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Basic Drug Info
Drug Name:Arthrotec
Manufacturer:G.D. Searle, LLC
Other Info:Rx only LAB-0061-11.0September 2008



Clinical Trials:


Indications and Usage

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

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).ARTHROTEC is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.

See WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding and Perforation for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.
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.

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.

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.

Duodenal Ulcer -- A PEPTIC ULCER located in the DUODENUM.

Complication -- Any disease or disorder that occurs during the course of (or because of) another disease.

Complication Aspects -- Used with diseases to indicate conditions that co-exist or follow, i.e., co-existing diseases, complications, or sequelae.

Ulcer -- A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.

Contraindications

See boxed CONTRAINDICATIONS AND WARNINGS related to misoprostol.

ARTHROTEC should not be taken by pregnant women.ARTHROTEC is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins.

ARTHROTEC should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

Severe, rarely fatal, anaphylactic-like reactions to diclofenac sodium have been reported in such patients (see WARNINGS- Anaphylactoid Reactions, and PRECAUTIONS- Preexisting Asthma).ARTHROTEC is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see boxed CONTRAINDICATIONS AND 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
Regarding misoprostol:See boxed CONTRAINDICATIONS AND WARNINGS.Regarding diclofenac:See boxed CONTRAINDICATIONS AND WARNINGS.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.