- Short-term symptomatic treatment of exacerbations of osteoarthrosis.
- Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.

Posology
The total daily amount should be taken as a single dose.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to
control symptoms (see section 4.4). The patient's need for symptomatic relief and response to therapy should be
re-evaluated periodically, especially in patients with osteoarthritis.
- Exacerbations of osteoarthrosis: 7.5 mg/day (one 7.5 mg tablet).
If necessary, in the absence of improvement, the dose may be increased to 15 mg/day (two 7.5 mg tablets).
- Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (two 7.5 mg tablets).
(see also section 'Special populations' below)
According to the therapeutic response, the dose may be reduced to 7.5 mg/day (one 7.5 mg tablet).
DO NOT EXCEED THE DOSE OF 15 MG/DAY.
Special populations
Elderly patients and patients with increased risks for adverse reaction (see section 5.2):
The recommended dose for long term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly
patients is 7.5 mg per day. Patients with increased risks for adverse reactions should start treatment with 7.5 mg
per day (see section 4.4).
Renal impairment (see section 5.2):
In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg per day.
No dose reduction is required in patients with mild to moderate renal impairment (i.e. patients with a creatinine
clearance of greater than 25 ml/min). (For patients with non-dialysed severe renal failure, see section 4.3)
Hepatic impairment (see section 5.2):
No dose reduction is required in patients with mild to moderate hepatic impairment (For patients with severely
impaired liver function, see section 4.3).
Paediatric population:
Coxicam tablets is contraindicated in children and adolescents aged under 16 years (see section 4.3).
Method of administration
For oral use
Coxicam tablets are swallowed with water or other fluid in conjunction with food.
This medicinal product exists in other dosages, which may be more appropriate.

