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. 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.
Administration
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Contraindications
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.
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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