ISOTRETINOIN AN isotretinoin 20mg capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
isotretinoin
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Isotretinoin
Authorization status:
Registered
Patient Information leaflet
_Isotretinoin AN capsules – Consumer Medicine Information _
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_Isotretinoin AN CMI v3.0 _
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_Page 1 _
ISOTRETINOIN AN CAPSULES
_Isotretinoin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Isotretinoin AN capsules. It does
not
contain
all
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
Isotretinoin AN capsules against
the benefits they expect it will
have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST.
Keep
this
leaflet
with
your
medicine.
You may need to read it again.
WHAT ISOTRETINOIN AN
IS USED FOR
Isotretinoin
AN
capsules
contains
the
active
ingredient
isotretinoin.
Isotretinoin AN is used to treat
acne.
Isotretinoin
AN
belongs
to
a
group
of
medicines
called
retinoids,
which
are
similar
to
vitamin A.
The retinoids work by reducing
the amount of the oily substance
(i.e. sebum) made by glands in
your
skin,
reducing
bacteria,
reducing
inflammation
and
opening clogged pores.
There are many different types
of medicines used to treat acne.
Isotretinoin AN is used for more
severe cases.
YOUR
DOCTOR,
HOWEVER,
MAY
HAVE
PRESCRIBED
ISOTRETINOIN
AN FOR ANOTHER PURPOSE.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
ISOTRETINOIN
AN
HAS
BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
Isotretinoin AN is not addictive.
BEFORE YOU TAKE
ISOTRETINOIN AN
_WHEN YOU MUST NOT TAKE _
_ISOTRETINOIN AN _
DO NOT TAKE ISOTRETINOIN AN IF:
3. YOU
HAVE
HAD
AN
ALLERGIC
REACTION
TO
ISOTRETINOIN
AN,
VITAMIN A, OTHER RETINOIDS OR
ANY
OTHER
INGREDIENTS
OF
ISOTRETINOIN AN (LISTED AT THE
END OF THIS LEAFLET)
4.
YOU
ARE
TAKING
TETRACYCLINE
ANTIBIOTICS (SUCH AS AKAMIN®,
VIBRAMYCIN®,
DOXYCYCLINE
HYDROCHLORIDE,
DORYX®,
FRAKAS®, MINOMYCIN®)
5. YOU HAVE SEVERE LIVER DISEASE
6. YOU HAVE VERY HIGH FAT LEVELS
(CHOLESTEROL,
TRIGLYCERIDES)
IN
YOUR BLOOD
7. YOU HA
Read the complete document
Summary of Product characteristics
_ _
_ _
_Isotretinoin AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Doc ID: 68.AN.P.2.0
Page 1 of 11
ISOTRETINOIN AN
_ _
_(ISOTRETINOIN TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE:
The name of the medicine is isotretinoin.
CHEMICAL NAME:
is
3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-cis-(4,6,8)-trans-nonatetraenoic
acid
MOLECULAR FORMULA:
C
20
H
28
0
2
MOLECULAR WEIGHT:
300.44
CAS REGISTRY NUMBER: _[4759-48-2] _
DESCRIPTION
Isotretinoin is related to both retinoic acid and retinol (Vitamin A).
Isotretinoin is a yellow - orange
to
orange crystalline powder that is practically insoluble in water,
soluble in methylene chloride,
sparingly soluble in ether and slightly soluble in alcohol. It is
sensitive to air, heat and light,
especially in solution.
Isotretinoin AN
capsules
contain
Isotretinoin,
yellow beeswax,
Disodium
edetate,
Butylated
Hydroxyanisole,
dl-alpha-tocopherol,
hydrogenated soya
oil,
Soya
oil,
hydrogenated vegetable
oil (5mg, 10mg and 20mg only), Soya oil – hydrogenated (40mg only).
The capsule shell contains Sorbitol solution (70% non-crystallising),
Glycerol, Gelatin, Titanium
dioxide,purified water, Brilliant scarlet 4R (10mg and 20mg only),
Sunset yellow FCF
(40mg
only), Indigo carmine (20mg only), Iron oxide black (10mg only).
PHARMACOLOGY
_PHARMACODYNAMICS_
Isotretinoin AN contains isotretinoin; this is a retinoid that
inhibits sebaceous gland function and
keratinisation. The exact mechanism of action of isotretinoin is
unknown.
Clinical improvement in cystic acne patients occurs in association
with a reduction in sebum secretion.
The decrease in sebum secretion is reversible and the extent is
related to the dose and duration of
treatment with Isotretinoin AN and reflects a reduction in sebaceous
gland size and an inhibition of
sebaceous gland differentiation.
PHARMACOKINETICS
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_Isotretinoin AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Doc ID: 68.AN.P.2.0
Page 2 of 11
ABSORPTION
There is considerable interindivi
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