Zhejiang Huahai Pharmaceutical Co., Ltd.

Zhejiang Huahai Pharmaceutical Co., Ltd. Drugs

• Ropinirole Hydrochlorid...
  

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  Ropinirole Hydrochloride

  

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  General Dosing Considerations for Parkinson's Disease and RLS:

  Ropinirole hydrochloride can be taken with or without food. Patients may be advised that taking ropinirole hydrochloride 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 ropinirole hydrochloride has occurred, retitration of therapy may be warranted.

  Geriatric Use:

  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.

  Renal Impairment:

  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 ropinirole hydrochloride in patients with severe renal impairment has not been studied.

  Hepatic Impairment:

  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, ropinirole hydrochloride 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 Ropinirole Hydrochloride for Parkinson’s Disease Week Dosage Total Daily Dose

  1

  2

  3

  4

  0.25 mg 3 times daily

  0.5 mg 3 times daily

  0.75 mg 3 times daily

  1 mg 3 times daily

  0.75 mg

  1.5 mg

  2.25 mg

  3 mg

  When ropinirole hydrochloride 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 ropinirole hydrochloride and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with ropinirole hydrochloride.

  Ropinirole hydrochloride 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 ropinirole hydrochloride.

  Dosing for Restless Legs Syndrome:

  In all clinical trials, the dose for ropinirole hydrochloride 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 and 2 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, ropinirole hydrochloride was discontinued without a taper.

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