ROPINIROLE HYDROCHLORIDE tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Wockhardt Limited

INN (International Adı):

ROPINIROLE HYDROCHLORIDE

Kompozisyon:

ROPINIROLE 0.25 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Tablets: Each irregular hexagonal shaped, film-coated tablet contains ropinirole hydrochloride as follows: 0.25 mg: white tablets debossed with "W" on one side and "154" on the other side in bottles of 30 (NDC 64679-154-01), 100 (NDC 64679-154-02), 500 (NDC 64679-154-03) and 100 Unit Dose Tablets (10 x 10's ) blister pack  (NDC 64679-154-04) 0.5 mg: yellow tablets debossed with "W" on one side and "155" on the other side in bottles of 30 (NDC 64679-155-01), 100 (NDC 64679-155-02), 500 (NDC 64679-155-03) and 100 Unit Dose Tablets (10 x 10's ) blister pack  (NDC 64679-155-04) 1 mg: green tablets debossed with "W" on one side and "171" on the other side in bottles of 30 (NDC 64679-171-01), 100 (NDC 64679-171-02),  500 (NDC 64679-171-03) 100 Unit Dose Tablets (10 x 10's ) blister pack  (NDC 64679-171-04). 2 mg: pale yellowish pink tablets, debossed with "W" on one side and "172" on the other side in bottles of 30 (NDC 64679-172-01), 100 (NDC 64679-172-02), 500 (NDC 64679-172-03) and 100 Unit Dose Tablets (10 x 10's ) blister pack (NDC 64679-172-04). 3 mg: purple tablets, debossed with "W" on one side and "174" on the other side in bottles of 30 (NDC 64679-174-01), 100 (NDC 64679-174-02), 500 (NDC 64679-174-03) and 100 Unit Dose Tablets (10 x 10's )  blister pack  (NDC 64679-174-04). 4 mg: brown tablets debossed with "W" on one side and "175" on the other side in bottles of 30 (NDC 64679-175-01), 100 (NDC 64679-175-02), 500 (NDC 64679-175-03) and 100 Unit Dose Tablets (10 x 10's ) blister pack  (NDC 64679-175-04). 5 mg: blue tablets debossed with "W" on one side and "177" on the other side in bottles of 30 (NDC 64679-177-01), 100 (NDC 64679-177-02), 500 (NDC 64679-177-03) and 100 Unit Dose Tablets (10 x 10's ) blister pack  (NDC 64679-177-04).

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED
WOCKHARDT LIMITED
----------
ROPINIROLE TABLETS, USP
RX ONLY
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 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 coloured crystalline
powder with a melting range of 241°
to 245°C. It is soluble in water and methanol, very slightly soluble
in ethyl alcohol.
Each irregular hexagonal shaped, film-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, hypromellose, magnesium
stearate, microcrystalline
cellulose and one or more of the following: carmine, FD&C Blue No. 2
aluminum lake, iron oxide
black, iron oxide yellow, iron oxide red, polyethylene glycol 400,
titanium dioxide.
Ropinirole Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5
mg meet, USP Dissolution Test
2.
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 -
16
24
2
2
3
3
2
4
1
1
2
1
, 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 caud