Expiration date: 11/2026
The composition and form of issue:
1 tablet contains pramipeksola (in form of dichloride monohydrate) 0.25 mg in bottles of 90 capsules, in a cardboard bundle 1 vial or 1 mg, in a contour cells packing 10 PCs., in a cardboard 3 bundle packaging.
Pharmacological action:
Stimulates D2 dopamine receptors, including striped body.
Indications:
Parkinson's Disease.
Contraindications:
Hypersensitivity.
Application of pregnancy and breast-feeding:
In pregnancy only if benefit to the mother outweighs the potential risk to the fetus. At the time of treatment should stop breastfeeding.
Side effects:
From the side of cardiovascular system: postural hypotension.
From the nervous system: dyskinesia, extrapyramidal syndrome, insomnia, drowsiness, dizziness, hallucinations.
Other: constipation, dry mouth, nausea, rarely — increased frequency of urination, violation of accommodation, peripheral edema, myasthenia gravis.
Drug interactions:
Cimetidine increases T1/2 (40%) ranitidine, diltiazem, triamterene, verapamil, quinidine and quinine reduce Cl (20%). Dopamine antagonists, including neuroleptics, metoclopramide, reduce efficiency.
Method of application and dose:
Inside. Initial dose at any stage of Parkinson's disease is 0.375 mg/day in 3 divided doses, if necessary, may increase, but not more frequently than every 5-7 days according to the scheme: 1 day — 0.375 mg/day, from the 2nd to 7th — 0.75 mg/day maintenance dose of 1.5 — 4.5 mg/day in 3 divided doses.
In patients with renal insufficiency dose depends on Cl creatinine: if Cl creatinine more than 60 ml/min, 0.125 mg 3 times a day (maximum dose 1.5 mg 3 times a day), 35-59 ml/min, 0.125 mg 2 times daily (maximum of 1.5 mg 2 times a day), 15-34 ml/min, 0.125 mg 1 time per day (maximum of 1.5 mg 1 time per day).
Precautions:
Patients should be warned about the risks of hallucinations (especially older patients), the development orthostatic hypotension (at the beginning of treatment or when the dose) and episodes of sudden sleepiness. Be wary appoint patients with renal failure in history. In combination therapy with levodopa are required to decrease dosage. Withdrawal of the drug should continue for 1 week (at least).
