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Tenoject-L

Tyonex Nigeria Ltd
251, Idimu-Ikotun Road, Idimu, Lagos
Email: info@tyonex.com
Tel: 234-1-812-9299, 43544857; 0802-300-2632
Fax: 234-1-269-4642

Brand Name

Tenoject-L

Manufacturer

Mustafa Nevzat Ilac Sanayi A.S., Turkey.

Therapeutic Class

Non-steroidal anti-inflammatory drugs (NSAIDs), Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Injection (NRN: ): Each vial contains 20 mg Tenoxicam as active ingredient and also manitol 57.33 mg sodium hydroxide 3.28 mg, trometamol 3 mg sodium metabisulfite 2 mg and sodium E.DT.A. 0.2 mg. Each diluent ampoule contains 2 mL water for injection.

 

Pack size: Tenoject-L injection 20 mg 1 vial + diluent ampoule (sterile water).

Pharmacology

Tenoxicam, a thienothiazine derivative of the oxicam class is a non-steroidal anti-inflamatory agent. It has anti-inflammatory, analgesic and antipyretic activities and it also prevents platelet aggregation.

Tenoxicam exerts its anti-inflammatory effects by inhibiting preferentially, cyclooxygenase enzyme and subsequent proftaglandin production in arachidonic acid metabolism, it has no therapeutic effect on lipooxygenase enzyme. Its ability to inhibit leucocyte functions including phagocytosis and histamine release and to eliminate active oxygen radicals in the inflammation site, contributes to its anti-inflammatory activity.

The pharmacokinetic profile of Tenoxicam after parenteral administration is similar to that observed following oral administration, however, higher plasma concentration were achieved within the first two (2) hours after parental administration.

Complete absorption, 100% bioavailability, high protein rate (99%) efficient penetration into synovial fluid, low systemic clearance and long elimination half life (70 hours) allows once daily dosing of Tenoxicam. About ²⁄³ of an administered doses excreted in urine and ¹⁄³ in faeces.

Indications

Tenoject-L injection is indicated in acute exacerbation of painful, inflammatory and degenerative disease of the muscokeletal system such as: Epiconilitis, Sciatica, Lumbago, Gout, Traumatic episodes.

In extra particular disease such as: Tendonitis, Bursitis, Shoulder arthritis (shoulder-hand syndrome), Pelvic periathristis, Sprains and in rheumatoid arthritis, osteoarthrosis, ankylosing spondilitis.

In surgery (Anesthesia), Obstetric and Gynecology: Reduces the intensity of uterine cramps in patient undergoing caesarian delivery; Improve post operation analgesia as an adjunct in intravenous regional anesthesia (VRA) for surgical procedures; Reduction of incidence of low back pain after lumbar epidural anesthesia with local addition of Tenoksan.

Also in: Dental and Ophthalmology post operation pain.

Contra-indications

Tenoject-L injection should not be used in patients hypersensitive to Tenoxicam and in patients with history of gastric duodenal ulcers, gastrointestinal hemorrhage and chronic gastritis.

Tenoject film coated tablets should not be used in patients with several renal or hepatic failure.

Precautions/Warnings

Warning and precautions required for all other non-steroidal anti-inflammatory drugs are valid for Tenoject-L injectable, Tenoject-L injectable should not be used in patients with known aspirin and other non-steroidal drugs induced asthma, rhinitis, urticaria and angioedeme.

Patients receiving anti-coagulants or anti-diabetic drugs should be closely monitored and if they cannot be monitored Tenoxicam should not be administered concomitantly.

In patients with conditions that might increase the risk of renal failure such as pre-existing renal disease, diabetic nephropathy, severe liver failure, congestive heart failure, volume depletion, concomitant diuretic and nephrotoxic drug treatment and in elderly BUN serum creatinine, weight gain and development or peripheric edema should be closely monitored.

Safety of Tenoxicam administration in patients younger than 18 years of age and in pregnant or nursing women has not been established.

Interactions

The recommended doses there is no pharmacokinetic interaction between Tenoxicam and anti acids, cimetine, oral anti coagulants and oral anti diabetic drug, however, it can increase the effect of anticoagulants such as coumarin, probenecid increases the elimination rate of Tenoxicam.

Although, there is no interaction with cardiotonic and anti hypertensive drugs, Tenoxicam should not be used concomitantly with potassium sparing diuretics.

Adverse Effects

In long-term clinical studies (one year), the drug was well tolerated by patients receiving the recommended daily doses.

Side effect that can be seen during Tenoxicam treatment are summarized below:

Gastrointestinal System (11.4%): Heartburn, epigastria pain, nausea, diarrhea and constipation.

Central nervous system (2.6%): Headache, dizziness.

Skin and Soft tissue (2.5%): Rash, itching, erythema and urthicaria, skin lesion such as photodematosis, Stevens-Johnson syndrome and Lyell syndrome are very rarely seen.

Urinary System (1-2%): Increase BUN and serum Creatinine levels.

Liver and Biliary Tract (1-2%): Increase SGOT, SGPT, Gramma GT and bilirubin levels.

Hematopoetic system side effects include decreased hemoglobin levels and granulocytopenia, which are seen very rarely psychiatric (1.7%) and metabolic (1%) side effects can be observed during the treatment period.

Dosage & Administration

The recommended daily dosage of Tenoject-L injectable is 20 mg administered once a day.

In long-term treatment, 10 mg daily can be given as maintenance therapy.

In acute attacks of gouty arthritis, 40 mg daily for the first two (2) days followed by 20 mg daily for five (5) days is the recommended regime.

Overdosage

In case of over dosage of Tenoxicam, supportive symptomatic therapy should employed.

Storage/Handling Recommendations

Keep it out of the reach of children in a cool, dry place in its package

Review Date

2017-05-18 03:18:45