Haldol decanoate injection site reactions

Special considerations
• Drug has few CV adverse effects and may be preferred in patients with cardiac disease.
• Dose of 2 mg is therapeutic equivalent of 100 mg chlorpromazine.
• When changing from tablets to decanoate injection, patient should initially receive 10 to 20 times the oral dose once monthly (not more than 100 mg).
• Assess patient periodically for extrapyramidal reactions and tardive dyskinesia.
• Don’t withdraw drug abruptly except when required, because abrupt withdrawal may cause severe adverse reaction. Taper dosage over several weeks.
Pediatric patients
• Safety and efficacy of drug injection in children haven’t been established, and oral drug isn’t recommended for children younger than age 3.
Geriatric patients
• Drug is especially useful for agitation related to senile dementia. Tardive dyskinesia may occur more often, especially in elderly women.
• Elderly patients usually need lower initial doses and a more gradual dosage adjustment.

At the request of the Pharmacovigilance Department of the Italian Drug Agency (AIFA), the sponsor (Johnson & Johnson) performed two post-marketing analyses of QT interval prolongation and TdP with haloperidol administration (oral or injectable).  In one analysis, the sponsor searched their Benefit Risk Management worldwide safety database for QT prolongation -related adverse event reports received through June 30, 2005.  This search identified 229 reports, many of which the sponsor described as confounded by concomitant QT-prolonging drugs or medical conditions.  The reports included 73 cases of TdP, eleven of which were fatal.  Eight of the eleven fatal cases involved intravenous administration of various doses 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 (. 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 haloperidol equivalents; limited clinical experience suggests that lower initial doses may be adequate.

Haldol decanoate injection site reactions

haldol decanoate injection site reactions

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