This medicinal product is contra-indicated in the following situations: − hypersensitivity to the active substance or to any of the excipients listed in section 6.1; − third trimester of pregnancy (see section 4.6 'Fertility, pregnancy and lactation'); − children and adolescents aged under 16 years; − hypersensitivity to substances with a similar action, e.g. NSAIDs, aspirin. Meloxicam should not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs; − history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; − active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding); − severely impaired liver function; − non-dialysed severe renal failure; − gastrointestinal bleeding, history of cerebrovascular bleeding or other bleeding disorders; − severe heart failure.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary
to control symptoms (see section 4.2, and GI and cardiovascular risks below).
The recommended maximum daily dose should not be exceeded in case of insufficient therapeutic effect,
nor should an additional NSAID be added to the therapy because this may increase the toxicity while
therapeutic advantage has not been proven. The use of meloxicam with concomitant NSAIDs including
cyclooxygenase-2 selective inhibitors should be avoided.
Meloxicam is not appropriate for the treatment of patients requiring relief from acute pain.
In the absence of improvement after several days, the clinical benefit of the treatment should be reassessed.
Any history of oesophagitis, gastritis and/or peptic ulcer must be sought in order to ensure their total cure
before starting treatment with meloxicam. Attention should routinely be paid to the possible onset of a
recurrence in patients treated with meloxicam and with a past history of this type.
Gastrointestinal effects
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time
during treatment, with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a
history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the
elderly. These patients should commence treatment on the lowest dose available. Combination therapy with
protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and
also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal
risk (see below and 4.5).
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal
symptoms (especially GI bleeding) particularly in the initial stages of treatment.
In patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such
as heparin as curative treatment or given in geriatrics, anticoagulants such as warfarin, other nonsteroidal
anti-inflammatory drugs, or acetylsalicylic acid given at doses ≥500 mg as single intake or ≥ 3g as total
daily amount the combination with meloxicam is not recommended (see section 4.5).
When GI bleeding or ulceration occurs in patients receiving meloxicam the treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis,
Crohn's disease) as these conditions may be exacerbated (see section 4.8 – undesirable effects).
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 monitoring of blood pressure for patients at risk is recommended at baseline and especially during
treatment initiation with meloxicam.
Clinical trial and epidemiological data suggest that use of some NSAIDs including meloxicam (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 meloxicam.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease,
peripheral arterial disease, and/or cerebrovascular disease should only be treated with meloxicam 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).
Skin reactions
Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis
(TEN) have been reported with the use of Meloxicam. Patients should be advised of the signs and
symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is
within the first weeks of treatment. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often
with blisters or mucosal lesions) are present, Meloxicam treatment should be discontinued. The best results
in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug.
Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the
use of Meloxicam, Meloxicam must not be re-started in this patient at any time.
Parameters of liver and renal function
As with most NSAIDs, occasional increases in serum transaminase levels, increases in serum bilirubin or
other liver function parameters, as well as increases in serum creatinine and blood urea nitrogen and other
laboratory disturbances, have been reported. The majority of these instances involved transitory and slight
abnormalities. Should any such abnormality prove significant or persistent, the administration of
Meloxicam should be stopped and appropriate investigations undertaken.
Functional renal failure
NSAIDs, by inhibiting the vasodilating effect of renal prostaglandins, may induce a functional renal failure
by reduction of glomerular filtration. This adverse event is dose-dependant. At the beginning of the
treatment, or after dose increase, careful monitoring of diuresis and renal function is recommended in
patients with the following risk factors:
• Elderly
• Concomitant treatments such as ACE inhibitors, angiotensin-II antagonists, sartans, diuretics (see section
4.5. Interaction with other medicinal products and other forms of interaction)
• Hypovolemia (whatever the cause)
• Congestive heart failure
• Renal failure
• Nephrotic syndrome
• Lupus nephropathy
• Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10)
In rare instance NSAIDs may be the cause of interstitial nephritis, glomerulonephritis, renal medullary
necrosis or nephrotic syndrome.
The dose of meloxicam in patients with end-stage renal failure on haemodialysis should not be higher than
7.5 mg. No dose reduction is required in patients with mild or moderate renal impairment (i.e. in patients
with a creatinine clearance of greater than 25 ml/min).
Sodium, potassium and water retention
Induction of sodium, potassium and water retention and interference with the natriuretic effects of diuretics
may occur with NSAIDs. Furthermore, a decrease of the antihypertensive effect of antihypertensive drugs
can occur (see section 4.5). Consequently, oedema, cardiac failure or hypertension may be precipitated or
exacerbated in susceptible patients as a result. Clinical monitoring is therefore necessary for patients at risk
(see sections 4.2 and 4.3).
Hyperkalaemia
Hyperkalaemia can be favoured by diabetes or concomitant treatment known to increase kalaemia (see
section 4.5). Regular monitoring of potassium values should be performed in such cases.
Combination with pemetrexed
In patients with mild to moderate renal insufficiency receiving pemetrexed, meloxicam should be
interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed
administration (see section 4.5).
Other warnings and precautions
Adverse reactions are often less well tolerated in elderly, fragile or weakened individuals, who therefore
require careful monitoring. As with other NSAIDs, particular caution is required in the elderly, in whom
renal, hepatic and cardiac functions are frequently impaired. The elderly have an increased frequency of
adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see
section 4.2).
Meloxicam, as any other NSAID may mask symptoms of an underlying infectious disease.
The use of meloxicam may impair female fertility and is not recommended in women attempting to
conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility,
withdrawal of meloxicam should be considered (see section 4.6).

