HALDOL (haloperidol) is indicated for use in the treatment of schizophrenia.

HALDOL is indicated for the control of tics and vocal utterances of Tourette's Disorder.

There is considerable variation from patient to patient in the amount of medication required for treatment. As with all drugs used to treat schizophrenia, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control.

To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less HALDOL (haloperidol). The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels.

Parenteral medication, administered intramuscularly in doses of 2 to 5 mg, is utilized for prompt control of the acutely agitated schizophrenic patient with moderately severe to very severe symptoms. Depending on the response of the patient, subsequent doses may be given, administered as often as every hour, although 4 to 8 hour intervals may be satisfactory.

Controlled trials to establish the safety and effectiveness of intramuscular administration in children have not been conducted.

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

Switchover Procedure

An oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient's clinical status, the first oral dose should be given within 12-24 hours following the last parenteral dose.

HALDOL® brand of haloperidol Injection (For Immediate Release) 5 mg per mL (as the lactate) - NDC 0045-0255-01, units of 10 x 1 mL ampuls.

Store HALDOL® haloperidol Injection at controlled room temperature (15°-30°C, 59°-86°F). Protect from light. Do not freeze.

Manufactured by: Janssen Pharmaceutica N.V. Beerse, Belgium
Distributed by: ORTHO-McNEIL PHARMACEUTICAL, INC., Raritan, New Jersey 08869
Revised May 2007
FDA rev date: 5/4/2007

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