Meloxi TM is a non-steroidal anti-inflammatory drug (NSAID) of the enolic acid class which has shown antiinflammatory
analgesic and antipyretic properties in animals. Meloxicam showed potent anti-inflammatory
activity in all standard models of inflammation. A common mechanism for the above effects may exist in the
ability of Meloxicam to inhibit the biosynthesis of prostaglandins, known mediators of inflammation.
Comparison of the ulcerogenic dose and the anti-inflammatory effective dose in the rat adjuvant arthritis
model confirmed a superior therapeutic margin in animals over standard NSAIDs. In vivo Meloxicam
inhibited prostaglandin biosynthesis more potently at the site of inflammation than in the gastric mucosa or
the kidney.
These differences are thought to be related to a selective inhibition of COX-2 relative to COX- 1 and it is
believed that COX-2 inhibition provides the therapeutic effects of NSAIDs whereas inhibition of constitutive
COX-1 may be responsible for gastric and renal side effects.
The COX-2 selectivity of Meloxicam has been confirmed both in vitro and ex vivo in a number of test
systems. In the human whole blood assay, Meloxicam has been shown in vitro to inhibit COX-2 selectively.
Meloxicam (7.5 and 15 mg) demonstrated a greater inhibition of COX-2 ex vivo, as demonstrated by a
greater inhibition of lipopoly-saccharide-stimulated PGE production (COX-2) as compared with thromboxane
production in clotting blood (COX-1) These effects were dose- dependent. Meloxicam has been
demonstrated to have no effect on either platelet aggregation or bleeding time at recommended doses ex
vivo, while indomethacin, diclofenac, ibuprofen and naproxen significantly inhibited platelet aggregation and
prolonged bleeding.
In clinical trials, gastro-intestinal adverse events overall were reported less frequently with Meloxicam 7.5mg
and 15mg than with the NSAIDs with which it has been compared, due predominantly to a lower reporting
incidence of events such as dyspepsia, vomiting, nausea and abdominal pain. The incidence of upper
gastro-intestinal perforation, ulcer and bleeds reported in association with Meloxicam is low and dose
dependent.

Known hypersensitivity to Meloxicam or any excipient of the product. There is a potential for cross sensitivity
to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs). Meloxi TM should not be
given to patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the
administration of acetylsalicylic acid or other NSAIDs.

Active peptic ulceration
- Severe hepatic insufficiency
Non-dialyzed sever renal insufficiency.
- Children and adolescents aged lees than 15 years
- Pregnancy or breastfeeding

- Other NSAIDs, including salicylates: Concomitant administration of more than one NSAID may increase the
risk of gastrointestinal ulceration and bleeding through synergistic action.
- Oral anticoagulants, ticlopidine, systematically administered heparin, thrombolytics; increased risk of
bleeding. If such co-prescribing cannot be avoided, close monitoring of the effects of anticoagulants is
required.
- Lithium: NSAIDs have been reported to increase lithium plasma levels. It is recommended that plasma
lithium levels be monitored when initiating, adjusting and discontinuing Meloxi TM.
- Methotrexate: As other NSAIDs, Meloxi TM may increase the haematologic toxicity of methotrexate. In this
situation, strict monitoring of blood cell count is recommended.
- Contraception: NSAIDs have been reported to decrease the efficacy of intrauterine devices.
- Diuretics: Treatment with NSAIDs is associated with the potential for acute renal insufficiency in patients
who are dehydrated. Patients receiving Meloxi TM and diuretics should be a hydrated and be monitored for
renal function prior to initiating treatment.
- Antihypertensives (e.g. beta-blockers, ACE inhibitors, vasodilators, diuretics): A reduced effect of the
antihypertensive drug by inhibition of vasodilating prostaglandins has been reported during
treatment with NSAIDs.
Cholestyramine binds Meloxicam in the gastro-intestinal tract leading to a faster elimination of Meloxicam.
- Nephrotoxicity of cyclosporine may be enhanced by NSAIDs via renal prostaglandin mediated effects.
During combined treatment renal function is to be measured.
Meloxicam is eliminated almost entirely by hepatic metabolism, of which approximately two thirds are
mediated by cytochrome (CYP) P450 enzymes (CYP2C9 major pathway and CYP3A4 minor pathway) and
one-third by other pathways, such as peroxidase oxidation. The potential for a pharmacokinetic interaction
should be taken into account when Meloxicam and drugs known to inhibit, or to be metabolized by, CYP2C9
and/or CYP3A4 are administered concurrently.
No relevant pharmacokinetic drug-drug interactions were detected with respect to the concomitant
administration of antacids, cimetidine, digoxin and furosemide.
Interactions with oral antidiabetic cannot be excluded.

Pregnancy and Lactation:
Pregnancy Category C, D. Although no teratogenic effects were seen in preclinical testing, Meloxi
tablets are not to be used during pregnancy & nursing mothers, unless the potential benefits outweigh
the risk.

Osteoarthritis: 7.5 mg/day. If necessary, the dose may be increased to 15 mg/day.
Rheumatoid arthritis: 15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5
mg/day.
Ankylosing spondylitis: 15 mg/day.
In patients with increased risks of adverse reaction; 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 maximum recommended daily dose of Meloxi is 15 mg. As a dosage for use in children has yet to be
established, usage should be restricted to adults. Tablets should be swallowed with water or other fluid in
conjunction with food.

The following adverse events which may be causally related with the administration of Meloxi TM have bean
reported. The frequencies given below are based on corresponding occurrences in clinical trials, regardless
of any causal relationship. The information is based on clinical trials involving 3750 patients who have been
treated with daily oral doses of 7.5 or 15mg Meloxi TM tablets or capsules over a period of up to 18 months
(mean duration of treatment 127 days).
Gastrointestinal: Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea (more
frequent than 1%). Transitory abnormalities of liver function parameters e.g. raised transaminases or bilirubin
eructation. Oesophagitis, gastroduodenal ulcer, occult or macroscopic gastrointestinal bleeding (between 0.1
and 1%). Gastrointestinal perforation, colitis, hepatitis, gastritis (less frequent than 0.1%).

Hematological: Anemia (more frequent than 1%). Disturbances of blood count, including differential white
cell count, leucopenia and thrombocytopenia. Concomitant administration of a potentially myelotoxic drug, in
particular methotrexate, appears to be a predisposing factor to the onset of a cytopenia (between 0.1 and
1%).
Dermatological: Pruritus, skin rash (more frequent than 1%); stomatitis, urticaria (between 0.1 and 1%);
photosensitization, on rare occasions bullous reactions, erythema multiforme, stevens johnson syndrome,
toxic epidermal necrosis may develop (less frequent than 0.1%).
Respiratory: Onset of acute asthma has been reported (less frequent than 0.1%) in certain individuals
following the administration of aspirin or other NSAIDs, including Meloxi.
Central nervous system: lightheadedness, headache (more frequent then 1%) vertigo. tinnitus, drowsiness
(between 0.1and 1%) confusion, disorientation, alteration of mood (less frequent then 0.1%).
Cardiovascular: Oedema (more frequent than 1% increase of blood pressure, palpitations, flushes (between
0.1 and 1%).
Genitourinary: Abnormal renal function parameters increased serum creatinine and/or serum urea (between
0.1 and 1%), acute renal failure (less frequent than 0.1%).
Vision disorders: Conjunctivitis, visual disturbances including blurred vision (less frequent 0.1%).
Hypersensitivity reactions: angio-oedema and immediate hypersensitivity reactions, including anaphylactoid
/anaphylactic reactions (less frequent than 0.1%).

Protect from heat. Store between 15 ° C — 25 ° C