ROPINIROLE HYDROCHLORIDE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

STAT RX USA LLC

INN（国际名称）:

ROPINIROLE HYDROCHLORIDE

组成:

ROPINIROLE 1 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Ropinirole hydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The effectiveness of ropinirole hydrochloride tablets 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 fr

產品總結:

Ropinirole Hydrochloride Tablets are available containing 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg of ropinirole hydrochloride. The 0.25 mg tablets are white, round unscored tablets debossed with M on one side of the tablet and N over 25 on the other side. They are available as follows: NDC 0378-5525-01 bottles of 100 tablets NDC 0378-5525-05 bottles of 500 tablets The 0.5 mg tablets are yellow, round unscored tablets debossed with M on one side of the tablet and N over 5 on the other side. They are available as follows: NDC 0378-5550-01 bottles of 100 tablets NDC 0378-5550-05 bottles of 500 tablets The 1 mg tablets are green, round unscored tablets debossed with M on one side of the tablet and N over 10 on the other side. They are available as follows: NDC 0378-5501-01 bottles of 100 tablets NDC 0378-5501-05 bottles of 500 tablets The 2 mg tablets are orange, round unscored tablets debossed with M on one side of the tablet and N over 20 on the other side. They are available as follows: NDC 0378-5502-01 bottles of 100 tablets NDC 0378-5502-05 bottles of 500 tablets The 3 mg tablets are lavender, round unscored tablets debossed with M on one side of the tablet and N over 30 on the other side. They are available as follows: NDC 0378-5503-01 bottles of 100 tablets NDC 0378-5503-05 bottles of 500 tablets The 4 mg tablets are grayish beige, round unscored tablets debossed with M on one side of the tablet and N over 40 on the other side. They are available as follows: NDC 0378-5504-01 bottles of 100 tablets NDC 0378-5504-05 bottles of 500 tablets The 5 mg tablets are blue, round unscored tablets debossed with M on one side of the tablet and N over 50 on the other side. They are available as follows: NDC 0378-5505-01 bottles of 100 tablets NDC 0378-5505-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED AUGUST 2009 RPNL:R2ppbpt

授权状态:

Abbreviated New Drug Application

产品特点

ROPINIROLE HYDROCHLORIDE - ROPINIROLE HYDROCHLORIDE TABLET
STAT RX USA LLC
----------
0.25 MG, 0.5 MG, 1 MG, 2 MG, 3 MG, 4 MG AND 5 MG
RX ONLY
DESCRIPTION
Ropinirole hydrochloride 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 and has an
molecular
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 cream colored crystalline
powder with a melting range of 241°
to 245°C and a solubility of 133 mg/mL in water.
Each 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: anhydrous lactose,
colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate and microcrystalline
cellulose. In addition, the following
product specific coloring agents are employed:
0.5 mg -
D and C Yellow No. 10 Aluminum Lake
1 mg -
D and C Yellow No. 10 Aluminum Lake, FD and C Blue No. 2 Aluminum Lake
2 mg -
D and C Yellow No. 10 Aluminum Lake, FD and C Blue No. 2 Aluminum
Lake, FD and C Yellow No. 6 Aluminum Lake
3 mg -
D and C Yellow No. 10 Aluminum Lake, FD and C Blue No. 2 Aluminum
Lake, FD and C Yellow No. 6 Aluminum Lake, FD and C Red No. 40
Aluminum Lake
4 mg -
D and C Yellow No. 10 Aluminum Lake, FD and C Blue No. 2 Aluminum
Lake, FD and C Yellow No. 6 Aluminum Lake, FD and C Red No. 40
Aluminum Lake
5 mg -
D and C Yellow No. 10 Aluminum Lake, FD and C Blue No. 2 Aluminum
Lake, FD and C Yellow No. 6 Aluminum Lake, FD and C Red No. 40
Aluminum Lake
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Ropinirole 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