Usual Adult Dose for Parkinson's Disease

Immediate-release tablets:
Initial: 0.25 mg orally three times daily

After 1 week, the dose may be titrated up in weekly increments based on individual efficacy and tolerability:
Week 2: give 0.5 mg orally 3 times daily
Week 3: give 0.75 mg orally 3 times daily
Week 4: give 1 mg orally 3 times daily
After week 4, increase by 1.5 mg/day on a weekly basis up to a dose of 9 mg/day, then increase by 3 mg/day on a weekly basis up to a maximum daily dose of 24 mg
Maximum Dose: 8 mg orally three times a day

Extended-release tablets:
Initial: 2 mg orally once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals, depending on therapeutic response and tolerability
Maximum dose: 24 mg orally once a day

Patients may switch from immediate-release to extended-release: The initial dose of extended-release tablet should most closely match the total daily dose of immediate-release formulation. Following conversion, adjust dose depending on response and tolerability.

Comments:

• If significant interruption in therapy occurs, retitration may be necessary; upon discontinuation, this drug should be gradually tapered over a 7-day period.
• The extended-release tablet is designed to release medication over a 24-hour period, if rapid gastrointestinal transit occurs, and tablet residue is observed in the stool, there is a risk of incomplete release of medication,

Usual Adult Dose for Restless Legs Syndrome

Immediate-release tablets:
Initial: 0.25 mg orally once a day on Day 1 and Day 2
Dose titration: May titrate as follows based on individual efficacy and tolerability:
Days 3 to 7: give 0.5 mg orally once a day

• Week 2: give 1 mg orally once a day
• Week 3: give 1.5 mg orally once a day
• Week 4: give 2 mg orally once a day
• Week 5: give 2.5 mg orally once a day
• Week 6: give 3 mg orally once a day
• Week 7: give 4 mg orally once a day

• Take 1 to 3 hours before bedtime.
• In clinical trials, this drug was not tapered prior to discontinuation.

Renal Dose Adjustments

Parkinson's disease:
Moderate renal impairment (CrCl 30 to 50 mL/mi): No dosage adjustment is necessary
Severe renal impairment without regular dialysis: No data available

Restless Leg Syndrome:
Moderate renal impairment (CrCl 30 to 50 mL/min): No dosage adjustment is necessary
Severe renal impairment without regular dialysis: No data available

Liver Dose Adjustments

Dose adjustments may be required; however, no specific guidelines have been suggested. Caution is recommended.

Dose Adjustments

Doses are individually titrated based on efficacy and tolerability.

Parkinson's disease:

• If this drug is administered as adjunct therapy to levodopa, the concurrent dose of levodopa may be decreased gradually as tolerated; the average dose reduction of levodopa was 31% and 34% with immediate-release and extended-release tablets, respectively.

• If significant interruption in therapy occurs, this drug may need to be retitrated.

• Immediate-release tablets: Reduce the frequency of administration from 3 times a day to 2 times a day for 4 days, then once a day for 3 days, prior to discontinuation.
• Extended-release tablets: Gradually discontinue over a 7-day period

Precautions

Safety and efficacy of ropinirole have not been established in patients younger than 18 years.

Safety and efficacy of the extended-release product have not been established in patients with Restless Legs Syndrome (RLS).

Consult WARNINGS section for additional precautions.

Dialysis

Peritoneal dialysis: Data not available

End stage renal disease (ESRD) on hemodialysis:
Parkinson's disease, Immediate-release:

• Initial dose: 0.25 mg orally 3 times a day
• Dose titration should be based on tolerability and need for efficacy
• Maximum dose: 6 mg orally 3 times a day

• Initial dose: 2 mg orally once a day
• Dose titration should be based on tolerability and need for efficacy
• Maximum dose: 18 mg orally once a day

• Initial dose: 0.25 mg orally once a day
• Dose titration should be based on tolerability and need for efficacy
• Maximum dose: 3 mg orally once a day

Other Comments

Administration advice:

• May take with or without food
• If a dose is missed, take your next dose as scheduled; do not double your next dose
• Extended-release products should be taken once a day at a similar time each day; they should not be chewed, crushed, or split
• Restless Leg Syndrome: Take once a day 1 to 3 hours before bedtime

• If significant interruption to therapy occurs, this drug should be retitrated.
• Parkinson's Disease: This product should be tapered before discontinuation.
• Restless Legs Syndrome: This drug was not tapered to discontinuation during clinical trials.

• Cardiovascular: Monitor for signs and symptoms of orthostatic hypotension, particularly during dose escalation; consider blood pressure monitoring at the start of treatment, especially in patients with significant cardiovascular disease.
• Nervous System: Monitor for somnolence and drowsiness
• Dermatologic: Monitor for melanomas; consider periodic skin examinations by dermatologists.
• Psychiatric: Question patients about new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges.

• This drug frequently causes drowsiness; patients should not drive a car or operate machinery or other potentially dangerous activities until it is determined how this drug affects their mental and/or motor performance.
• Patients should be instructed to report episodes of sudden onset of sleep, new or worsening dyskinesia, new or worsening compulsive behaviors and/or unusual urges.
• Patients should be instructed to report changes in the size, shape, or color of moles on their skin and should have their skin checked on a regular basis for melanomas.
• Patients should be aware that this drug may cause orthostatic blood pressure changes including fainting and dizziness and patients should be advised to avoid standing rapidly after sitting or lying down.
• Patients should speak to their physician or health care provider if they become pregnant, intend to become pregnant, or are breastfeeding.