Barrier-dyne 10

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  Barrier-dyne 10 | Solco Healthcare U.s., Llc

  

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  2.1 General Dosing Recommendations

  Ropinirole hydrochloride tablets can be taken with or without food [see Clinical Pharmacology (12.3)].

  If a significant interruption in therapy with ropinirole hydrochloride tablets has occurred, retitration of therapy may be warranted.

  2.2 Dosing for Parkinson’s Disease

  The recommended starting dose for Parkinson's disease is 0.25 mg three times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described in Table 1. After Week 4, if necessary, the daily dose 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 up to a maximum recommended total daily dose of 24 mg/day (8 mg three times daily). Doses greater than 24 mg/day have not been tested in clinical trials.

  Table 1. Ascending-dose Schedule of Ropinirole Hydrochloride Tablets for Parkinson’s Disease 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
  

  Ropinirole hydrochloride tablets should be discontinued gradually over a 7-day period in patients with Parkinson's disease. The frequency of administration should be reduced from three 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 tablets.

  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 for patients with end-stage renal disease on hemodialysis is 0.25 mg three times a day. 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 hydrochloride tablets in patients with severe renal impairment without regular dialysis has not been studied. 

  2.3 Dosing for Restless Legs Syndrome

  The recommended adult starting dose for RLS is 0.25 mg once daily 1 to 3 hours before bedtime. After 2 days, if necessary, the dose 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 2 as needed to achieve efficacy. Titration should be based on individual patient therapeutic response and tolerability, up to a maximum recommended dose of 4 mg daily. For RLS, the safety and effectiveness of doses greater than 4 mg once daily have not been established.

  Table 2. Dose Titration Schedule of Ropinirole for Restless Legs Syndrome Day/Week
  Dose to be taken once daily, 1 to 3 hours before bedtime
  Days 1 and 2
  0.25 mg
  Days 3 to 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 treated for RLS with doses up to 4 mg once daily, ropinirole hydrochloride tablets was discontinued without a taper.

  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 for patients with end-stage renal disease on hemodialysis is 0.25 mg once daily. Further dose escalations should be based on tolerability and need for efficacy. The recommended maximum total daily dose is 3 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole hydrochloride tablets in patients with severe renal impairment without regular dialysis has not been studied. 

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