Drug Catalog - Product Detail
ROPINIROLE HCL TB 5MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 43547-0274-10 | SOLCO HEALTHCARE | 100 | 5MG | TABLET |
PACKAGE FILES
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Description
11 DESCRIPTION Ropinirole hydrochloride 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 empirical formula is C 16 H 24 N 2 OHCl. 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 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients of the core tablets consist of croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below: Strength Inactive ingredients of the film coat 0.25 mg polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide and lecithin (soya). 0.5 mg polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide and iron oxide yellow. 1 mg polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, FD&C Blue No. 2 aluminum lake and iron oxide yellow. 2 mg polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, lecithin (soya) and iron oxide red. 3 mg polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, carmine and FD&C Blue No. 1 aluminum lake. 4 mg polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, iron oxide yellow and iron oxide red. 5 mg polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, talc, titanium dioxide, FD&C Blue No. 2 aluminum lake and lecithin (soya). USP dissolution test is pending. structural formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Each round biconvex film-coated ropinirole hydrochloride tablet, USP, contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: 0.25 mg: white tablets debossed “972” on one side and “HH” on the other side Bottles of 100 – NDC 43547-268-10 0.5 mg: yellow tablets debossed “973” on one side and “HH” on the other side Bottles of 100 – NDC 43547-269-10 1 mg: green tablets debossed “974” on one side and “HH” on the other side Bottles of 100 – NDC 43547-270-10 2 mg: pink tablets debossed “975” on one side and “HH” on the other side Bottles of 100 – NDC 43547-271-10 3 mg: purple tablets debossed “976” on one side and “HH” on the other side Bottles of 100 – NDC 43547-272-10 4 mg: beige tablets debossed “977” on one side and “HH” on the other side Bottles of 100 – NDC 43547-273-10 5 mg: blue tablets debossed “978” on one side and “HH” on the other side Bottles of 100 – NDC 43547-274-10 Storage Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.
Indications & Usage
1 INDICATIONS AND USAGE Ropinirole hydrochloride is a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.1 , 1.2 ) 1.1 Parkinson’s Disease Ropinirole hydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Ropinirole hydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Ropinirole Hydrochloride Tablets can be taken with or without food ( 2.1 ) Retitration of ropinirole hydrochloride tablets may be warranted if therapy is interrupted ( 2.1 ) Parkinson's Disease: The recommended starting dose is 0.25 mg taken three times daily; titrate to a maximum daily dose of 24 mg ( 2.2 ) Renal Impairment: The maximum recommended dose is 18 mg/day in patients with end-stage renal disease on hemodialysis ( 2.2 ) Restless Legs Syndrome: The recommended starting dose is 0.25 mg once daily, 1 to 3 hours before bedtime, titrate to a maximum recommended dose of 4 mg daily ( 2.3 ) Renal Impairment: The maximum recommended dose is 3 mg/day in patients with end-stage renal disease on hemodialysis ( 2.3 ) 2.1 General Dosing Recommendations Ropinirole hydrochloride tablets can be taken with or without food [see Clinical Pharmacology ( 12.3 )] . If a significant interruption in therapy with ropinirole hydrochloride tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease The recommended starting dose for Parkinson's disease is 0.25 mg three times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described in Table 1. After Week 4, if necessary, the daily dose may be increased by 1.5 mg/day on a weekly basis up to a dose of 9 mg/day, and then by up to 3 mg/day weekly up to a maximum recommended total daily dose of 24 mg/day (8 mg three times daily). Doses greater than 24 mg/day have not been tested in clinical trials. Table 1. Ascending-dose Schedule of Ropinirole Hydrochloride Tablets for Parkinson’s Disease Week Dosage Total Daily Dose 1 0.25 mg 3 times daily 0.75 mg 2 0.5 mg 3 times daily 1.5 mg 3 0.75 mg 3 times daily 2.25 mg 4 1 mg 3 times daily 3 mg Ropinirole hydrochloride tablets should be discontinued gradually over a 7-day period in patients with Parkinson's disease. The frequency of administration should be reduced from three times daily to twice daily for 4 days. For the remaining 3 days, the frequency should be reduced to once daily prior to complete withdrawal of ropinirole hydrochloride tablets. 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 for patients with end-stage renal disease on hemodialysis is 0.25 mg three times a day. 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 hydrochloride tablets in patients with severe renal impairment without regular dialysis has not been studied. 2.3 Dosing for Restless Legs Syndrome The recommended adult starting dose for RLS is 0.25 mg once daily 1 to 3 hours before bedtime. After 2 days, if necessary, the dose can be increased to 0.5 mg once daily, and to 1 mg once daily at the end of the first week of dosing, then as shown in Table 2 as needed to achieve efficacy. Titration should be based on individual patient therapeutic response and tolerability, up to a maximum recommended dose of 4 mg daily. For RLS, the safety and effectiveness of doses greater than 4 mg once daily have not been established. Table 2. Dose Titration Schedule of Ropinirole for Restless Legs Syndrome Day/Week Dose to be taken once daily, 1 to 3 hours before bedtime Days 1 and 2 0.25 mg Days 3 to 7 0.5 mg Week 2 1 mg Week 3 1.5 mg Week 4 2 mg Week 5 2.5 mg Week 6 3 mg Week 7 4 mg In clinical trials of patients treated for RLS with doses up to 4 mg once daily, ropinirole hydrochloride tablets was discontinued without a taper. 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 for patients with end-stage renal disease on hemodialysis is 0.25 mg once daily. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 3 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole hydrochloride tablets in patients with severe renal impairment without regular dialysis has not been studied.