Sulfasalazin tablets film-coated

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

sulfasalazine

Disponível em:

KRKA d.d.

Código ATC:

A07EC01

DCI (Denominação Comum Internacional):

sulfasalazine

Dosagem:

500mg

Forma farmacêutica:

tablets film-coated

Unidades em pacote:

(50/5x10/) in blister

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2016-11-23

Características técnicas

1
1.
NAME OF THE MEDICINAL PRODUCT
Sulfasalazin 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg sulfasalazine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The tablets are
round, brow-yellow, slightly biconvex tablets, bevel-edged, coated
with
colourless film.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The drug is recommended for:
-
treatment of acute outbreaks and exacerbations of Crohn’s disease,
ulcerative colitis and
proctitis,
-
maintenance of remission of ulcerative colitis and proctitis,
-
treatment of rheumatoid arthritis and juvenile idiopathic chronic
polyarthritis that do not respond
sufficiently to nonsteroidal anti-inflammatory drugs.
Sulfasalazin can be combined with corticosteroids and metronidazole.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage should be adjusted according to the severity of the disease and
possible undesirable effects.
_Acute outbreak of ulcerative colitis and proctitis, and Crohn's
disease_
Adults and children over 16 years of age should take 2 to 4 tablets (1
to 2 g) 4 times a day.
Children over 2 years of age can be given 40 to 60 mg of the drug per
kg body weight a day.
After achieving remission, the dose should be gradually reduced.
_Maintenance of remission of ulcerative colitis and proctitis_
The recommended maintenance dosage for adults and children over 16
years of age is 1 tablet
(500 mg) 4 times a day.
Children over 2 years of age can be given 20 to 30 mg sulfasalazine
per kg body weight a day.
The duration of maintenance treatment is unlimited.
_Rheumatoid arthritis and juvenile idiopathic chronic polyarthritis_
The recommended dose for adults and children over 16 years of age is 2
to 3 g a day. Treatment
should be started with 1 tablet (500 mg) of sulfasalazine a day. The
dose should be increased
gradually, at weekly intervals, so that after 4 weeks 2 tablets (1 g)
are taken 2 to 3 times a day. The
clinical effect should become evident a