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REQUIP (ropinirole hcl) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
The effectiveness of REQUIP (ropinirole hcl) was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).
Restless Legs Syndrome
REQUIP (ropinirole hcl) is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.
DOSAGE AND ADMINISTRATION
General Dosing Considerations for Parkinson's Disease and RLS
REQUIP (ropinirole hcl) can be taken with or without food. Patients may be advised that taking REQUIP (ropinirole hcl) with food may reduce the occurrence of nausea. However, this has not been established in controlled clinical trials.
If a significant interruption in therapy with REQUIP (ropinirole hcl) has occurred, retitration of therapy may be warranted.
Pharmacokinetic studies demonstrated a reduced clearance of ropinirole in the elderly (see CLINICAL PHARMACOLOGY). Dose adjustment is not necessary since the dose is individually titrated to clinical response.
The pharmacokinetics of ropinirole were not altered in patients with moderate renal impairment (see CLINICAL PHARMACOLOGY). Therefore, no dosage adjustment is necessary in patients with moderate renal impairment. The use of REQUIP (ropinirole hcl) in patients with severe renal impairment has not been studied.
The pharmacokinetics of ropinirole have not been studied in patients with hepatic impairment. Since patients with hepatic impairment may have higher plasma levels and lower clearance, REQUIP (ropinirole hcl) should be titrated with caution in these patients.
Dosing for Parkinson's Disease
In all clinical studies, dosage was initiated at a subtherapeutic level and gradually titrated to therapeutic response. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of nausea, dizziness, somnolence, and dyskinesia.
The recommended starting dose for Parkinson's disease is 0.25 mg 3 times daily. Based on individual patient response, dosage should then be titrated with weekly increments as described in Table 5. After week 4, if necessary, daily dosage 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 to a total dose of 24 mg/day. Doses greater than 24 mg/day have not been tested in clinical trials.
Table 5: Ascending-Dose Schedule of REQUIP (ropinirole hcl) for Parkinson's
|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|
When REQUIP (ropinirole hcl) is administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. L-dopa dosage reduction was allowed during the advanced Parkinson's disease (with L-dopa) study if dyskinesias or other dopaminergic effects occurred. Overall, reduction of L-dopa dose was sustained in 87% of patients treated with REQUIP (ropinirole hcl) and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with REQUIP (ropinirole hcl) .
REQUIP (ropinirole hcl) for Parkinson's disease patients should be discontinued gradually over a 7-day period. The frequency of administration should be reduced from 3 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 REQUIP (ropinirole hcl) .
Dosing for Restless Legs Syndrome
In all clinical trials, the dose for REQUIP (ropinirole hcl) was initiated at 0.25 mg once daily, 1 to 3 hours before bedtime. Patients were titrated based on clinical response and tolerability.
The recommended adult starting dosage for RLS is 0.25 mg once daily, 1 to 3 hours before bedtime. After 2 days, the dosage 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 6 as needed to achieve efficacy.
For RLS, the safety and effectiveness of doses greater than 4 mg once daily have not been established.
Table 6: Dose Titration Schedule for RLS
|Day/Week||Dosage to be taken once daily, 1 to 3 hours before bedtime|
|Days 1 anD2||0.25 mg|
|Days 3-7||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 being treated for RLS with doses up to 4 mg once daily, REQUIP (ropinirole hcl) was discontinued without a taper.
Tablets: Each pentagonal film-coated TILTAB® tablet with beveled edges contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:
0.25 mg: white tablets imprinted with “SB” and “4890” in bottles of 100 (NDC 0007-4890-20).
0.5 mg: yellow tablets imprinted with “SB” and “4891” in bottles of 100 (NDC 0007-4891-20).
1 mg: green tablets imprinted with “SB” and “4892” in bottles of 100 (NDC 0007-4892-20).
2 mg: pale yellowish-pink tablets imprinted with “SB” and “4893” in bottles of 100 (NDC 0007-4893-20).
3 mg: pale to moderate reddish-purple tablets, imprinted with “SB” and “4895” in bottles of 100 (NDC 0007-4895-20).
4 mg: pale brown tablets imprinted with “SB” and “4896” in bottles of 100 (NDC 0007-4896-20).
5 mg: blue tablets imprinted with “SB” and “4894” in bottles of 100 (NDC 0007-4894-20).
Protect from light and moisture. Close container tightly after each use. Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].
GlaxoSmithKline, Research Triangle Park, NC 27709. May 2009.
Last reviewed on RxList: 11/30/2010
This monograph has been modified to include the generic and brand name in many instances.
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