Lorista H 100 tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

losartan (losartan potassium), hydrochlorothiazide

Available from:

KRKA d.d.

ATC code:

C09DA01

INN (International Name):

losartan (losartan potassium), hydrochlorothiazide

Dosage:

100mg+ 12,5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-10-03

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Lorista
®
H 100, 100 mg/12.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg losartan potassium and 12.5 mg
hydrochlorothiazide.
Excipient: lactose monohydrate.
Each tablet contains:
Lorista H 100
100 mg/12.5 mg
lactose
83.98 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Lorista H 100, 100 mg/12.5 mg: white, oval, biconvex film coated
tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lorista H 100, 100 mg/12.5 mg is indicated for the treatment of
essential hypertension in patients whose
blood pressure is not adequately controlled on losartan or
hydrochlorothiazide alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Hypertension
The combination of losartan and hydrochlorothiazide (HCTZ) is not for
use as initial therapy, but in
patients whose blood pressure is not adequately controlled by losartan
or hydrochlorothiazide alone.
Dose titration with the individual components (losartan and
hydrochlorothiazide) is recommended.
When clinically appropriate, a direct change from monotherapy to the
fixed combination may be
considered in patients whose blood pressure is not adequately
controlled.
The usual maintenance dose of Lorista H is one tablet of Lorista H 50
mg/12.5 mg (losartan 50
mg/hydrochlorothiazide 12.5 mg) once daily. For patients who do not
respond adequately to Lorista H 50
mg/12.5 mg, the dosage may be increased to one tablet of Lorista HD
100 mg/25 mg (losartan 100
mg/hydrochlorothiazide 25 mg) once daily. The maximum dose is one
tablet of Lorista HD 100 mg/25 mg
once daily. In general, the antihypertensive effect is attained within
three to four weeks after the initiation
of therapy.
Lorista H 100 (losartan 100 mg/HCTZ 12.5 mg) is available for those
patients titrated to 100 mg of
Lorista who require additional blood pressure control.
CONFIDENTIAL
Lorista H 100 film-coated tablet 100 mg/12.5 mg
VOL: 1; P: 16 / 165
2
Use in patients with renal impairment and