Avegesic Tablet 7.5mg: Meloxicam 7.5 mg/tablet
Avegesic Tablet 15mg: Meloxicam 15 mg/tablet
Avegesic Tablet 7.5mg: Light yellow, round, flat tablet, 8mm diameter,
cross-scored on one side.
Avegesic Tablet 15mg: Light yellow, round, concave tablet, 10mm diameter,
scored on one side.
Non-steroidal anti-inflammatory agent (M; locomotor system).
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam
family, with anti-inflammatory, analgesic and antipyretic properties.
The anti-inflammatory activity of meloxicam has been proven in classical
models of inflammation. As with other NSAIDs, its precise mechanism of
action remains unknown. However there is at least one common mode of action
shared by all NSAIDs (including meloxicam): inhibition of the biosynthesis
of prostaglandins, known inflammation mediators.
The bioavailability of meloxicam following oral administration is on the
With the doses of 7.5 and 15 mg, plasma concentrations are proportional
to dose: 0.4 to 1.0 mg/lt for 7.5 mg and 0.8 to 2.0 mg/It for 15 mg, on
average (Cmin and Cmax at steady state).
Meloxicam is very strongly bound to plasma proteins, essentially albumin
Meloxicam is extensively metabolized, chiefly by oxidation of the methyl
radical attached to the thiazolyl ring. Elimination is unchanged form
accounts for 3% of the dose. Half of the substance is eliminated in urine
and the other half in faeces.
The mean elimination half-life of the order of 20 hours.
Steady state is reached in 5 days.
In terminal renal failure, the volume of distribution is increased and a
daily dose of 7.5 mg must not be exceeded.
Plasma clearance is on average 8 ml/min. Clearance is decreased in the
elderly. Volume of distribution is low, on average 11 litres. Inter
individual variation is the order of 30 - 40%.
- symptomatic treatment of painful osteoarthritis (- arthrosis, degenerative
- symptomatic treatment of rheumatoid arthritis.
- symptomatic treatment of ankylosing spondylitis
Meloxicam may be taken without regard to timing of meals.
Osteoarthritis: 7.5mg per day. If necessary, the dose may be
increased to 15 mg/day.
Rheumatoid arthritis: 15 mg/day. According to therapeutic
response, the dose may be reduced to 7.5 mg/day
Ankylosing spondylitis: 15 mg/day.
In patients with increased risks of adverse reactions: Start
treatment at the dose of 7.5 mg/day.
In dialysis patients with severe renal failure: The dose should
not exceed 7.5 mg/day.
The total daily dosage of meloxicam should not exceed 15mg. As a dosage
for used in children has yet to established, usage should be restricted to
adults. Tablets should be swallowed with water or other fluid in conjunction
Elderly: In elderly patients being treated for rheumatoid
arthritis the recommended dose for long term treatment is 7.5 mg a day.
Children (Under 15 years of age): Not recommended After assessing
the risk/benefit ratio in each individual patient, the lowest effective dose
for the shortest possible duration should be used.
Mode of administration
Hypersensitivity to meloxicam or to one of the excipients. The possibility
exists of crossover sensitivity with aspirin and other non-steroidal
anti-inflammatory drugs (NSAIDs).
Meloxicam should not be given to patients who have developed signs of
asthma, nasal polyps, angioneurotic oedema or urticaria following the
administration of aspirin or NSAIDs
- Severe hepatic failure.
- Severe heart failure.
- Non-dialyzed severe renal failure.
- Children aged under 15.
- Pregnancy (see Pregnancy and lactation).
- Active, or history of recurrent peptic ulcer/haemorrhage (two or more
distinct episodes of proven ulceration or bleeding).
- History of gastrointestinal bleeding or perforation, related to previous
- Gastrointestinal bleeding, cerebrovascular bleeding or other bleeding
Warning and Precaution
RISK OF GI ULCERATION, BLEEDING AND
PERFORATION WITH NSAID
Serious GI toxicity such as bleeding, ulceration and perforation can occur
at any time, with or without warning symptoms, in patients treated
with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are
common, usually developing early in therapy, prescribers should remain alert
for ulceration and bleeding in patients treated with NSAIDs even in the
absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk of
developing peptic ulceration and bleeding. Patients with prior history of
serious GI events and other risk factors associated with peptic ulcer
disease (e.g. alcoholism, smoking, and corticosteroid therapy) are at
increased risk. Elderly or debilitated patients seem to tolerate ulceration
or bleeding less than other individuals and account for most spontaneous
reports for fatal GI events.
Under the Precautions Section:
Cardiovascular Thrombotic Events Observational studies have indicated
that non-selective NSAIDs may be associated with an increased risk of
serious cardiovascular events, principally myocardial infarction, which may
increase with dose or duration of use. Patients with cardiovascular disease
or cardiovascular risk of an adverse cardiovascular event in patient taking
NSAID, especially in those with cardiovascular risk factors, the lowest
effective dose should be used for the shortest possible duration. There is
no consistent evidence that the concurrent use of aspirin mitigates the
possible increased risk of serious cardiovascular thrombotic events
associated with NSAID use.
Hypertension NSAIDs may lead to the onset of new hypertension or
worsening the pre-existing hypertension and patients taking antihypertensive
with NSAIDs may have an impaired anti-hypertensive response. Caution is
advised when prescribing NSAIDs to patients with hypertension. Blood
pressure should be monitored closely during initiation of NSAID treatment
and at regular intervals thereafter.
Heart Failure Fluid retention and oedema have been observed in
some patients taking NSAIDs, there caution is advised in patients with fluid
retention or heart failure.
Gastrointestinal Events All NSAIDs can cause gastrointestinal
discomfort and rarely serious, potentially fatal gastrointestinal effects
such as ulcers, bleeding and perforation which may increase with dose or
duration of use, but can occur at any time without warning. Caution is
advised in patients with risk factors for gastrointestinal events e.g. the
elderly, those with a history of serious gastrointestinal events, smoking
and alcoholism. When gastrointestinal bleeding or ulcerations occur in
patients receiving NSAIDs, the drug should be withdrawn immediately. Doctors
should warn patient about signs and symptoms of serious gastrointestinal
toxicity. The concurrent use of aspirin and NSAIDs also increases the risk
of serious gastrointestinal adverse events.
Severe Skin Reactions NSAIDs may very rarely cause serious
cutaneous adverse events such as exfoliative dermatitis, toxic epidermal
necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), which can be fatal and
occur without warning. These serious adverse events are idiosyncratic and
are independent of dose or duration of use. Patients should be advised of
the signs and symptoms of serious skin reactions and to consult their doctor
at the first appearance of a skin rash or any other sign of