ROPINIROLE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 frequently be

Product summary:

Ropinirole Tablets, USP are available containing ropinirole hydrochloride, USP equivalent to 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg of ropinirole. 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 0615-7536-39 blisterpacks of 30 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 0615-7537-39 blisterpacks of 30 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 0615-7538-39 blisterpacks of 30 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 0615-7539-39 blisterpacks of 30 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 0615-7567-39 blisterpacks of 30 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. *SINEMET® is a registered trademark of Bristol Myers Squibb.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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ROPINIROLE HYDROCHLORIDE TABLETS
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, USP 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&C Yellow No. 10 Aluminum Lake
1 mg
-
D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake
2 mg
-
D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C
Yellow No. 6
Aluminum Lake
3 mg
-
D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C
Yellow No. 6
Aluminum Lake, FD&C Red No. 40 Aluminum Lake
4 mg
-
D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C
Yellow No. 6
Aluminum Lake, FD&C Red No. 40 Aluminum Lake
5 mg
-
D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C
Yellow No. 6
Aluminum Lake, FD&C Red No. 40 Aluminum Lake
_Ropinole Tablets USP, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg and 5mg Meets
USP Dissolution Test 2._
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
16
24
2
Ropinirole is a non-ergoline dopamine agonist with high relative in
vitro specificity and full intrinsic
activity at the D2 and D3 dopamine receptor subtypes, binding with
higher affinity to D3 than to D2 or
D4 receptor subtypes. Ropinirole has moderate in vitro affinity for
opioid receptors. Ropinirole and its
metaboli