Methods for dose initiation of aripiprazole treatments

Abstract

The present disclosure is directed to a method of dose initiation for an aripiprazole treatment to a patient in need thereof; the patient is administered two, separate 100 to 500 mg injections of an aripiprazole intramuscular (IM) depot formulation at separate gluteal and/or deltoid injection sites, and a single dose of oral aripiprazole. The administration occurs on a first day of the treatment.

1 - 15 . (canceled) 
     
     
         16 . A method of dose initiation for an aripiprazole treatment to a patient in need thereof comprising:
 administering two, separate injections of an aripiprazole intramuscular (IM) depot formulation, wherein each injection comprises from about 10 mg to about 500 mg of aripiprazole, to the patient at an injection site chosen from a gluteal site, a deltoid site, and combinations thereof, and a single dose of oral aripiprazole, wherein the step of administering occurs on a first day of the treatment.   
     
     
         17 . The method according to  claim 16 , wherein each of the two, separate injections comprise 400 mg of aripiprazole. 
     
     
         18 . The method according to  claim 16 , further comprising after the first day of treatment, administering a single monthly, maintenance injection of the aripiprazole IM depot formulation. 
     
     
         19 . The method according to  claim 18 , wherein the single monthly, maintenance injection is chosen from about 300 mg and about 400 mg of aripiprazole in the aripiprazole IM depot formulation. 
     
     
         20 . The method according to  claim 18 , wherein when the patient is a CYP2D6 poor metabolizer or is taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days, the single monthly, maintenance injection is chosen from 160 mg and 200 mg of aripiprazole in the aripiprazole IM depot formulation. 
     
     
         21 . The method according to  claim 16 , wherein the two, separate injections of the aripiprazole IM depot formulation are administered at separate gluteal injection sites of the patient. 
     
     
         22 . The method according to  claim 16 , wherein the two, separate injections of the aripiprazole IM depot formulation are administered at gluteal and deltoid injection sites of the patient. 
     
     
         23 . The method according to  claim 16 , wherein the two, separate injections of the aripiprazole IM depot formulation are administered at separate deltoid injection sites of the patient. 
     
     
         24 . The method according to  claim 16 , wherein the patient has schizophrenia. 
     
     
         25 . The method according to  claim 16 , wherein the patient has bipolar I disorder. 
     
     
         26 . The method according to  claim 16 , wherein the single dose of oral aripiprazole ranges from about 2 mg to about 30 mg of aripiprazole. 
     
     
         27 . The method according to  claim 26 , wherein the single dose of oral aripiprazole ranges from about 10 mg to about 30 mg. 
     
     
         28 . The method according to  claim 26 , wherein the single dose of oral aripiprazole is 20 mg. 
     
     
         29 . The method according to  claim 26 , wherein the single dose of oral aripiprazole is 10 mg. 
     
     
         30 . The method according to  claim 16 , wherein when the patient is a CY2D6 poor metabolizer, each of the two, separate injections comprises about 300 mg of aripiprazole and the single dose of oral aripiprazole is about 20 mg.