TENOXICAM
Tab Tobitil
Composition:
Each film coated tablet contains: Tenoxicam -20
mg.
Pharmacology: Tobitil (Tenoxicam) is
non-steroidal anti-inflammatory drug which has
potent anti-inflammatory and analgesic activity
and some antipyretic activity. The mechanism of
action of tenoxicam which is a non-steroidal
anti-inflammatory drug is probably multifactorial,
Tenoxicam is a potent inhibitor of prostaglandin
biosynthesis by inhibiting the enzyme
cyclo-oxygenase. Studies have provided evidence of
additional mechanisms of action such as scavenging
or inhibition of free oxygen radicals at the
inflammatory site, and by inhibiting neutrophil
chemotaxis and both neutrophil and monocyte
phagocytosis. Tenoxicam showed more potent
inhibitory activity than piroxicam on these
phenomena.
Indications: Tobitil is indicated for the
symptomatic management of pain and inflammation in
rheumatic disorders such as: Rheumatoid arthritis,
Osteoarthrosis, Ankylosing spondylitis, Gout and
Non articular rheumatic conditions such as
tendinitis, bursitis, sciatica and back pain.
Dosage and administration:
Adults: A single daily dose of 20 mg Tobitil
should be taken orally at the same time each day
with water or other liquids. Higher doses should
be avoided as they do not usually achieve
significantly greater therapeutic effect but may
be associated with a higher risk of adverse
events. For acute gouty arthritis the recommended
dosage is 40 mg (2 tablets) once daily for 2 days
followed by one tablet 20 mg once daily for a
further 5 days. Use in Elderly: As with other
non-steroidal anti-inflammatory drugs. Tobitil
should be used with special caution in elderly
patients since they may be less able to tolerate
side effects than younger patients. The dose of
Tobitil is however similar to that in adults.
Children: There is insufficient data to make a
recommendation for administration of Tobitil in
children.
Contraindications:
Active peptic ulceration and a past history of
peptic ulceration, gastrointestinal bleeding of
severe gastritis. Hypersensitivity to tenoxicam.
Tenoxicam should also be avoided in cases where
the patient has suffered a hypersensitivity
reaction (symptoms of asthma, rhinitis, angioedema
or urticaria) to other non-steroidal
anti-inflammatory agents including aspirin. Use in
pregnancy: The safety of tenoxicam during
pregnancy and lactation has not been established
and the drug should therefore not be given in
these conditions. No information is available on
penetration of tenoxicam into milk in humans.
Precautions :
Any patient being treated with tenoxicam who
presents with symptoms of gastro intestinal
disease should be closely monitored. It peptic
ulceration or gastro-intestinal bleeding occurs,
tenoxicam should be withdrawn immediately. In rare
cases, non-steroidal anti-inflammatory drugs may
cause interstitial nephritis, glomerulonephritis,
papillary necrosis and the nephritic syndrome.
Patients at greatest risk of such a reaction are
those with pre-existing renal disease, congestive
cardiac failure and those patients receiving
concomitant therapy with diuretics of potentially
nephrotoxic drugs. Such patients should have their
renal, hepatic and cardiac functions carefully
monitored. Occasional elevations of serum
transaminases or other indications of liver
function have been reported. If the abnormality is
significant of persistent, tenoxicam should be
stopped and follow-up tests carried out,
particular care is required in patients with
preexisting hepatic disease. Tenoxicam reduces
platelet aggregation and may prolong bleeding
time. This should be borne in mind for patients
who undergo major surgery and when bleeding time
needs to be determined. Particular care should be
taken to regularly monitor elderly patients to
detect possible interactions with concomitant
therapy and to review renal, hepatic and
cardiovascular function which may be potentially
influenced by non-steroidal anti-inflammatory
drugs. Adverse eye findings have been reported
with non-steroidal anti-inflammatory drugs,
therefore it is recommended that patients who
develop visual disturbance during treatment with
tenoxicam have ophthalmic evaluation.
Drug Interactions:
Antacids may reduce the rate, but not the extent
of absorption of tenoxicam. Tenoxicam is highly
bound to serum albumin. Although potentiation of
warfarin or sulphonyl urea compounds such as
glibenclamide has not been observed; close
monitoring of the effects of anticoagulants or
oral hypoglycemic agents is advised, especially
during the initial stages of treatment with
tenoxicam. Salicylates can displace tenoxicam from
protein binding sites and so increase the
clearance and the volume of distribution of
tenoxicam. Concurrent treatment with salicylates
or other non-steroidal anti-inflammatory drugs
should therefore be avoided because of the
increased risk of adverse reactions (particularly
gastrointestinal). Non- steroidal
anti-inflammatory drugs have been reported to
produce lithium retention. Non-reported to produce
lithium retention. Non-steroidal anti-inflammatory
drugs may also cause sodium, potassium and fluid
retention and may interfere with the natriuretic
action of diuretic agents. These properties should
be kept in mind when treating patients with
compromised cardiac function or hypertension.
Side effects :
For most patients side-effects are transient and
resolve without discontinuation of treatment.
Overall pooled data has shown that the incidence
of side effects with tenoxicam is 10.6%, about one
half of that with piroxicam (20.9%) given in
similar doses. The most common side effects are
related to the gastrointestinal tract (8%). They
include dyspepsia. nausea, abdominal pain and
discomfort, constipation, diarrhoea, flatulence,
indigestion, epigastric distress, stomatitis and
anorexia. As with other non-steroidal
anti-inflammatory drugs there is a risk of peptic
ulceration and gastrointestinal bleeding, both of
which have been reported with tenoxicam. Should
this occur, tenoxicam is to be discontinued
immediately and appropriate treatment instituted.
As with other non-steroidal anti-inflammatory
drugs, peripheral oedema of mild or moderate
degree and without clinical sequelae can occur in
small proportion of patients. Central nervous
system reactions of headache and dizziness have
been reported in a small number of patients.
Somnolence, insomnia, depression, nervousness have
been reported rarely. Skin reactions of rash,
urticaria and pruritus have been reported. As with
most other non-steroidal anti-inflammatory drugs,
change in various liver function parameters have
been observed. Some patients may develop raised
serum transaminase levels during treatment.
Although such reactions are rare, if abnormal
liver disease develop or if systemic
manifestations occur tenoxicam should be
discontinued. Swollen eyes, blurred vision and eye
irritation have been reported very rarely.
Ophthalmoscopy and slit-lamp examination have
revealed no evidence or ocular changes. Treatment
of overdosage: There is no reported experience of
serious overdosage. No specific measures are
available, administration of H2 antagonist drugs
may be of benefit. Gastric lavage should be
carried out as soon as possible after drug
ingestion and the patient should be closely
observed and general supportive measures taken as
necessary.