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Haldol Decanoate Inj Generic Name & Formulations
Legal Class
Rx
General Description
Haloperidol (as decanoate) 50mg/mL, 100mg/mL; for IM inj; contains benzyl alcohol.
Pharmacological Class
Butyrophenone.
See Also
How Supplied
Inj (1mL amps)—10; Decanoate 50 (1mL amps)—3; Decanoate 100 (1mL amps)—5
Manufacturer
Haldol Decanoate Inj Indications
Indications
Schizophrenia when prolonged parenteral therapy required.
Haldol Decanoate Inj Dosage and Administration
Adult
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.
Children
Not established.
Haldol Decanoate Inj Contraindications
Contraindications
Severe toxic CNS depression. Coma. Parkinson's disease. Dementia with Lewy bodies.
Haldol Decanoate Inj Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis.
Haldol Decanoate Inj Warnings/Precautions
Warnings/Precautions
Elderly with dementia-related psychosis (not approved use): increased risk of death or cerebrovascular reactions (eg, stroke, TIA). Risk of QT prolongation: electrolyte disturbances (eg, hypokalemia, hypomagnesemia), underlying cardiac abnormalities, hypothyroidism, familial long QT-syndrome. Increased risk of Torsades de Pointes if QT interval >500msec. Seizures. Thyrotoxicosis. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline or ANC <1000/mm3. Severe cardiovascular disorders. Mania. Perform fall risk assessments when initiating and recurrently on long-term therapy. Hepatic impairment. Debilitated. Avoid abrupt cessation. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: not recommended.
Haldol Decanoate Inj Pharmacokinetics
See Literature
Haldol Decanoate Inj Interactions
Interactions
CNS depression potentiated with alcohol (avoid), anesthetics, opioids, other CNS depressants. Possible neurotoxicity with lithium: monitor, discontinue if occurs. Caution with drugs that prolong the QT interval (eg, Class 1A [eg, procainamide, quinidine, disopyramide] or Class 3 antiarrhythmics [eg, amiodarone, sotalol], citalopram, erythromycin, levofloxacin, methadone, ziprasidone, ketoconazole, paroxetine). Caution with drugs known to cause electrolyte imbalance (eg, diuretics, corticosteroids). May be potentiated by CYP3A4 or CYP2D6 inhibitors/substrates (eg, itraconazole, ketoconazole, nefazodone, alprazolam, chlorpromazine, promethazine, quinidine, paroxetine, sertraline, venlafaxine, fluoxetine, fluvoxamine, ritonavir, buspirone); monitor. May be antagonized by CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s wort); monitor and adjust doses. May potentiate CYP2D6 substrates (eg, desipramine, imipramine). May impair effects of levodopa, other dopamine agonists. May increase intraocular pressure with anticholinergics, antiparkinson agents. Monitor anticoagulants.
Haldol Decanoate Inj Adverse Reactions
Adverse Reactions
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, hypersensitivity reactions, cerebrovascular reactions.
Haldol Decanoate Inj Clinical Trials
See Literature
Haldol Decanoate Inj Note
Not Applicable
Haldol Decanoate Inj Patient Counseling
See Literature
