K-CAB FILM-COATED TABLETS 50MG

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Tegoprazan

Disponível em:

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Código ATC:

A02BC09

Forma farmacêutica:

TABLET, FILM COATED

Composição:

Tegoprazan 50.0mg

Via de administração:

ORAL

Tipo de prescrição:

Prescription Only

Fabricado por:

HK inno.N Corporation

Status de autorização:

ACTIVE

Data de autorização:

2023-01-11

Folheto informativo - Bula

671693I01
671693I01
TEGOPRAZAN
K-CAB
PRODUCT DESCRIPTION
A light pink, oblong, film-coated tablet, engraved with “50|K” on
one side and “|” on the other. The line in the middle of the
tablet is for design purposes only.
It is not meant to be scored or taken in half.
FORMULATION
Each film-coated tablet contains:
Tegoprazan
..................................................................................................................................................................................................
50.0mg
List of excipients:
D-mannitol, microcrystalline cellulose, croscarmellose sodium,
hydroxypropylcellulose, colloidal silicon dioxide, magnesium stearate,
opadry II pink
(85 F240134): PVA (polyvinyl alcohol), titanium dioxide, PEG
(polyethylene glycol), talc, iron oxide red.
PHARMACODYNAMICS
_Mechanism of Action:_
Tegoprazan is a potassium-competitive acid blocker (P-CAB) that
reversibly blocks gastric acid secretion by competitively binding with
potassium
to the proton pumps (H+/K+-ATPase) present in gastric wall cells.
Tegoprazan binds in a concentration-dependent manner and blocks
gastric acid
secretion. Binding has reversibility. Tegoprazan inhibits the proton
pump directly without activation by acid.
_Pharmacodynamic Effects:_
After single and multiple oral dosing with 50 mg and 100 mg of
tegoprazan to healthy subjects, tegoprazan showed rapid and potent
inhibitory
effects on gastric acid secretion from the first dose. Intragastric pH
above 4 was reached within 1 hour. The 24-hr pH 4 holding time ratio
after
single dosing with 50mg and 100mg of tegoprazan were 55.07% to 68.38%,
respectively. After 7 days of multiple dosing with 50 mg and 100
mg of tegoprazan, the 24-hr pH 4 holding time ratio were 58.35% and
66.55%, respectively. Using AUC as a surrogate parameter for plasma
concentration, a relationship between inhibition of acid secretion and
exposure has been shown. After multiple oral dosing with 100 mg
tegopr-
azan, the gastrin level was significantly increased compared to the
bas

Características técnicas

671693I02
671693I02
TEGOPRAZAN
K-CAB
PRODUCT DESCRIPTION
A light pink, oblong, film-coated tablet, engraved with “K|50” on
one side and “|” on the other. The line in the middle of the
tablet is for design purposes only.
It is not meant to be scored or taken in half.
FORMULATION
Each film-coated tablet contains:
Tegoprazan
..................................................................................................................................................................................................
50.0mg
List of excipients:
D-mannitol, microcrystalline cellulose, croscarmellose sodium,
hydroxypropylcellulose, colloidal silicon dioxide, magnesium stearate,
opadry II pink
(85 F240134): PVA (polyvinyl alcohol), titanium dioxide, PEG
(polyethylene glycol), talc, iron oxide red.
PHARMACODYNAMICS
_Mechanism of Action:_
Tegoprazan is a potassium-competitive acid blocker (P-CAB) that
reversibly blocks gastric acid secretion by competitively binding with
potassium
to the proton pumps (H+/K+-ATPase) present in gastric wall cells.
Tegoprazan binds in a concentration-dependent manner and blocks
gastric acid
secretion. Binding has reversibility. Tegoprazan inhibits the proton
pump directly without activation by acid.
_Pharmacodynamic Effects:_
After single and multiple oral dosing with 50 mg and 100 mg of
tegoprazan to healthy subjects, tegoprazan showed rapid and potent
inhibitory
effects on gastric acid secretion from the first dose. Intragastric pH
above 4 was reached within 1 hour. The 24-hr pH 4 holding time ratio
after
single dosing with 50mg and 100mg of tegoprazan were 55.07% to 68.38%,
respectively. After 7 days of multiple dosing with 50 mg and 100
mg of tegoprazan, the 24-hr pH 4 holding time ratio were 58.35% and
66.55%, respectively. Using AUC as a surrogate parameter for plasma
concentration, a relationship between inhibition of acid secretion and
exposure has been shown. After multiple oral dosing with 100 mg
tegopr-
azan, the gastrin level was significantly increased compared to the
bas