Sifrol/Sifrol ER

Sifrol/Sifrol ER

pramipexole

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pramipexole diHCl monohydrate
Indications/Uses
Idiopathic Parkinson's disease as monotherapy or in combination w/ levodopa. Symptomatic treatment of idiopathic restless legs syndrome.
Dosage/Direction for Use
Dose tapering: Taper off at rate of 0.75 mg daily until dose is reduced to 0.75 mg daily. Thereafter, reduce dose to 0.375 mg daily. Sifrol Parkinson's disease Dose escalation: 0.125 mg tid on wk 1, 0.25 mg tid on wk 2, 0.5 mg tid on wk 3. May be increased by 0.75 mg at wkly intervals up to max 4.5 mg daily. Maintenance: 0.375-4.5 mg daily. Renal impairment w/ CrCl 20-50 mL/min Initially 0.125 mg bid (0.25 mg daily). Max: 2.25 mg daily, <20 mL/min Initially 0.125 mg as single daily dose. Max: 1.5 mg daily. Restless legs syndrome Initially 0.125 mg once daily 2-3 hr before bedtime. May be increased every 4-7 days to max 0.75 mg daily. Sifrol ER Parkinson's disease 0.375 mg on wk 1, 0.75 mg on wk 2, 1.5 mg on wk 3. Increase by 0.75 mg at wkly intervals if necessary up to max 4.5 mg/day. Maintenance: 0.375-4.5 mg/day. All doses to be taken once daily. Renal impairment w/ CrCl 30-50 mL/min Initially 0.375 mg every other day, may be increased to daily dosing after 1 wk. May further increase by 0.375 mg at wkly intervals up to max of 2.25 mg daily.
Administration
May be taken with or without food: ER tab: Swallow whole w/ water, do not chew/crush/divide.
Special Precautions
Hallucinations & confusion; abnormal behaviour eg, binge eating, compulsive shopping, hypersexuality & pathological gambling; sudden onset of sleep & somnolence; remnants in stool; dystonia; augmentation in restless legs syndrome. Risk of postural hypotension; melanoma. Symptoms suggestive of NMS w/ abrupt w/drawal of therapy. Drug w/drawal syndrome during or after discontinuation. Patients w/ psychotic disorders. Consider dose reduction/tapered discontinuation if abnormal behavior occurs; temporary re-administration of dopamine agonist at lowest effective dose in case of severe w/drawal symptoms. Monitor for melanoma; BP especially at beginning of treatment in case of severe CV disease. Not recommended to co-administer w/ antipsychotics. May affect ability to drive or use machines. Renal impairment. Pregnancy. Not to be used during lactation. Childn & adolescent up to 18 yr.
Adverse Reactions
Pneumonia; inappropriate antidiuretic hormone secretion; abnormal behaviour (eg, binge eating, compulsive shopping, hypersexuality & pathological gambling), abnormal dreams, confusion, delusion, hallucinations, hyperphagia, insomnia, libido disorders, paranoia, restlessness; amnesia, antecollis, dizziness, dyskinesia, headache, hyperkinesia, somnolence, sudden onset of sleep, syncope; visual impairment including diplopia, blurred vision & reduced visual acuity; cardiac failure; hypotension; dyspnoea, hiccups; constipation, nausea, vomiting; hypersensitivity, pruritus, rash; fatigue, peripheral oedema, drug w/drawal syndrome; decreased wt & appetite, increased wt.
Drug Interactions
Reduced clearance w/ drugs that inhibit active renal tubular secretion of basic (cationic) drugs eg, cimetidine, amantadine. Not recommended to co-administer w/ antipsychotics. Possible additive effects w/ other sedatives 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 tab 0.25 mg
Packing/Price
3 × 10's
Form
Sifrol tab 1 mg
Packing/Price
3 × 10's
Form
Sifrol ER tab 0.375 mg
Packing/Price
3 × 10's
Form
Sifrol ER tab 1.5 mg
Packing/Price
3 × 10's
Form
Sifrol ER tab 3 mg
Packing/Price
3 × 10's
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