AMLODIPINE SANDOZ amlodipine besilate 5mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

amlodipine besilate

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: A white or almost white, oblong, bevelled tablet, scored on one side and coded 5 on the other. Size: approx. 8.6 x 5.8mm; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-04-24

Summary of Product characteristics

_Product Information _
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_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