Risek 20mg Capsule

Pajjiż: Filippini

Lingwa: Ingliż

Sors: FDA (Food And Drug Administration)

Ingredjent attiv:

Omeprazole

Disponibbli minn:

Getz Pharma (Phils.) Inc.

INN (Isem Internazzjonali):

Omeprazole

Dożaġġ:

20mg

Għamla farmaċewtika:

Capsule

Unitajiet fil-pakkett:

Alu-Alu Blister Pack x 7's (Box of 14's), Alu/Alu Blister pack x 14's in a box

Manifatturat minn:

Getz Pharma (Private) Limited, Pakistan

Data ta 'l-awtorizzazzjoni:

2022-12-27

Karatteristiċi tal-prodott

DESCRIPTION
Omeprazole (Risek
®
), a substituted benzimedazole, is a proton pump
inhibitor that inhibits gastric acid secretion.
Chemically omeprazole is 5-methoxy-2-[(4-methoxy-3, 5-dimethyl-2-
pyridinyl) methyl] sulfinyl]-1H benzimidazole. The molecular formula
is
C
17
H
19
N
3
O
3
S and the structural formula is:
FORMULATION
1.
Omeprazole (Risek
®
) 20mg Capsules:
Each capsule contains: Omeprazole E.Ph…20mg
2.
Omeprazole (Risek
®
) 40mg Capsules:
Each capsule contains: Omeprazole E.Ph…40mg
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Omeprazole (Risek
®
) reduces gastric acid secretion through a unique
mechanism of action. Omeprazole belongs to a new class of
anti-secretory
compounds, the substituted benzimidazoles that do not exhibit anti-
cholinergic or histamine antagonistic properties. It inhibits
secretion of
gastric acid by irreversibly blocking the enzyme system of
hydrogen/potassium adenosine triphosphatase (H
+
/K
+
ATPase), the
proton pump of the gastric parietal cell. This effect is dose-related
and
leads to inhibition of both basal and stimulated acid secretion
irrespective
of the stimulus.
PHARMACOKINETICS
_Absorption/Distribution_
Omeprazole (Risek
®
) is acid-labile and is administered orally as enteric-
coated pellets in capsules. Omeprazole is rapidly but variably
absorbed
following oral administration, with peak plasma levels of omeprazole
occurring within 0.5 to 3.5 hours. Absorption of omeprazole is not
affected
by food and also appears to be dose dependant. Increasing the dosage
above 40mg has been reported to increase plasma concentrations in a
non-linear fashion because of saturable first pass metabolism.
Absorption
is higher after long-term administration.
The systemic bioavailability of omeprazole is approximately 35%. After
repeated once daily administration, the bioavailability increases to
about
60%.
The
plasma
protein
binding
is
approximately
95%.
_Metabolism & Excretion_
Following absorption, omeprazole is almost completely metabolized in
the liver, primarily by the cytochro