APO-LERCANIDIPINE lercanidipine hydrochloride 20 mg film coated tablet bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

lercanidipine hydrochloride, Quantity: 20 mg

Tilgængelig fra:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Lercanidipine hydrochloride

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: hypromellose; butylated hydroxytoluene; lactose monohydrate; magnesium stearate; titanium dioxide; purified talc; croscarmellose sodium; iron oxide red; macrogol 8000; microcrystalline cellulose

Indgivelsesvej:

Oral

Enheder i pakken:

30, 100, 500

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Lercanidipine is indicated for the treatment of hypertension.

Produkt oversigt:

Visual Identification: Pink coloured, film coated, round shaped, biconvex tablets, engraved 'APO' on one side and score line on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisation status:

Licence status A

Autorisation dato:

2010-08-12

Produktets egenskaber

Product Information – Australia
APO- Lercanidipine Tablets
Page 1
APO-LERCANIDIPINE TABLETS
NAME OF THE MEDICINE
Lercanidipine Hydrochloride.
Chemical Name:
3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,
6-dimethyl-4-(3-nitrophenyl)-2-[(3,3-
diphenylpropyl)methylamino]-1,1-dimethylethyl methyl ester
hydrochloride.
Structural Formula:
HCl
Molecular Formula:
C
36
H
42
ClN
3
O
6
Molecular Weight:
648.2 (free base: 611.7)
CAS Registry Number:
132866-11-6
DESCRIPTION
Lercanidipine is a dihydropyridine derivative. It is a racemate due to
the presence of a chiral carbon atom
at position 4 of the 1,4-dihydropyridine ring.
Lercanidipine hydrochloride is a yellow amorphous powder, readily
soluble in chloroform and methanol,
practically insoluble in water. Octanol:water partition coefficient
(LogP): 6.4.
Each tablet contains 10 mg or 20 mg lercanidipine hydrochloride as the
active ingredient.
In addition, each tablet contains the following inactive ingredients:
Cellulose – microcrystalline , lactose
monohydrate, croscarmellose sodium, butylated hydroxytoluene,
magnesium stearate, hypromellose,
macrogol 8000, titanium dioxide, purified talc, yellow iron oxide (10
mg only) and red iron oxide (20 mg
only).
`
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Lercanidipine
is
a
calcium
antagonist
of
the
dihydropyridine
group
and
selectively
inhibits
the
transmembrane influx of calcium into cardiac and vascular smooth
muscle, with a greater effect on vascular
smooth muscle than on cardiac smooth muscle. The antihypertensive
action is due to a direct relaxant
effect on vascular smooth muscle which lowers total peripheral
resistance and hence blood pressure.
Lercanidipine has a prolonged antihypertensive activity because of its
high membrane partition coefficient.
It is devoid of negative inotropic effects and its vascular
selectivity is due to its voltage dependent calcium
antagonist activity. Since the vasodilatation induced by lercanidipine
hydrochloride is gradual in onset,
acute hypotension with reflex tachycardia has rarely been observ