Ropinirole Hydrochloride

Ropinirole Hydrochloride Manufacturers

• Cardinal Health
  

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  Ropinirole Hydrochloride |

  

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• Aidarex Pharmaceuticals Llc
  

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  Ropinirole Hydrochloride | Aidarex Pharmaceuticals Llc

  

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  General Dosing Considerations for Parkinson's Disease and RLS
  Ropinirole Hydrochloride Tablets can be taken with or without food. Patients may be advised that taking Ropinirole Hydrochloride Tablets 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 Tablets 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 Tablets 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 Tablets 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 Tablets for Parkinson’s Disease

  Week

  Dosage

  Total Daily Dose

  1

  0.25mg 3 times daily

  0.75mg

  2

  0.5mg 3 times daily

  1.5mg

  3

  0.75mg 3 times daily

  2.25mg

  4

  1mg 3 times daily

  3mg

   
  When Ropinirole Hydrochloride Tablets are 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 Tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with Ropinirole Hydrochloride Tablets.
   
  Ropinirole Hydrochloride Tablets 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 Tablets.
  
  Dosing for Restless Legs Syndrome
  In all clinical trials, the dose for Ropinirole Hydrochloride Tablets 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

  2.5mg

  Week 6

  3mg

  Week 7

  4mg

  
  In clinical trials of patients being treated for RLS with doses up to 4 mg once daily, Ropinirole Hydrochloride Tablets were discontinued without a taper.

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• Major Pharmaceuticals
  

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  Ropinirole Hydrochloride | Major Pharmaceuticals

  

  ---

  General Dosing Considerations for Parkinson’s Disease and RLS

  Ropinirole hydrochloride tablets can be taken with or without food. Patients may be advised that taking ropinirole hydrochloride tablets 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 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

  When ropinirole hydrochloride tablets are 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 tablets 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 tablets.

  Dosing for Restless Legs Syndrome

  In all clinical trials, the dose for ropinirole 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 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 being treated for RLS with doses up to 4 mg once daily, ropinirole was discontinued without a taper.

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• Heritage Pharmaceuticals Inc.
  

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  Ropinirole Hydrochloride | Heritage Pharmaceuticals Inc.

  

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  General Dosing Considerations for Parkinson's Disease and RLS
  Ropinirole Hydrochloride Tablets can be taken with or without food. Patients may be advised that taking Ropinirole Hydrochloride Tablets 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 Tablets 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 Tablets 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 Tablets 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 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
   
  When Ropinirole Hydrochloride Tablets are 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 Tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with Ropinirole Hydrochloride Tablets.
   
  Ropinirole Hydrochloride Tablets 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 Tablets.
  
  Dosing for Restless Legs Syndrome
  In all clinical trials, the dose for Ropinirole Hydrochloride Tablets 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 Tablets were discontinued without a taper.

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• Rebel Distributors Corp
  

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  Ropinirole Hydrochloride | Rebel Distributors Corp

  

  ---

  General Dosing Considerations for Parkinson's Disease and RLS: Ropinirole hydrochloride tablets can be taken with or without food. Patients may be advised that taking ropinirole hydrochloride tablets 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 tablets has occurred, retitration of therapy may be warranted.

  Geriatric Use: Pharmacokinetic studies demonstrated a reduced clearance of ropinirole in the elderly (seeCLINICAL 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 (seeCLINICAL PHARMACOLOGY). Therefore, no dosage adjustment is necessary in patients with moderate renal impairment. The use of ropinirole hydrochloride tablets 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 tablets should be titrated with caution in these patient.

  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 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

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

  Ropinirole hydrochloride tablets 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 tablets.

  Dosing for Restless Legs Syndrome: In all clinical trials, the dose for ropinirole hydrochloride tablets 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 dose 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 tablets were discontinued without a taper.

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• Cadila Healthcare Limited
  

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  Ropinirole Hydrochloride | Cadila Healthcare Limited

  

  ---

  General Dosing Considerations for Parkinson’s Disease and RLS:

  Ropinirole hydrochloride tablets can be taken with or without food. Patients may be advised that taking ropinirole hydrochloride tablets 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 tablets 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 5Ascending-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
  

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

  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 tablets.

