Pramipexole Dihydrochloride

Warnings and Precautions, Postural Deformity (5.6)                 5/2018

Warnings and Precautions,

      Events Reported with Dopaminergic Therapy (5.10);

     Melanoma                                               Removed                5/2018

Pramipexole dihydrochloride extended-release  tablets  are indicated for the treatment of Parkinson’s disease.

•Pramipexole dihydrochloride extended-release tablets are taken once daily, with or without food (2.1)

•Tablets must be swallowed whole and must not be chewed, crushed, or divided (2.1)

•Starting dose is 0.375 mg given once daily (2.2)

•Dose may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. Assess therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment (2.2)

•Patients may be switched overnight from immediate-release pramipexole tablets to pramipexole dihydrochloride extended-release tablets at the same daily dose. Dose adjustment may be needed in some patients (2.3)

•Pramipexole dihydrochloride extended-release tablets should be discontinued gradually (2.2)

0.375 mg: white to off white, round, biconvex, uncoated extended-release tablets debossed with ‘401’ on one side and ‘ER’ on other side.



0.75 mg: white to off white, round, biconvex, uncoated extended-release tablets debossed with ‘402’ on one side and ‘ER’ on other side.



1.5 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘403’ on one side and ‘ER’ on other side.



2.25 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘413’ on one side and ‘ER’ on other side.





3 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘404’ on one side and ‘ER’ on other side.



3.75 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘414’ on one side and ‘ER’ on other side.





4.5 mg: white to off white, oval, biconvex, uncoated extended-release tablets debossed with ‘405’ on one side and ‘ER’ on other side.

Pregnancy: Based on animal data, may cause fetal harm (8.1)