AMLOZIC amlodipine (as besilate) 10 mg tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg)

Prieinama:

Arrotex Pharmaceuticals Pty Ltd

INN (Tarptautinis Pavadinimas):

amlodipine besilate

Vaisto forma:

Tablet, uncoated

Sudėtis:

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

Vartojimo būdas:

Oral

Vienetai pakuotėje:

30 tablets

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Hypertension: Amlodipine is indicated for the first line treatment of hypertension and 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, which has been used in combination with a thiazide diuretic, beta adrenoreceptor blocking agent or an angiotensin converting enzyme inhibitor. Angina: Amlodipine is indicated for the first line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs.

Produkto santrauka:

Visual Identification: White to off-white, flat, bevel edged, round shaped, uncoated tablets, debossed with "C" on one side and "59" on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorizacija statusas:

Registered

Leidimo data:

2009-06-25

Pakuotės lapelis

AURO-AMLODIPINE
TM 5 & 10
CONSUMER MEDICINE INFORMATION
Amlodipine (as besilate) 5 mg and 10 mg tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions people ask about
AURO-AMLODIPINE.
It does not contain all the available information. It does not take
the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking AURO-
AMLODIPINE against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT AURO-AMLODIPINE IS USED FOR
AURO-AMLODIPINE is used to lower high blood pressure (hypertension).
There are usually no symptoms of hypertension. The only way of knowing
that you have hypertension
is to have your blood pressure checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems.
AURO-AMLODIPINE is also used to treat angina pectoris.
Angina is a pain or uncomfortable feeling in the chest, often
spreading to the arms or neck, and
sometimes to the shoulders and back. The pain of angina is due to a
shortage of oxygen to the heart.
AURO-AMLODIPINE is not for the relief of a sudden attack of angina.
Your doctor may have given you
other medication to treat this.
AURO-AMLODIPINE belongs to a group of medicines called calcium channel
blockers or calcium ion
antagonists. They work by widening your blood vessels, making it
easier for your heart to pump blood
around the body and help increase the supply of blood and oxygen to
your heart. Calcium channel
blockers do not change the amount of calcium in your blood or bones.
Your doctor may have prescribed AURO-AMLODIPINE for another purpose.
ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION.
AURO-AMLODIPINE is available only with a doctor's prescription.
USE IN CHILDREN
There is not enough information to recommend the use of this medicine
in children.
BEFORE YOU TAKE
IT
TELL YOUR DOCTOR IF YOU HAV

Prekės savybės

Page 1 of 11
PRODUCT INFORMATION
AURO-AMLODIPINE
TM
5 & 10
TABLETS
NAME OF MEDICINE
Active ingredient:
Amlodipine besilate
Chemical name:
3-Ethyl 5-methyl(4_RS_)-2-[(2-aminoethoxy)methyl]-4-(2-
chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
benzenesulfonate
Molecular weight:
567.1
Molecular formula:
C
26
H
31
ClN
2
O
8
S
CAS number:
111740-99-6
Chemical structure:
DESCRIPTION
Amlodipine besilate is a white or almost white powder and is slightly
soluble in water,freely soluble
in methanol, sparingly soluble in anhydrous ethanol and slightly
soluble in 2-propanol.
INACTIVES: microcrystalline cellulose-, calcium hydrogen phosphate
anhydrous, sodium starch
glycollate and magnesium stearate
.
PHARMACOLOGY
_ _
_PHARMACODYNAMICS _
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
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
physiologic pH range,
amlodipine is an ionised compound (pKa=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.
Page 2 of 11
Amlodipine is a peripheral arterial vasodilator that acts directly on
vascular smooth muscle to
cause a reduction in peripheral vascular resistance and reduction in
blood pressure. T