  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 6Dose 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 tablets were discontinued without a taper.

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• Stat Rx Usa Llc
  

  ×

  Ropinirole Hydrochloride | Stat Rx Usa Llc

  

  ---

  General Dosing Considerations for Parkinson's Disease and RLS

  Ropinirole hydrochloride tablets can be taken with or without food. Patients may be advised that taking ropinirole hydrochloride tablets 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 tablets 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 tablets 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 tablets 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 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
  

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

  Ropinirole hydrochloride tablets 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 tablets.

  
  Dosing for Restless Legs Syndrome

  In all clinical trials, the dose for ropinirole hydrochloride tablets 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 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 being treated for RLS with doses up to 4 mg once daily, ropinirole hydrochloride tablets was discontinued without a taper.
  
  

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• Rebel Distributors Corp
  

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  Ropinirole Hydrochloride | Rebel Distributors Corp

  

  ---

  General Dosing Considerations for Parkinson’s Disease and RLS:

  Ropinirole hydrochloride tablets can be taken with or without food. Patients may be advised that taking ropinirole hydrochloride tablets 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 tablets 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 5Ascending-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
  

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

  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 tablets.

  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 6Dose 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 tablets were discontinued without a taper.

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• Bryant Ranch Prepack
  

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  Ropinirole Hydrochloride | Bryant Ranch Prepack

  

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  General Dosing Considerations for Parkinson's Disease and RLS
  Ropinirole Hydrochloride Tablets can be taken with or without food. Patients may be advised that taking Ropinirole Hydrochloride Tablets 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 Tablets 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 Tablets 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 Tablets 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 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
   
  When Ropinirole Hydrochloride Tablets are 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 Tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with Ropinirole Hydrochloride Tablets.
   
  Ropinirole Hydrochloride Tablets 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 Tablets.
  
  Dosing for Restless Legs Syndrome
  In all clinical trials, the dose for Ropinirole Hydrochloride Tablets 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 Tablets were discontinued without a taper.

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• Zhejiang Huahai Pharmaceutical Co., Ltd.
  

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  Ropinirole Hydrochloride | Zhejiang Huahai Pharmaceutical Co., Ltd.

  

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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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• Watson Laboratories, Inc.
  

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  Ropinirole Hydrochloride | Watson Laboratories, Inc.

  

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  2.1 General Dosing Considerations Ropinirole extended-release tablets are taken once daily, with or without food. Taking ropinirole extended-release tablets with food may reduce the occurrence of nausea; this has not been established in controlled clinical trials [see Clinical Pharmacology (12.3)].
  Tablets must be swallowed whole and must not be chewed, crushed, or divided.
  If a significant interruption in therapy with ropinirole extended-release tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease

  The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, depending on therapeutic response and tolerability, up to a maximally recommended dose of 24 mg/day.

  In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Caution should be exercised during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [see Clinical Studies (14.2)]. Due to the flexible dosing design used in clinical studies, specific dose response information could not be determined.

  When ropinirole extended-release tablets are administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. In the placebo-controlled advanced Parkinson's disease study, the L-dopa dose was reduced once patients reached a dose of ropinirole extended-release tablets of 8 mg/day. Overall, L-dopa dose reduction was sustained in 93% of patients treated with ropinirole extended-release tablets and in 72% of patients on placebo. On average the L-dopa dose was reduced by 34% in patients treated with ropinirole extended-release tablets [see Clinical Studies (14)]. Ropinirole extended-release tablets should be discontinued gradually over a 7–day period.

  2.3 Switching From Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets

  Patients may be switched directly from immediate-release ropinirole to ropinirole extended-release tablets. The initial dose of ropinirole extended-release tablets should most closely match the total daily dose of the immediate-release formulation of ropinirole tablets, as shown in Table 1.

