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The tablets should be swallowed whole with water, and must not be chewed, divided or crushed. The tablets may be taken either with or without food and should be taken each day at about the same time.
Initial treatment: Doses should be increased gradually from a starting dose of 0.375 mg of salt per day and then increased every 5-7 days. Providing patients do not experience intolerable undesirable effects, the dose should be titrated to achieve a maximal therapeutic effect. (See Table 1.)
Click on icon to see table/diagram/imageIf a further dose increase is necessary the daily dose should be increased by 0.75 mg of salt at weekly intervals up to a maximum dose of 4.5 mg of salt per day. However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg of salt per day.
Maintenance treatment: The individual dose of pramipexole should be in the range of 0.375 mg of salt to a maximum of 4.5 mg of salt per day. During dose escalation in pivotal studies, efficacy was observed starting at a daily dose of 1.5 mg of salt. Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions. In clinical trials, approximately 5% of patients were treated at doses below 1.5 mg of salt. In advanced Parkinson's disease, pramipexole doses higher than 1.5 mg of salt per day can be useful in patients where a reduction of levodopa therapy is intended. It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with OPRYMEA, depending on reactions in individual patients.
Missed dose: When the intake of a dose is missed, OPRYMEA prolonged-release tablets should be taken within 12 hours after the regularly scheduled time. After 12 hours, the missed dose should be left out and the next dose should be taken on the following day at the next regularly scheduled time.
Treatment discontinuation: Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome. Pramipexole should be tapered off at a rate of 0.75 mg of salt per day until the daily dose has been reduced to 0.75 mg of salt. Thereafter the dose should be reduced by 0.375 mg of salt per day.
Renal impairment: The elimination of pramipexole is dependent on renal function. The following dose schedule is suggested: Patients with a creatinine clearance above 50 mL/min require no reduction in daily dose or dosing frequency.
Prolonged-release tablet: In patients with a creatinine clearance between 30 and 50 mL/min, treatment should be started with 0.375 mg of salt OPRYMEA prolonged-release tablets every other day. Caution should be exercised and careful assessment of therapeutic response and tolerability should be made before increasing to daily dosing after one week. If a further dose increase is necessary, doses should be increased by 0.375 mg of salt at weekly intervals up to a maximum dose of 2.25 mg of salt daily. The treatment of patients with a creatinine clearance below 30 mL/min with OPRYMEA prolonged-release tablets is not recommended as no data are available for this patient population.
Hepatic impairment: Dose adjustment in patients with hepatic failure is probably not necessary, as approx. 90% of the absorbed active substance is excreted through the kidneys.
Paediatric population: OPRYMEA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Restless Legs Syndrome: The tablet should be taken with water and can be taken with or without food. The recommended starting dose of OPRYMEA is 0.125 mg of salt taken once daily 2-3 hours before bedtime. For patients requiring additional symptomatic relief, the dose may be increased every 4-7 days (interval between dosage increments) to a maximum of 0.75 mg of salt per day (as shown in the table as follows). (See Table 2.)
Click on icon to see table/diagram/imageThe patient's response should be evaluated after 3 months of treatment and the need for treatment continuation should be reconsidered. If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as previously mentioned
Treatment discontinuation: Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.75 mg of salt OPRYMEA can be discontinued without tapering off. Recovery of rebound of RLS symptoms (worsening of symptom severity as compared to baseline) after abrupt discontinuation of treatment..
Renal impairment: The elimination of pramipexole is dependent on renal function. Patients with a creatinine clearance above 20 mL/min require no reduction in daily dose.
The use of OPRYMEA has not been studied in hemodialysis patients, or patients with severe renal impairment.
Hepatic impairment: Dose adjustment in patients with hepatic failure is not required, as approx. 90% of the absorbed active substance is excreted through the kidneys.
Paediatric population: OPRYMEA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
