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Product Catalogue
ROCHE
TILCOTIL
Scientific Name:
Tenoxicam
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Antirheumatic and anti-inflammatory agent
Composition
Tenoxicam is a thienothiazine derivative belonging to the chemical class of oxicams.
Tablets 20mg
Properties / Effects
Tenoxicam has anti-inflammatory, analgesic, antipyretic properties and also inhibits platelet aggregation. Tenoxicam is a potent inhibitor of prostaglandin biosynthesis, both in vitro and in vivo.
Pharmacokinetics
On extravascular administration tenoxicam is absorbed in unchanged form: On oral administration it is absorbed completely, whereas absorption after rectal administration is approximately 80%. Peak plasma concentrations following oral or rectal administration are reached within two hours in fasting subjects. If tenoxicam is taken orally with a meal, it is absorbed to the same extent but at a somewhat slower rate. In the blood over 99% of the drug is bound to albumin. Tenoxicam is eliminated with an average half-life of 72 hours (range: 42-98 hours). Up to two third of an oral dose is excreted in the urine (mainly as the inactive metabolite 5-hydroxy-pyridyl) and the rest via the bile (as significant portion in the form of glucuronidated compounds). Studies in the elderly and in patients with renal insufficiency or liver cirrhosis suggest that no dose adjustment is necessary to achieve plasma concentrations similar to those in healthy subjects. Because of the high plasma protein binding of tenoxicam, caution is required when plasma albumin levels are markedly reduced (e.g. in nephrotic syndrome).
Indications
TILCOTIL is indicated for the symptomatic treatment of the following painful inflammatory and degenerative disorders of the musculoskeletal system:
- Rheumatoid arthritis.
- Osteoarthritis, arthrosis.
- Ankylosing spondylitis.
- Extraarticular disorders,e.g. tendinitis, bursitis periarthritis of shoulders (shoulder-hand syndrome) or hips, strains and sprains.
- Acute gout.
Standard dosage
For all indications with the exception of gouty arthritis, 20 mg (1 tablet) should be taken once daily at the same time each day. The tablets should be taken with a glass of water. Daily doses higher than 20 should be avoided, since this would increase the frequency and intensity of adverse reactions without significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily dose of 10 mg (1/2 tablet) may be tried for maintenance. For acute attacks of gouty arthritis, the recommended dose is 40 mg (2 tabs) once daily for two days followed by 20 mg (1 tablet) once daily for a further five days.
Special Dosage Instructions
In principle, the above dosage recommendations also apply to elderly patients and to patients suffering from kidney or liver disease. Because of lack of clinical experience, no dosage recommendations have so far been established for patients under 18 years of age.
Precautions and Contraindications
TILCOTIL should not be administered to patients known to be hypersensitive to the drug. Patients in whom salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDs) induce symptoms of asthma, rhinitis or urticaria should also be excluded. This also applies to patients who are suffering or have suffered from severe diseases of the upper gastrointestinal tract, including gastritis, gastric and duodenal ulcer. Before anesthesia or surgery, TILCOTIL, like other NSAIDs, should not be given to elderly patients, to patients at risk of kidney failure, or to patients with increased risk of bleeding, because of an increased risk of acute renal failure and possibly of impaired hemostasis. Prostaglandin synthesis inhibition may have an adverse effect on renal function. As with other NSAIDs, therefore with TILCOTIL it is necessary to adequately monitor renal function (BUN, creatinine, development of edema, weight gain, etc.) when giving a NSAID to the elderly or to patients with conditions that could increase their risk of developing renal failure such as:
- Preexisting renal disease.
- Impaired renal function in diabetics.
- Hepatic cirrhosis.
- Congestive heart failure.
- Volume depletion.
- Concomitant treatment with diuretics.
- Concomitant treatment with drugs of known nephrotoxic potential.
Use in pregnancy:
no teratogenic effects were seen in animal studies in humans; however, the safety of TILCOTIL during pregnancy or lactation has not yet been established.
Undersirable effects
In treatment lasting several weeks to three months the following undesirable effects may be observed:
- gastrointestinal tract (gastralgia, heartburn, nausea, diarrhea, constipation, etc…)
- central nervous system (dizziness and headache).
- Skin (itching – also in the renal region after rectal administration – rash, erythema, urticaria).
- As with other NSAIDs, in rare instances severe skin reactions such as Stevens – Johnson syndrome and Lyeil syndrome may occur.
- urinary tract and kidneys (increase in BUN or creatinine).
- liver and biliary tract (increase in SGOT, SGPT,Y – GT, Bilirubin).
Rare miscellaneous effects include decreased hemoglobin, granulocytopenia, slight edema and photodermatosis.
Long-term studies (12 – 48 months) have not revealed any increase in the frequency of side effects.
Interactions
Concurrent treatment with salicylates or other NSAID should be avoided because of the increased risk of gastrointestinal adverse reactions. As with other NSAID simultaneous treatment with anticoagulants and/or oral antidiabetics should be avoided unless the patient can be closely monitored. As in the case of other NSAIDs, salicylate displaces tenoxicam from protein binding sites and thus increases clearance and volume of distribution of tenoxicam. As with NSAIDs in general, TILCOTIL should not be administered concurrently with potassium sparing dehydrating drugs (diuretics). Until further data are available, the possibility that the diuretic effect of other dehydrating drugs is reduced by TILCOTIL cannot be ruled out.
Overdosage
In case of real or suspected overdosage the drug should be discontinued. No specific antidote is known at present. Overdosage should be countered by measures to reduce absorption and speed up elimination. Gastrointestinal disorders may be treated with antacids and H2-receptor-blocking drugs. If necessary the elimination of tenoxicam can be accelerated significantly by the administration of three time 4g doses of cholestyramine.
Stability
This medicine should be used before the date shown after EXP on the pack.
Packs
Pack of 10 tablets tenoxicam 20 mg.
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