Transcription of DOSAGE FORMS AND STRENGTHS------------------ …
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DOSAGE FORMS AND STRENGTHS------------------ …
Page 1 of 28 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MIRAPEX safely and effectively. See full prescribing information for MIRAPEX. MIRAPEX (pramipexole dihydrochloride) tablets, for oral use Initial Approval: 1997 ---------------------------RECENT MAJOR CHANGES--------------------------- Warnings and Precautions, Postural Deformity ( ) 5/2018 Warnings and Precautions, Rhabdomyolysis ( ) 5/2018 Warnings and Precautions, Events Reported with Dopaminergic Therapy ( ); Melanoma Removed 5/2018 ----------------------------INDICATIONS AND USAGE--------------------------- MIRAPEX is a non-ergot dopamine agonist indicated for the treatment of: Parkinson s disease (PD) ( ) Moderate-to-severe primary Restless Legs Syndrome (RLS) ( ) ---------------------- DOSAGE AND ADMINISTRATION----------------------- Parkinson s Disease-Normal Renal Function* ( ) Week DOSAGE (mg) Total Daily Dose (mg) 1 TID
Page 2 of 28 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Parkinson's Disease MIRAPEX tablets are indicated for the treatment of …
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