Lorista HD 100mg+25mg tablets film-coated

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

losartan (losartan potassium), hydrochlorothiazide

Доступна с:

KRKA d.d.

код АТС:

C09DA01

ИНН (Международная Имя):

losartan (losartan potassium), hydrochlorothiazide

дозировка:

100mg+25mg

Фармацевтическая форма:

tablets film-coated

Штук в упаковке:

(28/2x14/), in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2016-05-19

Характеристики продукта

1.3.1
Losartan potassium + Hydrochlorothiazide
SPC, Labeling and Package Leaflet
SmPCPIL057943_1
21.11.2014 – Updated: 21.11.2014
Page 1 of 8
1
NAME OF THE MEDICINAL PRODUCT
Lorista
®
HD film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
contains
100
mg
losartan,
potassium
salt,
and
25
mg
hydrochlorothiazide.
The excipients are stated under item 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets: yellow, oval, slightly biconvex tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arterial hypertension when combined treatment is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lorista HD is not recommended as initial therapy. One Lorista HD
tablet once daily is
recommended for those patients who do not respond adequately to
Lorista H (losartan 50 mg/
hydrochlorothiazide 12.5 mg) given once daily. Dosage should be
adjusted according to the
blood pressure reduction achieved in 3 weeks of treatment. The maximum
recommended
daily dose is 1 Lorista HD tablet.
_Dosage in renal impairment: _
No initial dosage adjustment is necessary in
patients with mild renal impairment (i.e.
creatinine clearance 20-50 ml/min). Lorista HD is not recommended in
patients with moderate
to severe renal impairment and in patients on hemodialysis.
_Dosage in patients with intravascular volume depletion_:
Lorista HD should not be initiated in patients who are intravascularly
volume depleted (e.g.
those treated with high-dose diuretics). therefore treatment with
Lorista HD should not be
initiated before treatment with diuretics is discontinued and
hypovolemia improved.
_Dosag in hepatic impairment_:
Lorista HD is not recommended for treatment of patients with hepatic
impairment.
Patients can take Lorista HD with food or on an empty stomach. In
order not to leave out any
tablets, they should take the drug at the same time every day. They
should not take a double
dose to make up for a forgotten dose. They should take the next dose
at the usually scheduled
time.
The duration of treatment is not limited.