Betacid ointment for topical use

देश: आर्मेनिया

भाषा: अंग्रेज़ी

स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

सक्रिय संघटक:

betamethasone (betamethasone dipropionate), salicylic acid

थमां उपलब्ध:

Arpimed LLC

ए.टी.सी कोड:

D07XC01

INN (इंटरनेशनल नाम):

betamethasone (betamethasone dipropionate), salicylic acid

डोज़:

0,5mg/g+ 30mg/g

फार्मास्यूटिकल फॉर्म:

ointment for topical use

पैकेज में यूनिट:

15g aluminium tube

प्रिस्क्रिप्शन प्रकार:

Prescription

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2018-10-09

उत्पाद विशेषताएं

SUMMARY PRODUCT CHARACTERISTIC (SPC)
BETACID
®
OINTMENT
1.1 BRAND NAME – BETACID
1.2 INTERNATIONAL NON-PROPERTY NAME –
- BETAMETHASONE / SALICYLIC ACID
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH GRAM CONTAINS:
_ACTIVE INGREDIENTS: _betamethasone - 0.5 mg (as dipropionate),
salicylic acid - 30 mg; _ _
_FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 _
3. PHARMACEUTICAL FORM
White to yellowish white odorless ointment.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betamethasone Dipropionate is a synthetic fluorinated corticosteroid.
It is active topically and
produces a rapid and sustained response in those inflammatory
dermatoses that are normally
responsive to topical corticosteroid therapy, and it is also effective
in the less responsive conditions,
such as psoriasis of the scalp, chronic plaque psoriasis of the hands
and feet, but excluding
widespread plaque psoriasis.
Topical salicylic acid softens keratin, loosens cornified epithelium
and desquamates the epidermis.
Betacid
presentations
are
therefore
indicated
for
the
treatment
of
hyperkeratotic
and
dry
corticosteroid-responsive dermatoses where the cornified epithelium
may resist penetration of the
steroid. The salicylic acid constituent of Betacid preparations, as a
result of its descaling action,
allows access of the dermis more rapidly than by applying steroid
alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Once to twice daily. In most cases a thin film should be applied to
cover the affected area twice
daily.
For some patients adequate maintenance therapy may be achieved with
less frequent application.
It is recommended that Betacid preparations are prescribed for two
weeks, and that treatment is
reviewed at that time. The maximum weekly dose should not exceed 60g.
Children:
Dosage in children should be limited to 5 days.
4.3 CONTRAINDICATIONS
Rosacea, acne, perioral dermatitis, perianal and genital pruritus.
Hypersensitivity to any of the
ingredients of the Betacid presentations contra-indicates their use as
does tuberculous and