DONEPEZIL-DRLA donepezil hydrochloride (as monohydrate) 5mg tablet bottle

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

donepezil hydrochloride monohydrate, Quantity: 5.22 mg (Equivalent: donepezil hydrochloride, Qty 5 mg)

Commercializzato da:

Dr Reddys Laboratories Australia Pty Ltd

INN (Nome Internazionale):

donepezil hydrochloride monohydrate

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: pregelatinised maize starch; microcrystalline cellulose; magnesium stearate; lactose monohydrate; hyprolose; titanium dioxide; hypromellose; macrogol 400

Via di somministrazione:

Oral

Confezione:

28, 100, 120, 30, 14, 56, 98

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Treatment of mild, moderate and severe Alzheimer's disease.

Dettagli prodotto:

Visual Identification: White, round, biconvex, film coated tablets debossed 'DNP' on one side and '5' on opposite side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Stato dell'autorizzazione:

Registered

Scheda tecnica

DONEPEZIL-DRLA TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active:
Donepezil hydrochloride monohydrate
CAS Number: 120011-70-3
.
HCl.
.
H
2
O
DESCRIPTION
Donepezil hydrochloride monohydrate is a white
crystalline
powder and is freely soluble
in chloroform, soluble in water and in glacial acetic acid, slightly
soluble in
ethanol and
in acetonitrile and practically insoluble in ethyl acetate and in
_n_-hexane.
Chemical Name:
(_RS_)-1-benzyl-4-[5,6-dimethoxy-1-indanon)-2-yl]-
methylpiperidine
hydrochloride monohydrate.
Molecular formula:
C
24
H
29
NO
3
HCl.H
2
O
Molecular Weight:
433.97
Excipient:
Lactose monohydrate, pregelatinised maize starch, microcrystalline
cellulose,
hyprolose, magnesium stearate. The film coating
contains
macrogol 400, hypromellose, titanium
dioxide.
Additionally, the 10 mg
tablet contains yellow iron oxide as a
colouring agent.
ACTIONS
Specific and reversible acetylcholinesterase inhibitor.
PHARMACOLOGY
It has been demonstrated
that Alzheimer’s disease is associated with a relative
decrease in the activity of the cholinergic system in the cerebral
cortex and other
areas of the brain. Studies suggest that donepezil hydrochloride
exerts its therapeutic
effect by enhancing cholinergic function in the central nervous
system. This is
Product Information for Donepezil-DRLA V3
Product Information for Donepezil-DRLA –V3
2 of 34
accomplished by increasing the concentration of acetylcholine through
reversible
inhibition of acetylcholinesterase.
PHARMACODYNAMICS
Donepezil hydrochloride is a specific and reversible inhibitor of
acetylcholinesterase,
the predominant cholinesterase in the brain. Donepezil hydrochloride
was found _in_
_ _
_vitro _ to be over 1,000 times more potent an inhibitor of this
enzyme than of
butyrylcholinesterase, an enzyme which is present mainly outside the
central nervous
system.
In patients with Alzheimer’s dementia participating in clinical
trials, administration of
single daily doses of donepezil hydrochloride 5 or 10 mg produced
steady-state
inhibition of acetyl