Drug Catalog - Product Detail
ROPINIROLE HCL ER TB 2MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-5780-92 | SANDOZ | 90 | 2MG | NA |
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Description
11 DESCRIPTION Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C 16 H 24 N 2 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 colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength). Chemical structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Ropinirole exended-release tablets are biconvex, capsule-shaped, film-coated tablets that contain ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: • 2 mg, light pink coloured, capsule shaped, biconvex film-coated tablets with "SZ" debossed on one side and "770" debossed on other side. NDC 0781-5780-31, bottle of 30 tablets NDC 0781-5780-92, bottle of 90 tablets • 4mg, light brown coloured, capsule shaped, biconvex film-coated tablets with "SZ" debossed on one side and "796" debossed on other side. NDC 0781-5782-31, bottle of 30 tablets NDC 0781-5782-92, bottle of 90 tablets • 6 mg, white to off-white coloured, capsule shaped, biconvex film-coated tablets with "SZ" debossed on one side and "797" debossed on other side. NDC 0781-5784-31, bottle of 30 tablets NDC 0781-5784-92, bottle of 90 tablets • 8mg, dark brown coloured, capsule shaped, biconvex film-coated tablets with "SZ" debossed on one side and "161" debossed on other side. NDC 0781-5786-31, bottle of 30 tablets NDC 0781-5786-92, bottle of 90 tablets • 12 mg, light green coloured, capsule shaped, biconvex film-coated tablets with "SZ" debossed on one side and "162" debossed on other side. NDC 0781-5788-31, bottle of 30 tablets NDC 0781-5788-92, bottle of 90 tablets Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Indications & Usage
1 INDICATIONS AND USAGE Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease. Ropinirole extended-release tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Ropinirole extended-release tablets are taken once daily, with or without food; tablets must be swallowed whole and not be chewed, crushed, or divided. ( 2.1 ) • The recommended starting dose is 2 mg taken once daily for 1 to 2 weeks; the dose should be increased by 2 mg/day at 1 week or longer intervals. The maximum recommended dose of ropinirole extended-release tablets is 24 mg/day. ( 2.2 , 14.2 ) • Renal Impairment: In patients with end-stage renal disease on hemodialysis, the maximum recommended dose is 18 mg/day. ( 2.2 ) • If ropinirole extended-release tablets must be discontinued, it should be tapered gradually over a 7-day period; retitration of ropinirole extended-release tablets may be warranted if therapy is interrupted. ( 2.1 , 2.2 ) • Patients may be switched directly from immediate-release ropinirole to ropinirole extended-release tablets; the initial switching dose of ropinirole extended-release tablets should approximately match the total daily dose of immediate-release ropinirole. ( 2.3 ) 2.1 General Dosing Recommendations • Ropinirole extended-release tablets are taken once daily, with or without food [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 Disease The recommended starting dose of ropinirole extended-release tablets is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at weekly or longer intervals, based on therapeutic response and tolerability. Monitor patients at least weekly during dose titration. Too rapid a rate of titration may lead to the selection of a dose that does not provide additional benefit, but increases the risk of adverse reactions. In fixed-dose studies designed to characterize the dose-response to ropinirole extended-release tablets, there was no additional therapeutic benefit shown in patients with advanced stage Parkinson’s disease taking daily doses greater than 8 mg/day, or with early stage Parkinson’s disease taking doses greater than 12 mg/day [see Clinical Studies ( 14.1 and 14.2 )]. Although the maximum recommended dose of ropinirole extended-release tablets is 24 mg, patients with advanced Parkinson’s disease should generally be maintained at daily doses of 8 mg or lower and patients with early Parkinson’s disease should generally be maintained at daily doses 12 mg or lower. Ropinirole extended-release tablets should be discontinued gradually over a 7–day period [see Warnings and Precautions ( 5.9 )]. Renal Impairment No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole extended-release tablets for patients with end-stage renal disease on hemodialysis is 2 mg once daily. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole extended-release tablets in patients with severe renal impairment without regular dialysis has not been studied. 2.3 Switching From Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets Patients may be switched directly from immediate-release ropinirole to ropinirole extended-release tablets. The initial dose of ropinirole extended-release tablets should approximately match the total daily dose of the immediate-release formulation of ropinirole, as shown in Table 1 . Table 1. Conversion from Immediate-Release Ropinirole to Ropinirole Extended-Release Tablets Immediate-Release Ropinirole Tablets Total Daily Dose (mg) Ropinirole Extended-Release 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 16 18 18 21 20 24 24 Following conversion to ropinirole extended-release tablets, the dose may be adjusted depending on therapeutic response and tolerability [see Dosage and Administration (2.2) ] . 2.4 Effect of Gastrointestinal Transit Time on Medication Release Ropinirole extended-release tablets are designed to release medication over a 24-hour period. If rapid gastrointestinal transit occurs, there may be risk of incomplete release of medication and medication residue being passed in the stool.