PK-MERZ TABLET 100MG

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

AMANTADINE SULPHATE

Disponible desde:

SUMMIT COMPANY (MALAYSIA) SENDIRIAN BERHAD

Designación común internacional (DCI):

AMANTADINE SULPHATE

Unidades en paquete:

30Tablet Tablets; 100Tablet Tablets

Fabricado por:

MERZ PHARMA GMBH & CO. KGAA

Ficha técnica

DIRECTION FOR USE, PLEASE READ CAREFULLY!
COMPOSITION:
One film-coated tablet contains:
Active ingredient: Amantadine sulphate 100 mg.
Excipients: Lactose monohydrate, microcrystalline cellulose, potato
starch, gelatine, povidone, talc, colloidal silicon
dioxide, magnesium stearate, croscarmellose sodium, eudragit E,
yellow-orange S and titanium dioxide.
PRODUCT DESCRIPTION:
Biconvex film-coated tablet with dividing groove on one side.
ROUTE OF ADMINISTRATION:
Oral route
PHARMACODYNAMICS:
_Pharmacotherapeutic group:_
Anti-Parkinson Drug
_Pharmacological properties:_
Amantadine has various pharmacological effects. The agent has an
indirectly agonistic effect at the striatal
dopamine receptor. Animal studies have shown that amantadine increases
the extracellular dopamine concentration
both by increased dopamine release and through blockade of re-uptake
into the presynaptic neurones. At therapeutic
concentrations, amantadine inhibits the release of acetylcholine
mediated by NMDA receptors and can thus trigger
anticholinergic effects. The agent has synergistic effects with
L-dopa.
PHARMACOKINETICS:
_Absorption:_
Amantadine hydrochloride undergoes rapid and complete absorption from
the gastrointestinal tract after oral
administration.
_Plasma concentration, elimination:_
Maximum plasma concentration are reached about 2 and 8 hours (tmax)
after administration of a single dose. The
freely soluble amantadine hydrochloride gives higher peak plasma
amantadine concentrations than the more spar-
ingly soluble amantadine sulphate, for which the peak plasma
concentration (Cmax) is reached later than that of the
hydrochloride. After a single oral dose of 250 mg amantadine
hydrochloride, a Cmax of 0.5mcg/ml is attained. At a
dose of 200 mcg/ml steady state is reached after 4–7 days, with
plasma concentration of 400–900 ng/ml. After
administration of 100 mg amantadine sulphate Cmax is 0.15 mcg/ml.
The total amount of active substance absorbed (AUC) is the same for
the two amantadine salts.
Plasma clearance was found to be ide