pharmacopeia
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/api/v1/drug/tolmetin

Boxed warning

Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ). TOLECTIN capsules are contraindicated 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 ).

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Cyclooxygenase Inhibitors.

Cyclooxygenase

Indications

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  • Carefully consider the potential benefits and risks of TOLECTIN capsules, USP and other treatment options before deciding to use TOLECTIN capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).

Contraindications

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  • TOLECTIN capsules are contraindicated in patients with known hypersensitivity to tolmetin sodium. TOLECTIN should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs.contraindicated

Dosage & administration

Sourced from openFDA

Carefully consider the potential benefits and risks of TOLECTIN capsules and other treatment options before deciding to use TOLECTIN capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with TOLECTIN capsules, the dose and frequency should be adjusted to suit an individual patient’s needs. For the relief of rheumatoid arthritis or osteoarthritis, the recommended starting dose for adults is 400 mg three times daily (1200 mg daily), preferably including a dose on arising and a dose at bedtime. To achieve optimal therapeutic effect the dose should be adjusted according to the patient’s response after 1 or 2 weeks. Control is usually achieved at doses of 600 mg to 1800 mg daily in divided doses (generally t.i.d.). Doses larger than 1800 mg/day have not been studied and are not recommended. For the relief of juvenile rheumatoid arthritis, the recommended starting dose for pediatric patients (2 years and older) is 20 mg/kg/day in divided doses (t.i.d. or q.i.d.). When control has been achieved, the usual dose ranges from 15 to 30 mg/kg/day. Doses higher than 30 mg/kg/day have not been studied, and, therefore, are not recommended. A therapeutic response to TOLECTIN can be expected in a few days to a week. Progressive improvement can be anticipated during succeeding weeks of therapy. If gastrointestinal symptoms occur, TOLECTIN capsules can be administered with antacids other than sodium bicarbonate.

Warnings & precautions

Sourced from openFDA

Cardiovascular Effects: Cardiovascular Thrombotic Events: Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

Adverse reactions

Sourced from openFDA

The adverse reactions which have been observed in clinical trials encompass observations in about 4,370 patients treated with TOLECTIN, 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, 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.

Overdosage

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Jul 31, 1992ANDAANDA073588Chartwell Rx
  • May 27, 1993ANDAANDA073393Rising
  • Aug 30, 1994ANDAANDA074473Rising

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
168 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Hypersensitivity3420%
  2. 2Headache169.5%
  3. 3Fatigue148.3%
  4. 4Vomiting127.1%
  5. 5Nausea116.5%
  6. 6Renal Failure116.5%
  7. 7Asthenia106.0%
  8. 8Depression106.0%
  9. 9Feeling Abnormal106.0%
  10. 10Arthralgia95.4%
  11. 11Dizziness95.4%
  12. 12Drug Ineffective95.4%
  13. 13Dyspnoea95.4%
  14. 14Pain84.8%
  15. 15Back Pain74.2%

Literature

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Recent PubMed references pinned to Tolmetin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Frequently asked questions

How does Tolmetin work?
Mechanism-of-action class: Cyclooxygenase Inhibitors.
What is Tolmetin used for?
According to FDA labeling, Tolmetin carries indications including: Carefully consider the potential benefits and risks of TOLECTIN capsules, USP and other treatment options before deciding to use TOLECTIN capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tolmetin?
Tolmetin is classified as Acetic acid derivatives and related substances, Antiinflammatory preparations, non-steroids for topical use, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitors, Decreased Prostaglandin Production.
What are the brand names for Tolmetin?
Tolmetin is marketed under brand names including Tolectin 600, Tolectin DS.
What are the contraindications for Tolmetin?
Tolmetin labeling lists contraindications including: TOLECTIN capsules are contraindicated in patients with known hypersensitivity to tolmetin sodium. TOLECTIN should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs.. Always consult the full prescribing information and a clinician.
Note. Data for tolmetin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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