"Sept. 19, 2012 -- The FDA is investigating a possible risk of heart failure linked to Mirapex, a drug used to treat Parkinson's disease and restless legs syndrome.
Officials say recent studies suggest a potential raised risk of heart "...
(pramipexole dihydrochloride) Extended Release Tablets
MIRAPEX tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S• 2HCl•H2O, and its molecular weight is 302.26. The structural formula is:
Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane.
MIRAPEX tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.
What are the possible side effects of pramipexole (Mirapex, Mirapex ER)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking pramipexole and call your doctor at once if you have any of these serious side effects:
- extreme drowsiness, falling asleep suddenly, even after feeling alert;
- nausea, sweating, feeling light-headed, fainting;
- muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
- chest pain, cough with white or pink phlegm...
What are the precautions when taking pramipexole (Mirapex)?
Before taking pramipexole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, heart problems (e.g., irregular heartbeat, heart failure), kidney problems, mental/mood disorders (e.g., confusion, hallucinations, psychosis, schizophrenia), sleep disorder (e.g., sleep apnea, narcolepsy).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic...
Last reviewed on RxList: 3/15/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Mirapex Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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