AMLODIPINE SANDOZ amlodipine besilate 2.5mg tablet bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

amlodipine besilate, Quantity: 3.47 mg (Equivalent: amlodipine, Qty 2.5 mg)

Tillgänglig från:

Sandoz Pty Ltd

INN (International namn):

amlodipine besilate

Läkemedelsform:

Tablet, uncoated

Sammansättning:

Excipient Ingredients: microcrystalline cellulose; calcium hydrogen phosphate; sodium starch glycollate; magnesium stearate

Administreringssätt:

Oral

Enheter i paketet:

30 tablets

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Hypertension: First line treatment of hypertension. It can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine besylate, which has been used in combination with a thiazide diuretic, beta-adrenoreceptor blocking agent, or an angiotensin converting enzyme inhibitor. Angina: First line treatment of chronic stable angina. Amlodipine besylate may be used alone, as monotherapy, or in combination with other antianginal drugs.

Produktsammanfattning:

Visual Identification: A white or almost white, oblong, bevelled tablet, coded 2,5 on one side. Size: approx. 6.8 x 4.7mm; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Licence status A

Tillstånd datum:

2007-04-24

Produktens egenskaper

_Product Information _
_ _
_Page 1 of 11 _
_Amlodipine Sandoz 2.5 / 5 / 10mg tablets _
10/2016
_Sandoz Pty Ltd _
PRODUCT INFORMATION
AMLODIPINE SANDOZ
® 2.5 / 5 / 10 MG TABLETS
NAME OF THE MEDICINE
Chemical name:
3-ethyl 5-methyl-2-(2-aminoethoxymethyl)- 4-(2-chlorophenyl)-
1,4-dihydro-6-methyl- 3,5-pyridinedicarboxylate benzene
sulfonate.
Generic name:
amlodipine besilate
Chemical structure:
_ _
_ _
CAS [111470-99-6]
Empirical formula: C
20
H
25
ClN
2
O
5
•C
6
H
6
O
3
S
MW:
567.1 (free base 408.9)
_ _
DESCRIPTION
Amlodipine besilate is a white or almost white powder, slightly
soluble in water, freely
soluble in methanol, sparingly soluble in ethanol, slightly soluble in
2-propanol.
Amlodipine Sandoz tablets also contain sodium starch glycollate,
calcium hydrogen
phosphate, cellulose-microcrystalline and magnesium stearate.
_ _
PHARMACOLOGY
Actions:
Amlodipine is a calcium ion influx inhibitor (slow channel blocker or
calcium ion
antagonist) and inhibits the transmembrane influx of calcium ions into
cardiac and
vascular smooth muscle.
PHARMACODYNAMICS
Experimental
data
suggest
that
amlodipine
binds
to
both
dihydropyridine
and
nondihydropyridine binding sites. The contractile processes of cardiac
muscle and
vascular smooth muscle are dependent upon the movement of
extracellular calcium
ions into these cells through specific ion channels. Amlodipine
inhibits calcium ion
influx across cell membranes selectively, with a greater effect on
vascular smooth
muscle cells than on cardiac muscle cells. Negative inotropic effects
can be detected
in vitro but such effects have not been seen in intact animals at
therapeutic doses.
Serum calcium concentration is not affected by amlodipine. Within the
physiological
pH range, amlodipine is an ionised compound (pK
a
= 8.6), and its kinetic interaction
with the calcium channel receptor is characterised by a gradual rate
of association and
dissociation with the receptor binding site, resulting in a gradual
onset of effect.
Amlodipine is a peripheral arterial vasodilator that acts