Isotretinoin Actavis

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Isotretinoin 20mg;  

Verfügbar ab:

Teva Pharma (New Zealand) Limited

INN (Internationale Bezeichnung):

Isotretinoin 20 mg

Dosierung:

20 mg

Darreichungsform:

Soft gelatin capsule

Zusammensetzung:

Active: Isotretinoin 20mg   Excipient: Ferrous oxide Gelatin Glycerol Soya bean oil, partially hydrogenated Ferrous oxide yellow Soya bean oil, hydrogenated Soya oil Titanium dioxide Yellow beeswax

Einheiten im Paket:

Blister pack, PVC/PE/PVDC Al, 100 capsules

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Ranbaxy Laboratories Ltd

Anwendungsgebiete:

Severe forms of nodulo-cystic acne which are resistant to therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. Isotretinoin Actavis should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists, and understand the risk of teratogenicity if Isotretinoin Actavis is used during pregnancy.

Produktbesonderheiten:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC Al - 60 capsules - 24 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PE/PVDC Al - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light

Berechtigungsdatum:

2009-07-03

Fachinformation

ARROW - ISOTRETINOIN 
Isotretinoin Capsules 5mg, 10mg & 20mg 
This product may not be interchangeable with similar products on the New Zealand 
market. 
PRESENTATION 
ARROW – ISOTRETINOIN 5 
Red-orange, oval, soft gelatin capsules approximately 11 mm in length and 8 mm in 
diameter.  Each capsule contains 5 mg of isotretinoin. 
ARROW – ISOTRETINOIN 10 
Red-orange, oval, soft gelatin capsules approximately 12 mm in length and 8 mm in 
diameter.  Each capsule contains 10 mg of isotretinoin. 
ARROW – ISOTRETINOIN 20 
Red-orange, oval, soft gelatin capsules approximately 15 mm in length and 10 mm in 
diameter.  Each capsule contains 20 mg of isotretinoin. 
USES 
_ACTIONS _
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 dose-related 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 (C
max
) of approximately 200-300 ng/ml have been 
achieved in healthy volunteers three to four hours (t
max
) 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 of this highly lipophilic 
medication.  Furthermore, there is an overall decrea