ROPINIROLE HYDROCHLORIDE tablet film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)

Dostupné s:

Cardinal Health

INN (Mezinárodní Name):

ROPINIROLE HYDROCHLORIDE

Složení:

ROPINIROLE 1 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
CARDINAL HEALTH
----------
ROPINIROLE TABLETS USP
8219501/0813
RX ONLY
PRESCRIBING INFORMATION
PATIENT INFORMATION INCLUDED
DESCRIPTION
Ropinirole is an orally administered non-ergoline dopamine agonist. It
is the hydrochloride salt of 4-[2-
(dipropylamino) ethyl]-1,3-dihydro-2_H_-indol-2-one monohydrochloride
and has an empirical formula of
C
H N O•HCl. The molecular weight is 296.84 (260.38 as the free base).
The structural formula is:
Ropinirole Tablets USP is a white to yellow solid with a melting range
of 243° to 250°C and a
solubility of 133 mg/mL in water.
Each circular, biconvex, film-coated tablet contains ropinirole
hydrochloride USP equivalent to
ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive
ingredients consist of:
croscarmellose sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and one
or more of the following: carmine, FD&C Blue No. 2 aluminum lake, FD&C
Yellow No. 6 aluminum
lake, hypromellose, iron oxides (iron oxide yellow, iron oxide red and
iron oxide black), polyethylene
glycol, polysorbate 80 and titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Ropinirole Hydrochloride is a non-ergoline dopamine agonist with high
relative in vitro specificity and
full intrinsic activity at the D and D dopamine receptor subtypes,
binding with higher affinity to D
than to D or D receptor subtypes.
Ropinirole has moderate in vitro affinity for opioid receptors.
Ropinirole and its metabolites have
negligible in vitro affinity for dopamine D , 5-HT , 5-HT ,
benzodiazepine, GABA, muscarinic,
alpha -, alpha -, and beta-adrenoreceptors.
PARKINSON’S DISEASE
16
24
2
2
3
3
2
4
1
1
2
1
2
The precise mechanism of action of Ropinirole Tablets in the treatment
for Parkinson’s disease is
unknown, although it is believed to be due to stimulation of
postsynaptic dopamine D -type receptors
within the caudate-putamen in the brain. This conclusion is supported
by studies that show that
ropin