Risks related to hyperkalaemia:
Certain medicinal products or therapeutic groups may promote hyperkalaemia: potassium salts, potassium-sparing
diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, non-steroidal antiinflammatory
drugs, (low-molecular-weight or unfractionated) heparins, cyclosporin, tacrolimus and
trimethoprim.
The onset of hyperkalaemia may depend on whether there are associated factors.
This risk is increased when the above-mentioned medicinal products are co-administered with meloxicam.
Pharmacodynamic Interactions:
Other non steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid:
combination (see section 4.4) with other non steroidal anti-inflammatory drugs, acetylsalicylic acid given at doses
≥500 mg as single intake or ≥ 3g as total daily amount is not recommended.
Corticosteroids (e.g. Glucocorticoids):
The concomitant use with corticosteroids requests caution because of an increased risk of bleeding or
gastrointestinal ulceration.
Anticoagulant or heparin:
Considerably increased risk of bleeding, via inhibition of platelet function and damage to the gastroduodenal
mucosa. NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4). The concomitant
use of NSAIDs and anticoagulants or heparin administered in geriatrics or at curative dose is not recommended
(see section 4.4).
In remaining cases (e.g. preventive doses) of heparin use caution is necessary due to an increased bleeding risk.
Careful monitoring of the INR is required if it proves impossible to avoid such combination.
Thrombolytics and antiplatelet drugs:
Increased risk of bleeding, via inhibition of platelet function and damage to the gastroduodenal mucosa.
Selective serotonin reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding.
Diuretics, ACE inhibitors and Angiotensin-II Antagonists:
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised
renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the coadministration
of an ACE inhibitor or Angiotensin-II antagonists and agents that inhibit cyclo-oxygenase may
result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Therefore, the combination should be administered with caution, especially in the elderly. Patients should be
adequately hydrated and consideration should be given to monitoring of renal function after initiation of
concomitant therapy, and periodically thereafter (see also section 4.4).
Other antihypertensive drugs (e.g. Beta-blockers):
As for the latter, a decrease of the antihypertensive effect of beta-blockers (due to inhibition of prostaglandins
with vasodilatory effect) can occur.
Calcineurin inhibitors (e.g. cyclosporin, tacrolimus):
Nephrotoxicity of calcineurin inhibitors may be enhanced by NSAIDs via renal prostaglandin mediated effects.
During combined treatment renal function is to be measured. A careful monitoring of the renal function is
recommended, especially in the elderly.
Intrauterine devices. A decrease of the efficacy of intrauterine devices by NSAIDs has been previously reported
but needs further confirmation.
Pharmacokinetic Interactions: Effect of meloxicam on the pharmacokinetics of other drugs
Lithium:
NSAIDs have been reported to increase blood lithium levels (via decreased renal excretion of lithium), which
may reach toxic values. The concomitant use of lithium and NSAIDs is not recommended (see section 4.4). If this
combination appears necessary, lithium plasma concentrations should be monitored carefully during the initiation,
adjustment and withdrawal of meloxicam treatment.
Methotrexate:
NSAIDs can reduce the tubular secretion of methotrexate thereby increasing the plasma concentrations of
methotrexate. For this reason, for patients on high dosages of methotrexate (more than 15 mg/week) the
concomitant use of NSAIDs is not recommended (see section 4.4).
The risk of an interaction between NSAID preparations and methotrexate, should be considered also in patients
on low dosage of methotrexate, especially in patients with impaired renal function. In case combination treatment
is necessary blood cell count and the renal function should be monitored. Caution should be taken in case both
NSAID and methotrexate are given within 3 days, in which case the plasma level of methotrexate may increase
and cause increased toxicity.
Although the pharmacokinetics of methotrexate (15mg/week) were not relevantly affected by concomitant
meloxicam treatment, it should be considered that the haematological toxicity of methotrexate can be amplified
by treatment with NSAID drugs (see above). (See section 4.8)
Pemetrexed:
For the concomitant use of meloxicam with pemetrexed in patients with mild to moderate renal impairment
(creatinine clearance from 45 to 79 ml/min), the administration of meloxicam should be paused for 5 days before,
on the day of, and 2 days following pemetrexed administration. If a combination of meloxicam with pemetrexed
is necessary, patients should be closely monitored, especially for myelosuppression and gastro-intestinal adverse
reactions. In patients with severe renal impairment (creatinine clearance below 45 ml/min) the concomitant
administration of meloxicam with pemetrexed is not recommended.
In patients with normal renal function (creatinine clearance ≥ 80 ml/min), doses of 15 mg meloxicam may
decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Therefore, caution should be exercised when administering 15 mg meloxicam concurrently with pemetrexed to
patients with normal function (creatinine clearance ≥ 80 ml/min).
Pharmacokinetic Interactions: Effect of other drugs on the pharmacokinetics of meloxicam
Cholestyramine:
Cholestyramine accelerates the elimination of meloxicam by interrupting the enterohepatic circulation so that
clearance for meloxicam increases by 50% and the half-life decreases to 13+3 hrs. This interaction is of clinical
significance.
No clinically relevant pharmacokinetic drug-drug interactions were detected with respect to the concomitant
administration of antacids, cimetidine and digoxin.
Paediatric population
Interaction studies have only been performed in adults.

