Lorista tablets film-coated

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

losartan (losartan potassium)

Доступна с:

KRKA d.d.

код АТС:

C09CA01

ИНН (Международная Имя):

losartan (losartan potassium)

дозировка:

25mg

Фармацевтическая форма:

tablets film-coated

Штук в упаковке:

(28/2x14/) in blister, (28/4x7/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2019-10-11

тонкая брошюра

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Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
LORISTA film-coated tablets 25 mg
LORISTA film-coated tablets 50 mg
LORISTA film-coated tablets 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg, 50 mg or 100 mg of losartan
potassium.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Lorista film-coated tablets 25 mg: oval, slightly biconvex, yellow,
one-side-scored tablets.
Lorista film-coated tablets 50 mg: round, slightly biconvex, white,
bevel-edged, one-side-scored
tablets.
Lorista film-coated tablets 100 mg: oval, slightly biconvex, white
tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Treatment of essential hypertension in adults and in children and
adolescents 6-18 years of age.
-
Treatment of renal disease in adult patients with hypertension and
type 2 diabetes mellitus with
proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment.
-
Treatment of chronic heart failure in adult patients when treatment
with Angiotensin converting
enzyme (ACE) inhibitors is not considered suitable due to
incompatibility, especially cough, or
contraindication. Patients with heart failure who have been stabilised
with an ACE inhibitor
should not be switched to losartan. The patients should have a left
ventricular ejection fraction
≤ 40 % and should be clinically stable and on an established
treatment regimen for chronic heart
failure.
-
Reduction in the risk of stroke in adult hypertensive patients with
left ventricular
hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension
The usual starting and maintenance dose is 50 mg once daily for most
patients. The maximal
antihypertensive effect is attained 3-6 weeks after initiation of
therapy. Some patients may receive
an additional benefit by increasing the dose to 100 mg once daily (in
the morning).
Losartan may be administered with other antihypertensive agents,
especially with diuretics (e.g.
h