Tolectin 600

Tolectin 600 is a prescription medication used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis.

Tolectin 600 is part of the drug class:

• Acetic acid derivatives and related substances

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.
• Tolmetin sodium is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

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 anytime during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events

This section provides information on the proper use of a number of products that contain tolmetin. It may not be specific to Tolectin 600. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

It is best to take this medicine on an empty stomach. However, if it upsets your stomach, you may take this medicine with an antacid that does not contain sodium bicarbonate.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or tablets):
  • For osteoarthritis and rheumatoid arthritis:
    • Adults—At first, 400 milligrams (mg) three times a day. Your doctor may increase your dose as needed up to a total dose of 1800 mg per day.
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. At first, 20 milligrams (mg) per kilogram (kg) of body weight per day, divided into smaller amounts that are taken three or four times a day. Your doctor may increase your dose as needed up to 30 mg per kg of body weight per day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Initial dose: 400 mg orally 3 times a day
Maintenance dose: 600 to 1800 mg orally in 3 divided doses
Maximum dose: 1800 mg orally per day

Comments:
-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 or 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, including acute flares and long term management of chronic disease.

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:
-Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.
-This drug is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
-NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 a greater risk for serious GI events.

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Animal studies have failed to reveal evidence of teratogenicity or impaired fertility. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Not recommended during last trimester of pregnancy. Prior to 30 weeks gestation: Use only if potential benefit justifies the potential risk to the fetus. US FDA pregnancy category: C Comment: -Avoid use in late pregnancy as it may cause premature closure of the ductus arteriosus.

Substance Name

Tolmetin

CAS Registry Number

26171-23-3

Drug Class

Analgesic Agents

Nonsteroidal Antiinflammatory Agents

LactMed Record Number

263

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.