Tolmetin

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

Tolmetin is used to relieve pain or swelling 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 reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the lowest effective dose for your condition.

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

If you use tolmetin for a long time, you may need to have frequent medical tests.

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

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

Tolmetin can raise your chance of having a fatal heart attack or stroke. Do not use tolmetin right before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Tolmetin may also lead to serious stomach or intestinal issues, such as bleeding, ulcers, or tears (perforation), which can be life-threatening. These issues can occur at any time while using tolmetin and without any warning. Older adults are at a higher risk. Stop taking tolmetin and contact your healthcare provider immediately if you vomit blood or have bloody, black, or tarry stools.

Tolmetin can raise your chance of having a fatal heart attack or stroke. Do not take this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Tolmetin can also cause stomach or intestinal bleeding, which can be life-threatening. This can happen suddenly, especially in older adults.

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

Inform your doctor if you have or have ever had:

• heart disease, high blood pressure, high cholesterol, smoking, diabetes;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• fluid retention; or
• liver or kidney disease.

Let your doctor know if you are pregnant or planning to become pregnant. Tolmetin may harm an unborn baby if taken at 20 weeks or later in pregnancy. If you are between 20 to 30 weeks of pregnancy, only take this medicine if your doctor has advised you to. Avoid this medicine around 30 weeks of pregnancy or later.

Check with your doctor if it is safe to breastfeed while taking this medicine.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty 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).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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.

Stop taking tolmetin and call your doctor at once if you have:

• changes in your vision;
• any skin rash, no matter how mild;
• severe headache, pounding in your neck or ears;
• heart problems--swelling, rapid weight gain, feeling short of breath;
• stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• a hole (perforation) in your digestive tract--fever, severe stomach pain, change in bowel habits;
• liver problems--loss of appetite, nausea, vomiting, indigestion, flu-like symptoms, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--urinating less, feeling tired or short of breath; or
• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed, cold hands and feet.

Older adults may be more likely to have serious stomach problems while taking medicine that contains an NSAID.

Common side effects of tolmetin may include:

• stomach pain, nausea, vomiting;
• diarrhea, constipation, gas;
• heartburn;
• headache, dizziness;
• swelling in any part of your body;
• high blood pressure;
• 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.

Usual Adult Dose for Osteoarthritis:

Initial dose: 400 mg orally 3 times a dayMaintenance dose: 600 to 1800 mg orally in divided doses, generally 3 times a dayMaximum dose: 1800 mg/dayComments:-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 to 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 or osteoarthritis, including acute flares and long-term management of chronic disease.

Usual Adult Dose for Rheumatoid Arthritis:

Initial dose: 400 mg orally 3 times a dayMaintenance dose: 600 to 1800 mg orally in divided doses, generally 3 times a dayMaximum dose: 1800 mg/dayComments:-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 to 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 or osteoarthritis, including acute flares and long-term management of chronic disease.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

2 years and 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/dayComment:-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.

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

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

Drinking alcohol may increase your risk of stomach or intestinal 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).

Ask your doctor before taking tolmetin if you are using an antidepressant. Taking some antidepressants together with an NSAID may make you more likely to bruise or bleed.

Tell your doctor about all your other medicines, especially:

• steroids; or
• a blood thinner--warfarin, Coumadin, Jantoven.

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