  Table 1. Conversion from Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets  Immediate-Release
  Ropinirole Tablets
  Total Daily Dose (mg)  Ropinirole Extended-
  Release Tablets
  Total Daily Dose (mg)  0.75 to 2.25  2  3 to 4.5  4  6  6  7.5 to 9  8  12  12  15 to 18  16  21  20  24  24

  Following conversion to ropinirole extended-release tablets, the dose may be adjusted depending on therapeutic response and tolerability [see Dosage and Administration (2.2)].

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• Avkare, Inc.
  

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  Ropinirole Hydrochloride | Avkare, Inc.

  

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  2.1 General Dosing Considerations Ropinirole extended-release tablets are taken once daily, with or without food. Taking ropinirole extended-release tablets with food may reduce the occurrence of nausea; this has not been established in controlled clinical trials [see Clinical Pharmacology (12.3)].
  Tablets must be swallowed whole and must not be chewed, crushed, or divided.
  If a significant interruption in therapy with ropinirole extended-release tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease

  The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, depending on therapeutic response and tolerability, up to a maximally recommended dose of 24 mg/day.

  In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Caution should be exercised during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [see Clinical Studies (14.2)]. Due to the flexible dosing design used in clinical studies, specific dose response information could not be determined.

  When ropinirole extended-release tablets are administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. In the placebo-controlled advanced Parkinson's disease study, the L-dopa dose was reduced once patients reached a dose of ropinirole extended-release tablets of 8 mg/day. Overall, L-dopa dose reduction was sustained in 93% of patients treated with ropinirole extended-release tablets and in 72% of patients on placebo. On average the L-dopa dose was reduced by 34% in patients treated with ropinirole extended-release tablets [see Clinical Studies (14)]. Ropinirole extended-release tablets should be discontinued gradually over a 7–day period.

  2.3 Switching From Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets

  Patients may be switched directly from immediate-release ropinirole to ropinirole extended-release tablets. The initial dose of ropinirole extended-release tablets should most closely match the total daily dose of the immediate-release formulation of ropinirole tablets, as shown in Table 1.

  Table 1. Conversion from Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets  Immediate-Release
  Ropinirole Tablets
  Total Daily Dose (mg)  Ropinirole Extended-
  Release Tablets
  Total Daily Dose (mg)  0.75 to 2.25  2  3 to 4.5  4  6  6  7.5 to 9  8  12  12  15 to 18  16  21  20  24  24

  Following conversion to ropinirole extended-release tablets, the dose may be adjusted depending on therapeutic response and tolerability [see Dosage and Administration (2.2)].

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• Wockhardt Usa Llc.
  

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  Ropinirole Hydrochloride | Wockhardt Usa Llc.

  

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  2.1 General Dosing Considerations Ropinirole Extended-release Tablets are taken once daily, with or without food. Taking Ropinirole Extended-release Tablets with food may reduce the occurrence of nausea; this has not been established in controlled clinical trials [see Clinical Pharmacology (12.3)].   Tablets must be swallowed whole and must not be chewed, crushed, or divided. If a significant interruption in therapy with Ropinirole Extended-release Tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease

  The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, depending on therapeutic response and tolerability, up to a maximally recommended dose of 24 mg/day.

  In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Caution should be exercised during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [see Clinical Studies (14.2)]. Due to the flexible dosing design used in clinical studies, specific dose response information could not be determined.   

  When Ropinirole Extended-release Tablets are administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. In the placebo-controlled advanced Parkinson’s disease study, the L-dopa dose was reduced once patients reached a dose of Ropinirole Extended-release Tablets of 8 mg/day. Overall, L-dopa dose reduction was sustained in 93% of patients treated with Ropinirole Extended-release Tablets and in 72% of patients on placebo. On average the L-dopa dose was reduced by 34% in patients treated with Ropinirole Extended-release Tablets [see Clinical Studies (14)].

  Ropinirole Extended-release Tablets should be discontinued gradually over a 7-day period.   

