Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
NCS HealthCare of KY, Inc dba Vangard Labs
ROPINIROLE HYDROCHLORIDE
ROPINIROLE 0.25 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- 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 Belgenin tamamını okuyun