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Pharmaceutical

Company
AMUN
Product Management
Department

AMOUN
Presents
“Non steroidal anti-
inflammatory drugs
(NSAIDs) are the most
widely used symptomatic
remedies for rheumatic
disorders”
Prostaglandins are important chemical mediators
derived from arachidonic acid by the enzyme
cyclooxygenase (COX)
Phospholipase A2

Arachidonic F.A.
Cyclooxygenase (COX)

Prostaglandins Prostacyclins
Thromboxan A2
Cyclooxygenase
(COX)
COX-1 COX-2
Constitutive Inducible Involved
Maintains normal in inflammation &
physiological pain
functions
Efficacy and Safety
of NSAIDs are due
to the effect on
cyclooxygenase
enzyme (COX)
Non-Selective NSAIDs

COX-1 COX-2

Side effects Therapeutic effects


Stomach Anti-inflammatory
Kidney Platelets Analgesic
Antipyretic
Melocam® is a selective Cox2
inhibitor which shows high anti-
inflammatory & analgesic potency with
less gastric irritation than other NSAIDs
Thus realize the balance between efficacy
& tolerability
Melocam®, an oxicam derivative, is
a member of the enolic acid group &
one of the most strong NSAIDs.
 Tablets:
Each tablet contains 7.5 mg or 15 mg
meloxicam.
 Ampoules:
Each 2 ml ampoule contains 15 mg
meloxicam.
 Suppositories:
Each suppository contains 15 mg
meloxicam.
Pharmacokinetic
 Prolonged and complete absorption after oral
administration.
 Bioavailability of 89%.
 Not affected by concomitant intake of food.
 More than 99 % bound to plasma protein.
 Elimination half-life is 20-24 hours.
 During distribution, Meloxicam penetrates the
synovial fluid, reaching concentrations are 45-57%
of those in plasma.
 Meloxicam was found in synovial fluid 1 hour after
administration and reached peak concentrations at
approximately 6 hours.
Pharmacokinetics
Melocam® Ampoules
 Intramuscular
meloxicam is rapidly absorbed, reaches
90% of the Cmax within 30 min of injection.

 Concentrations tend to remain stable for at least 5-6


hours, these data support the use of intramuscular
meloxicam in patients with acute arthropathies, since it
provides a fast relief of pain and inflammation.
 The pharmacokinetic profile of meloxicam is
not significantly altered in elderly patients or in
those with mild to moderate renal impairment.

The pharmacokinetic parameters of meloxicam


were found to be similar in patients with mild
hepatic impairment and healthy volunteers.
Rheumatic Disorders
Immunological
 Rheumatoid arthritis
 Ankylosing spondylitis
Rheumatic Disorders
Degenerative
 Osteoarthritis
Rheumatic Disorders
Metabolic
 Gouty Arthritis
Non-articular painful conditions
 Myositis
 Low back pain
 Bursitis & tenosynovitis
 Sprain & strain
 Sinusitis
 Otitis externa & otitis media
 Dysmenorrhea
 Pelvic inflammatory diseases
 Acute pain & inflammation of any
origin
In rheumatoid arthritis
15 mg once daily.
According to the response, dose could be
reduced to 7.5 mg once daily.
In acute exacerbations of
osteoarthritis
7.5 mg increased to a maximum of 15 mg
once daily.
In cases of acute pain &
inflammation
Start with ampoule form (1 ampoule /day) and
then maintain treatment with tablets or
suppositories.
 Tablets:strips of 10 tablets 7.5 mg or
15 mg in packs of 1 strip.

 Ampoules: packs of 3 ampoules.

 Suppositories: packs of 5
suppositories each containing 15 mg
meloxicam.
®
 Melocam as a selective inhibitor for COX-2,
retains the anti-inflammatory, analgesic & antipyretic
actions without the harmful side effects of COX-1
inhibitors
Thus realize the balance between efficacy &
tolerability
 No drug drug interaction
®
Melocam is compatible with other drugs

No dose adjustment is required with :


 Elderly
 Mild to moderate renal insufficiency
No inhibition of platelet aggregation
Once daily dose
Better convenience & compliance
 Melocam® available in ampoules, tablets &
suppositories to suit all patients.
Melocam® Ampoules
 90 % of the Cmax is achieved within 30
minutes.
The I.M. route of administration provides

fast relief of pain and inflammation.


A long-term study to evaluate the safety & efficacy
®
of Melocam (meloxicam) therapy in patients
with rheumatoid arthritis

British Journal of Rheumatology35:39-43


A long-term study to evaluate the safety &
efficacy of Meloxicam therapy in patients
with rheumatoid arthritis
Measurement tools: VAS

Assessment of global efficacy


changed on vas scale from 4 cm
to 2 cm at the end of the
study=better efficacy.
A long-term study to evaluate the safety &
efficacy of Meloxicam therapy in patients
with rheumatoid arthritis
Assessment of global
tolerance changed from
2cm to 1 cm=better
tolerability.
So Melocam® 15 mg once daily is
effective & well tolerated in long-
term management of RA patients.
Melocam® (meloxicam) in
osteoarthritis: A 6-month,double –blind
comparison with diclofenac sodium

British Journal of Rheumatology35:39-43


Melocam (meloxicam) in osteoarthritis: A 6-
month,double –blind comparison with
diclofenac sodium
Mesurement tools: VAS

Overall pain & pain on


movement showed marked
reductions with both Meloxicam
and Diclofenac.
Melocam (meloxicam) in osteoarthritis: A 6-
month,double –blind comparison with
diclofenac sodium
the amelioration in the duration
of stiffness at the end of the study
was greater in the Meloxicam
group.
 GI disorders were reported less frequent
with Meloxicam than Diclofenac.
Melocam® is beneficial for patients
suffering from this chronic and
disabling condition and demonstrates a
better safety profile with similar
efficacy compared to Diclofenac.
Melocam® (meloxicam) i.m.
A comparison with i.m. Piroxicam in patients
with RA or OA

British Journal of Rheumatology 35:51-55


Melocam (meloxicam) i.m. : A comparison with
i.m. Piroxicam in paients with RA or OA

Significant improvement in favor


of Meloxicam are observed in
global efficacy in RA & OA
patients.

Local tolerabiltiy assessment are


more significant in Meloxicam
group.
So Melocam® i.m. is effective &
tolerable for the treatment of acute
rheumatic pain and shows superiority
over Piroxicam.
AMOUN