Sifrol

Sifrol

pramipexole

Manufacturer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Pramipexole diHCl
Indications/Uses
Signs & symptoms of idiopathic Parkinson's disease w/ or w/o levodopa. Tab: Symptomatic treatment of idiopathic restless legs syndrome.
Dosage/Direction for Use
Initially 0.375 mg daily in 3 divided doses, may be increased every 5-7 days to max of 4.5 mg daily. Maintenance: 0.375-4.5 mg daily. Tab Renal impairment, CrCl 20-50 mL/min Initially 0.125 mg twice daily (0.25 mg daily) in 2 divided doses. Max daily dose: 2.25 mg, CrCl <20 mL/min Initially 0.125 mg daily single dose. Max daily dose: 1.5 mg. Restless legs syndrome Initially 0.125 mg taken once daily for 2-3 hr before bedtime. May be increased every 4-7 days to a max of 0.75 mg/day in patients requiring additional symptomatic relief. XR tab CrCl 30-50 mL/min Initially 0.375 mg every other day. Max: 2.25 mg/day.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Hallucinations & abnormal behaviour, patients w/ psychotic disorders. Retinal changes in albino rats. Postural hypotension. Sudden onset of sleep & somnolence, dystonia, melanoma, Parkinson's disease, drug w/drawal syndrome, augmentation in restless legs syndrome. Remnants in stool. Monitor BP especially at the beginning of treatment. May adversely affect ability to drive & using machinery. Renal impairment. Pregnancy, lactation & fertility. Childn & adolescent <18 yr.
Adverse Reactions
Abnormal behaviour eg, abnormal dreams, confusion, constipation, dizziness, dyskinesias, fatigue, hallucinations, headache, hypotension, inappropriate antidiuretic hormone secretion, insomnia, nausea, peripheral oedema, pneumonia; somnolence, visual impairment including diplopia, blurred vision & reduced visual acuity, vomiting, decreased wt including decreased appetite, drug w/drawal syndrome.
Drug Interactions
Other medication affecting plasma protein binding. Medication that inhibit the active renal tubular secretion of basic (cationic) drugs. Selegiline. Levodopa. Amantadine. Co-administration of antipsychotic medicinal products.
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 tab 0.125 mg
Packing/Price
3 × 10's
Form
Sifrol tab 0.25 mg
Packing/Price
3 × 10's
Form
Sifrol XR tab 0.375 mg
Packing/Price
3 × 10's
Form
Sifrol XR tab 0.75 mg
Packing/Price
3 × 10's
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