NEXIUM MUPS TABLET 20 mg

देश: सिंगापुर

भाषा: अंग्रेज़ी

स्रोत: HSA (Health Sciences Authority)

सक्रिय संघटक:

Esomeprazole Magnesium Trihydrate 22.3mg EQV Esomeprazole

थमां उपलब्ध:

ASTRAZENECA SINGAPORE PTE LTD

ए.टी.सी कोड:

A02BC05

डोज़:

20 mg

फार्मास्यूटिकल फॉर्म:

TABLET, FILM COATED

रचना:

Esomeprazole Magnesium Trihydrate 22.3mg EQV Esomeprazole 20 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

Prescription Only

द्वारा बनाया गया:

AstraZeneca AB

प्राधिकरण का दर्जा:

ACTIVE

प्राधिकरण की तारीख:

2001-04-27

सूचना पत्रक

1 
10/AD/SG/GI.000-059-920.12.0 
NEXIUM 
ESOMEPRAZOLE 
TABLETS 20 MG AND 40 MG 
COMPOSITION 
Each tablet contains: 20 mg or 40 mg esomeprazole (as
magnesium trihydrate). 
For excipients see "List of excipients". 
PHARMACEUTICAL FORM 
Gastro-resistant tablets 
20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20
mg on one side 
and
A
EH
on the other side. 
40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on
one side and
A
EI
on the 
other side. 
INDICATIONS 
Nexium tablets are indicated for: 
GASTROESOPHAGEAL REFLUX DISEASE (GERD) 
- Treatment of erosive reflux esophagitis. 
- Long-term management of patients with healed esophagitis to
prevent relapse. 
- Symptomatic treatment of gastroesophageal reflux disease (GERD). 
IN COMBINATION WITH AN APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMEN
FOR THE 
ERADICATION OF _HELICOBACTER PYLORI_ AND 
- Healing of _Helicobacter pylori_ associated duodenal ulcer and 
2 
- Prevention of relapse of peptic ulcers in patients
with _Helicobacter pylori_ associated ulcers. 
PATIENTS REQUIRING CONTINUED NSAID THERAPY 
- Healing of gastric ulcers associated with NSAID therapy. 
- Prevention of gastric and duodenal ulcers associated with
NSAID therapy in patients at risk. 
Patients are considered to be at risk due to their age (
 60) and/or documented history of 
gastric and/or duodenal ulcers. Controlled studies do not extend
beyond 6 months. 
PATIENTS REQUIRING CONTINUED LOW DOSE ASPIRIN (75-325 MG) THERAPY 
- Prevention of gastric and/or duodenal ulcers associated with low
dose aspirin therapy, in 
patients at risk. 
PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING
TREATMENT WITH NEXIUM 
IV SOLUTION BY INTRAVENOUS INFUSION. 
TREATMENT OF ZOLLINGER ELLISON SYNDROME 
POSOLOGY AND METHOD OF ADMINISTRATION 
The tablets should be swallowed whole with liquid. The tablets should
not be chewed or 
crushed. 
For patients who have difficulty in swallowing, the tablets can also
be

उत्पाद विशेषताएं

1
NEXIUM MUPS
®
(ESOMEPRAZOLE)
1.
NAME OF THE MEDICINAL PRODUCT
Nexium MUPS
®
Esomeprazole
Tablets 20 mg and 40 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Multiple-Unit Pellet System (MUPS) tablet contains: 20 mg or 40
mg esomeprazole (as
magnesium trihydrate).
For excipients see "List of excipients".
3.
PHARMACEUTICAL FORM
GASTRO-RESISTANT TABLETS
20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20
mg on one side and
A
EH
on the other side.
40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on
one side and
A
EI
on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nexium MUPS tablets are indicated for:
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
•
Treatment of erosive reflux esophagitis.
•
Long-term management of patients with healed esophagitis to prevent
relapse.
•
Symptomatic treatment of gastroesophageal reflux disease (GERD).
IN COMBINATION WITH AN APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMEN
FOR THE
ERADICATION OF
HELICOBACTER PYLORI AND
•
Healing of
_Helicobacter pylori_
associated duodenal ulcer and
•
Prevention of relapse of peptic ulcers in patients with
_Helicobacter pylori_
associated
ulcers.
PATIENTS REQUIRING CONTINUED NSAID THERAPY
•
Healing of gastric ulcers associated with NSAID therapy.
2
•
Prevention of gastric and duodenal ulcers associated with NSAID
therapy in patients at
risk. Patients are considered to be at risk due to their age (

60) and/or documented
history of gastric and/or duodenal ulcers. Controlled studies do not
extend beyond 6
months.
PATIENTS REQUIRING CONTINUED LOW DOSE ASPIRIN (75-325 MG) THERAPY
•
Prevention of gastric and/or duodenal ulcers associated with low dose
aspirin therapy, in
patients at risk.
PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING
TREATMENT WITH NEXIUM
IV SOLUTION BY INTRAVENOUS INFUSION
TREATMENT OF ZOLLINGER ELLISON SYNDROME
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be swallowed whole with liquid. The tablets should
not be chewed or
crushed.