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Drug description :
Each film-coated tablet contains 20mg Tenoxicam
Presentation :
Film-coated tablet. Round, yellowish film-coated tablet.
Indications :
Tenoxicam tablets are for the treatment of pain and inflammation
in osteoarthritis and rheumatoid arthritis. It is also indicated
for short term treatment of acute musculoskeletal disorders
including strains, sprains and other soft-tissue injuries.
Adult Dosage :
The tablets are for oral use and should be taken with water or
other fluid, preferably with or after food.
Adults:
The recommended dosage is a single daily dose of 20mg taken at the
same time each day.
As there is no significantly greater therapeutic effect at higher
doses, and higher doses may result in an increase of adverse
events, oral doses greater than recommended should be avoided.
Tenoxicam 20 mg Tablets should only be used for up to a maximum of
2 weeks in cases of severe acute musculoskeletal disorders.
Usually treatment of up to 7 days is sufficient.
Use in renal and hepatic insufficiency:
In
renal impairment, the normal dosage with careful monitoring is
recommended for patients with a creatinine clearance of greater
than 25ml/min. There are insufficient data to make dosage
recommendations for patients with a creatinine clearance of less
than 25ml/min .
There are insufficient data to make dosage recommendations for
Tenoxicam in patients with pre-existing hepatic impairment.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control symptoms
Child Dosage :
Tenoxicam 20mg Tablets should not be used in children until
sufficient data become available.
Elderly Dosage :
The elderly are at increased risk of the serious consequences of
adverse reactions. If an NSAID is considered necessary, the lowest
dose should be used and the patient should be monitored for GI
bleeding for 4 weeks following initiation of therapy.
Contra Indications :
Tenoxicam 20 mg Tablets is contra-indicated in:-
• Severe heart failure
• Active peptic ulceration.
• A previous history of peptic ulceration, severe gastritis, or
gastrointestinal bleeding.
• Patients with a known hypersensitivity to ibuprofen, aspirin or
other non-steroidal anti-inflammatory drugs (symptoms of asthma,
rhinitis, angioedema or urticaria).
• Previous known hypersensitivity to tenoxicam or any of the
excipients contained in Tenoxicam 20 mg Tablets
Special Precautions :
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control symptoms.
NSAIDs should only be given with care to patients with a history
of gastrointestinal disease.
Patients showing signs of gastrointestinal disease during
treatment with Tenoxicam, should be carefully monitored and if
peptic ulceration or gastrointestinal bleeding occurs, the drug
should be withdrawn immediately.
Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a
history of hypertension and/or mild to moderate congestive heart
failure as fluid retention and oedema have been reported in
association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of some
NSAIDs (particularly at high doses and in long term treatment) may
be associated with a small increased risk of arterial thrombotic
events (for example myocardial infarction or stroke). There are
insufficient data to exclude such a risk for Tenoxicam.
Patients with uncontrolled hypertension, congestive heart failure,
established ischaemic heart disease, peripheral arterial disease,
and/or cerebrovascular disease should only be treated with
Tenoxicam after careful consideration. Similar consideration
should be made before initiating longer-term treatment of patients
with risk factors for cardiovascular disease (e.g. hypertension,
hyperlipidaemia, diabetes mellitus, smoking).
In rare cases, NSAIDs may cause interstitial nephritis,
glomerulonephritis, papillary necrosis and the nephrotic syndrome.
Such agents inhibit the synthesis of renal prostaglandin which
plays a supportive role in the maintenance of renal perfusion in
patients whose renal blood flow and blood volume are decreased.
Administration of a NSAID in these patients may precipitate overt
renal decompensation, which returns to the pre-treatment state
upon withdrawal of the drug.
Patients at greatest risk of such a reaction are those with
pre-existing renal disease (including diabetics with impaired
renal function), nephrotic syndrome, volume depletion, hepatic
disease, congestive cardiac failure and those patients receiving
concomitant therapy with diuretics or potentially nephrotoxic
drugs. Such patients should have their renal, hepatic and cardiac
functions carefully monitored, and the dose should be kept as low
as possible in patients with renal, hepatic or cardiac impairment.
NSAIDs should be given with care to patients with a history of
heart failure or hypertension since oedema has been reported in
association with NSAID administration.
Caution is required if administered to patients suffering from, or
with a previous history of, bronchial asthma since NSAIDs have
been reported to cause bronchospasm in such patients.
Occasional elevations of serum transaminases or other indicators
of liver function have been reported. The reports in most cases,
have been small and transient increases above the normal range. If
the abnormality is significant or persistent, Tenoxicam should be
stopped and follow-up tests carried out. Particular care is
required in patients with pre-existing hepatic disease.
Tenoxicam reduces platelet aggregation and may prolong bleeding
time. Care is therefore required in patients undergoing major
surgery and in patients whose bleeding time needs to be
determined.
The elderly are at increased risk of the serious consequences of
adverse reactions. Care should be taken to regularly monitor the
patients to detect possible interactions with concomitant therapy
and to review renal, hepatic and cardiovascular function which may
be potentially influenced by NSAIDs.
Minor and serious ocular effects have been reported rarely in
patients taking NSAIDs; ophthalmic evaluation is recommended for
patients who develop visual disturbances during treatment with
Tenoxicam.
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