The influence of renal impairment on the pharmacokinetics of haloperidol has not been evaluated. About one-third of a haloperidol dose is excreted in urine, mostly as metabolites. Less than 3% of administered haloperidol is eliminated unchanged in the urine. Haloperidol metabolites are not considered to make a significant contribution to its activity, although for the reduced metabolite of haloperidol, back-conversion to haloperidol cannot be fully ruled out. Even though impairment of renal function is not expected to affect haloperidol elimination to a clinically relevant extent, caution is advised in patients with renal impairment, and especially those with severe impairment, due to the long half-life of haloperidol and its reduced metabolite, and the possibility of accumulation (see section ).
-Initial dose: to 10 mg orally in divided doses every 6 to 8 hours
-Maintenance dose: 1 to 5 mg/day
-Maximum dose: Up to 40 mg/day
-Maintenance doses may be given as single daily doses.
-Many patients achieve therapeutic effect with doses of less than 20 mg. Patients who are severely disturbed or inadequately controlled may require a dose of up to 40 mg/day.
Fluphenazine Decanoate for Injection:
-Initial dose: to 25 mg deep IM injection into the gluteal region
-Maintenance dose: to 100 mg IM, usually every 3 to 4 weeks
-Maximum dose: 100 mg/injection
Fluphenazine HCl for Injection:
-Initial dose: to 10 mg IM, given as divided doses every 6 to 8 hours
-Maximum dose: Up to 10 mg/day
-Patients may switch from Fluphenazine HCl for Injection to oral formulations when symptoms are controlled. The dose of an oral formulation is approximately 2 to 3 times the dose of fluphenazine HCl for injection.
-Fluphenazine decanoate for injection may be given subcutaneously.
-Management of manifestations of schizophrenia
-Management of patients requiring prolonged parenteral neuroleptic therapy (., patients with chronic schizophrenia)
3 to 12 years and 15 to 40 kg :
-Initial dose: mg/day orally in 2 to 3 divided doses
-Maintenance dose: to mg/kg/day
-The daily dose may be increased every 5 to 7 days in mg increments.
-There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
-Limitation of use: Treatment should be reserved for patients with severe behavior problems and/or hyperactive children only after failure to respond to psychotherapy or medications (other than antipsychotics).
-Treatment of severe behavior problems in children, including combative, explosive hyperexcitability not accounted for by immediate provocation
-Short-term treatment of hyperactive children with excessive motor activity and accompanying conduct disorder with impulsivity, difficulty sustaining attention, aggressiveness, mood lability, and/or poor frustration tolerance.