Saranto-H 50mg12.5mg Tablets

País: Malásia

Língua: inglês

Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes ativos:

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

Disponível em:

HEALOL PHARMACEUTICALS SDN. BHD.

DCI (Denominação Comum Internacional):

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

Unidades em pacote:

30tablet Tablets; 10 x 10 Tablets

Fabricado por:

Aurobindo Pharma Limited

Folheto informativo - Bula

SARANTO-H
®
Losartan Potassium and Hydrochlorothiazide (50/12.5 mg)
Black
A/s: 280 x 600 mm
Booklet Size: 35 x 60 mm
_CONSUMER MEDICATION INFORMATION LEAFLET _
_(RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What SARANTO-H is used for (Losartan Potassium and
Hydrochlorothiazide Tablets)
2.
How SARANTO-H works
3.
Before you use SARANTO-H
4.
How to use SARANTO-H
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of SARANTO-H
8.
Product Description
9.
Manufacturer and Product Registration Holder
10. Date of revision
WHAT SARANTO-H IS USED FOR
•
Hypertension: Saranto-H is indicated for the treatment of
hypertension, for patients in whom combination therapy is
appropriate.
•
Hypertensive Patients with Left Ventricular Hypertrophy:
Saranto-H is indicated to reduce the risk of stroke in patients
with hypertension and left ventricular hypertrophy, but
there is evidence that this benefit does not apply to Black
patients.
HOW SARANTO-H WORKS
Saranto-H is the first combination of an angiotensin II receptor
antagonist and a diuretic.
Losartan inhibits systolic and diastolic pressor responses to
angiotensin II infusions. At peak, Losartan potassium 100 mg
inhibits these responses by approximately 85%; 24 hrs after
single and multiple-dose administration, inhibition is about
26-39%.
BEFORE YOU USE SARANTO-H
-
When you must not use it
_In case of_
•
Hepatic and Renal Impairment
•
Renal Function Impairment:
•
Hypotension and Electrolyte/Fluid Imbalance.
•
Metabolic and Endocrine Effects.
-
Before you start use it
_It is important to _
tell your doctor before
_taking _
Saranto-H
_in case of _
:-
•
Patients
with
a
history
of
angiooedema
(swelling
of
the face, lips, throat, and/or tongue) should be closely
monitored
•
Symptomatic hypotension, especially after the first dose,
may occur in patients who are volume- and/or sodium
depleted
by
vigorous
diuretic
therapy,
dietary
salt
restriction, diarrhoea or vomiting. Such conditions should
be corrected before the administration of Saranto-H.
•
Electrolyte
imbalan

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
SARANTO–H 50 MG/12.5 MG TABLETS
(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 50 MG/12.5 MG)
R
X ONLY
NAME OF THE DRUG PRODUCT:
SARANTO–H 50 MG/12.5 MG TABLETS
(Losartan Potassium and Hydrochlorothiazide
Tablets 50 mg/12.5 mg)
NAME AND STRENGTH OF ACTIVE INGREDIENT:
Losartan
Potassium Ph.Eur. 50 mg and
Hydrochlorothiazide Ph.Eur. 12.5 mg
DOSAGE FORM:
Film-Coated Tablet
PRODUCT DESCRIPTION:
Yellow colored, oval shaped, beveled edge, biconvex film coated
tablets debossed with ‘E’ on one side
‘48’ on the other side.
PHARMACODYNAMICS/PHARMACOKINETICS:
PHARMACODYNAMICS
Pharmacotherapeutic group: Angiotensin II antagonists and diuretics
Losartan -Hydrochlorothiazide
The components of Losartan and Hydrochlorothiazide have been shown to
have an additive effect on
blood pressure reduction, reducing blood pressure to a greater degree
than either component alone. This
effect is thought to be a result of the complimentary actions of both
components. Further, as a result of
its diuretic effect, hydrochlorothiazide increases plasma renin
activity, increases aldosterone secretion,
decreases serum potassium, and increases the levels of angiotensin II.
Administration of Losartan blocks
all the physiologically relevant actions of angiotensin II and through
inhibition of aldosterone could tend to
attenuate the potassium loss associated with the diuretic.
Losartan has been shown to have a mild and transient uricosuric
effect. Hydrochlorothiazide has been
shown to cause modest increase in uric acid; the combination of
Losartan and hydrochlorothiazide tends
to attenuate the diuretic induced hyperuricemia.
The anti hypertensive effect of Losartan Potassium and
hydrochlorothiazide is sustained for 24-hour
period. In clinical studies of one year duration, the antihypertensive
effect was maintained with continued
therapy .Despite the significant decrease in blood pressure,
administration of Losartan Potassium and
Hydrochlorothiazide had no significant effect on heart rate.
Losartan Pota