Mustafa Nevzat Pharmaceuticals
Oksamen
Oksamen
  • Oksamen film-coated tablet 20 mg, 10 film-coated tablets
  • Oksamen – L freeze-dried for injection 20 mg, 1 vial + 1 diluent ampoule

Composition

Each film-coated tablet contains 20 mg tenoxicam.

Each freeze-dried injection contains 20 mg tenoxicam.

Features

  • A non-steroidal antiinflammatory drug.
  • Has antiinflammatory, analgesic, antipyretic and anti-rheumatic activity.
  • Once daily dosing.
  • Inhibits prostaglandin synthesis.
  • Inhibits leucocyte functions including phagocytosis and histamine release.
  • Eliminates active oxygen radicals at the inflammation site.
  • Is absorbed unchanged through the gastrointestinal tract following oral administration.
  • Exerts its effect rapidly.
  • Low gastric toxicity.
  • Presence of food or coadministration with antacids does not alter the rate of absorption.
  • Similar pharmacokinetics following parenteral and oral administration.
  • Its bioavailability is 100 % and protein binding is almost 99 %.
  • Has low systemic clearance and long elimination half-life (70 hours).
  • Does not accumulate in prolonged therapies.
  • Drug interaction is low.
  • No dosage adjustment is required in the elderly or in patients with renal or hepatic failure.

Indications

  • Rheumatoid arthritis
  • Osteoarthritis
  • Ankylosing spondylitis
  • Arthrosis
  • Non-articular conditions such as tendinitis, bursitis, periarthritis of the shoulder or hips, sprains and strains
  • Painful, inflammatory and degenerative diseases of the musculoskeletal system such as epicondylitis, sciatica, lumbago, acute gout and traumatic cases

Contraindications

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

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.

Adverse Reactions

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%).

Drug Interactions

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.

Dosage and Administration

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.

Overdosage

In case of tenoxicam overdosage, supportive symptomatic therapy should be administered.

Storage Conditions

Should be kept out of reach of children, at room temperature (< 25 ºC) and in its package.

Available Forms

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)

Name And Address Of The Authorisation Holder

Mustafa Nevzat Ilaç Sanayii A.Ş. Prof. Dr. Bülent Tarcan Sok., Pak Iş Merkezi No: 5/1 34349 Gayrettepe/Istanbul.

Name And Address Of The Manufacturing Company

Mustafa Nevzat Ilaç Sanayii A.Ş. ÇobançeşmeMah.Sanayi Cad. No:13 Yenibosna-Istanbul.

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