  2.3 Switching From Immediate-Release Ropinirole Tablets to Ropinirole Extended-release Tablets

  Patients may be switched directly from immediate-release ropinirole to Ropinirole Extended-release Tablets. The initial dose of Ropinirole Extended-release Tablets should most closely match the total daily dose of the immediate-release formulation of ropinirole tablets as shown in Table 1.  

  Table 1. Conversion from Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets Immediate-Release Ropinirole Tablets 
  Total Daily Dose  (mg)
  Ropinirole Extended-Release Tablets
  Total Daily Dose  (mg)
  0.75 to 2.25
  2
  3 to 4.5
  4
  6
  6
  7.5 to 9
  8
  12
  12
  15 to 18
  16
  21
  20
  24
  24
  

  Following conversion to Ropinirole Extended-release Tablets the dose may be adjusted depending on therapeutic response and tolerability [see Dosage and Administration (2.2)].

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• Wockhardt Limited
  

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  Ropinirole Hydrochloride | Wockhardt Limited

  

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  2.1 General Dosing Considerations Ropinirole Extended-release Tablets are taken once daily, with or without food. Taking Ropinirole Extended-release Tablets with food may reduce the occurrence of nausea; this has not been established in controlled clinical trials [see Clinical Pharmacology (12.3)].   Tablets must be swallowed whole and must not be chewed, crushed, or divided. If a significant interruption in therapy with Ropinirole Extended-release Tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease

  The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, depending on therapeutic response and tolerability, up to a maximally recommended dose of 24 mg/day.

  In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Caution should be exercised during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [see Clinical Studies (14.2)]. Due to the flexible dosing design used in clinical studies, specific dose response information could not be determined.   

  When Ropinirole Extended-release Tablets are administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. In the placebo-controlled advanced Parkinson’s disease study, the L-dopa dose was reduced once patients reached a dose of Ropinirole Extended-release Tablets of 8 mg/day. Overall, L-dopa dose reduction was sustained in 93% of patients treated with Ropinirole Extended-release Tablets and in 72% of patients on placebo. On average the L-dopa dose was reduced by 34% in patients treated with Ropinirole Extended-release Tablets [see Clinical Studies (14)].

  Ropinirole Extended-release Tablets should be discontinued gradually over a 7-day period.   

  2.3 Switching From Immediate-Release Ropinirole Tablets to Ropinirole Extended-release Tablets

  Patients may be switched directly from immediate-release ropinirole to Ropinirole Extended-release Tablets. The initial dose of Ropinirole Extended-release Tablets should most closely match the total daily dose of the immediate-release formulation of ropinirole tablets as shown in Table 1.  

  Table 1. Conversion from Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets Immediate-Release Ropinirole Tablets 
  Total Daily Dose  (mg)
  Ropinirole Extended-Release Tablets
  Total Daily Dose  (mg)
  0.75 to 2.25
  2
  3 to 4.5
  4
  6
  6
  7.5 to 9
  8
  12
  12
  15 to 18
  16
  21
  20
  24
  24
  

  Following conversion to Ropinirole Extended-release Tablets the dose may be adjusted depending on therapeutic response and tolerability [see Dosage and Administration (2.2)].

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  Ropinirole Hydrochloride | Unit Dose Services

  

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  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [seeWARNINGS AND PRECAUTIONS (5.1)]. The total dose of zolpidem tartrate extended-release tablet, USP should not exceed 12.5 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate extended-release tablets in both of these patient populations is 6.25 mg once daily immediately before bedtime [seeWARNINGS AND PRECAUTIONS (5.1);USE IN SPECIFIC POPULATIONS (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate extended-release tablets are combined with other CNS depressant drugs because of the potentially additive effects [seeWARNINGS AND PRECAUTIONS (5.1)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets may be slowed by ingestion with or immediately after a meal.

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• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

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  Ropinirole Hydrochloride | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

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  General Dosing Considerations for Parkinson's Disease and RLS

  Ropinirole tablets can be taken with or without food. Patients may be advised that taking ropinirole hydrochloride tablets 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 tablets 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 tablets 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 tablets 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 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

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

  Ropinirole tablets 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 tablets.

