APO-LERCANIDIPINE lercanidipine hydrochloride 10 mg film coated tablet bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

lercanidipine hydrochloride, Quantity: 10 mg

Disponível em:

Arrotex Pharmaceuticals Pty Ltd

DCI (Denominação Comum Internacional):

Lercanidipine hydrochloride

Forma farmacêutica:

Tablet, film coated

Composição:

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

Via de administração:

Oral

Unidades em pacote:

30, 500, 100

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Lercanidipine is indicated for the treatment of hypertension.

Resumo do produto:

Visual Identification: Yellow coloured, film coated, round shaped, biconvex tablets engraved 'APO' on one side and scoreline 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

Status de autorização:

Licence status A

Data de autorização:

2010-08-12

Características técnicas

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