ROPINIROLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

ROPINIROLE HYDROCHLORIDE

Composition:

ROPINIROLE 0.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ropinirole Tablets USP are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of ropinirole 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 Tablets USP 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 associated with moderate-to-severe RLS. R

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Ropinirole Tablets USP are supplied as round, biconvex tablets. The 0.25 mg tablets are debossed with "54 511" on one side and plain on the other side. The 0.5 mg tablets are debossed with "54 337" on one side and plain on the other side. The 1 mg tablets are debossed with "54 751" on one side and plain on the other side. The 2 mg tablets are debossed with "54 231" on one side and plain on the other side. The 3 mg tablets are debossed with "54 575" on one side and plain on the other side. The 4 mg tablets are debossed with "54 273" on one side and plain on the other side. The 5 mg tablets are debossed with "54 722" on one side and plain on the other side. 0054-0116-25 0.25 mg, white tablet, bottle of 100 0054-0117-25 0.5 mg, yellow tablet, bottle of 100 0054-0118-25 1 mg, green tablet, bottle of 100 0054-0119-25 2 mg, orange tablet, bottle of 100 0054-0120-25 3 mg, red tablet, bottle of 100 0054-0121-25 4 mg, brown tablet, bottle of 100 0054-0122-25 5 mg, blue tablet, bottle of 100 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].Protect from light and moisture. Close container tightly after each use.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROPINIROLE- ROPINIROLE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
ROPINIROLE TABLETS USP
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 a 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 pale greenish-yellow powder
with a melting range of 243° to
250°C and a solubility of 133 mg/mL in water.
Each round, biconvex 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:
colloidal silicon dioxide,
croscarmellose sodium, lactose (anhydrous), magnesium stearate,
microcrystalline cellulose, and one or
more of the following: D&C Yellow #10 aluminum lake, FD&C Blue # 2
aluminum lake, FD&C Yellow
# 6 aluminum lake, FD&C Red #40 aluminum lake, FD&C Lime Green lake
blend, and FD&C brown
lake blend.
USP dissolution test is pending.
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 for dopamine D1, 5-HT , 5-HT ,
benzodiazepine, GABA, muscarinic,
alpha
, alpha
, and beta-adrenoreceptors.
Parkinson’s Disease
The precise mechanism of action of ropinirole 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
16
24
2
2
3
3
2
4
1
2
1-
2-
2
motor function in various animal models of Parkinson’s dise