  Dosing for Restless Legs Syndrome

  In all clinical trials, the dose for ropinirole hydrochloride tablets 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 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 being treated for RLS with doses up to 4 mg once daily, ropinirole hydrochloride tablets was discontinued without a taper.

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• Bryant Ranch Prepack
  

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  Ropinirole Hydrochloride | Bryant Ranch Prepack

  

  ---

  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 tablets 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 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 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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  General Dosing Considerations for Parkinson's Disease and RLS

  Ropinirole tablets can be taken with or without food. Patients may be advised that taking ropinirole tablets 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 tablets 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 tablets 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 Tablets 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 tablets are 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 tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with ropinirole tablets.

  Ropinirole tablets 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 tablets.

  Dosing for Restless Legs Syndrome

  In all clinical trials, the dose for ropinirole tablets 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
  Days 3-7
  Week 2
  Week 3
  Week 4
  Week 5
  Week 6
  Week 7
  0.25 mg
  0.5 mg
  1 mg
  1.5 mg
  2 mg
  2.5 mg
  3 mg
  4 mg
  

  In clinical trials of patients being treated for RLS with doses up to 4 mg once daily, ropinirole tablets was discontinued without a taper.

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  General Dosing Considerations for Parkinson's Disease and RLS

  Ropinirole tablets can be taken with or without food. Patients may be advised that taking ropinirole tablets 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 tablets 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 tablets 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 Tablets 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 tablets are 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 tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with ropinirole tablets.

  Ropinirole tablets 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 tablets.

  Dosing for Restless Legs Syndrome

  In all clinical trials, the dose for ropinirole tablets 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
  Days 3-7
  Week 2
  Week 3
  Week 4
  Week 5
  Week 6
  Week 7
  0.25 mg
  0.5 mg
  1 mg
  1.5 mg
  2 mg
  2.5 mg
  3 mg
  4 mg
  

  In clinical trials of patients being treated for RLS with doses up to 4 mg once daily, ropinirole tablets was discontinued without a taper.

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  General Dosing Considerations for Parkinson's Disease and RLS

  Ropinirole tablets can be taken with or without food. Patients may be advised that taking ropinirole tablets 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 tablets 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 tablets 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 Tablets 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 tablets are 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 tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with ropinirole tablets.

  Ropinirole tablets 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 tablets.

  Dosing for Restless Legs Syndrome

  In all clinical trials, the dose for ropinirole tablets 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
  Days 3-7
  Week 2
  Week 3
  Week 4
  Week 5
  Week 6
  Week 7
  

  0.25 mg
  0.5 mg
  1 mg
  1.5 mg
  2 mg
  2.5 mg
  3 mg
  4 mg
  

  In clinical trials of patients being treated for RLS with doses up to 4 mg once daily, ropinirole tablets was discontinued without a taper.

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  General Dosing Considerations for Parkinson's Disease and RLS
  Ropinirole Hydrochloride Tablets can be taken with or without food. Patients may be advised that taking Ropinirole Hydrochloride Tablets 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 Tablets 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 Tablets 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 Tablets 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 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

  
  
  When Ropinirole Hydrochloride Tablets are 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 Tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with Ropinirole Hydrochloride Tablets.
  
  Ropinirole Hydrochloride Tablets 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 Tablets.
  
  Dosing for Restless Legs Syndrome
  In all clinical trials, the dose for Ropinirole Hydrochloride Tablets 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 Tablets were discontinued without a taper.

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  General Dosing Considerations for Parkinson's Disease and RLS
  Ropinirole Tablets can be taken with or without food. Patients may be advised that taking Ropinirole Tablets 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 Tablets 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 Tablets 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 Tablets 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 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
  
  

  When Ropinirole Tablets are 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 Tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with Ropinirole Tablets.
  
  Ropinirole Tablets 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 Tablets.
  
  Dosing for Restless Legs Syndrome
  In all clinical trials, the dose for Ropinirole Tablets 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 Tablets were discontinued without a taper.

