Lorista

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

losartan (losartan potassium)

Доступна с:

KRKA d.d.

ИНН (Международная Имя):

losartan (losartan potassium)

дозировка:

50mg

Фармацевтическая форма:

tablets film-coated

Тип рецепта:

Prescription

Характеристики продукта

1.3.1
Losartan potassium
SPC, Labeling and Package Leaflet
AM
SmPCPIL050418_3
13.05.2014 – Updated: 10.07.2014
Page 1 of 8
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
-
Hypertension
Lorista is indicated for the treatment of hypertension.
-
Reduction in the risk of cardiovascular morbidity and mortality in
hypertensive patients with
left ventricular hypertrophy
Lorista is indicated to reduce the risk of cardiovascular morbidity
and mortality as measured by
the combined incidence of cardiovascular death, stroke, and myocardial
infarction in
hypertensive patients with left ventricular hypertrophy.
-
Heart failure
Lorista is indicated for the treatment of heart failure when treatment
with an ACE inhibitor is
not appropriate.
Switching patients with heart failure who are stable on an ACE
inhibitor to Lorista is not
recommended.
-
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Patients may take the drug with or without food.
Patients may take Lorista concomitantly with other antihypertensive
agents.
Hypertension
In most patients, the initial and maintenance doses are 50 mg once
daily. The maximal
antihypertensive effect is attained after three to six weeks of
treatment. In some patients, greater effect
may be achieved