Each film-coated tablet contains 20 mg tenoxicam.
Each freeze-dried injection contains 20 mg tenoxicam.
Is contraindicated in patients who are hypersensitive to tenoxicam and also in patients who have a history of gastric or duodenal ulcer, gastrointestinal bleeding and chronic gastritis. Should not be administered in patients with severe renal failure or hepatic insufficiency.
Warnings and precautions required for all non-steroidal antiinflammatory drugs are also valid for OKSAMEN tablet and OKSAMEN-L for injection. OKSAMEN tablet and OKSAMEN-L for injection should not be used in patients with aspirin and other NSAID-induced asthma, rhinitis, urticaria and angioedema. Patients on oral antidiabetic or anticoagulant therapy should be closely monitored; if monitoring is not possible, they should not be used concomitantly.BUN, serum creatinine, weight gain and development of peripheral edema should be closely monitored in patients with conditions that may increase the risk of renal failure such as the elderly, patients with diabetic nephropathy, severe hepatic failure, congestive heart failure, hypovolemia, patients with a history of renal disease and those receiving diuretics or nephrotic agents. Safety of administration of OKSAMEN-L for injection and OKSAMEN tablet in patients younger than 18 years and in pregnant and nursing women have not been determined.
In prolonged clinical trials with tenoxicam (1 year) the drug was well tolerated when given in the recommended dosage. Side effects that may be seen with OKSAMEN-L for injection and OKSAMEN tablet are listed below:
Gastrointestinal tract : Heart burn, gastric pain, nausea, diarrhea and constipation, etc. (11.4%).
Central nervous system : Headache, dizziness (2.6%).
Skin and soft tissue : Rash, itching, eryhtema, urticaria and rarely skin lesions such as Stevens-Johnson syndrome, Lyell syndrome and photodermatosis (2.5%).
Urinary tract : Increases in BUN and serum creatinine values (1-2%).
Liver and biliary tract : Increases in SGOT, SGPT, gamma GT and bilirubin. Hematopoietic side effects decreases in hemoglobin levels and granulocytopenia and are very rarely seen.Psychiatric (1.7%) and metabolic (1%) side effects can also occur during treatment (1-2%).
Tenoxicam, at therapeutic doses, has no pharmacokinetic interaction with antacids, cimetidine, oral antidiabetics and oral anticoagulant agents; however, it can increase the effects of anticoagulant agents such as coumarine. Probenecid increases the elimination rate of tenoxicam. Although no interaction is reported with cardiotonic and antihypertensive drugs, it should not be used concurrently with potassium-sparing diuretics.
The recommended dose for OKSAMEN tablet is 20 mg once daily. In prolonged therapies, maintenance dose is 10 mg daily. The recommended dose for OKSAMEN-L for injection is 20 mg once daily. In the treatment of acute gout arthritis, OKSAMEN-L for injection or OKSAMEN tablet is administered 40 mg daily for the first 2 days and 20 mg daily for the following 5 days.
In case of tenoxicam overdosage, supportive symptomatic therapy should be administered.
Should be kept out of reach of children, at room temperature (< 25 ºC) and in its package.
OKSAMEN tablet 20 mg, in 10-30-tablet blister packs
OKSAMEN-L freeze-dried for injection 20 mg, 1 vial + 1 diluent ampoule (2 mL)
Mustafa Nevzat Ilaç Sanayii A.Þ. Prof. Dr. Bülent Tarcan Sok., Pak Iþ Merkezi No: 5/1 34349 Gayrettepe/Istanbul.
Mustafa Nevzat Ilaç Sanayii A.Þ. ÇobançeþmeMah.Sanayi Cad. No:13 Yenibosna-Istanbul.