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  2.1 General Dosing Considerations Ropinirole extended-release tablets are taken once daily, with or without food. Taking ropinirole extended-release tablets with food may reduce the occurrence of nausea; this has not been established in controlled clinical trials [see Clinical Pharmacology (12.3)].
  Tablets must be swallowed whole and must not be chewed, crushed, or divided.
  If a significant interruption in therapy with ropinirole extended-release tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease

  The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, depending on therapeutic response and tolerability, up to a maximally recommended dose of 24 mg/day.

  In clinical trials, dosage was initiated at 2 mg/day and gradually titrated based on individual therapeutic response and tolerability. Doses greater than 24 mg/day have not been studied in clinical trials. Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment. Caution should be exercised during dose titration because too rapid a rate of titration may lead to dose selection that may not provide additional benefit, but that may increase the risk of adverse reactions [see Clinical Studies (14.2)]. Due to the flexible dosing design used in clinical studies, specific dose response information could not be determined.

  When ropinirole extended-release tablets are administered as adjunct therapy to L-dopa, the concurrent dose of L-dopa may be decreased gradually as tolerated. In the placebo-controlled advanced Parkinson's disease study, the L-dopa dose was reduced once patients reached a dose of ropinirole extended-release tablets of 8 mg/day. Overall, L-dopa dose reduction was sustained in 93% of patients treated with ropinirole extended-release tablets and in 72% of patients on placebo. On average the L-dopa dose was reduced by 34% in patients treated with ropinirole extended-release tablets [see Clinical Studies (14)]. Ropinirole extended-release tablets should be discontinued gradually over a 7–day period.

  2.3 Switching From Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets

  Patients may be switched directly from immediate-release ropinirole to ropinirole extended-release tablets. The initial dose of ropinirole extended-release tablets should most closely match the total daily dose of the immediate-release formulation of ropinirole tablets, as shown in Table 1.

  Table 1. Conversion from Immediate-Release Ropinirole Tablets to Ropinirole Extended-Release Tablets  Immediate-Release
  Ropinirole Tablets
  Total Daily Dose (mg)  Ropinirole Extended-
  Release Tablets
  Total Daily Dose (mg)  0.75 to 2.25  2  3 to 4.5  4  6  6  7.5 to 9  8  12  12  15 to 18  16  21  20  24  24

  Following conversion to ropinirole extended-release tablets, the dose may be adjusted depending on therapeutic response and tolerability [see Dosage and Administration (2.2)].

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  Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  Indomethacin extended-release capsules 75 mg are available for oral use. Indomethacin extended-release capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant differences between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, indomethacin extended-release capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin extended-release capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.

  Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.

  Always give indomethacin extended-release capsules 75 mg with food, immediately after meals or with antacids to reduce gastric irritation.

  Pediatric Use

  Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).

  Adult Use

  Dosage Recommendations for Active Stages of the Following:

  1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.

  The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):

  Suggested Dosage:

  The following recommendations on dosing pertain to immediate-release indomethacin capsules USP and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.

  Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.

  In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.

  The following information refers to extended-release Indomethacin Capsules (75 mg):

  If indomethacin extended-release capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin extended-release capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, indomethacin extended-release capsules 75 mg may be prescribed as one capsule twice daily.

  If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.

  If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.

  Careful instructions to and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.

  As advancing years appear to increase the possibility of adverse reactions, indomethacin extended-release capsules should be used with greater care in the aged.

  2. Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.

  The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.

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  ---

  General Dosing Considerations for Parkinson's Disease and RLS:

  Ropinirole hydrochloride tablets can be taken with or without food. Patients may be advised that taking ropinirole hydrochloride tablets 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 tablets 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 tablets 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 tablets 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 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

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

  Ropinirole hydrochloride tablets 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 tablets.

  Dosing for Restless Legs Syndrome:

  In all clinical trials, the dose for ropinirole hydrochloride tablets 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 dose 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 tablets were discontinued without a taper.

