CONTROLOC IV

Country: Malasía

Tungumál: enska

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

Virkt innihaldsefni:

PANTOPRAZOLE SODIUM

Fáanlegur frá:

Takeda Malaysia Sdn Bhd

INN (Alþjóðlegt nafn):

PANTOPRAZOLE SODIUM

Einingar í pakka:

1 Vials

Framleitt af:

Takeda GmbH

Vara einkenni

CONTROLOC
®
I.V.
ACTIVE INGREDIENT: PANTOPRAZOLE SODIUM
COMPOSITION
One vial contains
_Active ingredient _
Pantoprazole sodium 42.3 mg (equivalent to pantoprazole 40 mg)
_Excipients _
Disodium edetate; sodium hydroxide
PRODUCT DESCRIPTION
Powder for preparation of an injection solution
White to off-white powder.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic / indication group / action mechanism
Selective proton pump inhibitor, substituted benzimidazole
ATC Code: A02BC02
_Mechanism of action _
Pantoprazole is a substituted benzimidazole which inhibits the
secretion of hydrochloric acid in the
stomach by specific blockade of the proton pumps of the parietal
cells.
Pantoprazole is converted to its active form in the acidic environment
in the parietal cells where it
inhibits the H+, K+-ATPase enzyme, i. e. the final stage in the
production of hydrochloric acid in the
stomach. The inhibition is dose-dependent and affects both basal and
stimulated acid secretion. In
most patients, freedom from symptoms is achieved within 2 weeks. As
with other proton pump
inhibitors and H2 receptor inhibitors, treatment with pantoprazole
reduces acidity in the stomach
and thereby increases gastrin in proportion to the reduction in
acidity. The increase in gastrin is
reversible. Since pantoprazole binds to the enzyme distal to the cell
receptor level, it can inhibit
hydrochloric acid secretion independently of stimulation by other
substances (acetylcholine,
histamine, gastrin). The effect is the same whether the product is
given orally or intravenously.
The fasting gastrin values increase under pantoprazole. On short-term
use, in most cases they do
not exceed the upper limit of normal. During long-term treatment,
gastrin levels double in most
cases. An excessive increase, however, occurs only in isolated cases.
As a result, a mild to moderate
increase in the number of specific endocrine (ECL) cells in the
stomach is observed in a minority of
cases during long-term treatment (simple to adenomatoid hyperplasia).
However, according to th