Sifstad 0.18

Rx

Indications

• Treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone or in combination with levodopa.
• Symptomatic treatment of moderate to severe idiopathic restless legs syndrome.

Dosage

Parkinson’s disease: The daily dose is in equally divided doses 3 times a day.

Initial treatment (daily dosage)

• 1^st week: 1.5 tablets Sifstad 0.18.
• 2^nd week: 3 tablets Sifstad 0.18 hoặc ¾ tablets Sifstad 0.7.
• 3^rd week: 6 tablets Sifstad 0.18 hoặc 1.5 tablets Sifstad 0.7.
• Then the daily dose should be increased by 3 tablets Sifstad 0.18 or ¾ tablet Sifstad 0.7 at weekly intervals up to a maximum dose of 18 tablets Sifstad 0.18 or 4.5 tablets Sifstad 0.7 per day.

Maintenance treatment (daily dosage)

• 5 tablets Sifstad 0.18 to a maximum of 18 tablets Sifstad 0.18 or 4.5 tablets Sifstad 0.7.
• Efficacy was observed starting at a daily dose of 6 tablets Sifstad 0.18 or 1.5 tablets Sifstad 0.7.

Treatment discontinuation

• Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome. Pramipexole should be tapered off until the daily dose has been reduced to 3 tablets Sifstad 0.18 or ¾ tablet Sifstad 0.7. Thereafter the dose should be reduced by 1.5 tablets Sifstad 0.18.

Patients with renal impairment

• Clcr = 20 – 50 ml/min, start at ½ tablet Sifstad 0.18 twice a day, a maximum daily dose is 9 tablets Sifstad 0.18 or 2 ¼ tablets Sifstad 0.7.
• Clcr < 20 ml/min, start at ½ tablet Sifstad 0.18, a maximum daily dose is 6 tablets Sifstad 0.18 or 1.5 tablets Sifstad 0.7.

Restless legs syndrome

• Start with ½ tablet Sifstad 0.18 taken once daily 2 – 3 hours before bedtime, the dose may be increased every 4 – 7 days to a maximum of 3 tablets Sifstad 0.18 or ¾ tablet Sifstad 0.7 per day.
• Patient’s response should be evaluated after 3 months treatment and the need for treatment continuation should be reconsidered.
• Treatment discontinuation: Can be discontinued without tapering off.

Usage

• Sifstad 0.18 should be taken orally, swallowed with water, and can be taken either with or without food.

• Hypersensitivity to pramipexole or to any ingredient in the formulation.
• Children and adolescents below 18 years.

Very common

• Dizziness, dyskinesia, somnolence, nausea.

Common

• Abnormal dreams, confusion, hallucinations, insomnia; headache;
• Visual impairment including diplopia, vision blurred and visual acuity reduced;
• Hypotension; constipation, vomiting;
• Fatigue.

• In case of severe cardiovascular disease, care should be taken.
• The following should be taken into account: Hallucinations; ophthalmologic monitoring is recommended at regular intervals; the dose of levodopa should be decreased if dyskinesia occurs; caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole; symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
• Co-administration of antipsychotic medicinal products with pramipexole should be avoided.
• Not recommended for use in pregnant and breast-feeding women.
• Patients being treated with pramipexole and presenting with somnolence and/or sudden sleep must refrain from driving or operating machines.