Prolox

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Rabeprazole sodium 10mg equivalent to Rabeprazole 9.42 mg

Disponibil de la:

Douglas Pharmaceuticals Limited

INN (nume internaţional):

Rabeprazole sodium 10 mg (equiv to Rabeprazole 9.42 mg)

Dozare:

10 mg

Forma farmaceutică:

Enteric coated tablet

Compoziție:

Active: Rabeprazole sodium 10mg equivalent to Rabeprazole 9.42 mg Excipient: Dibutyl sebacate Ethylcellulose Heavy magnesium oxide   Hyprolose Hypromellose phthalate Iron oxide red Magnesium stearate Mannitol Purified talc Titanium dioxide

Unități în pachet:

Blister pack, PVC/PDVC base with Alu/Alu peelable or Alu/Alu non-peelable foil, 7 tablets

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Quimica Sintetica SA

Indicații terapeutice:

Prolox is indicated for: · Treatment and prevention of relapse of gastro-oesophageal reflux disease · Symptomatic treatment of gastro-oesophageal reflux disease · Treatment of duodenal ulcers · Treatment of gastric ulcers. Patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, PVC/PDVC base with Alu/Alu peelable or Alu/Alu non-peelable foil - 7 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PDVC base with Alu/Alu peelable or Alu/Alu non-peelable foil - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PDVC base with Alu/Alu peelable or Alu/Alu non-peelable foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PDVC base with Alu/Alu peelable or Alu/Alu non-peelable foil - 56 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PDVC base with Alu/Alu peelable or Alu/Alu non-peelable foil - 98 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Data de autorizare:

2011-10-06

Prospect

 
CONSUMER MEDICINE INFORMATION 

PROLOX 
Tablets

_Rabeprazole sodium 10mg and 20 mg _ 

WHAT IS IN THIS LEAFLET  

This leaflet will answer some of the common questions about PROLOX
tablets. It 
does not contain all of the information available on this medicine and
does not take 
the place of talking to your doctor or pharmacist.  
If you have any concerns about using PROLOX tablets, ask your doctor
or 
pharmacist. Your doctor and pharmacist have more information.  
Keep this leaflet with your PROLOX tablets. You may want to read it
again. 

WHAT PROLOX IS USED FOR  

The name of your medicine is PROLOX. It contains the active
ingredient 
rabeprazole sodium.  
_Reflux Oesophagitis: _ 
PROLOX is used to treat reflux oesophagitis or reflux disease.
This can be caused 
by food and acid from the stomach flowing the wrong way (reflux) back
up the food 
pipe, also known as the oesophagus.  
Reflux can cause a burning sensation in the chest rising up to the
throat, also 
known as heartburn.  
PROLOX is also used to help stop reflux oesophagitis from coming back
or 
relapsing.  
_Peptic Ulcers: _ 
PROLOX is used to treat peptic ulcers. Depending on the position of
the ulcer it is 
called a gastric or duodenal ulcer. A gastric ulcer occurs in the
stomach. A 
duodenal ulcer occurs in the duodenum which is the tube leading out of
the 
stomach.  
These ulcers can be caused by too much acid being made in the stomach.

Most people who have a peptic ulcer also have a bacteria called
Helicobacter pylori 
in their stomach. Your doctor may also prescribe a course of
antibiotics 
(clarithromycin and amoxycillin) for you. When PROLOX is taken with
antibiotics, 
the combination therapy will kill the Helicobacter pylori and let your
ulcer heal.  

HOW PROLOX WORKS  

PROLOX belongs to a group of medicines called proton pump inhibitors
(PPIs). 
PROLOX works by decreasing the amount of acid the stomach makes, to
give relief 
from the symptoms and allow healing

Caracteristicilor produsului

DATASHEET
PROLOX
_RABEPRAZOLE SODIUM 10 MG AND 20 MG GASTRO RESISTANT TABLETS _
DESCRIPTION
Rabeprazole sodium is a substituted benzimidazole and belongs to the
class of proton pump
inhibitors. Its solubility in water is pH dependent, being very
soluble in water at pH 9 to 11, and only
slightly soluble in water at pH 8. It is very soluble in methanol,
freely soluble in dichloromethane
and practically insoluble in hexane.
The chemical name for rabeprazole sodium is (±)
2-[{4-(3-methoxypropoxy)-3-methylpyridin-2-yl}-
methylsulphinyl]-1H-benzimidazole sodium. Rabeprazole has one chiral
centre and is a racemate
of two enantiomers. It has the following structural formula:
C
18
H
20
N
3
NaO
3
S MW: 381.43
CAS-117976-89-3 (rabeprazole) CAS-117976-90-6 (rabeprazole sodium)
PROLOX is available as enteric coated tablets containing 10 mg
rabeprazole sodium (equivalent to
9.42 mg rabeprazole) or 20 mg rabeprazole sodium (equivalent to 18.85
mg rabeprazole).
PROLOX
tablets
contain
the
inactive
ingredients
mannitol,
magnesium
oxide,
hydroxypropylcellulose,
magnesium
stearate,
ethylcellulose,
hypromellose
phthalate,
dibutyl
sebacate, purified talc, titanium dioxide (E 171). The 10 mg tablet
also contains red iron oxide
(E172) and the 20 mg tablet contains yellow iron oxide (E172)
PROLOX tablets do not contain lactose or gluten.
PHARMACOLOGY
Rabeprazole sodium suppresses gastric acid secretion by the specific
inhibition of the H
+
/K
+
-
ATPase enzyme (proton pump) at the secretory surface of the gastric
parietal cell thereby blocking
the final step of acid production. This effect is dose-related and
leads to inhibition of both basal and
stimulated
acid
secretion
irrespective
of
the
stimulus.
Animal
studies
indicate
that
after
administration, rabeprazole sodium rapidly disappears from both the
plasma and gastric mucosa.
PHARMACODYNAMICS
_Anti-Secretory Activity: _ Oral administration of a 20 mg dose of
rabeprazole provides rapid and
effective reduction of gastric acid secretion. The onset of the
anti-secretory effect occurs wit