ROPINIROLE HYDROCHLORIDE tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Zhejiang Huahai Pharmaceutical Co., Ltd.

INN (Међународно име):

ROPINIROLE HYDROCHLORIDE

Састав:

ROPINIROLE HYDROCHLORIDE 0.25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of ropinirole hydrochloride was demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associ

Резиме производа:

Tablets: 0.25 mg: white tablets debossed “972” on one side and “HH” on the other side Bottles of 100 – NDC 64220-420-01 Bottles of 500 – NDC 64220-420-02 0.5 mg: yellow tablets debossed “973” on one side and “HH” on the other side Bottles of 100 – NDC 64220-421-01 Bottles of 500 – NDC 64220-421-02 1 mg: green tablets debossed “974” on one side and “HH” on the other side Bottles of 100 – NDC 64220-422-01 Bottles of 500 – NDC 64220-422-02 2 mg: pink tablets debossed “975” on one side and “HH” on the other side Bottles of 100 – NDC 64220-423-01 Bottles of 500 – NDC 64220-423-02 3 mg: purple tablets debossed “976” on one side and “HH” on the other side Bottles of 100 – NDC 64220-423-01 Bottles of 500 – NDC 64220-424-02 4 mg: beige tablets debossed “977” on one side and “HH” on the other side Bottles of 100 – NDC 64220-425-01 Bottles of 500 – NDC 64220-425-02 5 mg: blue tablets debossed “978” on one side and “HH” on the other side Bottles of 100 – NDC 64220-426-01 Bottles of 500 – NDC 64220-426-02

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
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ROPINIROLE HYDROCHLORIDE TABLETS
PATIENT INFORMATION INCLUDED
DESCRIPTION
Ropinirole hydrochloride is an orally administered non-ergoline
dopamine agonist. It is the
hydrochloride salt of 4-[2-(dipropylamino)
ethyl]-1,3-dihydro-2H-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 hydrochloride 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 round biconvex film-coated ropinirole hydrochloride tablet
contains ropinirole hydrochloride
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, hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, and one or more of the following: D&C
Yellow No. 10, D&C Red No. 27
aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum
lake, iron oxides,
lecithin, polyethylene glycol, polyvinyl alcohol, talc, 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:
The precise mechanism of action of ropinirole hydrochloride as a
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