Adelphane-Esidrex

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

reserpine, dihydralazine sulfate, hydrochlorothiazide

Available from:

Sandoz Private Limited

INN (International Name):

reserpine, dihydralazine sulfate, hydrochlorothiazide

Dosage:

0,1g+10mg+10mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Adelphane-Esidrex
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One
tablet
contains
0.1
mg
reserpine,
10
mg
dihydralazine
sulfate,
and
10
mg
hydrochlorothiazide
3.
PHARMACEUTICAL FORM
Tablets.
White to off white, uncoated, round, both sides fkat with beveled edge
tablets, impressed with
letters CIBA on one side and letters A F with score in between on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
DosageGeneral target population
The dosage of Adelphane-Esidrex should be individually adapted to the
needs of the patient.
Treatment is started at the lowest possible dose, which can be
increased slowly, depending on
the patient's response (not more often than every 2-3 weeks as
applicable). A total daily
dosage of 1-3 tablets is usually sufficient and should not be
exceeded. The daily dosage
should be taken in 2-3 divided doses as applicable. If blood pressure
control is still not
adequate, switching to another pharmacological approach (e.g.
restarting treatment with a
beta-blocker,
calcium-antagonist
or
ACE-inhibitor)
should
be
considered
rather
than
increasing the dosage.
Special populations
_Renal impairment _
The dosage or dosing interval should be adjusted carefully, based on
therapeutic goals and
tolerability.
In
patients
with
impaired
renal
function
(creatinine
clearance
less
than 30 mL/min) who require treatment with a diuretic, it is
preferable to give a loop diuretic
rather than a thiazide diuretic (see section 4.4).
_Hepatic impairment _
In patients with hepatic impairment, the dosage or dosing interval
should be adjusted
carefully, based on therapeutic goals and tolerability (see section
4.4 and section 5.1).
_Paediatric patients _
This fixed-combination product should not be used in children due to
the absence of clinical
experience in this population.
_Geriatric patients _
In geriatric patients, the dosage or dosing interval should be
a