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. Patient w/ psychotic disorder. Augmentation in restless legs syndrome (RLS). Reassess response to therapy in case of remnants in faeces. Sudden onset of sleep & somnolence. Hallucinations can occur & may adversely affect ability to drive & use machines. Patients w/ CrCl <30 mL/min; dose reduction for patients w/ renal impairment. Pregnancy. Not to be used during breast-feeding. Childn & adolescent up to 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 administration 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
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in