Pregnancy
From the 20th week of pregnancy on ward, coxicam use may cause oligohydramnios resulting from foetal
renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon
discontinuation, in addition there have been reports of ductus arteriosus constriction following treatment
in the second trimester, most of which resolve after treatment cessation. Therefore, during the first and
second trimesters of pregnancy, coxicam should not be given unless clearly necessary. If coxicam is used by a
woman trying to conceive, or during the first and second trimesters of pregnancy, the dose should be kept low and
the duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus
arteriosus constriction should be considered after exposure to coxicam for several days from gestational
week 20 onwards. coxicam should be discontinued if hypoamniotic fluid or ductus arteriosus constriction is
found.
During the last trimester of pregnancy, all inhibitors of fetal prostaglandin synthesis may expose the foetus to:
• cardiopulmonary toxicity (with premature constriction/closure of the ductus arteriosus and pulmonary
hypertension).
• Renal impairment (see above)
Mother and neonate, at the end of pregnancy, to:
• Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low
doses
• Inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, coxicam is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3)
Breastfeeding
While no specific experience exists for meloxicam, NSAIDs are known to pass into mother's milk.
Administration therefore is not recommended in women who are breastfeeding.
Fertility
The use of meloxicam, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair
female fertility and is not recommended in women attempting to conceive. In women who have difficulties
conceiving or who are undergoing investigation of infertility, withdrawal of meloxicam should be considered.

No specific studies on the effect on the ability to drive and use machineries have been performed. However, on
the basis of the pharmacodynamic profile and reported adverse drug reactions, meloxicam is likely to have no or
negligible influence on these abilities. However, when visual disturbances including blurred vision, dizziness,
drowsiness, vertigo or other central nervous system disturbances occur, it is advisable to refrain from driving and
operating machinery.

