CYTOTEC Misoprostol 200 microgram tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

misoprostol, Quantity: 200 microgram

Disponibil de la:

Pfizer Australia Pty Ltd

Forma farmaceutică:

Tablet, uncoated

Compoziție:

Excipient Ingredients: sodium starch glycollate; hydrogenated castor oil; microcrystalline cellulose; hypromellose

Calea de administrare:

Oral

Unități în pachet:

120 tablets, 20 tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Cytotec is indicated in the treatment of acute duodenal and gastric ulcers. Cytotec is indicated for the prevention of stress-induced upper gastrointestinal mucosal bleeding and lesions in post-surgical patients in intensive care units. Cytotec is indicated for the prevention of gastric ulceration in patients in whom NSAID therapy is essential and who have been assessed at high risk of gastric ulceration, or the complications of gastric ulceration.

Rezumat produs:

Visual Identification: White, hexagonal tablet, scored, marked "SEARLE/1461" on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statutul autorizaţiei:

Registered

Data de autorizare:

1998-06-23

Prospect

CYTOTEC
®
_misoprostol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CYTOTEC.
It does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking CYTOTEC
against the benefits they expect it
will have for you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CYTOTEC IS
USED FOR
•
TO TREAT ACUTE ULCERS IN THE
STOMACH (GASTRIC ULCERS), OR IN
THE FIRST PART OF THE SMALL
INTESTINE (DUODENAL ULCERS).
•
TO PREVENT DEVELOPMENT OF
STOMACH ULCERS, WHICH MAY
SOMETIMES BE CAUSED BY
ARTHRITIS MEDICINES THAT ARE
CALLED NON-STEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS).
•
TO PREVENT BLEEDING IN THE
STOMACH OR UPPER INTESTINE IN
HOSPITAL PATIENTS AFTER SURGERY.
CYTOTEC makes your stomach
produce less acid, and it helps your
stomach protect itself against damage
from acid and certain other
substances, such as NSAIDs.
The active ingredient in CYTOTEC
is called misoprostol. Misoprostol is
very similar to a group of substances
called prostaglandins, which occur
naturally in the stomach and other
parts of the body. When the amount
of these natural prostaglandins is
lower than normal, there is a risk that
ulcers may occur in the stomach or
duodenum. This reduction in
prostaglandins is often a side effect
of NSAIDs. CYTOTEC can replace
prostaglandins and help to prevent
ulcers, or help heal the ulcer if you
already have one. If you are taking an
NSAID, CYTOTEC helps protect
your stomach while you continue to
receive the benefit of pain relief and
reduction in joint swelling from your
arthritis medicine.
Your doctor, however, may prescribe
CYTOTEC for another purpose.
Ask your doctor if you have any
questions about why CYTOTEC has
been prescribed for you.
There is no evidence that CYTOTEC
is addictive.
BEFORE YOU TAKE
CYTOTEC
_WHE

Caracteristicilor produsului

Version: pfpcytot11119
Supersedes: pfpcytot10609
Commercial/Non Commercial
Page 1 of 9
AUSTRALIAN
PRODUCT
INFORMATION
–
CYTOTEC
® (MISOPROSTOL)
1.
NAME OF THE MEDICINE
Misoprostol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CYTOTEC tablets contain 200 micrograms of misoprostol
3.
PHARMACEUTICAL FORM
Tablets 200 micrograms:
Scored, white, hexagonal tablets, debossed on one side with
SEARLE/1461.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CYTOTEC is indicated in the treatment of acute duodenal and gastric
ulcers.
CYTOTEC is indicated in the prevention of stress-induced upper
gastrointestinal mucosal
bleeding and lesions in post-surgical patients in intensive care
units.
CYTOTEC is indicated for the prevention of gastric ulceration in
patients in whom NSAID
therapy is essential and who have been assessed at high risk of
gastric ulceration, or the
complications of gastric ulceration.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
TREATMENT OF DUODENAL ULCERS:
800 micrograms per day in four divided doses with meals for four to
eight weeks. The last
dose should be taken at bedtime.
TREATMENT OF GASTRIC ULCERS:
800 micrograms per day in four divided doses with meals for four to
eight weeks. The last
dose should be taken at bedtime.
PREVENTION OF STRESS-INDUCED MUCOSAL BLEEDING AND LESIONS IN
POST-SURGICAL ICU PATIENTS:
200 micrograms every four hours for up to 14 days.
Version: pfpcytot11119
Supersedes: pfpcytot10609
Commercial/Non Commercial
Page 2 of 9
PREVENTION OF NSAID-INDUCED GASTRIC ULCERATION:
400 to 800 micrograms
per
day
in
divided
doses
with
meals
and
at
bedtime,
taken
simultaneously with the NSAID as appropriate. The NSAID should be
taken according to the
schedule prescribed by the physician. Cytotec may be administered for
the duration of NSAID
therapy. There are no data beyond 12 months to support the long-term
efficacy for misoprostol
for this indication.
Concomitant aluminium-containing antacids may be given as needed for
relief of pain.
DOSAGE ADJUSTMENT
ELDERLY
No dosage adjustment is recomme