Drug information of Tolmetin


Tolmetin

Drug group:

Tolmetin sodium is a nonselective non-steroidal anti-inflammatory agent .

Mechanism of effect

Inhibits cyclooxygenase-1 (COX-1) and COX-2.

Pharmacodynamic

Pharmacologic actions similar to those of other prototypical NSAIDs; exhibits anti-inflammatory, analgesic, and antipyretic activity.

Pharmacokinetics

Well absorbed following oral administration. Bioavailability reduced 16% when administered immediately after food or with milk. Peak plasma concentrations reduced 50% when administered immediately after food. Distributed into human milk.
Plasma Protein Binding is 99%. Oxidized in liver to an inactive dicarboxylic acid metabolite. Excreted in the urine within 24 hours as the dicarboxylic acid metabolite (60%), unchanged tolmetin (20%), and tolmetin conjugates (20%).

Dosage

Usual Adult Dose for Rheumatoid Arthritis
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
Usual Adult Dose for Osteoarthritis
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.
Usual Pediatric Dose for Juvenile Rheumatoid Arthritis
2 years or older:
Initial dose: 20 mg/kg/day orally in 3 to 4 divided doses
Maintenance dose: 15 to 30 mg/kg/day orally in 3 to 4 divided doses
Maximum dose: 30 mg/kg/day

Alerts

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
NSAIDs, including Tolmetin sodium capsules, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.
NSAIDs, including Tolmetin sodium capsules , can cause serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms in patients treated with NSAIDs.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Acute interstitial nephritis with hematuria, proteinuria, and occasionally nephritic syndrome have been reported in patients treated with Tolmetin sodium.
As with other NSAIDs, anaphylactoid reactions may occur in patients with known prior exposure to Tolmetin sodium. Tolmetin sodium capsules should not be given to patients with the aspirin triad.
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, Tolmetin sodium capsules should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

Points of recommendation

To make sure this medicine is safe for you, tell your doctor if you have :
• If you have an allergy to this medicine or any other part of it.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have an allergy to aspirin or NSAIDs.
• If you have any of these health problems: GI (gastrointestinal) bleeding or kidney problems.
• If you are having trouble getting pregnant or you are having your fertility checked.
• If you are pregnant or may be pregnant. Do not take this medicine if you are in the third trimester of pregnancy. You may also need to avoid tolmetin at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this medicine during pregnancy.
• If you are breast-feeding or plan to breast-feed.
• If you are taking sodium bicarbonate.
• If you are taking any other NSAID.
• If you are taking a salicylate drug like aspirin.
• If you are taking pemetrexed.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised.
• If you are 65 or older, use tolmetin with care. You could have more side effects.
• Take with or without food. Take with food if it causes an upset stomach. Take with a full glass of water.
• Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.


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