DERMATANE isotretinoin 10mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isotretinoin, Quantity: 10 mg

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Isotretinoin

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: Soya Oil; dl-alpha-tocopherol; disodium edetate; butylated hydroxyanisole; partially hydrogenated soya oil; yellow beeswax; hydrogenated vegetable oil; Gelatin; glycerol; sorbitol solution (70 per cent) (non-crystallising); brilliant scarlet 4R; iron oxide black; titanium dioxide; purified water

Administration route:

Oral

Units in package:

60 capsules, 15 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of severe cystic acne. A single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Product summary:

Visual Identification: Light violet coloured oval soft gelatin capsules, containing a yellow-orange opaque viscous liquid; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-01-08

Patient Information leaflet

1
DERMATANE™
DERMATANE™
_contains the active ingredient isotretinoin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Dermatane.
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 Dermatane
against the benefits the medicine is
expected to 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 DERMATANE IS USED
FOR
Dermatane contains the active
ingredient isotretinoin.
Dermatane is used to treat acne.
Dermatane 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.
Dermatane is used for more severe
cases.
YOUR DOCTOR MAY HAVE PRESCRIBED
DERMATANE FOR ANOTHER PURPOSE.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DERMATANE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
DERMATANE is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DERMATANE IF:
1.
YOU ARE PREGNANT OR FOR AT LEAST
ONE MONTH BEFORE YOU INTEND TO
BECOME PREGNANT
IF YOU FALL PREGNANT WHILE
TAKING DERMATANE, THERE IS AN
EXTREMELY HIGH RISK OF HAVING A
BABY THAT IS SEVERELY DEFORMED.
YOU MUST USE EFFECTIVE
CONTRACEPTION FOR ONE MONTH
BEFORE, DURING AND ONE MONTH
AFTER TREATMENT WITH
DERMATANE.
2.
YOU ARE BREASTFEEDING
BREASTFEEDING MUST STOP BEFORE
DERMATANE TREATMENT CAN
BEGIN. DO NOT BREASTFEED WHILE
TAKING DERMATANE.
3.
YOU HAVE HAD AN ALLERGIC
REACTION TO DERMATANE, VITAMIN
A, OTHER RETINOIDS OR ANY
INGREDIENTS OF DERMATANE LISTED
AT THE END OF THIS LEAFLET
4.
YOU ARE TAKING TETRACYCLINE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – DERMATANE (ISOTRETINOIN)
1
NAME OF THE MEDICINE
Isotretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Dermatane 5 mg capsule contains isotretinoin 5 mg
Each Dermatane 10 mg capsule contains isotretinoin 10 mg
Each Dermatane 20 mg capsule contains isotretinoin 20 mg
Each Dermatane 40 mg capsule contains isotretinoin 40 mg
Isotretinoin is a yellow or light orange crystalline powder
practically insoluble in water, soluble
in methylene chloride and slightly soluble in ethanol (96 per cent).
It is sensitive to air, heat and
light, especially in solution.
Excipients with known effect
Contains soya bean oil (refined, hydrogenated and partially
hydrogenated).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Dermatane 5: Faint pinkish-cream to cream coloured oval, soft gelatin
capsules, containing a
yellow/orange, viscous liquid.
Dermatane 10: Light violet coloured oval soft gelatin capsules,
containing a yellow/ orange
viscous liquid.
Dermatane 20: Maroon coloured oval soft gelatin capsules, containing a
yellow/orange viscous
liquid.
Dermatane 40: Light orange coloured, oval, soft gelatin capsules,
containing a yellow/orange,
opaque, viscous liquid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Dermatane is indicated for the treatment of severe cystic acne and a
single course of therapy
has been shown to result in complete and prolonged remission of
disease in many patients. If a
second course of therapy is needed, it should not be initiated until
at least eight weeks after
completion of the first course, since experience has shown that
patients may continue to
improve while off the drug. Due to significant adverse effects
associated with its use,
isotretinoin should be reserved for patients with severe cystic acne
who are unresponsive to
conventional therapy, including systemic antibiotics.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The therapeutic response to isotretinoin is dose related and varies
between patients. This
necessitate