Kinetica

Kinetica Dosage/Direction for Use

ropinirole

Manufacturer:

KRKA

Distributor:

UNILAB, Inc

Marketer:

UNILAB, Inc
Full Prescribing Info
Dosage/Direction for Use
The dose should be titrated according to individual clinical response and tolerability of the patient.
Ropinirole hydrochloride prolonged-release tablets should be taken once a day, at a similar time each day. The prolonged-release tablets may be taken with or without food.
Ropinirole hydrochloride prolonged-release tablets must be swallowed whole and must not be chewed, crushed, or divided because the coating is intended to ensure a prolonged release.
Ropinirole hydrochloride prolonged-release tablets are designed to release the medication over a 24-hour period. If a rapid gastrointestinal transit occurs, there may be a risk of incomplete release of medication, and of medication residue being passed in the stool.
Adults: Initial titration: The starting dose of ropinirole is 2 mg once daily for the first week; this should be increased to 4 mg once daily from the second week of treatment. A therapeutic response may be seen at a dose of 4 mg once daily.
Patients who initiate treatment with a dose of 2 mg/day and who experience undesirable effects that they cannot tolerate, may benefit from switching to treatment with ropinirole immediate-release tablets at a lower daily dose, divided into three equal doses.
Therapeutic regimen: Patients should be maintained on the lowest dose of ropinirole that achieves symptomatic control.
If sufficient symptomatic control is not achieved or maintained at a dose of 4 mg once daily, the daily dose may be increased by 2 mg at weekly intervals or longer, up to a dose of 8 mg once daily.
If sufficient symptomatic control is still not achieved or maintained at a dose of 8 mg once daily, the daily dose may be increased by 2 mg to 4 mg at every two-week intervals or longer. The maximum daily dose of ropinirole is 24 mg.
When ropinirole is administered as adjunct therapy to levodopa, it may be possible to gradually reduce the levodopa dose, depending on the clinical response. In clinical trials on patients receiving ropinirole, the levodopa dose was gradually reduced by approximately 30%.
It is recommended that patients are prescribed the minimum number of ropinirole prolonged-release tablets that are necessary to achieve the required dose by utilizing the highest available strengths of ropinirole prolonged-release tablets.
If treatment is interrupted for one day or more, re-initiation by dose titration should be considered.
Dose titration due to adverse events: Treatment with ropinirole should be down-titrated. If the patient experiences disabling somnolence at any dose level. For other adverse events, down-titration followed by gradual up-titration has been beneficial to patients.
Switching from another dopamine agonist to ropinirole hydrochloride prolonged-release tablets: When switching treatment from another dopamine agonist to ropinirole hydrochloride prolonged-release tablet, the instructions on discontinuation of the withdrawn treatment should be followed before initiating treatment with ropinirole.
Switching from ropinirole immediate-release tablets to ropinirole hydrochloride prolonged-release tablets: Patients may be switched overnight from ropinirole immediate-release tablets to ropinirole hydrochloride prolonged-release tablets. The dose of ropinirole hydrochloride prolonged-release tablets should be based on the total daily dose of ropinirole immediate-release tablets that the patient was taking. The following table shows the recommended dose of ropinirole hydrochloride prolonged-release tablets for patients switching from ropinirole immediate-release tablets: (See Table 3.)

Click on icon to see table/diagram/image

After switching to ropinirole hydrochloride prolonged-release tablets, the dose may be adjusted depending on the therapeutic response (see Initial titration and Therapeutic regimen as mentioned previously).
Treatment Discontinuation: As with other dopamine agonists, it is necessary to discontinue ropinirole treatment gradually by reducing the daily dose over the period of one week.
Special Populations: Renal impairment: In patients with mild to moderate renal impairment (CrCl 30 to 50 mL/min), no change in the clearance of ropinirole was observed, indicating that no dosage adjustment is necessary in this population.
For patients with end stage renal disease receiving hemodialysis, the recommended initial dose of is 2 mg once daily. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose is 18 mg/day in patients receiving regular hemodialysis. Supplemental doses after dialysis are not required.
The use of ropinirole is not recommended in patients with severe renal impairment (CrCl <30 mL/min) who are not undergoing regular hemodialysis.
Hepatic Impairment: The administration of ropinirole prolonged-release tablets is contraindicated in patients with hepatic impairment.
Children: The use of ropinirole prolonged-release tablets in children less than 18 years of age is not recommended.
Elderly: The clearance of ropinirole is decreased by approximately 15% in patients aged 65 years or above. Although a dose adjustment is not required, ropinirole dose should be individually titrated, with careful monitoring of tolerability, to the optimal clinical response. In patients aged 75 years and above, slower titration during treatment initiation may be considered.