ACITRETIN-TEVA acitretin 10mg capsule blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

acitretin, Quantity: 10 mg

Beschikbaar vanaf:

Teva Pharma Australia Pty Ltd

INN (Algemene Internationale Benaming):

Acitretin

farmaceutische vorm:

Capsule, hard

Samenstelling:

Excipient Ingredients: iron oxide yellow; spray-dried liquid glucose; iron oxide black; titanium dioxide; iron oxide red; microcrystalline cellulose; Gelatin; sodium ascorbate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol; Shellac; sulfuric acid

Toedieningsweg:

Oral

Eenheden in pakket:

10 Capsules Starter Pack, 30 capsules, 100 capsules

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Acitretin may be used for the treatment of Severe intractable psoriasis in all its forms. Severe forms of disorders of keratinisation such as: hyperkeratosis palmaris et plantaris; pustulosis palmaris et plantaris; ichthyosis; keratosis follicularis (Darier's disease); lichen planus affecting the skin or the mucosae; pityriasis rubra pilaris.

Product samenvatting:

Visual Identification: Hard gelatin capsules with a white opaque body and a brown opaque cap printed in black ink on the cap, and '10' on the body.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Licence status A

Autorisatie datum:

2011-01-12

Productkenmerken

AUSTRALIAN PI – ACITRETIN TEVA (ACITRETIN) CAPSULES
1
NAME OF THE MEDICINE
Acitretin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACITRETIN TEVA (acitretin) is a retinoid for the oral treatment of
severe cases of psoriasis and
disorders of keratinisation. It is available as 10 and 25 mg capsules.
The
chemical
name
of
acitretin
is
all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-
2,4,6,8-nonatetranoic acid. Its empirical formula is C
21
H
26
O
3
with a molecular weight of 326.44.
Each 10 mg Acitretin TEVA capsule contains 10 mg of acitretin.
Each 25 mg Acitretin TEVA capsule contains 25 mg of acitretin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Acitretin is a metabolite of etretinate and is related to both
retinoic acid and retinol (Vitamin A).
Acitretin is a green-yellow crystalline powder. It is virtually
insoluble in water (< 0.1 mg/100 mL).
The pKa is approximately 5. It is present in the capsules as a
spray-dried powder.
The hard gelatin capsules have a white opaque body and a brown opaque
cap with the number “10”
printed in black ink on the body.
The hard gelatin capsules have a yellow opaque body and a brown opaque
cap with the number
“25” printed in black ink on the body.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Acitretin may be used for the treatment of:
•
Severe intractable psoriasis in all its forms
•
Severe forms of disorders of keratinisation such as
−
hyperkeratosis palmaris et plantaris
−
pustulosis palmaris et plantaris
−
ichthyosis
−
keratosis follicularis (Darier's disease)
−
lichen planus affecting the skin or the mucosae
−
pityriasis rubra pilaris
Teva Pharma Australia Pty Limited Version 4.0 1
Based on Teva CCSI: No. 918/03/07/19
4.2
D
OSE AND METHOD OF ADMINISTRATION
ACITRETIN TEVA should only be prescribed by physicians who are
experienced in the use of systemic
retinoids and understand the risk of teratogenicity associated with
acitretin therapy.
ADULTS
Because there are differences in the absorpti