DYNA MELOXICAM TABLET 7.5MG

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

MELOXICAM

Предлага се от:

DYNAPHARM (M) SDN BHD

INN (Международно Name):

MELOXICAM

Броя в опаковка:

100x10'stablet Tablets; 10x10'stablet Tablets; 50x10'stablet Tablets; 1x10'stablet Tablets

Произведено от:

DYNAPHARM (M) SDN BHD

Данни за продукта

DYNAPHARM (M) SDN BHD
DYNA MELOXICAM TABLET 7.5MG
MALxxyyzzzzA
CONTENT PER TABLET
Meloxicam 7.5 mg
PRODUCT DESCRIPTION
Yellow coloured, round, flat and double scored uncoated tablet.
PHARMACODYNAMICS
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the
enolic
acid class which has shown anti-inflammatory, 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 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.
PHARMACOKINETICS
Absorption
Meloxicam is well absorbed from the gastrointestinal tract, which is
reflected
by a high absolute bioavailability of 89% following oral
administration.
Following single dose administration of meloxicam, mean maximum plasma
concentrations are achieved within 2 hours for the suspension and
within 5-
6 hours with solid oral dosage forms.
With multiple dosing, steady state conditions were reached within 3 to
5
days. Once daily dosing leads to drug plasma concentrations with a
relatively small peak-trough fluctuation in the range of 0.4 -
1.0µg/mL for
7.5mg doses and 0.8 - 2.0µg/mL for 15mg doses, respectively (Cmin and
Cmax at steady state, respectively). Maximum plasma concentrations of
meloxicam at steady state, are achieved within five to six hours for
the tablet,
capsule and the oral suspension, respectively.
Continuous treatment for longer periods (e.g. six months) did not
point to
any changes in pharmacokinetics compared to steady state
pharmacokinetics after two weeks of oral treatment with 15 mg
meloxicam/day. Any differences after treatment longer than six mo