Ropinirole 2 Mg
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Uses
Ropinirole extended-release tablet is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
History
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Other Information
Ropinirole is an orally administered non-ergoline dopamine agonist. It is supplied as the hydrochloride salt of ropinirole 4-[2-(dipropylamino)-ethyl]-1,3-dihydro-2H-indol-2-one and has a molecular formula of C16H24 N2O•HCl. The molecular weight is 296.84 (260.38 as the free base).
The structural formula is:
Ropinirole hydrochloride white to yellow solidwith a melting range of 243° to 250°C and a solubility of 133 mg/mL in water.
Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch,ethylcellulose and one or more of the following: FD&C Blue No. 2 Aluminum Lake. ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc.
Sources
Ropinirole 2 Mg Manufacturers
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Trigen Laboratories, Inc.
![Ropinirole 2 Mg (Ropinirole) Tablet, Film Coated, Extended Release Ropinirole 4 Mg (Ropinirole) Tablet, Film Coated, Extended Release Ropinirole 6 Mg (Ropinirole) Tablet, Film Coated, Extended Release Ropinirole 8 Mg (Ropinirole) Tablet, Film Coated, Extended Release Ropinirole 12 Mg (Ropinirole) Tablet, Film Coated, Extended Release [Trigen Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ropinirole 2 Mg | Trigen Laboratories, Inc.
2.1 General Dosing Considerations Ropinirole extended-release tablets are taken once daily, with or without food. Taking ropinirole extended-release tablets with food may reduce the occurrence of nausea; this has not been established in controlled clinical trials [see Clinical Pharmacology (12.3)]. Tablets must be swallowed whole and must not be chewed, crushed or divided. If a significant interruption in therapy with ropinirole extended-release tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s DiseaseThe starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, depending on therapeutic response and tolerability, up to a maximally recommended dose of 24 mg/day.
In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Caution should be exercised during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [see Clinical Studies (14.2)]. Due to the flexible dosing design used in clinical studies, specific dose response information could not be determined.
When ropinirole extended-release tablets are administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. In the placebo-controlled advanced Parkinson’s disease study, the L-dopa dose was reduced once patients reached a dose of ropinirole extended-release of 8 mg/day. Overall, L-dopa dose reduction was sustained in 93% of patients treated with ropinirole extended-release tablets and in 72% of patients on placebo. On average the L-dopa dose was reduced by 34% in patients treated with ropinirole extended-release tablets [see Clinical Studies (14)]
Ropinirole extended-release tablets should be discontinued gradually over a 7-day period.
2.3 Switching from Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release TabletsPatients may be switched directly from immediate-release ropinirole to extended-release ropinirole tablets. The initial dose of ropinirole extended-release tablets should most closely match the total daily dose of the immediate-release formulation of ropinirole tablets, as shown in Table 1.
Table 1: Conversion from Immediate-Release Ropinirole Tablets to Extended-Release Ropinirole Tablets Immediate-Release Ropinirole Tablets
Total Daily Dose (mg) Extended-Release Ropinirole Tablets
Total Daily Dose (mg) 0.75 to 2.25 2 3 to 4.5 4 6 6 7.5 to 9 8 12 12 15 to 18 16 21 20 24 24Following conversion to ropinirole extended-release tablets, the dose may be adjusted depending on therapeutic response and tolerability [see Dosage and Administration (2.2)].
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