Asomex-D

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate), hydrochlorothiazide

Available from:

Emcure Pharmaceuticals Ltd.

INN (International Name):

amlodipine (amlodipine besilate), hydrochlorothiazide

Dosage:

2,5mg+12,5mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Patient Information leaflet

Asomex-D_PI_04.07.13BS, v1
PRESCRIBING INFORMATION
_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory Only_
_ _
TRADE NAME: ASOMEX-D
INN: S (-) AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS
COMPOSITION:
Each uncoated tablet contains:
S (-) Amlodipine besilate equivalent to S (-) Amlodipine…….2.5 mg
Hydrochlorothiazide
BP……………………………………...12.5 mg
EXCIPIENTS:
Pregelatinised Starch, Lake of Sunset Yellow, Microcrystalline
Cellulose, Colloidal
Silicon Dioxide, Sodium Starch Glycolate, Purified Talc, Magnesium
Stearate
PHARMACEUTICAL FORM: Tablets
DESCRIPTION:
This is fixed dose combination (FDC) of S (-) Amlodipine, a chirally
pure calcium
channel blocker and a thiazide diuretic hydrochlorothiazide. S (-)
Amlodipine is the
pharmacologically active isomer of amlodipine. S (-) Amlodipine is
chemically
designated
as
S(-)-3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-
1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
benzenesulphonate.
Its
empirical
formula
is:
C
20
H
25
ClN
2
O
5
·C
6
H
6
O
3
S
with
a
molecular
weight
of
567.1.
Hydrochlorothiazide
is
a
thiazide
diuretic.
Hydrochlorothiazide
is
chemically
designated
as
6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide
1,1-
dioxide. Its empirical formula is C
7
H
8
ClN
3
O
4
S
2.
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS
S
(-)
Amlodipine,
the
chirally
pure
form
of
amlodipine
is
a
calcium
channel
antagonist belonging to the dihydropyridine class. The S (-) isomer of
amlodipine is
2
found to possess greater pharmacological effects than R (+)
Amlodipine. S (-)
Amlodipine is 1000 times more potent than the R (+) isomer in binding
to the
dihydropyridine
receptor.
In
humans,
the
dominant
effects
of
amlodipine
are
consequent to vasodilation. S (-) Amlodipine lowers peripheral
vascular resistance
without causing a reflex tachycardia. It is effective as a once daily
dosage in the
control of hypertension. In patients with angina pectoris S (-)
Amlodipine is thought
to
exert
its
effect
by
reducing
myocard

Summary of Product characteristics

EMCURE
ASOMEX-D
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
ASOMEX-D
[S (-) Amlodipine 2.5 mg + Hydrochlorothiazide 12.5 mg Tablets]
EMCURE
ASOMEX-D
Page 2 of 12
1. NAME OF THE MEDICINAL PRODUCT
ASOMEX-D
2. QUALITATIVE AND QUANTITATIVE COMPOSITION ASOMEX-D
Each uncoated tablets contains;
S (-) Amlodipine besilate, equivalent to S(-)Amlodipine….…2.5 mg
Hydrochlorothiazide BP .…….………………………….…..
12.5 mg
3. PHARMACEUTICAL FORM
Tablets
4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION
For the treatment of mild to moderate hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual initial dosage is one tablet of Asomex-D daily.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the components of the formulation and other
sulfonamide
derived drugs. Amlodipine is contraindicated in patients with severe
hypotension,
shock (including cardiogenic shock), obstruction of the outflow tract
of the left
ventricle (e.g. high grade aortic stenosis), and in haemodynamically
unstable heart
failure
patients
after
acute
myocardial
infarction.
Hydrochlorothiazide
is
contraindicated in patients with anuria (failure of the kidneys to
produce urine which
is
associated
with
uremia
and
therefore
may
require
hemodialysis).
Owing
to
EMCURE
ASOMEX-D
Page 3 of 12
absence of human data, this combination should not be administered to
pregnant
women.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
S-Amlodipine
No controlled clinical study of S (-) Amlodipine has been performed in
patients with
hepatic impairment and renal impairment. Clinical studies in patients
with normal
liver function have shown that there is no elevation in the hepatic
enzymes with the
use of S (-) Amlodipine. However, caution should be taken while
administering S (-)
Amlodipine to patients with hepatic and renal impairment.
Hydrochlorothiazide
Acute
myopia
and
secondary
angle-closure
glaucoma:
Hydrochlorothiazide,
a
sulfonamide, can cause an idiosyncratic reaction, resulting in acute
transient myopia
and acute angle-closure glaucoma. Symp