SIMPRAL

What it is

SIMPRAL is a tablet containing pramipexole dihydrochloride monohydrate, available in strengths of 0.125 mg, 0.25 mg or 1 mg. Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the dopamine D2 subfamily receptors and has a preferential affinity to D3 receptors.

Approved indications

— Treatment of signs and symptoms of idiopathic Parkinson's disease. — Symptomatic treatment of primary Restless Legs Syndrome.

Dosing overview

SIMPRAL may be used as monotherapy or in combination with levodopa for Parkinson's disease.

Key safety warnings

Pramipexole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs such as excessive drowsiness, has been reported. Some of these events have been reported as late as one year after the initiation of treatment. Patients should neither drive a car nor operate other complex machinery until they have gained sufficient experience with pramipexole to gauge whether or not it affects their mental and/or motor performance adversely. Hallucinations and confusion are known side effects of treatment with dopamine agonists and levodopa in Parkinson's disease patients. Hallucinations were more frequent when pramipexole was given in combination with levodopa in Parkinson's disease patients with advanced disease than monotherapy in patients with early disease. Abnormal behaviours reflecting symptoms of impulse control disorders and compulsive behaviours such as pathological gambling, hypersexuality, compulsive shopping, binge eating, medication use, and punding have been reported in patients taking dopamine agonists for the treatment of Parkinson's disease, especially at high doses. Prescribers, patients and caregivers should be alert to the possibility of such behaviours, which may have serious financial and social consequences. Treatment of Restless Legs Syndrome with pramipexole can result in augmentation, which refers to the earlier onset of symptoms in the evening or even in the afternoon, increase in symptoms, and spread of symptoms to involve other extremities. The risk of augmentation may increase with higher dose.

Contraindications

SIMPRAL is contraindicated in patients with known hypersensitivity to pramipexole or any excipients in the formulation.

PBS listing

Information regarding PBS listing is not available in the provided sources.

Regulatory history

SIMPRAL pramipexole dihydrochloride monohydrate tablets in strengths of 0.125 mg, 0.25 mg and 1 mg were first listed on the ARTG on 9 April 2013.