APO-LERCANIDIPINE lercanidipine hydrochloride 10 mg film coated tablet bottle

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

lercanidipine hydrochloride, Quantity: 10 mg

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

INN (mednarodno ime):

Lercanidipine hydrochloride

Farmacevtska oblika:

Tablet, film coated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

30, 500, 100

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Lercanidipine is indicated for the treatment of hypertension.

Povzetek izdelek:

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 dovoljenje:

Licence status A

Datum dovoljenje:

2010-08-12

Lastnosti izdelka

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