Description: Pramipexole (Mirapex, Mirapexin, Sifrol) is a dopamine agonist of the non-ergoline class indicated for treating Parkinson's disease (PD) and restless legs syndrome (RLS).Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.Only immediate-release pramipexole (Mirapex) is approved to treat either Parkinson symptoms or RLS. Extended-release pramipexole (Mirapex ER) is approved only to treat Parkinson symptoms.In a single controlled study of twenty one patients, pramipexole was found to be highly effective in the treatment of bipolar depression. Treatment was initiated at 0.125 mg three times a day and increased at a rate of 0.125 mg three times a day to a limit of 4.5 mg daily until the patients' condition satisfactorily responded to the medication or they could not abide the side effects. The final average dosage was 1.7 ± 0.9 mg daily. The incidence of hypomania in the treatment group was no greater than in the control group, although the size of the study is too small to determine risks for manic switch.
Applications: Pramipexole dihydrochloride is a non-ergoline dopamine agonist indicated for treating early-stage Parkinson's disease (PD) andrestless legs syndrome (RLS). It is also sometimes used off-label as a treatment for cluster headache and to counteract the problems with sexual dysfunction experienced by some users of the selective serotonin reuptake inhibitor (SSRI) antidepressants. Pramipexole has shown robust effects on pilot studies in a placebo-controlled proof of concept study in bipolar disorder.It is also being investigated for the treatment of clinical depression and fibromyalgia.pramipexole hydrochloride
A white to off white powder
A. Meets the requirement
B. IR: similar to Reference Substance
Loss on drying
Any single impurity ≤0.1% Total impurity ≤0.8%
Purity By HPLC R-isomer
Residue on ignition
Isopropyl alcohol ≤5000ppm Ethyl Acetate ≤5000ppm
Analyse according to Factory Standard , Conform
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