Tolectin

Tolmetin is generally used with caution in patients taking blood thinning medications (anticoagulants), such as warfarin (Coumadin), because of an increased risk of bleeding. Patients taking lithium (Eskalith, Lithobid) or methotrexate (Rheumatrex, Trexall) can develop toxic blood levels of either drug because tolmetin may inhibit their elimination from the body by the kidney. Side effects from cyclosporine also may be increased by tolmetin. Tolmetin may reduce the effectiveness of antihypertensives because it causes or worsens high blood pressure. NSAIDs may diminish the antihypertensive effect of ACE inhibitors.

Combining NSAIDs with angiotensin receptor blockers (for example, valsartan [Diovan], losartan [Cozaar], irbesartan [Avapro]) or angiotensin converting enzyme inhibitors (for example, enalapril [Vasotec], captopril [Capoten]) in patients who are elderly, volume-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure. These effects usually are reversible.

Persons who have more than three alcoholic beverages per day are at increased risk of developing stomach ulcers when taking tolmetin or other NSAIDs.

Tolmetin is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

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, especially if you use it long term or take high doses, or if you have heart disease. 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.

Tolmetin can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

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.

To make sure tolmetin is safe for you, tell your doctor if you have:

• 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;
• liver or kidney disease; or
• fluid retention.

Taking tolmetin during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using tolmetin.

Tolmetin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

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

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

Avoid taking aspirin while you are taking tolmetin.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain aspirin or other medicines similar to tolmetin. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Ask your doctor before using tolmetin if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use tolmetin if you are also using any of the following drugs:

• lithium;
• methotrexate;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or "water pill"; or
• steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with tolmetin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the event of overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage followed by the administration of activated charcoal.

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non- Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

• with longer use of NSAID medicines
• in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

• can happen without warning symptoms
• may cause death

The chance of a person getting an ulcer or bleeding increases with:

• taking medicines called "corticosteroids" and "anticoagulants"
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

NSAID medicines should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

• different types of arthritis
• menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery

Tell your healthcare provider:

• about all of your medical conditions.
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show your healthcare provider and pharmacist.
• if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
• if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Get emergency help right away if you have any of the following symptoms:

• shortness of breath or trouble breathing
• chest pain
• weakness in one part or side of your body
• slurred speech
• swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

• nausea
• more tired or weaker than usual
• itching
• your skin or eyes look yellow
• stomach pain
• flu-like symptoms
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms and legs, hands, and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

This Medication Guide has been approved by the U.S. Food and Drug Administration. August 2007.

Tolmetin is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Tolmetin is used to treat pain, inflammation, and stiffness caused by arthritis.

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

The adverse reactions which have been observed in clinical trials encompass observations in about 4370 patients treated with TOLECTIN (tolmetin sodium), over 800 of whom have undergone at least one year of therapy. These adverse reactions, reported below by body system, are among those typical of nonsteroidal anti- inflammatory drugs and, as expected, gastrointestinal complaints were most frequent. In clinical trials with TOLECTIN (tolmetin sodium) , about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature.

Incidence Greater Than 1%

The following adverse reactions which occurred more frequently than 1 in 100 were reported in controlled clinical trials.

Gastrointestinal: Nausea (11%), dyspepsia,* gastrointestinal distress,* abdominal pain,* diarrhea,* flatulence,* vomiting,* constipation, gastritis, and peptic ulcer. Forty percent of the ulcer patients had a prior history of peptic ulcer disease and/or were receiving concomitant anti- inflammatory drugs including corticosteroids, which are known to produce peptic ulceration.

Body as a Whole: Headache, * asthenia, * chest pain

Cardiovascular: Elevated blood pressure, * edema*

Central Nervous System: Dizziness, * drowsiness, depression

Metabolic/Nutritional: Weight gain, * weight loss*

Dermatologic:Skin irritation

Special Senses: Tinnitus, visual disturbance

Hematologic: Small and transient decreases in hemoglobin and hematocrit not associated with gastrointestinal bleeding have occurred. These are similar to changes reported with other nonsteroidal anti- inflammatory drugs.

Urogenital: Elevated BUN, urinary tract infection

*Reactions occurring in 3% to 9% of patients treated with TOLECTIN (tolmetin sodium) . Reactions occurring in fewer than 3% of the patients are unmarked.

Incidence Less Than 1%

(Causal Relationship Probable)

The following adverse reactions were reported less frequently than 1 in 100 controlled clinical trials or were reported since marketing. The probability exists that there is a causal relationship between TOLECTIN (tolmetin sodium) and these adverse reactions.

Gastrointestinal: Gastrointestinal bleeding with or without evidence of peptic ulcer, perforation, glossitis, stomatitis, hepatitis, liver function abnormalities.

Body as a Whole: Anaphylactoid reactions, fever, lymphadenopathy, serum sickness

Hematologic: Hemolytic anemia, thrombocytopenia, granulocytopenia, agranulocytosis

Cardiovascular: Congestive heart failure in patients with marginal cardiac function.

Dermatologic: Urticaria, purpura, erythema multiforme, toxic epidermal necrolysis

Urogenital: Hematuria, proteinuria, dysuria, renal failure

Incidence Less Than 1%

(Causal Relationship Unknown)

Other adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing, but a causal relationship between TOLECTIN (tolmetin sodium) and the reaction could not be determined. These rarely reported reactions are being listed as alerting information for the physician since the possibility of a causal relationship cannot be excluded.

Body as a Whole: Epistaxis

Special Senses: Optic neuropathy, retinal and macular changes

Read the entire FDA prescribing information for Tolectin (Tolmetin Sodium)

• Ankle Pain
• Ankylosing Spondylitis
• Juvenile Idiopathic Arthritis (Juvenile Rheumatoid Arthritis)
• NSAIDs (Nonsteroidal Antiinflammatory Drugs)
• Pain Management Medication Types
• Psoriatic Arthritis
• Rheumatoid Arthritis (RA)

Tolectin is a prescription medication used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis and rheumatoid arthritis. It is also used to treat juvenile rheumatoid arthritis in children. Tolectin belongs to a group of drugs called NSAIDs. These work by stopping the body's production of a substance that causes pain, fever, and inflammation.

This medication comes in tablet form and is typically taken 3 or 4 times a day.

Common side effects of Tolectin include nausea, upset stomach, and stomach pain.

Tolectin is a prescription medication used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis.