Sifrol ER

Sifrol ER



Boehringer Ingelheim


Concise Prescribing Info
Pramipexole diHCl monohydrate
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. During dose escalation in pivotal studies both in early & advanced disease, efficacy was observed starting at a daily dose of 1.5 mg. Concomitant levodopa therapy Dosage of levodopa is reduce 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/day.
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Special Precautions
Dose reduction for patients w/ renal impairment. Hallucinations & behavioural changes may occur (reflecting symptoms of impulse control disorders & compulsive behaviours eg, binge eating, compulsive shopping, hypersexuality & pathological gambling). Dose reduction/tapered discontinuation should be considered. Ophthalmological monitoring is recommended at regular interval or if visual abnormalities occur. Severe CV disease. Monitor BP & occurrence of melanoma. Dystonia. Symptoms suggestive of a neuroleptic malignant syndrome w/ abrupt w/drawal of therapy. Drug w/drawal syndrome during or after discontinuation. Patients w/ psychotic disorder. Augmentation in RLS. Reassess response to therapy in case of remnants in faeces. Sudden onset of sleep & somnolence. Hallucinations can occur & may adversely affect their ability to drive & use machines. Pregnancy. Not to be used during breast-feeding. Childn & adolescent up to 18 yr.
Adverse Reactions
Somnolence, dizziness, dyskinesia; 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 & amantadine. Not recommended to be co-administered w/ antipsychotics. Possible additive effects in concomitant administration w/ other sedating medications 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.
Sifrol ER XR tab 0.375 mg
Sifrol ER XR tab 1.5 mg
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in