Trilisate

(Generic versions may still be available.)

DRUG DESCRIPTION

Trilisate (choline magnesium trisalicylate) (choline magnesium trisalicylate) TABLETS/LIQUID
500 mg, 750 mg or 1000 mg salicylate content

TRILISATE (choline magnesium trisalicylate) Tablets/ Liquid are nonsteroidal, anti-inflammatory preparations containing choline magnesium trisalicylate which is freely soluble in water. The absolute structure of choline magnesium trisalicylate is not known at this time. Choline magnesium trisalicylate has a molecular formula of C26H29O10NMg, and a molecular weight of 539.8.

This substance when dissolved in water would appear to form 5 ions (1 choline ion, 1 magnesium ion and 3 salicylate ions).

TRILISATE (choline magnesium trisalicylate) Tablets/ Liquid are available in scored, pale pink 500 mg tablets; in scored, white, film-coated 750 mg tablets, and in scored, red, film-coated 1000 mg tablets. TRILISATE (choline magnesium trisalicylate) Liquid is a cherry cordial-flavored liquid providing 500 mg salicylate content per teaspoonful (5 ml) for oral administration.

Each 500 mg tablet contains 293 mg of choline salicylate combined with 362 mg of magnesium salicylate to provide 500 mg salicylate content.

Each 750 mg tablet contains 440 mg of choline salicylate combined with 544 mg of magnesium salicylate to provide 750 mg salicylate content.

Each 1000 mg tablet contains 587 mg of choline salicylate combined with 725 mg magnesium salicylate to provide 1000 mg salicylate content.

TRILISATE (choline magnesium trisalicylate) Liquid contains 293 mg of choline salicylate combined with 362 mg of magnesium salicylate to provide 500 mg salicylate per teaspoonful (5 ml) in a clear amber, cherry cordial-flavored vehicle.

Inactive Ingredients

Each 500 mg tablet contains: Carboxymethylcellulose sodium, Corn starch, Edetate disodium, FD& C Yellow No. 6, Stearic acid, and other ingredients.

Each 750 mg tablet contains: Carboxymethylcellulose sodium, Edetate disodium, Hydroxypropyl methylcellulose, Polyethylene glycol, Polysorbate 20, Stearic acid, Talc, Titanium dioxide, and other ingredients.

Each 1000 mg tablet contains: Carboxymethylcellulose sodium, Edetate disodium, FD& C Red No. 40, FD& C Yellow No. 6, FD& C Blue No. 2, Hydroxypropyl methylcellulose, Polyethylene glycol, Polysorbate 20, Polysorbate 80, Stearic acid, Talc, Titanium dioxide, and other ingredients.

Each teaspoonful (5 ml) of Liquid contains: Caramel, Carboxymethylcellulose sodium, Edetate disodium, FD& C Yellow No. 6, Glycerin, High fructose corn syrup, Potassium sorbate, Water, and Artificial flavors.

What are the possible side effects of choline magnesium trisalicylate (Choline Magnesium Trisalicylate, Tricosal, Trilisate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • chest pain, severe dizziness, shortness of breath, slurred speech, problems with vision or balance;
  • sudden numbness or weakness, especially on one side of the body;
  • feeling like you...

Read All Potential Side Effects and See Pictures of Trilisate

What are the precautions when taking choline magnesium trisalicylate (Trilisate)?

Before taking choline salicylate/magnesium salicylate, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, salsalate); 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), severe kidney disease.

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

Read All Potential Precautions of Trilisate


Trilisate Consumer (continued)

SIDE EFFECTS: Upset stomach, heartburn, nausea, or vomiting may occur. If any of these effects persist or worsen, tell 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: dizziness/drowsiness, hearing changes (e.g., ringing in the ears, decreased hearing), stomach pain, swelling of ankles/feet/hands, sudden/unexplained weight gain.

See also Warning section.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, easy bruising/bleeding, fast/pounding heartbeat, persistent nausea/vomiting, unusual/extreme tiredness, change in amount/color of urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, 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 any other side 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 choline salicylate/magnesium salicylate, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, salsalate); 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), severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding/clotting problems, blood disorders (e.g., anemia), a severe loss of body water (dehydration), kidney disease, liver disease, diabetes, certain genetic conditions (G6PD deficiency, pyruvate kinase deficiency), heart disease (e.g., congestive heart failure, history of heart attack), high blood pressure, growths in the nose (nasal polyps), stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), stroke, swelling of the ankles/feet/hands.

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

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

If you have diabetes, this drug may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Promptly report any abnormal results as directed. Your medicine, exercise plan, or diet may need to be adjusted.

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 medication is similar to aspirin. Children and teenagers should not take this medication if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and problems with normal labor/delivery. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Trilisate Patient Information Including Side Effects

Brand Names: Choline Magnesium Trisalicylate, Tricosal, Trilisate

Generic Name: choline magnesium trisalicylate (Pronunciation: KOE leen mag NEE see um TRYE sa LIS i late)

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

What is choline magnesium trisalicylate (Trilisate)?

Choline magnesium trisalicylate is a non-steroidal anti-inflammatory drug (NSAID). This medication is a combination of choline salicylate and magnesium salicylate. Both are in a group of drugs called salicylates (sa-LIS-il-ates). This medicine works by reducing substances in the body that cause pain, fever, and inflammation.

Choline magnesium trisalicylate is used to reduce pain and inflammation caused by conditions such as arthritis. This medication is also used to treat fever in adults.

Choline magnesium trisalicylate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of choline magnesium trisalicylate (Trilisate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • chest pain, severe dizziness, shortness of breath, slurred speech, problems with vision or balance;
  • sudden numbness or weakness, especially on one side of the body;
  • feeling like you might pass out;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • blood in your urine, urinating more or less than usual;
  • hearing problems, ringing in your ears;
  • severe stomach pain, ongoing nausea or vomiting;
  • swelling, rapid weight gain;
  • easy bruising or bleeding, unusual weakness;
  • fast or pounding heartbeats; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • heartburn, upset stomach, diarrhea, constipation;
  • dizziness, drowsiness, lack of energy; or
  • headache.

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 choline magnesium trisalicylate (Trilisate)?

You should not use this medication if you are allergic to aspirin or to an NSAID (non-steroidal anti-inflammatory drug), or if you have recently used cidofovir (Vistide), ketorolac (Toradol), or nasal flu vaccine (FluMist).

Before taking choline magnesium salicylate, tell your doctor if you have asthma, heart disease, high blood pressure, stomach or intestinal bleeding, diabetes, anemia, a bleeding disorder, liver or kidney disease, nasal polyps, a genetic enzyme deficiency, or if you are dehydrated.

Choline magnesium trisalicylate may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use choline magnesium trisalicylate just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, severe dizziness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking choline magnesium trisalicylate, especially in older adults.

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

This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Salicylates can cause a serious and sometimes fatal condition called Reye's syndrome in children.

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