a) General Description
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) (see section 4.4).
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI
bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea,
flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of
colitis and Crohn's disease (see section 4.4 - Special warnings and precautions for use) have been reported
following administration. Less frequently, gastritis has been observed.
Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis
(TEN) have been reported (see section 4.4).
The frequencies of adverse drug reactions given below are based on corresponding occurrences of reported
adverse events in 27 clinical trials with a treatment duration of at least 14 days. The information is based on
clinical trials involving 15197 patients who have been treated with daily oral doses of 7.5 or 15 mg meloxicam
tablets or capsules over a period of up to one year.
Adverse drug reactions that have come to light as a result of reports received in relation to administration of the
marketed product are included.
Adverse reactions have been ranked under headings of frequency using the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
<1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data)
b) Table of adverse reactions
Blood and lymphatic system disorders
Uncommon: Anaemia
Rare: Blood count abnormal (including differential white cell count), leukopenia,
thrombocytopenia
Very rare cases of agranulocytosis have been reported (see section c).
Immune system disorders
Uncommon: Allergic reactions other than anaphylactic or anaphylactoid reactions
Not known: Anaphylactic reaction, anaphylactoid reaction
Psychiatric disorders
Rare: Mood altered, nightmares
Not known: Confusional state, disorientation
Nervous system disorders
Common: Headache
Uncommon: Dizziness, somnolence
Eye disorders
Rare: Visual disturbance including vision blurred; conjunctivitis
Ear and labyrinth disorders
Uncommon: Vertigo
Rare: Tinnitus
Cardiac disorders
Rare: Palpitations
Cardiac failure has been reported in association with NSAID treatment.
Vascular disorders
Uncommon: Blood pressure increased (see section 4.4), flushing
Respiratory, thoracic and mediastinal disorders
Rare: Asthma in individuals allergic to aspirin or other NSAIDs
Gastrointestinal disorders
Very common: Gastrointestinal disorders such as dyspepsia, nausea, vomiting, abdominal pain,
constipation, flatulence, diarrhoea
Uncommon: Occult or macroscopic gastrointestinal haemorrhage, stomatitis, gastritis, eructation
Rare: Colitis, gastroduodenal ulcer, oesophagitis
Very rare: Gastrointestinal perforation
Not known: Pancreatitis
Gastrointestinal haemorrhage, ulceration or perforation may sometimes be severe and potentially fatal,
especially in elderly (see section 4.4).
Hepatobiliary disorders
Uncommon: Liver function disorder (e.g. raised transaminases or bilirubin)
Very rare: Hepatitis
Skin and subcutaneous tissue disorders
Uncommon: Angioedema, pruritus, rash
Rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Very rare: Dermatitis bullous, erythema multiforme
Not known: Photosensitivity reaction
Renal and urinary disorders
Uncommon: Sodium and water retention, hyperkalaemia (see section 4.4.Special warnings and
precautions for use and section 4.5.), renal function test abnormal (increased serum
creatinine and/or serum urea)
Very rare: Acute renal failure in particular in patients with risk factors (see section 4.4.)
General disorders and administration site conditions
Uncommon: Oedema including oedema of the lower limbs.
c) Information Characterising Individual Serious and/or Frequently Occurring Adverse Reactions
Very rare cases of agranulocytosis have been reported in patients treated with meloxicam and other potentially
myelotoxic drugs (see section 4.5).
d) Adverse reactions which have not been observed yet in relation to the product, but which are generally
accepted as being attributable to other compounds in the class
Organic renal injury probably resulting in acute renal failure: very rare cases of interstitial nephritis, acute tubular
necrosis, nephrotic syndrome, and papillary necrosis have been reported (see section 4.4).
Reporting of suspected adverse reactions
To report any side effects
- National Pharmacovigilance and Drug Safety Center (NPC)
o Fax: +966-11-205-7662
o To call the executive management of vigilance and crisis management: +966-11-2038222 ext.: 2353 – 2356 –
2317 – 2354 – 2334 – 2340
o Toll-free: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
United Arab Emirates
Pharmacovigilance & Medical device Section
•P.O. Box: 1853
Tel: 80011111
• E-mail: pv@mohap.gov.ae
• Drug Department
• Ministry of Health & Prevention
•Dubai

Symptoms
Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and
epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe
poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma,
convulsions, cardiovascular collapse and cardiac arrest. Anaphylactoid reactions have been reported with
therapeutic ingestion of NSAIDs and may occur following an overdose.
Treatment
Patients should be managed with symptomatic and supportive care following an NSAID overdose. Accelerated
removal of meloxicam by 4 g oral doses of cholestyramine given three times a day was demonstrated in a clinical
trial.

Pharmacotherapeutic group: Non Steroidal Anti-Inflammatory agent, Oxicams
ATC code: M01AC06
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.

