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Each ( film coated ) caplet contains Tenoxicam 20 mg.
Anti-inflammatory , analgesic, antipyretic and also an inhibitor of platelet aggregation.
Tenoxicam is a potent inhibitor of prostagladin biosynthesis, both in vitro ( sheep seminal vesicles ) and in vivo, ( protection of
arachidonic acid – induced toxicity in mice ). 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 succeseful
use of Xotilon in the treatment of painful inflammatory and degenaritive disorders of the musculoskeletal system.
Tenoxicam showed no mutagenic, carcinogenic or teratogenic effects in animals.
As with other prostaglandin inhibitor, renal and gastrointestinal effects, increased incidence of dystocia and parturition were
observed in animal safety studies.
On extravascular administration tenoxicam is absorbed in unchanged form. Peak plasma concentrations following oral
administration are reached within 2 hrs in fasting subjects. If tenoxicam is taken 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 penetrates well into the synovial fluid, but peak
concentrations are reached later than in plasma. With the recommended dosage regimen of 20 mg once daily, steady-state
conditions are reached within 10-15 days without unexpected accumulation. Maximum steady-state concentrations in the
plasma amount to 10 – 15 mcg/mL (29.7-44.5 umol/L) and did not change even treatment for up to 2 years.
Before leaving the body, tenoxicam undergoes virtually complete biodegradation. Tenoxicam is eliminated with an average
half-life of 72 hrs ( range : 42-98 hrs ). Up to 2/3 of an oral dose is excreted in the urine ( mainly as the inactive 5
hydroxy-pyridil metabolite ) and the rest via the bile ( a 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 ( eg, in nephrotic syndrome )
Symptomatic treatment of painful inflammatory and degenerative disorders of the musculoskeletal system : Rheumatoid
arthritis; osteorthritis arthrosis;ankylosing spondylitis;extra-articular disorders, eg tendinitis, periarthritis of shoulders
(shoulder-hand syndrome ) or hips, strains; and sprains; acute gout.
DOSAGE & ADMINISTRATION :
Standard Dosage : For all indications with the exception of gouty arthritis; 20 mg ( 1 tab ) should be taken once daily at the
same time each day, with a glass of water if administration is by the oral route. Although the therapeutic effect of Xotilon is
evident early in treatment, there is a progressive increase in response over the first 2 weeks until the steady – state plasma
level is reached.
Daily doses > 20 mg should be avoided, since this would increase the frequency and intensity of adverse reaction without
significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily dose of 10 mg ( ½ tab ) may
be used for maintenance.
For acute Attacks of Gouty Arthritis : Recommended Dose : 40 mg ( 2 tabs ) once daily for 2 days followed by 20 mg ( 1 tab )
once daily for a further 5 days.
Special Dosage Instructions : The previously-mentioned dosage recommendations also apply to elderly patients suffering from
kidney or liver disease ( see Precautions ). Because of lack of clinical experience, no dosage recommendations have so far
been established for patients under 18 years.
Although there is no experience of acute over-dosage with tenoxicam it may be expected that the signs and symptoms
mentioned under Adverse Reactions would be more pronounced.
In case of real or suspected over-dosage, the drug should be discontinued. No specific antidote is known at percent. Over
dosage should be counter measured to reduce absorption and speed up elimination. Gastrointestinal disorders may be treated
with antacids and H2 receptor-blocking drug. If necessary, the elimination of tenoxicam can be accelerated significantly by the
administration of three 4-g doses of cholestyramine .
Xotilon 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, eg
gastritis, gastric and duodenal ulcer. Before anesthesia or surgery, Xotilon like other NSAIDs, should not be given to elderly,
patients at risk of kidney failure or patients with increased risk of bleeding because of an increased risk of acute renal failure
and possibly of impaired hemostasis.
Concurrent treatment with salicylates or other NSAIDs should be avoided because of the increased of gastrointestinal adverse
reactions. At with other NSAIDs, simultaneous treatment with anticoagulants and or oral anti diabetics should be avoided unless
the patients can be closely monitored.
Prostaglandin synthesis inhibition may have an adverse effect on renal function. It is therefore necessary to adequately
monitor renal function ( BUN, creatinine, development of edema, weight gain etc ) when giving NSAID to the elderly or to
patients with conditions that could increase their risk of developing renal function in diabetics ; hepatic cirrhosis; congestive
heart failure ; volume depletion; concomitant treatment with drugs of known nephrotoxic potential.
Use in pregnancy & lactation :
No teratogenic effects were seen in animal studies. In humans, however, the safety of Xotilon during pregnancy or lactation
has not yet been established.
ADVERSE REACTIONS :
During clinical trials lasting from 2 weeks – 1 years, Xotilon proved to be generally well tolerated in the recommended daily
dose of 20 mg . The proportion of patients with undesirable clinical or laboratory effects was found to be around 12,5 %.
Usually, these effects were mild and transient and resolved even when treatment was continued. Only in about 1 % of all
patients did these effects necessitate interruption of treatment with Xotilon at a dosage of 20 mg daily.
Based on these trials, the following incidences of undesirable effects can be estimated : in treatment lasting several weeks to
3 months : 11 % gastrointestinal tract ( gastralgia, heartburn, nausea, diarrhea, constipation, etc ); 3 % central nervous
system ( dizziness and headache ); 1-2 % skin ( itching, rash, erythema, urticaria ).
As with other NSAIDs, in rare instances, severe skin reaction, eg Stevens-Johnson syndrome and Lyell syndrome may occur, 1-
2 urinary tract and kidney ( increase in BUN or creatinine ); 1-2% liver and biliary tract ( increase in SGOT, SGPT, -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.
No interaction has been found with concomitantly administered antacids, probenecid, cimetidine, tolbutamide, warfarin and
phenprocoumon at the recommended dosages. As in the case of other NSAIDs, salicylate displaces tenoxicam from protein
binding sites and thus increases clearance and volume of distribution of tenoxicam ( see Precautions ). 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 anti hypertensives.. During
clinical trials, no interaction was reported for patient treated concomitantly with digitalis products. Xotilon should not be
administered concurrently with potassium-sparing diuretics, dehydrating drugs ( diuretics ). Until further data are available , the
possibility that the diuretic effect of other dehydrating drugs is reduces by Xotilon cannot be ruled out.
Box of 5x6’s. Reg.No.DKL9421007904A1.
On medical prescription only.