מדינה: סינגפור
שפה: אנגלית
מקור: HSA (Health Sciences Authority)
ROPINIROLE HCl EQV ROPINIROLE
GLAXOSMITHKLINE PTE LTD
N04BC04
0.25 mg
TABLET, FILM COATED
ROPINIROLE HCl EQV ROPINIROLE 0.25 mg
ORAL
Prescription Only
Catalent UK Packaging Limited (Primary and Secondary Packager)
ACTIVE
1999-06-11
1 REQUIP™ ROPINIROLE QUALITATIVE AND QUANTITATIVE COMPOSITION Ropinirole hydrochloride equivalent to 0.25 mg, 1.0 mg, 2.0 mg or 5.0 mg ropinirole free base. 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. 5.0 mg: blue, pentagonal-shaped, film-coated tablets marked "SB" on one side and "4894" on the other. CLINICAL PARTICULARS INDICATIONS REQUIP is indicated for the treatment of idiopathic Parkinson's disease: • REQUIP may be used alone (without levodopa [L-Dopa]) in the treatment of idiopathic Parkinson's disease. • 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. REQUIP is indicated for the treatment of moderate to severe primary Restless Legs Syndrome (RLS). DOSAGE AND ADMINISTRATION When switching treatment from another dopamine agonist to REQUIP, the manufacturer's guidance on discontinuation should be followed before initiating REQUIP. 2 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 _ • ADULTS REQUIP should be taken three times a day and may be taken with or without food (_see _ _Pharmacokinetics_). _TREATMENT INITIATION: קרא את המסמך השלם
1 REQUIP ROPINIROLE QUALITATIVE AND QUANTITATIVE COMPOSITION Ropinirole hydrochloride equivalent to 0.25 mg, 1.0 mg or 2.0 mg ropinirole free base. CLINICAL INFORMATION INDICATIONS REQUIP is indicated for the treatment of idiopathic Parkinson's disease: • REQUIP may be used alone (without levodopa [L-Dopa]) in the treatment of idiopathic Parkinson's disease. • 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. REQUIP is indicated for the treatment of moderate to severe primary Restless Legs Syndrome (RLS). 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. 2 _PARKINSON'S DISEASE _ • ADULTS REQUIP should be taken three times a day and may be taken with or without food (see _ _ _Pharmacokinetics_ ). _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: Week 1 2 3 4 Unit dose (mg) 0.25 0.5 0.75 1.0 Total daily dose (mg) 0.75 1.5 2.25 3.0 _THERAPEUTIC REGIMEN_ : After the initial titration, weekly increments of up to 3 mg/day may be given. REQU קרא את המסמך השלם