Dexamethason tablets

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

dexamethasone

Доступна с:

KRKA d.d.

код АТС:

H02AB02

ИНН (Международная Имя):

dexamethasone

дозировка:

0,5mg

Фармацевтическая форма:

tablets

Штук в упаковке:

(10/1x10/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2019-05-23

Характеристики продукта

1.3.1
Dexamethasone
SPC, Labeling and Package Leaflet
SmPCPIL145918_1
09.03.2020 – Updated: 09.03.2020
Page 1 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Dexamethason 0.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5 mg dexamethasone.
Excipient with known effect:
Each tablet contains 40.38 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White or almost white, round tablets with bevel edges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Replacement therapy for adrenocortical insufficiency and congenital
diseases of the adrenal
cortex (congenital adrenal hyperplasia),
-
Due to anti-inflammatory, analgesic and anti-allergic and
imuno-supressive effects it is
recommended for the treatment of rheumatic diseases, systemic
connective tissue disorders,
allergic and skin disorders, eye disorders, gastrointestinal
disorders, respiratory disorders,
haematological disorders, renal disorders, some malignant disorders
and after organ
transplantation,
-
In inflammatory rheumatic disorders (mainly rheumatoid arthritis ) the
drug is generally
recommended as bridging therapy over the period during which the basic
medication is not yet
effective, and in patients in whom the analgesic and anti-inflammatory
effects of nonsteroidal
anti-inflammatory drugs have been unsatisfactory.
-
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage should be adjusted to each individual patient according to the
disease, expected duration of
treatment, tolerance to the drug and response to treatment.
_Treatment_
The recommended initial dose for adults is 0.5 mg to 9 mg daily. The
usual maintenance dose is
0.5 mg to 3 mg daily. The daily dose can be divided into 2 to 4 doses.
Initial doses of dexamethasone should be given until clinical response
is achieved, then the dosage
should be gradually reduced to the lowest, still clinically effective
level. When high-dose treatment
lasts for more than a few days, the dose should be gradually reduced
over se