HALOPERIDOL LA

DO NOT USE INTRAVENOUSLY. As with all parenteral drug products, haloperidol decanoate (intramuscular) should be inspected visually for clarity, particulate matter, precipitation, discolouration and leakage prior to administration whenever solution and container permit.

Solutions showing haziness, particulate matter, precipitate, that does not clear upon warming to room temperature (see STABILITY AND STABILITY), discolouration or leakage should not be used. Do not use if precipitate appears and discard unused portion.

As with all oily injections it is important to ensure, by aspiration before injection, that inadvertent intravascular injection does not occur. A dry syringe and a dry 5 cm needle of 21 gauge should be used for patients with a normal amount of body fat.

5 cm needle in order to ensure that the injection goes into muscle. Adults Administer by deep IM injection, preferably in the gluteus maximus. As a long-acting depot neuroleptic, haloperidol decanoate (intramuscular) has been found useful in the maintenance management of chronic schizophrenic patients.

These patients have been stabilized with other medications, and might benefit from a transfer to longer acting injectable therapy. The changeover to haloperidol decanoate (intramuscular) should aim at maintaining a clinical outcome similar to or better than that obtained with previous therapy in patients who cannot be relied upon to take oral medication regularly.

It is suggested that previous antipsychotic medication be discontinued before instituting therapy with haloperidol decanoate (intramuscular). Continuous supervision is required during the initial period of dosage adjustment in order to minimize the risk of overdosage or insufficient suppression of psychotic symptoms before the next injection.

Supplemental oral haloperidol may be required in diminishing dosage during this period. The selection of the initial dose of haloperidol decanoate (intramuscular) should be based on the patient’s symptomatology and previous oral neuroleptic dosage.

A ratio of 20:1 of haloperidol decanoate (intramuscular) to oral haloperidol appears to produce comparable steady-state plasma levels of haloperidol with both dosage forms. Control of psychotic symptoms, however, has also been achieved with doses based on lower ratios (10 to 15 times the daily maintenance dose of oral haloperidol).

In order to reduce the possible occurrence of adverse effects, it is advisable to initiate therapy with haloperidol decanoate (intramuscular) at lower doses and adjust the dose upwards as needed. There is limited experience with patients transferred to haloperidol decanoate (intramuscular) from other oral neuroleptics.

If such a transfer is deemed desirable, it is suggested that the patient be converted initially from the previous antipsychotic medication to oral Haloperidol LA Page 16 of 29 haloperidol in order to exclude the possibility of an unexpected adverse sensitivity to haloperidol.