Asomex-2,5

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate)

Available from:

Emcure Pharmaceuticals Ltd.

INN (International Name):

amlodipine (amlodipine besilate)

Dosage:

2,5mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Patient Information leaflet

S-Amlodipine_Armenia_PI_12.12.13_BS, v1
_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory Only_
_ _
ASOMEX – 2.5 / ASOMEX – 5
S (-) Amlodipine Besilate Tablets
THERAPEUTIC CATEGORY:
_ _Calcium channel blocker
PHARMACEUTICAL FORM:
Tablets
COMPOSITION:
ASOMEX - 2.5
Each uncoated tablet contains:
S (-) Amlodipine besilate equivalent to
S (-) Amlodipine
2.5 mg
Colour: Yellow Oxide of Iron
ASOMEX - 5
Each uncoated tablet contains:
S (-) Amlodipine besilate equivalent to
S (-) Amlodipine
5 mg
Colour: Yellow Oxide of Iron
Excipients: Microcrystalline cellulose, Colloidal silicon dioxide,
Yellow oxide of Iron, Croscarmellose sodium,
Magnesium stearate
DESCRIPTION
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
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 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.
PHARMACOKINETICS:
Administration of S (-) Amlodipine 5 mg as a single dose in the
fasting state produced maximum plasma
concentration (C
max
) of 2.98
±
0.441 ng/ml in 8.05
±
2.24 hours (T
max
). The mean AUC
0-t
value (t= 196 hours) of
S (-) Amlodipine (5 mg tablet) was 163.89 ± 42.52 ng.hr/ml. The AUC
0-
∞
value was 176.57 ± 44.31 ng.hr/ml.
Amlodipine is extensively (abou

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
ASOMEX - 2.5 / ASOMEX-5
[S (-) Amlodipine Besilate Tablets]
SUMMARY OF PRODUCT CHARACTERISTICS
ASOMEX – 2.5 / 5 TABS
TABLE OF CONTENTS
1. NAME OF THE MEDICAL PRODUCT
..........................................................................
3
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION............................................ 3
3. PHARMACEUTICAL FORM
..........................................................................................
3
4. CLINICAL
PARTICULARS.............................................................................................
3
4.1 Therapeutic
Indications................................................................................................
3
4.2 Posology and method of administration
......................................................................
3
4.3 Contraindications
.........................................................................................................
4
4.4 Special warnings and precautions for
use....................................................................
4
4.5 Interaction with other medicinal products and other forms of
Interaction .................. 5
4.6 Pregnancy and
Lactation..............................................................................................
6
4.7 Effects on ability to drive and use machines
............................................................... 6
4.8 Undesirable
Effects......................................................................................................
6
4.9 Overdose
......................................................................................................................
8
5. PHARMACOLOGICAL
PROPERTIES...........................................................................
9
5.1 Pharmacodynamic
properties:......................................................................................
9
5.2 Pharmacokinetic
properties:.......................................................................................
14
5.3 Precl