ISOTRETINOIN ASCENT isotretinoin 40mg capsule blister pack

Active ingredient:

isotretinoin, Quantity: 40 mg

Available from:

Douglas Pharmaceuticals Australia Pty Ltd

INN (International Name):

Isotretinoin

Pharmaceutical form:

Capsule, soft

Composition:

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

Administration route:

Oral

Units in package:

60 capsules, 15 capsules, 90 capsules, 30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ISOTRETINOIN ASCENT 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 cyctic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Product summary:

Visual Identification: Light orange, oval, soft gelatin capsule 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:

2012-06-08