Drug Catalog - Product Detail
ROPINIROLE ER TAB 4MG 90CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 13811-0640-90 | TRIGEN LABORATORIES | 90 | 4MG | NA |
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Description
11 DESCRIPTION Ropinirole extended-release tablets 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 empirical 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 yellow solid with 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. Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Each capsule shaped, film coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: 2 mg: pink tablets debossed with 'L191' NDC 13811-639-30 bottle of 30 tablets NDC 13811-639-90 bottle of 90 tablets NDC 13811-639-10 bottle of 100 tablets NDC 13811-639-50 bottle of 500 tablets NDC 13811-639-01 bottle of 1000 tablets NDC 13811-639-11 carton of 100 (10X10) unit dose tablets 4 mg: light brown tablets debossed with 'L193' NDC 13811-640-30 bottle of 30 tablets NDC 13811-640-90 bottle of 90 tablets NDC 13811-640-10 bottle of 100 tablets NDC 13811-640-50 bottle of 500 tablets NDC 13811-640-01 bottle of 1000 tablets NDC 13811-640-11 carton of 100 (10X10) unit dose tablets 6 mg: white to off white tablets debossed with 'L321' NDC 13811-641-30 bottle of 30 tablets NDC 13811-641-90 bottle of 90 tablets NDC 13811-641-10 bottle of 100 tablets NDC 13811-641-50 bottle of 500 tablets NDC 13811-641-01 bottle of 1000 tablets NDC 13811-641-11 carton of 100 (10X10) unit dose tablets 8 mg: dark brown to red tablets debossed with 'L194' NDC 13811-642-30 bottle of 30 tablets NDC 13811-642-90 bottle of 90 tablets NDC 13811-642-10 bottle of 100 tablets NDC 13811-642-50 bottle of 500 tablets NDC 13811-642-01 bottle of 1000 tablets NDC 13811-642-11 carton of 100 (10X10) unit dose tablets 12 mg: light green tablets debossed with 'L195' NDC 13811-643-30 bottle of 30 tablets NDC 13811-643-90 bottle of 90 tablets NDC 13811-643-10 bottle of 100 tablets NDC 13811-643-50 bottle of 500 tablets NDC 13811-643-01 bottle of 1000 tablets NDC 13811-643-11 carton of 100 (10X10) unit dose tablets Storage Store at 20° to 25°C (68° 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 indicated for the treatment of Parkinson’s disease. Ropinirole extended-release tablets are 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 are 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. Although the maximum recommended dose of ropinirole extended-release tablets is 24 mg. Ropinirole extended-release tablets should be discontinued gradually over a 7-day period. 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 Extended-Release Ropinirole Tablets Patients may be switched directly from immediate-release ropinirole to extended-release ropinirole 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 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 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.