HALDOL DECANOATE INJ Rx
Generic Name and Formulations:
Haloperidol (as decanoate) 50mg/mL, 100mg/mL; for IM inj; contains benzyl alcohol.
Janssen Pharmaceuticals, Inc.
Indications for HALDOL DECANOATE INJ:
Treatment of schizophrenia when prolonged parenteral therapy required.
Individualize. Administer by deep IM every 4 weeks. Initial therapy: switching from oral form: initially 10–20 times previous daily dose of oral haloperidol. Stabilized on low daily oral dose, elderly, or debilitated: 10–15 times previous daily dose of oral haloperidol. Maintained on high dose antipsychotics, risk of relapse, or if tolerant: consider 20 times previous daily oral dose; then titrate downward subsequently. Max initial dose: 100mg; if conversion requires >100mg, then give balance in 3–7 days. Maintenance therapy: usual range: 10–15 times previous daily dose of oral haloperidol based on response. Max: 450mg/month.
Severe CNS depression. Coma. Parkinsonism.
Increased mortality in elderly patients with dementia-related psychosis.
Elderly with dementia-related psychosis (not approved use): increased risk of death. Risk of QT prolongation: electrolyte disturbances (eg, hypokalemia, hypomagnesemia), underlying cardiac abnormalities, hypothyroidism, familial long QT-syndrome, concomitant drugs known to prolong the QT interval. Seizures. Thyrotoxicosis. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Severe cardiovascular disorders. Mania. Perform fall risk assessments when initiating and recurrently on long-term therapy. Avoid abrupt cessation. Debilitated. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.
CNS depression potentiated with alcohol, other CNS depressants. Possible neurotoxicity with lithium: monitor, discontinue if occurs. Caution with drugs that prolong the QT interval (eg, ketoconazole, paroxetine). May be potentiated by CYP3A4 or CYP2D6 inhibitors/substrates (eg, itraconazole, nefazodone, buspirone, venlafaxine, alprazolam, fluvoxamine, quinidine, fluoxetine, sertraline, chlorpromazine, promethazine. May be antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine); monitor and adjust doses. May increase intraocular pressure with anticholinergics, antiparkinson agents. Monitor anticoagulants.
Tardive dyskinesia, neuroleptic malignant syndrome, extrapyramidal symptoms, hyperpyrexia, heat stroke, bronchopneumonia, cardiovascular effects, hematological effects, GI upset, anticholinergic effects; QT prolongation, Torsades de Pointes, dystonia.
Inj (1mL amps)—10; Decanoate 50 (1mL amps)—3; Decanoate 100 (1mL amps)—5