Oratane 5mg Capsule

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ISOTRETINOIN

Boleh didapati daripada:

SCHMIDT BIOMEDTECH SDN BHD

INN (Nama Antarabangsa):

ISOTRETINOIN

Unit dalam pakej:

60capsule Capsules

Dikeluarkan oleh:

Swiss Caps AG

Risalah maklumat

ORATANE 5MG, 10 MG AND 20 MG CAPSULES
(Isotretinoin)
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1. What ORATANE CAPSULES is used for
2. How ORATANE CAPSULES works
3. Before you use ORATANE CAPSULES
4. How to take ORATANE CAPSULES
5. While you are using ORATANE CAPSULES
6. Side effects
7. Storage and Disposal of ORATANE CAPSULES
8. Product Description
9. Manufacturer and Product Registration Holder
10. Date of revision
WHAT ORATANE CAPSULES IS USED FOR
The active ingredient in ORATANE CAPSULES is Oratane, a substance
very similar to vitamin A. ORATANE belongs to a group of medicines
called retinoids.
ORATANE CAPSULES are used to treat acne. Of the many acne
medicines, ORATANE is used for more severe cases.
YOUR DOCTOR MAY HAVE PRESCRIBED ORATANE FOR ANOTHER PURPOSE.
Ask your doctor if you have any questions about why ORATANE has
been prescribed for you.
ORATANE capsules are not addictive.
How ORATANE capsules works ORATANE capsules work by cutting
down the amount of oily substances (sebum) made by our glands
in your skin. ORATANE capsules will also help to reduce the bacteria,
inflammation and open clogged pores.
BEFORE YOU USE ORATANE CAPSULES
_- When you must not use it_
DO NOT TAKE ORATANE CAPSULES IF:
1. DO NOT USE IF YOU ARE PREGNANT OR THINKING OF BECOMING PREGNANT. YOUR DOCTOR CAN GIVE YOU MORE INFORMATION. IF YOU FALL PREGNANT WHILE TAKING ORATANE CAPSULES THERE IS AN EXTREMELY HIGH RISK OF HAVING A BABY THAT IS SEVERELY DEFORMED. THIS MEANS THAT YOU MUST USE EFFECTIVE CONTRACEPTION FOR ONE MONTH BEFORE, DURING AND AT LEAST ONE MONTH AFTER TREATMENT WITH ORATANE.
2. YOU ARE BREAST-FEEDING. Breastfeeding must stop before ORATANE
treatment can start. Do not breast-feed while taking ORATANE
capsules.
3. YOU HAVE HAD AN ALLERGIC REACTION TO ORATANE CAPSULES, VITAMIN A, OTHER RETINOIDS OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
4. YOU ARE TAKING TETRACYCLINE ANTIBIOTICS. These include Doxine®,
DoxyTM Achromycin ®, and Minomycin®.
5. YOU HAVE KIDNEY OR LIVER DISEASE.

Ciri produk

PRESENTATION
ORATANE
5
mg
capsules
are
faint
pinkish-cream
to
cream coloured, oval, soft-gelatin capsules containing
a yellow/ orange, opaque, viscous liquid. ORATANE 10
mg capsules are opaque, violet, oval, length 10 mm and
diameter 7 mm, containing 10 mg of isotretinoin.
ORATANE 20 mg capsules are opaque, maroon, oval,
length 13 mm and diameter 8 mm, containing 20 mg
of isotretinoin.
ACTIONS
Isotretinoin is a retinoid with a specific antiseborrheic
action
for
oral
treatment
of
severe
cystic
acne
and
conglobate
acne
resistant
to
other
forms
of
treatment.
Isotretinoin,
the
active
ingredient
of
ORATANE,
is
a
synthetic
stereoisomer
of
alltrans
retinoic
acid
(tretinoin),
an
active
substance
which
has
proved
effective
in
topical
treatment
of
acne
vulgaris, Isotretinoin is chemically identified as 13-cis
retinoic
acid:
(2Z,
4E,
6E,
8E)-3,7-dimethyl-9-(2,6,6-
trimethylcyclohexen-1-yl)
nona-2,4,6,8-tetraenoic
acid, molecular weight 300.42 and molecular formula is
C
20
H
28
O
2
Administered orally, isotretinoin has a marked
effect
in
severe
forms
of
acne,
which
have
proved
insufficiently
responsive
to
previous
treatment.
The
mechanism of action of isotretinoin has not yet been
elucidated in detail, but it has been established that
the
improvement
observed
in
the
clinical
picture
of
severe acne is associated with doserelated suppression
of
sebaceous
gland
activity
and
a
histologically
demonstrated reduction in the size of the sebaceous
glands. Furthermore, a dermal anti-inflammatory effect
of isotretinoin has been established.
PHARMACOKINETICS
Time-related blood concentrations can be predicted on
the basis of linear pharmacokinetics.
_ABSORPTION:_
Peak plasma concentrations (Cmax) of approximately
200-300ng/ml have been achieved in healthy volunteers
three
to
four
hours
(tmax)
after
administration
of
40
mg
isotretinoin.
Taking
isotretinoin
with
food
increases bioavailability up to twofold relative to fasting
conditions, probably as a result of easier absorption oft
his highly lipophilic medication. Furthermore, there is a