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Sifrol ER

Sifrol ER

pramipexole

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Pramipexole diHCl monohydrate
Indications/Uses
Signs & symptoms of idiopathic Parkinson's disease as monotherapy or in combination w/ levodopa.
Dosage/Direction for Use
Parkinson's disease Dose escalation: 0.375 mg on wk 1, followed by 0.75 mg on wk 2 & then 1.5 mg on wk 3. Maintenance: 0.375-4.5 mg daily. Concomitant levodopa therapy Reduce levodopa dose during dose escalation & maintenance treatment. Renal impairment CrCl 30-50 mL/min Initially 0.375 mg every other day, may be increased by 0.375 mg at wkly intervals up to a max of 2.25 mg daily.
Administration
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Contraindications
Special Precautions
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 visual 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. Possible augmentation in restless legs syndrome (RLS); regularly monitor for the occurrence of augmentation. Reassess response to therapy in case of remnants in faeces. Sudden onset of sleep & somnolence; continually reassess for drowsiness or sleepiness. Hallucinations can occur & may adversely affect ability to drive & use machines. Patients w/ CrCl <30 mL/min; dose reduction is suggested for patients w/ renal impairment. Pregnancy. Not to be used during breast-feeding. Childn & adolescents ≤18 yr.
Adverse Reactions
Somnolence, dizziness, dyskinesia, augmentation in RLS; nausea. Insomnia, hallucinations, abnormal dreams, confusion, behavioural symptoms of impulse control disorders & compulsions; headache; visual impairment including diplopia, blurred vision, reduced visual acuity; hypotension; constipation, vomiting; fatigue, peripheral oedema; decreased wt including decreased appetite.
Drug Interactions
Reduced clearance w/ basic cationic drugs (eg, cimetidine). Potential dopamine overstimulation eg, dyskinesias, agitation or hallucinations w/ amantadine. Not recommended to be co-administered w/ antipsychotics. Possible additive effects in concomitant use w/ other sedating medication or alcohol.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BC05 - pramipexole ; Belongs to the class of dopamine agonist. Used in the management of Parkinson's disease.
Presentation/Packing
Form
Sifrol ER XR tab 0.375 mg
Packing/Price
30's
Form
Sifrol ER XR tab 1.5 mg
Packing/Price
30's
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