Signs & symptoms of idiopathic Parkinson's disease as monotherapy or in combination w/ levodopa. Symptomatic treatment of moderate to severe idiopathic restless legs syndrome (RLS).
Parkinson's disease Dose escalation: 0.125 mg tds on wk 1, followed by 0.25 mg tds on wk 2 & then 0.5 mg tds on wk 3. Increase by 0.75 mg at wkly intervals to a max of 4.5 mg daily if necessary. Maintenance: 0.375-4.5 mg daily. Concomitant levodopa therapy Reduce levodopa dose during dose escalation & maintenance treatment. Renal impairmentCrCl 20-50 mL/min Initially 0.125 mg bd. Max daily dose: 2.25 mg, <20 mL/min Initially 0.125 mg daily as single dose. Max daily dose: 1.5 mg. RLS Initially 0.125 mg once daily 2-3 hr before bedtime. Patient requiring additional symptomatic relief May be increased every 4-7 days to a max of 0.75 mg daily.
Possible hallucinations & confusion. Abnormal behaviour may occur (reflecting symptoms of impulse control disorders & compulsive behaviours eg, binge eating, compulsive shopping, hypersexuality & pathological gambling); consider dose reduction/tapered discontinuation. Ophthalmological monitoring is recommended at regular interval or if vision abnormalities occur. Severe CV disease; monitor BP especially at the beginning of treatment due to general risk of postural hypotension. Patients w/ Parkinson's disease may present w/ axial dystonia (eg, antecollis, camptocormia or pleurothotonus). Symptoms suggestive of NMS w/ abrupt w/drawal of therapy. Drug w/drawal syndrome during or after discontinuation. Monitor for melanoma. Patients w/ psychotic disorder. Not recommended in co-administration w/ antipsychotics. Possible augmentation in RLS; regularly monitor for the occurrence of augmentation. Sudden onset of sleep & somnolence; continually reassess for drowsiness or sleepiness. Hallucinations can occur & may adversely affect ability to drive. Alert patients on potential sedating effects including somnolence while engaged in daily living activities. Dose reduction is suggested for patients w/ renal impairment. Pregnancy. Not to be used during breast-feeding. Childn & adolescents ≤18 yr.
Reduced clearance w/ basic cationic drugs (eg, cimetidine). Potential dopamine overstimulation eg, dyskinesias, agitation or hallucinations w/ inhibitors/competitors of active renal elimination pathway including amantadine. Not recommended to be co-administered w/ antipsychotics (eg, phenothiazines, butyrophenones, thioxanthenes) or other centrally active dopamine antagonists (eg, metoclopramide). Possible additive effects in concomitant use w/ other sedating medication or alcohol.
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