OMETAC 20 CAPSULES

Страна: Малайзия

Език: английски

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

Активна съставка:

OMEPRAZOLE

Предлага се от:

Noripharma Sdn. Bhd.

INN (Международно Name):

OMEPRAZOLE

Броя в опаковка:

14 Capsule Capsules

Произведено от:

Noripharma Sdn. Bhd.

Данни за продукта

OMETAC 20 CAPSULES
DESCRIPTION:
Opaque pink/ reddish brown size 2 hard gelatin capsule with OMETAC 20
printed on both cap
and body.
COMPOSITION:
Each capsule contains Omeprazole (as enteric-coated pellets) 20 mg
PHARMACODYNAMICS:
Omeprazole inhibits secretion of gastric acid and is considered to do
so by irreversibly
blocking the enzyme system of hydrogen / potassium adenosine
triphosphatase, the so-called
proton pump of the gastric parietal cell. It thereby inhibits the
final transport of hydrogen ions
(via exchange with potassium ions) into the gastric lumen. Omeprazole
inhibits both basal and
stimulated
acid
secretion
irrespective
of
the
stimulus.
Omeprazole
also
inhibits
hepatic
cytochrome P-450 mixed-function oxidase system.
During treatment with antisecretory medicinal products, serum gastrin
increases in response to
the decreased acid secretion. Also CgA increases due to decreased
gastric acidity. The
increased CgA level may interfere with investigations for
neuroendocrine tumours. Available
published evidence suggests that proton pump inhibitors should be
discontinued between 5
days and 2 weeks prior to CgA measurements. This is to allow CgA
levels that might be
spuriously elevated following PPI treatment to return to reference
range.
PHARMACOKINETICS:
Omeprazole
is
acid-labile
and
absorption
from
the
gastrointestinal
tract
appears
to
be
formulation-dependent and dose dependent. Following absorption, it is
distributed in tissues,
particularly gastric parietal cells. Approximately 95% of the drug is
bound to plasma proteins.
Omeprazole is almost completely metabolised in the liver and rapidly
eliminated mostly in the
urine (about 80%) and faeces (about 20%). Although the elimination
half-life from plasma is
short (0.5 to 1.5 hour), it’s duration of action can last up to 72
hours. The inhibition of acid
secretion is directly related to the area under the plasma
concentration time curve but not to
the plasma concentration at any given time.
INDICATIONS:
Treatment of duodenal and benign gastric ulcers inclu