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  Ropinirole Hydrochloride | Vi-jon

  

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  do not exceed recommended daily dosage drink a full glass (8 ounces) of liquie with each dose may be taken as a single daily dose or in divided doses dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste

  adults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) daily

  children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily

  children under 6 years - consult a doctor

  Directions for Soaking

  Directions: Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or towelling for 30 minutes up to three times a day, or use as a soak or in bath. Use warm water for best results.

  Directions for Plant Food Supplement

  For use as a fertilizer apply at the following rates:

  LAWNS - Apply at a rate of 1/2 pound per one thousand square feet of lawn.

  For use as a plant food supplement apply at the following rates:

  TOMATOES, ROSES - One teaspoon per foot plat height every two weeks.

  EVERGREENS, AZALEAS, RHODODENDRONS - apply one tablespoon per nine sq. t. (3' x 3') over root zone once every two to four weeks.

  GARDEN PLANTS AND SHRUBBERY - Sprinkle 2 tablespoons around the base of each plant.

  TREES - Apply two tablespoons per nine sq. ft. (3'x 3') over root zone once every four months.

  GARDEN STARTUP - Sprinkle approximately one cup per 100 sq. ft. (10' x 10') and mix into soil prior to planting.

  HOUSEPLANTS - Mix one teaspoon per gallon of water and feed to plants ever one to four weeks.

  For quicker results water plants after applying this product.

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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 tablets 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 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 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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  ---

  
  

  General Dosing Considerations for Parkinson's Disease and RLS

  Ropinirole Hydrochloride Tablets can be taken with or without food. Patients may be advised that taking Ropinirole Hydrochloride Tablets 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 Tablets 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 Tablets 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 Tablets 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 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
  
  

  When Ropinirole Hydrochloride Tablets are 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 Tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with Ropinirole Hydrochloride Tablets.

  Ropinirole Hydrochloride Tablets 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 Tablets.

  Dosing for Restless Legs Syndrome

  In all clinical trials, the dose for Ropinirole Hydrochloride Tablets 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 Tablets were discontinued without a taper.

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  Ropinirole Hydrochloride | Bryant Ranch Prepack

  

  ---

  
  

  General Dosing Considerations for Parkinson's Disease and RLS

  Ropinirole Hydrochloride Tablets can be taken with or without food. Patients may be advised that taking Ropinirole Hydrochloride Tablets 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 Tablets 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 Tablets 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 Tablets 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 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
  
  

  When Ropinirole Hydrochloride Tablets are 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 Tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with Ropinirole Hydrochloride Tablets.

  Ropinirole Hydrochloride Tablets 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 Tablets.

  Dosing for Restless Legs Syndrome

  In all clinical trials, the dose for Ropinirole Hydrochloride Tablets 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 Tablets were discontinued without a taper.

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  Adults and Children (12 years and older): Take 10 to 30 drops one to three times daily, or as recommended by your healthcare practitioner. Children (6-11 years): Take 5 to 15 drops one to three times daily, or as recommended by your healthcare practitioner.

  Children (1-5 years): Take 5 to 10 drops one to three times daily, or as recommended by your healthcare practitioner.

  Infants (0-11 months): Take 1 to 5 drops one to three times daily, or as recommended by your healthcare practitioner.

  Acute Dosing: Follow the above age recommended drop amounts and take every 15 to 60 minutes (up to 12 times per day) or until symptoms improve, then resume general dosing.

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  ---

  2.1 General Dosing Recommendations

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

  If a significant interruption in therapy with ropinirole 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 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 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 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 in patients with severe renal impairment without regular dialysis has not been studied. 

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  General Dosing Considerations for Parkinson's Disease and RLS
  Ropinirole Tablets can be taken with or without food. Patients may be advised that taking Ropinirole Tablets 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 Tablets 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 Tablets 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 Tablets 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 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
  
  

  When Ropinirole Tablets are 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 Tablets and in 57% of patients on placebo. On average the L-dopa dose was reduced by 31% in patients treated with Ropinirole Tablets.
  
  Ropinirole Tablets 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 Tablets.
  
  Dosing for Restless Legs Syndrome
  In all clinical trials, the dose for Ropinirole Tablets 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 Tablets were discontinued without a taper.

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