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Basic Drug Info
Drug Name:TOLMETIN SODIUM
Manufacturer:MUTUAL PHARMACEUTICAL COMPANY, INC.
Other Info:Manufactured by:MUTUAL PHARMACEUTICAL COMPANY, INC.Philadelphia, PA 19124 USARevised: January 2008S



Clinical Trials:


Indications and Usage

Carefully consider the potential benefits and risks of tolmetin sodium and other treatment options before deciding to use tolmetin sodium.

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Tolmetin sodium is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis.

Tolmetin sodium is indicated in the treatment of acute flares and the long-term management of the chronic disease.Tolmetin sodium is also indicated for treatment of juvenile rheumatoid arthritis.

The safety and effectiveness of tolmetin sodium have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION).
Physical findings -- Objective evidence of disease perceptible to the examining physician.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Rheumatoid Arthritis -- A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.

Degenerative polyarthritis -- A progressive, degenerative joint disease, the most common form of arthritis, especially in older persons. The disease is thought to result not from the aging process but from biochemical changes and biomechanical stresses affecting articular cartilage. In the foreign literature it is often called osteoarthrosis deformans.

Flare -- Flare; reddening of the skin spreading outward from a focus of infection or irritation; a sudden recurrence or worsening of symptoms.

Chronic disease -- Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care. (Dictionary of Health Services Management, 2d ed)

Chronic Childhood Arthritis -- Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Contraindications

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

Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma).Tolmetin sodium is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Urticaria -- A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress.

Allergic Reaction --

ANAPHYLACTOID REACTION --

Pain -- An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.

Warnings

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, myocardial infarction, and stroke, which can be fatal.

All NSAIDs, both COX-2 selective and nonselective, may have a similar risk.

Patients with known CV disease or risk factors for CV disease may be at greater risk.

To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible.

Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms.

Patients should be informed about the signs and/or 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.

The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see WARNINGS: Gastrointestinal (GI) Effects–Risk of Ulceration, Bleeding, and Perforation).Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
Branded Drugs
The following US Branded drugs contain TOLMETIN SODIUM


TOLECTIN DS -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

TOLECTIN -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

TOLECTIN 600 -- ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC


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