Haldol Indications, Dosage, Storage, Stability - Haloperidol Decanoate

Haldol Indications, Dosage, Storage, Stability - Haloperidol Decanoate

INDICATIONS AND USAGE

HALDOL Decanoate 50 and HALDOL Decanoate 100 are indicated for the treatment of schizophrenic patients who require prolonged parenteral antipsychotic therapy.

HALDOL Decanoate 50 and HALDOL Decanoate 100 should be administered by deep intramuscular injection. A 21 gauge needle is recommended. The maximum volume per injection site should not exceed 3 mL. DO NOT ADMINISTER INTRAVENOUSLY.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HALDOL Decanoate 50 and HALDOL Decanoate 100 are intended for use in schizophrenic patients who require prolonged parenteral antipsychotic therapy. These patients should be previously stabilized on antipsychotic medication before considering a conversion to haloperidol decanoate. Furthermore, it is recommended that patients being considered for haloperidol decanoate therapy have been treated with, and tolerate well, short-acting HALDOL (haloperidol) in order to reduce the possibility of an unexpected adverse sensitivity to haloperidol. Close clinical supervision is required during the initial period of dose adjustment in order to minimize the risk of overdosage or reappearance of psychotic symptoms before the next injection. During dose adjustment or episodes of exacerbation of symptoms of schizophrenia, haloperidol decanoate therapy can be supplemented with short-acting forms of haloperidol.

The dose of HALDOL Decanoate 50 or HALDOL Decanoate 100 should be expressed in terms of its haloperidol content. The starting dose of haloperidol decanoate should be based on the patient’s age, clinical history, physical condition, and response to previous antipsychotic therapy. The preferred approach to determining the minimum effective dose is to begin with lower initial doses and to adjust the dose upward as needed. For patients previously maintained on low doses of antipsychotics (e.g. up to the equivalent of 10 mg/day oral haloperidol), it is recommended that the initial dose of haloperidol decanoate be 10-15 times the previous daily dose in oral haloperi-dol equivalents; limited clinical experience suggests that lower initial doses may be adequate.

Conversion from oral haloperidol to haloperidol decanoate can be achieved by using an initial dose of haloperidol decanoate that is 10 to 20 times the previous daily dose in oral haloperidol equivalents.

In patients who are elderly, debilitated, or stable on low doses of oral haloperidol (e.g. up to the equivalent of 10 mg/day oral haloperidol), a range of 10 to 15 times the previous daily dose in oral haloperidol equivalents is appropriate for initial conversion.

In patients previously maintained on higher doses of antipsychotics for whom a low dose approach risks recurrence of psychiatric decompensation and in patients whose long-term use of haloperidol has resulted in a tolerance to the drug, 20 times the previous daily dose in oral haloperidol equivalents should be considered for initial conversion, with downward titration on succeeding injections.

The initial dose of haloperidol decanoate should not exceed 100 mg regardless of previous antipsy-chotic dose requirements. If, therefore, conversion requires more than 100 mg of haloperidol decanoate as an initial dose, that dose should be administered in two injections, i.e. a maximum of 100 mg initially followed by the balance in 3 to 7 days.

The maintenance dosage of haloperidol decanoate must be individualized with titration upward or downward based on therapeutic response. The usual maintenance range is 10 to 15 times the previous daily dose in oral haloperidol equivalents dependent on the clinical response of the patient.

Close clinical supervision is required during initiation and stabilization of haloperidol decanoate therapy. Haloperidol decanoate is usually administered monthly or every 4 weeks. However, variation in patient response may dictate a need for adjustment of the dosing interval as well as the dose (See CLINICAL PHARMACOLOGY).

Clinical experience with haloperidol decanoate at doses greater than 450 mg per month has been limited.

HALDOL^® (haloperidol) Decanoate 50 for IM injection, 50 mg haloperidol as 70.5 mg per mL haloperidol decanoate—NDC 0045-0253, 10 x 1 mL ampuls, 3 x 1 mL ampuls and 5 mL multiple dose vials.

HALDOL^® (haloperidol) Decanoate 100 for IM injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate—NDC 0045-0254, 5 x 1 mL ampuls and 5 mL multiple dose vials. Store at controlled room temperature (15°-30° C, 59°-86° F). Do not refrigerate or freeze.

Protect from light.

OMP DIVISION ORTHO-McNEIL, PHARMACEUTICAL, INC., Raritan, New Jersey 08869 Revised September 2001, 643-94-253-5