In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of MIRAPEX tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. MIRAPEX tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day). Table 1 Ascending Dosage Schedule of MIRAPEX tablets for Parkinson's Disease Week A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1: Dosing In Patients With Normal Renal Functionĭoses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth. MIRAPEX tablets should be titrated gradually in all patients. In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. If a significant interruption in therapy with MIRAPEX tablets has occurred, re-titration of therapy may be warranted. MIRAPEX tablets are taken orally, with or without food. DOSAGE AND ADMINISTRATION General Dosing Considerations MIRAPEX tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). MIRAPEX tablets are indicated for the treatment of Parkinson's disease.
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With free coupon View Coupon INDICATIONS Parkinson's Disease Inactive ingredients consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate. 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. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Melting occurs in the range of 296☌ to 301☌, with decomposition. Pramipexole dihydrochloride is a white to off-white powder substance. H 2O, and its molecular weight is 302.26.The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. MIRAPEX tablets contain pramipexole, a nonergot dopamine agonist. You may report side effects to FDA at 1-80. For more information, ask your doctor or pharmacist.Ĭall your doctor for medical advice about side effects. These are not all the possible side effects of Mirapex. Tell the doctor if you have any side effect that bothers you or that does not go away. The most common side effects of Mirapex include: Get medical help right away, if you have any of the symptoms listed above. involuntary bending forward of your neck, waist or tilting sideways when you sit, stand or walk.
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