Composition

Tenoxicam

1 Tablet 20 mg

1 Suppository 20 mg

1 Lyophilized Vial 20 mg

Properties and Mode of Action
EPICOTIL, tenoxicam has anti-inflammatory, analgesic and antipyretic properties. It also inhibits platelet aggregation and is a potent inhibitor of prostaglandin biosynthesis. In vitro tests of leukocyte peroxidase suggest that tenoxicam may act as a scavenger for active oxygen at the site of inflammation. These pharmacological effects explain, at least in part, the successful use of EPICOTIL in the treatment of painful inflammatory and degenerative disorders of the musculoskeletal system.

Indications
Symptomatic treatment of the following painful inflammatory and degenerative disorders of the musculosketetal system: Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Extra-articular disorders: tendinitis, bursitis, periarthritis of shoulders or hips, strains and sprains. Back pain. Post - traumatic pain. Post - operative pain . Painful inflammatory conditions in gynaecology and obstetrics e.g. primary dysmenorrhea and postpartum conditions. Acute gout.

Dosage and Administration
20 mg once daily at the same time each day. For acute conditions start with 40 mg once daily for two days followed by 20 mg once daily. In principle, the above dosage recommendations also apply to elderly patients suffering from kidney or liver disease.

Precautions
As with other NSAIDs, simultaneous treatment with anticoagulants and/or antidiabetics should be avoided unless the patient can be closely monitored.
Pregnancy and Lactation:
EPICOTIL could be used during pregnancy if the benefits to the mother justify the potential risk to the fetus. Use of EPICOTIL during late pregnancy should be avoided.
EPICOTIL passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.

Drug Interactions
No interaction has been found with concomitantly-administered antacids, probenecid , cimetidine, glibornuride , tolbutamide, warfarin and phenprocoumon at the recommended dosages. Like other NSAIDs, salicylate increases clearance and volume of distribution of tenoxicam. No clinically relevant interaction was found in the small number of patients receiving concomitant treatment with gold or penicillamine. No changes in blood pressure or heart rate were observed in patients being treated concomitantly with various antihypertensives. During clinical trials no interaction was reported for patients treated concomitantly with digitalis products. As with other NSAIDs, EPICOTIL should not be administered concurrently with potassium-sparing diuretics.

Contra_indications
Known hypersensitivity to the drug. Patients in whom salicylates or other nonsteroidal anti-inflammatory drugs induce symptoms of asthma, rhinitis or urticaria. Patients who are suffering from severe diseases of the upper gastrointestinal tract, including gastritis, gastric and duodenal ulcers. Concurrent treatment with salicylate or other NSAIDs.

Side effects
EPICOTIL proved to be generally well-tolerated in the recommended daily dose of 20 mg. Gastrointestinal and central nervous system side effects are rare including gastralgia, heartburn, nausea,dizziness or headache. Long-term studies (12 - 48 months) have not revealed any increase in the frequency of side effects.

Presentation
EPICOTIL Tablets : Box of 1 blister of 10 scored tablets.
EPICOTIL Suppositories : Box of 1 strip of 5 suppositories.
EPICOTIL Vials : Box of 3 lyophilized vials + 3 (2ml) ampoules solvent.