ACITRETIN-TEVA acitretin 25mg capsule blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

acitretin, Quantity: 25 mg

थमां उपलब्ध:

Teva Pharma Australia Pty Ltd

INN (इंटरनेशनल नाम):

Acitretin

फार्मास्यूटिकल फॉर्म:

Capsule, hard

रचना:

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

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

30 capsules, 10 Capsules Starter Pack, 100 capsules

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

2011-01-12

उत्पाद विशेषताएं

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