Company: Rowex Ltd.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredient: Pramipexole (as dihydrochloride monohydrate) 1.05mg, 2.1mg.
Description: White, cylindrical, biconvex prolonged-release tablets marked 105 or 210, respectively.
Presentation: 1.05mg-30, €39.63; 2.1mg-30, €69.93.
Indications: Treatment of signs and symptoms of idiopathic Parkinson’s disease, alone or in combination with levodopa.
Pharmacology: Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity. It alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. It inhibits dopamine synthesis, release, and turnover.
Dosage: Adult: Swallow whole at same time each day. Week 1, 0.26mg base (0.375mg salt) daily, may increase daily dose every 5-7 days if tolerated; Week 2, 0.52mg base (0.75mg salt); Week 3, 1.05mg base (1.5mg salt). May further increase daily dose by 0.52mg base (0.75mg salt) at weekly intervals (maximum 3.15mg base (4.5mg salt) per day). May switch from pramipexole immediate-release tablets to prolonged-release tablets overnight, at same daily dose and adjust depending on therapeutic response. When co-prescribed, reduce dose of levodopa while titrating pramipexole. Renal impairment: See SPC. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy (unless clearly necessary), lactation.
Special precautions: Inform patients that somnolence/sudden sleep onset (reduce dose/ discontinue) and hallucinations may occur. Dyskinesia may occur during initial titration (reduce dose). Monitor for impulse control disorders, mania and delirium (reduce dose/ discontinue). Patients with psychotic disorders (assess risk/benefit). Regular ophthalmologic monitoring recommended or if vision abnormalities occur. Severe cardiovascular disorders (monitor blood pressure). Renal impairment. Neuroleptic malignant syndrome reported with abrupt withdrawal (see SPC). Hepatic impairment, no data. Driving/using machines.
Drug interactions: Avoid: Antipsychotics. Caution: Alcohol, sedating drugs. Levodopa, other anti-parkinsonian drugs. Inhibitors/competitors of active renal elimination pathway (reduce pramipexole dose).
Adverse drug reactions: Abnormal dreams, insomnia, dizziness, headache, somnolence, gastrointestinal disorders, fatigue, behavioural symptoms of impulse control disorders and compulsions, confusion, hallucinations, dyskinesia, amnesia, visual disturbances, hypotension, peripheral oedema, weight loss.
Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie
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