Tolectin

DRUG DESCRIPTION

TOLECTIN DS (tolmetin sodium) capsules for oral administration contain tolmetin sodium as the dihydrate in an amount equivalent to 400 mg of tolmetin. Each capsule contains 36 mg (1.568 mEq) of sodium and the following inactive ingredients: gelatin, magnesium stearate, corn starch, talc, FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide.

TOLECTIN 600 (tolmetin sodium) tablets for oral administration contain tolmetin sodium as the dihydrate in an amount equivalent to 600 mg of tolmetin. Each tablet contains 54 mg (2.35 mEq) of sodium and the following inactive ingredients: cellulose, silicon dioxide, crospovidone, hydroxypropyl methyl cellulose, magnesium stearate, polyethylene glycol, corn starch, titanium dioxide, FD&C Yellow No. 6 and D&C Yellow No. 10.

The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water.

Tolmetin sodium is a nonselective nonsteroidal anti- inflammatory agent. The structural formula is:

TOLECTIN DS (tolmetin sodium) structural formula illustration

Sodium 1- methyl-5-(4-methylbenzoyl)-1H-pyrrole-2-acetate dihydrate.

What are the possible side effects of tolmetin (Tolectin)?

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 using tolmetin and 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...

Read All Potential Side Effects and See Pictures of Tolectin

What are the precautions when taking tolmetin sodium (Tolectin)?

Before taking tolmetin, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, zomepirac, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding/clotting problems,...

Read All Potential Precautions of Tolectin


Tolectin Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, heartburn, dizziness, drowsiness, diarrhea, and headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, persistent/severe headache, fast/pounding heartbeat, hearing changes (e.g., ringing in the ears), mental/mood changes, stomach pain, difficult/painful swallowing, swelling of the ankles/feet/hands, sudden/unexplained weight gain.

Stop taking tolmetin and tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck, change in the amount/color of urine, vision changes.

This drug may rarely cause serious, possibly fatal liver disease. If you notice any of the following rare but very serious side effects, stop taking tolmetin and consult your doctor or pharmacist immediately: persistent nausea/vomiting, severe stomach/abdominal pain, extreme/unusual tiredness, weakness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, stop taking tolmetin and immediately seek medical attention if you notice any of the following symptoms of a serious allergic reaction: rash/blisters, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking tolmetin, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, zomepirac, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding/clotting problems, blood disorders (e.g., anemia), high blood pressure, a severe loss of body water (dehydration), diabetes, heart disease (e.g., congestive heart failure, history of heart attack), kidney disease, liver disease, growths in the nose (nasal polyps), obesity, tobacco use, stomach/intestine/esophagus problems (bleeding sores/ulcer, gastrointestinal bleeding, reflux disease), stroke, swelling of the ankles/feet/hands.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medicine contains sodium. If you are on a salt-restricted diet or have any condition that requires you to restrict your intake of salt, consult your doctor or pharmacist about using this drug safely.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and kidney effects.

This drug is not recommended for use during pregnancy, especially during the last 3 months of pregnancy, due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.


Tolectin Patient Information Including Side Effects

Brand Names: Tolectin

Generic Name: tolmetin (Pronunciation: TOLE met in)

  • What is tolmetin (Tolectin)?
  • What are the possible side effects of tolmetin (Tolectin)?
  • What is the most important information I should know about tolmetin (Tolectin)?
  • What should I discuss with my healthcare provider before taking tolmetin (Tolectin)?
  • How should I take tolmetin (Tolectin)?
  • What happens if I miss a dose (Tolectin)?
  • What happens if I overdose (Tolectin)?
  • What should I avoid while taking tolmetin (Tolectin)?
  • What other drugs will affect tolmetin (Tolectin)?
  • Where can I get more information?

What is tolmetin (Tolectin)?

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.

What are the possible side effects of tolmetin (Tolectin)?

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 using tolmetin and 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 side effects may include:

  • upset stomach, mild heartburn, diarrhea, constipation;
  • bloating, gas;
  • dizziness, headache, nervousness;
  • skin itching or rash;
  • blurred vision; or
  • ringing in your ears.

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.

What is the most important information I should know about tolmetin (Tolectin)?

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

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine 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. These gastrointestinal effects can occur without warning at any time while you are taking tolmetin. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

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 tolmetin (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 tolmetin. Alcohol can increase the risk of stomach bleeding caused by tolmetin.

Related Drug Centers
  • Tolectin


Related Drugs Index: