Tenoxicam

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Toxicological Effects
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Substrate of
  • Inhibits
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Belgium: Tilcotil; Bulgaria: Tilcotil; Denmark: Tilcotil; France: Tilcotil; Greece: Admiral, Algin-Vek, Amcinafal, Artroxicam-Medichrom, Aspagin, Hobaticam, Indo-Bros, Istotosal, Neo-Antiperstam, Neo-Endusix, Octiveran, Oxytel, Palitenox, Ponsolit, Portonal, Soral, Tecam, Tilcitin, Toscacalm, Voir; Hungary: Tilcotil; Italy: Bart, Dolmen, Tilcotil; Luxembourg: Tilcotil; Portugal: Doxican, Tenalgin, Tenoxicam, Tilcotil; Romania: Neo-Endusix, Tenoxicam, Tilcotil; Spain: Reutenox; Sweden: Alganex; UK: Mobiflex, Tenoxicam.

North America

Canada: Tenoxicam.

Latin America

Brazil: Inflagel, Prodoxican, Teflan, Tenotec, Tenoxicam, Tenoxil, Tilatil, Tilonax, Titenil.

Asia

Japan: Gescolilu, Rucornart, Tilcotil, Tiltria.

Drug combinations

Chemistry

Tenoxicam: C~13~H~11~N~3~O~4~S~2~. Mw: 337.37. (1) 2H-Thieno[2,3-e]-1,2-thiazine-3-carboxamide, 4-hydroxy-2-methyl-N-2-pyridinyl-,1,1-dioxide; (2) 4-Hydroxy-2-methyl-N-2-pyridyl-2H-thieno[2,3-e]-1,2-thiazine-3-carboxamine 1,1-dioxide. CAS-59804-37-4 (1987).

Pharmacologic Category

Analgesics and Antipyretics; Nonsteroidal Anti-inflammatory Agents; Cyclooxygenase-2 (COX-2) Inhibitors. Disease-modifying Antirheumatic Drugs. (ATC-Code: M01AC02).

Mechanism of action

A non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, antipyretic properties; also inhibits platelet aggregation. Inhibits prostaglandin biosynthesis, both in vitro (sheep seminal vesicles) and in vivo (protection of arachidonic acid-induced toxicity in mice). Tenoxicam inhibits COX-1/PTGS1 and COX-2/PTGS2 isoenzymes approximately to the same extent. May act as a scavenger for active oxygen at site of inflammation. A potent in vitro inhibitor of human metalloproteinases (stromelysin and collagenase) which induce cartilage breakdown. These pharmacological effects explain the therapeutic benefit of tenoxicam in treatment of painful inflammatory and degenerative disorders of musculoskeletal system.

Therapeutic use

Rheumatoid arthritis. Osteoarthritis. Arthrosis. Ankylosing spondylitis. Extra-articular disorders such as tendinitis, bursitis, periarthritis of shoulders (shoulder-hand syndrome) or hips, strains and sprains. Post-operative pain. Acute gout. Primary dysmenorrhea.

Pregnancy and lactiation implications

No adequate studies exist in pregnant women. NSAIDs have an inhibitory effect on prostaglandin synthesis and when given during late pregnancy may cause closure of fetal ductus arteriosus, prolong labor and delay parturition. Treatment during 3^rd^ trimester of pregnancy should be avoided. Very small amount (less than 0.3% of dose) of tenoxicam passes into breast milk. Despite lack of evidence of adverse reactions in breast-fed infants of mothers taking tenoxicam, infants should be weaned or medicine discontinued.

Unlabeled use

Contraindications

Known hypersensitivity to tenoxicam, to any component of the product or to other NSAIDs. Asthma, or cases where salicylates or other NSAIDs induce symptoms of asthma, rhinitis or urticaria. Active or past GI bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding). Hemorrhagic diathesis, as with other NSAIDs. Severe heart failure, as with other NSAIDs.

Warnings and precautions

Relatively contraindicated in liver dysfunction. Use of tenoxicam with concomitant NSAIDs, including COX-2 selective inhibitors, should be avoided. Non-selective NSAIDs may be associated with increased risk of serious cardiovascular events, including MI and stroke, which may increase with dose or duration of use. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with tenoxicam after careful consideration. NSAIDs may lead to onset of new hypertension or worsening of pre-existing hypertension, and patients taking anti-hypertensives with NSAIDs may have impaired anti-hypertensive response. Fluid retention and edema observed in some patients taking NSAIDs. All NSAIDs can cause GI discomfort and rarely serious, potentially fatal GI effects such as ulcers, bleeding and perforation which may increase with dose or duration of use, but can occur at any time without warning. The elderly have increased frequency of adverse reactions to NSAIDs, especially GI bleeding and perforation which may be fatal. Debilitated patients do not seem to tolerate ulceration or bleeding as well as others. Combination therapy with protective agents should be considered for these patients, also for patients requiring concomitant low dose aspirin or other drugs likely to increase GI toxicity. NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, toxic epidermal necrolysis and Stevens-Johnson syndrome, which can be fatal and occur without warning. These serious adverse effects are idiosyncratic and independent of dose or duration of use, the onset of the reaction occurring in the majority of cases within 1^st^ month of treatment. If severe skin reactions occur, tenoxicam should be discontinued immediately. Tenoxicam inhibits platelet aggregation and may affect hemostasis. Adverse eye findings reported with NSAIDs including tenoxicam (ophthalmic evaluation recommended for patients who develop visual disturbances). As known for other anti-inflammatory medicines, tenoxicam may mask usual signs of infection. Use of tenoxicam, as with any agent known to inhibit COX/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Due to the high plasma protein binding of tenoxicam, caution is required when plasma albumin levels are markedly reduced.

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