Drug Catalog - Product Detail
ROPINIROLE HCL XR TB 4MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55111-0661-90 | DR.REDDY'S LABORATORIES, INC. | 90 | 4MG | TABLET |
PACKAGE FILES
Generic Name
ROPINIROLE
Substance Name
ROPINIROLE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA201576
Description
11 DESCRIPTION Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Each biconvex, capsule-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: Ropinirole extended-release tablets USP, 2 mg are pink colored, capsule shaped, biconvex, film-coated tablets debossed ‘R2’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500. Bottles of 30 NDC 55111-659-30 Bottles of 90 NDC 55111-659-90 Bottles of 500 NDC 55111-659-05 Ropinirole extended-release tablets USP, 4 mg are light brown colored, capsule shaped, biconvex, film-coated tablets debossed ‘R4’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500. Bottles of 30 NDC 55111-661-30 Bottles of 90 NDC 55111-661-90 Bottles of 500 NDC 55111-661-05 Ropinirole extended-release tablets USP, 6 mg are white colored, capsule shaped, biconvex, film-coated tablets debossed ‘R6’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500. Bottles of 30 NDC 55111-727-30 Bottles of 90 NDC 55111-727-90 Bottles of 500 NDC 55111-727-05 Ropinirole extended-release tablets USP, 8 mg are brick red colored, capsule shaped, biconvex, film-coated tablets debossed ‘R8’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500. Bottles of 30 NDC 55111-662-30 Bottles of 90 NDC 55111-662-90 Bottles of 500 NDC 55111-662-05 Ropinirole extended-release tablets USP, 12 mg are light green colored, capsule shaped, biconvex, film-coated tablets debossed ‘R12’ on one side and plain on the other side and are supplied in bottles of 30, 90 and 500. Bottles of 30 NDC 55111-728-30 Bottles of 90 NDC 55111-728-90 Bottles of 500 NDC 55111-728-05 Storage Store at 20°C to 25°C (68°F to 77°F) [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 non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease. ( 1) Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.
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, 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 Tablets 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.