MISOPROSTOL TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

MISOPROSTOL

Tilgængelig fra:

AA PHARMA INC

ATC-kode:

A02BB01

INN (International Name):

MISOPROSTOL

Dosering:

100MCG

Lægemiddelform:

TABLET

Sammensætning:

MISOPROSTOL 100MCG

Indgivelsesvej:

ORAL

Enheder i pakken:

100/250/500

Recept type:

Prescription

Terapeutisk område:

PROSTAGLANDINS

Produkt oversigt:

Active ingredient group (AIG) number: 0116767002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2010-06-02

Produktets egenskaber

0
PRODUCT MONOGRAPH
MISOPROSTOL
MISOPROSTOL TABLETS
100 MCG AND 200 MCG
MUCOSAL PROTECTIVE AGENT
AA PHARMA INC.
DATE OF PREPARATION:
100 KING STREET WEST, SUITE 5700
May 28, 2010
TORONTO, ONTARIO
M5X 1C7
CONTROL NUMBER: 138783
1
PRODUCT MONOGRAPH
MISOPROSTOL
Misoprostol Tablets
100 mcg and 200 mcg
THERAPEUTIC CLASSIFICATION
Mucosal Protective Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Misoprostol is a synthetic analogue of prostaglandin E
1
. In animals and man, orally administered
misoprostol has both gastric antisecretory and mucosal protective
effects. Its antisecretory
activity is mediated by misoprostol acid binding to specific
prostaglandin receptors on gastric
parietal cells. The mechanism of the gastrointestinal mucosal
protective effect of misoprostol is
not as well understood, but is thought to involve the replacement of
prostaglandins following their
depletion or inhibition of production, the increasing of mucus
production, the increasing of
bicarbonate secretion in the duodenum, increased mucosal blood flow,
decreased vascular
permeability, increased cellular proliferation and migration, and the
restoration of the gastric
potential difference. Studies conducted in animals and clinical trials
in humans have
demonstrated that misoprostol can protect the gastric mucosa against
various irritants such as
alcohol, acetylsalicylic acid, naproxen, tolmetin and sodium
taurocholate.
Misoprostol is a prodrug for the active de-esterified misoprostol
acid. Conversion to misoprostol
acid occurs rapidly in the stomach. The misoprostol acid then binds
locally to receptors (e.g. on
the parietal cells), undergoes additional hydrolysis, is taken up and
metabolized by cells lining the
stomach or in the liver, or is passed on to the small intestine along
with stomach contents.
2
In a recent cross-over study (1995), a single 200 mcg oral dose of
misoprostol administered to
sixteen fasting, healthy male subjects produced mean C
max
, AUC (0-24), T
max
and elimination
half-life of misoprostol acid of: 206.5 pg/mL, 141.8 pg.hr/m