Kostarox tablets film-coated

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

etoricoxib

Disponível em:

Salutas Pharma GmbH

Código ATC:

M01AH05

DCI (Denominação Comum Internacional):

etoricoxib

Dosagem:

90mg

Forma farmacêutica:

tablets film-coated

Unidades em pacote:

(28/2x14/) in blister

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2018-08-31

Características técnicas

m13 - statement-spc_am_en - 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
KOSTAROX® film-coated tablets
60 mg, 90 mg, 120 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is etoricoxib.
Each film-coated tablet contains 60 mg, 90 mg or 120 mg of etoricoxib.
For the list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
_Description_:
60 mg: dark green, round, biconvex film-coated tablets.
90 mg: white, round, biconvex film-coated tablets.
120 mg: pale green, round, biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kostarox is indicated in adults and adolescents 16 years of age and
older for:
-
the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis
(RA), ankylosing spondylitis,
and the pain and signs of inflammation associated with acute gouty
arthritis,
-
the short-term treatment of moderate pain associated with dental
surgery.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of the
individual patient’s overall risks (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of etoricoxib may increase with dose and
duration of exposure, the shortest
duration possible and the lowest effective daily dose should be used.
The patient’s need for
symptomatic relief and response to therapy should be re-evaluated
periodically, especially in patients
with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
_Osteoarthritis_
The recommended dose is 30 mg once daily. In some patients with
insufficient relief from symptoms,
an increased dose of 60 mg once daily may increase efficacy. In the
absence of an increase in
therapeutic benefit, other therapeutic options should be considered.
_Rheumatoid arthritis_
The recommended dose is 60 mg once daily. In some patients with
insufficient relief from symptoms,
an increased dose of 90 mg once daily may increase efficacy. Once the
patient is clinically stabilised,
down-titration to a