Pramipexole Accord

Posology Parkinson’s disease The daily dose is administered in equally divided doses 3 times a day. 375 mg of salt) per day and then increased every 5-7 days. Providing patients do not experience intolerable undesirable effects, the dose should be titrated to achieve a maximal therapeutic effect.

5 mg of salt) per day. 8). 5 mg of salt) per day. 5 mg of salt). Further dose adjustments should be done based on the clinical response and the occurrence of adverse reactions. 5 mg of salt). 5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.

5). Treatment discontinuation Abrupt discontinuation of dopaminergic therapy can lead to the development of a neuroleptic malignant syndrome. 75 mg of salt). 4). Renal impairment The elimination of pramipexole is dependent on renal function.

The following dose schedule is suggested for initiation of therapy:

Patients with a creatinine clearance above 50 ml/min require no reduction in daily dose or dosing frequency. 25 mg of salt daily). 25 mg of salt) should not be exceeded. 125 mg of salt) daily. 5 mg of salt) should not be exceeded. e. if creatinine clearance declines by 30%, then the Pramipexole Accord daily dose should be reduced by 30%.

The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/min and as a single daily dose if creatinine clearance is less than 20 ml/min. Hepatic impairment Dose adjustment in patients with hepatic failure is probably not necessary, as approx.

90% of absorbed active substance is excreted through the kidneys. However, the potential influence of hepatic insufficiency on Pramipexole Accord pharmacokinetics has not been investigated. Paediatric population The safety and efficacy of Pramipexole Accord in children below 18 years has not been established.

There is no relevant use of Pramipexole Accord in the paediatric population for the children of Parkinson’s disease. Tourette Disorder Paediatric population Pramipexole Accord is not recommended for use in children and adolescents below 18 years since the efficacy and safety has not been established in this population.

1). Method of administration The tablets should be taken orally, swallowed with water, and can be taken either with or without food. Medicinal product no longer authorised 5

Based on the analysis of pooled placebo-controlled trials, comprising a total of 1,923 patients on pramipexole and 1,354 patients on placebo, adverse drug reactions were frequently reported for both Medicinal product no longer authorised 8 groups.

63% of patients on pramipexole and 52% of patients on placebo reported at least one adverse drug reaction. The majority of adverse drug reactions usually start early in therapy and most tend to disappear even as therapy is continued.

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) ; not known (cannot be estimated from the available data).

Parkinson’s disease, most common adverse reactions The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson’s disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.

2). A more frequent adverse drug reaction in combination with levodopa was dyskinesia. Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.

Medicinal product no longer authorised 9 Table 1:

Parkinson’s disease Body System Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to < 1/100) Rare (≥1/10,000 to <1/1,000) Not known Infections and infestations pneumonia Endocrine disorders inappropriate antidiuretic hormone secretion1 Psychiatric disorders Insomnia hallucinations abnormal dreams confusion behavioural symptoms of impulse control disorders and compulsions compulsive shopping pathological gambling restlessness hypersexuality delusion libido disorder paranoia delirium binge eating1 hyperphagia1 mania Nervous system disorders somnolence dizziness dyskinesia headache sudden onset of sleep amnesia hyperkinesia syncope Eye disorders visual impairment including diplopia vision blurred visual acuity reduced Cardiac disorders cardiac failure1 Medicinal product no longer authorised 10 Vascular disorders hypotension Respiratory, thoracic, and mediastinal disorders Dyspnoea hiccups Gastrointestinal disorders nausea constipation vomiting Skin and subcutaneous tissue disorders hypersensitivity pruritus rash General disorders and administration site conditions fatigue peripheral oedema Dopamine agonist withdrawal syndrome including apathy, anxiety, depression, fatigue, sweating and pain.

2. Hallucinations Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa. Patients should be informed that (mostly visual) hallucinations can occur. Dyskinesia In advanced Parkinson’s disease, in combination treatment with levodopa, dyskinesia can occur during the initial titration of Pramipexole Accord.

If they occur, the dose of levodopa should be decreased. Dystonia Axial dystonia including antecollis, camptocormia and pleurothotonus (Pisa Syndrome) has occasionally been reported in patients with Parkinson’s disease following initiation or incremental dose increase of pramipexole.

Although dystonia may be a symptom of Parkinson’s disease, the symptoms in these patients have improved after reduction or withdrawal of pramipexole. If dystonia occurs, the dopaminergic medication regimen should be reviewed and an adjustment in the dose of pramipexole considered.

Sudden onset of sleep and somnolence 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, has been reported uncommonly.

Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with Pramipexole Accord. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.

Furthermore a reduction of the dose or termination of therapy may be considered. 8). Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including Pramipexole Accord.

1.