ROPINIROLE HYDROCHLORIDE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

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 hydrochloride tablets 0.25 mg are white, round, coated tablets debossed cor  over 201 on one side and plain on the other side. They are supplied as follows: Ropinirole hydrochloride tablets 0.5 mg are yellow, round, coated tablets debossed cor over 202 on one side and plain on the other side. They are supplied as follows: Ropinirole hydrochloride tablets 1 mg are green, round, coated tablets debossed cor over 203 one one side and plain on the other side. They are supplied as follows: Ropinirole hydrochloride tablets 2 mg are pink, round, coated tablets debossed cor over 204 one one side and plain on the other side. They are supplied as follows: Ropinirole hydrochloride tablets 4 mg are brown, round, coated tablets debossed cor over 206 one one side and plain on the other side. They are supplied as follows: Ropinirole hydrochloride tablets 5 mg are blue, round, coated tablets debossed cor over 207 one one side and plain on the other side. They are supplied as follows:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE HYDROCHLORIDE - ROPINIROLE HYDROCHLORIDE TABLET, COATED
PHYSICIANS TOTAL CARE, INC.
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ROPINIROLE HYDROCHLORIDE TABLETS
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-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 pale greenish-yellow powder
with a melting range of 243° to
250°C and a solubility of 133 mg/mL in water.
Each round coated 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, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, and one
or more of the following:
carmine, FD&C Blue No. 2 aluminum lake, hypromellose, iron oxides,
POLYETHYLENE GLYCOLS,
polysorbate 80, 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.
16
24
2
2
3
3
2
4
1
1
2
1
2
_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
ropinirole improves motor function in various animal models of
Parkinson's diseas