Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
ROPINIROLE HYDROCHLORIDE (UNII: D7ZD41RZI9) (ROPINIROLE - UNII:030PYR8953)
Zhejiang Huahai Pharmaceutical Co., Ltd.
ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE 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 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 associ
Tablets: 0.25 mg: white tablets debossed “972” on one side and “HH” on the other side Bottles of 100 – NDC 64220-420-01 Bottles of 500 – NDC 64220-420-02 0.5 mg: yellow tablets debossed “973” on one side and “HH” on the other side Bottles of 100 – NDC 64220-421-01 Bottles of 500 – NDC 64220-421-02 1 mg: green tablets debossed “974” on one side and “HH” on the other side Bottles of 100 – NDC 64220-422-01 Bottles of 500 – NDC 64220-422-02 2 mg: pink tablets debossed “975” on one side and “HH” on the other side Bottles of 100 – NDC 64220-423-01 Bottles of 500 – NDC 64220-423-02 3 mg: purple tablets debossed “976” on one side and “HH” on the other side Bottles of 100 – NDC 64220-423-01 Bottles of 500 – NDC 64220-424-02 4 mg: beige tablets debossed “977” on one side and “HH” on the other side Bottles of 100 – NDC 64220-425-01 Bottles of 500 – NDC 64220-425-02 5 mg: blue tablets debossed “978” on one side and “HH” on the other side Bottles of 100 – NDC 64220-426-01 Bottles of 500 – NDC 64220-426-02
Abbreviated New Drug Application
ROPINIROLE HYDROCHLORIDE- ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. ---------- ROPINIROLE HYDROCHLORIDE TABLETS 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 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 yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each round biconvex film-coated ropinirole hydrochloride 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, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and one or more of the following: D&C Yellow No. 10, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, iron oxides, lecithin, polyethylene glycol, polyvinyl alcohol, talc, 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. 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 Прочитайте повний документ