Tolectin (Tolmetin Sodium) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Tolectin

Ankylosing Spondylitis »

What is ankylosing spondylitis?

Ankylosing spondylitis is a form of chronic inflammation of the spine and the sacroiliac joints. The sacroiliac joints are located in the low back where the sacrum (the bone directly above the tailbone) meets the iliac bones (bones on either side of the upper buttocks). Chronic inflammation in these areas causes pain and stiffness in and around the spine. Over time, chronic inflammation of the spine (spondylitis) can lead to a complete cementing together (fusion) of the vertebrae, a process referred to as ankylosis. Ankylosis leads to loss of mobility of the spine.

Ankylosing spondylitis is also a systemic disease, meaning it can affect other tissues throughout the body. Accordingly, it can cause inflammation in or injury to other joints away from the spine, as well as to other organs, such as the eyes, heart, lungs, and kidneys. Ankylosing spondylitis shares many features with several other arthritis conditions, suc...

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Tolectin

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TOLECTIN® DS
(tolmetin sodium) Capsules

TOLECTIN® 600
(tolmetin sodium) Tablets

For Oral Administration

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
TOLECTIN (tolmetin sodium) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).

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 »

Last reviewed on RxList: 2/11/2008
This monograph has been modified to include the generic and brand name in many instances.