Absorption
Meloxicam is well absorbed from the gastrointestinal tract, which is reflected by a high absolute bioavailability of
about 90% following oral administration (capsule). Tablets, oral suspension and capsules were shown to be
bioequivalent.
Following single dose administration of meloxicam, median maximum plasma concentrations are achieved within
2 hours for the suspension and within 5-6 hours with solid oral dosage forms (capsules and tablets).
With multiple dosing, steady state conditions were reached within 3 to 5 days. Once daily dosing leads to mean
drug plasma concentrations with a relatively small peak-trough fluctuation in the range of 0.4 - 1.0 μg/mL for 7.5
mg doses and 0.8 - 2.0 μg/mL for 15 mg doses, respectively (Cmin and Cmax at steady state, correspondingly).
Mean maximum plasma concentrations of meloxicam at steady state are achieved within five to six hours for the
tablet, capsule and the oral suspension, respectively. Extent of absorption for meloxicam following oral
administration is not altered by concomitant food intake or the use of inorganic antacids.
Distribution
Meloxicam is very strongly bound to plasma proteins, essentially albumin (99%). Meloxicam penetrates into
synovial fluid to give concentrations approximately half of those in plasma.
Volume of distribution is low, i.e. approx. 11 L after i.m. or i.v. administration, and shows interindividual
variation in the order of 7 - 20%. The volume of distribution following administration of multiple oral doses of
meloxicam (7.5 to 15 mg) is about 16 L with coefficients of variation ranging from 11 to 32%.
Biotransformation
Meloxicam undergoes extensive hepatic biotransformation. Four different metabolites of meloxicam were
identified in urine, which are all pharmacodynamically inactive. The major metabolite, 5'-carboxymeloxicam
(60% of dose), is formed by oxidation of an intermediate metabolite 5'- hydroxymethylmeloxicam, which is also
excreted to a lesser extent (9% of dose). In vitro studies suggest that CYP 2C9 plays an important role in this
metabolic pathway, with a minor contribution from the CYP 3A4 isoenzyme. The patient's peroxidase activity is
probably responsible for the other two metabolites, which account for 16% and 4% of the administered dose
respectively.
Elimination
Meloxicam is excreted predominantly in the form of metabolites and occurs to equal extents in urine and faeces.
Less than 5% of the daily dose is excreted unchanged in faeces, while only traces of the parent compound are
excreted in urine.
The mean elimination half-life varies between 13 and 25 hours after oral, i.m. and i.v. administration. Total
plasma clearance amounts about 7 – 12 mL/min following single doses orally, intravenously or rectally
administered.
Linearity/non-linearity
Meloxicam demonstrates linear pharmacokinetics in the therapeutic dose range of 7.5 mg 15 mg following per
oral or intramuscular administration.
Special populations
Patients with hepatic/renal insufficiency:
Neither hepatic, nor mild to moderate renal insufficiency has a substantial effect on meloxicam pharmacokinetics.
Subjects with moderate renal impairment had significant higher total drug clearance. A reduced protein binding is
observed in patients with terminal renal failure. In terminal renal failure, the increase in the volume of distribution
may result in higher free meloxicam concentrations, and a daily dose of 7.5 mg must not be exceeded (see section
4.2).
Elderly:
Elderly male subjects exhibited similar mean pharmacokinetic parameters compared to those of young male
subjects. Elderly female patients showed higher AUC-values and longer elimination half-lives compared to those
of young subjects of both genders. Mean plasma clearance at steady state in elderly subjects was slightly lower
than that reported for younger subjects.

The toxicological profile of meloxicam has been found in preclinical studies to be identical to that of NSAIDs:
gastrointestinal ulcers and erosions, renal papillary necrosis at high doses during chronic administration in two
animal species.
Oral reproductive studies in the rat have shown a decrease of ovulations and inhibition of implantations and
embryotoxic effects (increase of resorptions) at maternotoxic dose levels at 1mg/kg and higher. Studies of toxicity
on reproduction in rats and rabbits did not reveal teratogenicity up to oral doses of 4 mg/kg in rats and 80 mg/kg
in rabbits.
The affected dose levels exceeded the clinical dose (7.5-15 mg) by a factor of 10 to 5-fold on a mg/kg dose basis
(75 kg person). Fetotoxic effects at the end of gestation, shared by all prostaglandin synthesis inhibitors, have
been described. No evidence has been found of any mutagenic effect, either in vitro or in vivo. No carcinogenic
risk has been found in the rat and mouse at doses far higher than those used clinically.

Microcrystalline Cellulose PH 102
Lactose (100 mesh)
Povidone (K30)
Colloidal Anhydrous Silica
Crospovidone
Sodium Citrate (mesh 45)
Magnesium Stearate

Not applicable.

3 years

Store below 30°C.
Store in the original package in order to protect from light & moisture.

Transparent PVC-PVDC film / Aluminium foil blister pack of 10 tablets.

Not applicable.
Keep medicines out of reach of children.