• headache, dizziness;

• weakness; or

• changes in weight.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using tolmetin if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• lithium;

• methotrexate;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill"; or

• insulin or oral diabetes medicine.

This list is not complete. Other drugs may affect tolmetin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking tolmetin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.