REQUIP TABLET 0.25 MG

CATALENT UK PACKAGING LIMITED (PRIMARY AND SECONDARY PACKAGER) - UNITED KINGDOMGLAXO WELLCOME S.A. (SPAIN)🇸🇬 Health Sciences Authority

Approval Date: Jun 11, 1999
Approval ID: e4acde39bc5ae094
Company: CATALENT UK PACKAGING LIMITED (PRIMARY AND SECONDARY PACKAGER) - UNITED KINGDOMGLAXO WELLCOME S.A. (SPAIN)
Type: Therapeutic

Approval Details

Approval Id: e4acde39bc5ae094
Drug Name: REQUIP TABLET 0.25 MG
Product Name: REQUIP TABLET 0.25 MG
Approval Number: SIN10976P
Approval Date: 1999-06-11
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: Dosage and Administration Pharmaceutical form: Film-coated, pentagonal-shaped tablets for oral administration. The tablet strengths are distinguished by colour and debossing; 0.25 mg: white, pentagonal-shaped, film-coated tablets marked "SB" on one side and "4890" on the other. 1.0 mg: green, pentagonal-shaped, film-coated tablets marked "SB" on one side and "4892" on the other. 2.0 mg: pink, pentagonal-shaped, film-coated tablets marked "SB" on one side and "4893" on the other. When switching treatment from another dopamine agonist to REQUIP, the manufacturer's guidance on discontinuation should be followed before initiating REQUIP. Individual dose titration against efficacy and tolerability is recommended. Patients should be down-titrated if they experience disabling somnolence at any dose level. For other adverse events, down-titration followed by more gradual up-titration has been shown to be beneficial. Parkinson's Disease <ul> <li>Adults REQUIP should be taken three times a day and may be taken with or without food (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Treatment initiation: The initial dose should be 0.25 mg t.i.d (three times a day). A guide for the titration regimen for the first four weeks of treatment is given in the table below: <img src="/TGIF/Requip-Table1.png" alt="Requip Dosage Table 1" /> Therapeutic regimen: After the initial titration, weekly increments of up to 3 mg/day may be given. REQUIP is usually given in divided doses three times per day. A therapeutic response may be seen between 3 mg and 9 mg/day, although adjunct therapy patients may require higher doses. If sufficient symptomatic control is not achieved or maintained after the initial titration period, as described above, the dose of REQUIP may be increased until an acceptable therapeutic response is established. The safety and efficacy of doses above 24 mg/day have not been established and this dose should not be exceeded. When REQUIP is given as adjunct therapy to L-dopa, it may be possible to reduce gradually the L-dopa dose, depending on the clinical response. In clinical trials, the L-dopa dose was reduced gradually by approximately 20% in patients receiving ropinirole concurrently. In patients with advanced Parkinson’s disease receiving REQUIP in combination with L-dopa, dyskinesias can occur during the initial titration of REQUIP. In clinical trials, it was shown that a reduction of the L-dopa dose may ameliorate dyskinesia (see Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). As with other dopamine agonists, REQUIP should be discontinued gradually by reducing the number of daily doses over the period of one week (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If treatment is interrupted for one day or more, re-initiation by dose titration should be considered (see above). Restless Legs Syndrome REQUIP should be taken once-daily before bedtime, however the dose can be taken up to 3 hours before retiring. REQUIP may be taken with or without food. Treatment Initiation (Week 1) The recommended initial dose is 0.25 mg once daily for 2 days. If this dose is well tolerated the dose may be increased to 0.5 mg once daily for the remainder of Week 1. Therapeutic Regimen (Week 2 onwards) Following treatment initiation, the daily dose can be increased according to the regimen below until optimal therapeutic response is achieved. <img src="/TGIF/Requip-Table1.png" alt="Requip Dosage Table 1" /> First signs of a response can be anticipated after one week of treatment in some patients, although further titration to achieve optimal effect is likely to be required. The mean daily dose in clinical trials was 2 mg/day. The safety and efficacy of doses above 4 mg/day have not been established. As with other dopamine agonists, it is necessary to discontinue ropinirole treatment gradually by reducing the daily dose (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If treatment is interrupted for one day or more, re-initiation by dose titration should be considered (see above).</li> <li>Elderly The clearance of ropinirole is decreased in patients aged 65 years or above, but the dose of REQUIP for elderly patients can be titrated in the normal manner.</li> <li>Children and Adolescents The safety and efficacy of ropinirole have not been established in patients under 18 years of age, therefore REQUIP is not recommended for use in patients within this age group.</li> <li>Renal impairment In patients with mild to moderate renal impairment (creatinine clearance 30 – 50 mL/min) no change in the clearance of ropinirole was observed, indicating that no dosage adjustment is necessary in this population. A study into the use of ropinirole in patients with end stage renal disease (patients on haemodialysis) has shown that a dose adjustment in these patients is required as follows: For patients with Restless Legs Syndrome, the recommended initial dose of REQUIP is 0.25 mg once daily. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose is 3 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. For patients with Parkinson’s Disease, the initial dose of REQUIP should be 0.25 mg three times a day. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole in patients with severe renal impairment (creatinine clearance <30 mL/min) without regular dialysis has not been studied.</li> <li>Hepatic impairment The use of ropinirole in patients with hepatic impairment has not been studied. Administration of REQUIP to such patients is not recommended.</li> </ul>
Route Of Administration: ORAL
Indication Info: Indications REQUIP is indicated for the treatment of idiopathic Parkinson's disease: <ul> <li>REQUIP may be used alone (without levodopa [L-Dopa]) in the treatment of idiopathic Parkinson's disease.</li> <li>Addition of REQUIP to levodopa may be used to control "on-off" fluctuations and permit a reduction in the total daily dose of L-Dopa.</li> </ul> REQUIP is indicated for the treatment of moderate to severe primary Restless Legs Syndrome (RLS).
Contraindications: Contraindications Hypersensitivity to ropinirole or to any of the listed excipients.
Atc Code: N04BC04
Atc Item Name: ropinirole
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD

Active Ingredients

ROPINIROLE HCl EQV ROPINIROLE

0.25 mg

ROPINIROLE HCL EQV ROPINIROLE

0.25 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 11, 1999

Approval ID

e4acde39bc5ae094

Type

Therapeutic

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