ISOTRETINOIN-GA isotretinoin 30 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isotretinoin, Quantity: 30 mg

Available from:

Douglas Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Capsule, soft

Composition:

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

Administration route:

Oral

Units in package:

30 capsules, 60 capsules, 90 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: Pink coloured soft gelatin capsules containing a yellow/orange viscous liquid; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-05-08

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ISOTRETINOIN-GA
(ISOTRETINOIN) SOFT CAPSULES
1
NAME OF THE MEDICINE
Isotretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isotretinoin-GA capsules contain either 5 mg, 10 mg, 20 mg, 30 mg, or
40 mg of isotretinoin.
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.
Excipients with known effect: soy bean oil
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Isotretinoin-GA
5 mg capsules are soft, oval, faint pinkish/cream to cream in colour
containing a
yellow/orange liquid.
Isotretinoin-GA
10 mg capsules are light violet coloured soft capsules containing a
yellow/orange
viscous liquid.
Isotretinoin-GA
20 mg capsules are maroon coloured soft capsules containing a
yellow/orange viscous
liquid.
Isotretinoin-GA 30 mg capsules are pink coloured soft capsules
containing a yellow/orange viscous
liquid.
Isotretinoin-GA
40 mg capsules are orange coloured soft capsules containing a
yellow/orange viscous
liquid.
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Isotretinoin-GA 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.
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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The therapeutic response to isotretinoin is dose related and varies