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U.S. Department of Health and Human Services

Safety

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Haldol (haloperidol) Injection and Haldol Decanoate IM Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2011

 

Summary View

 

WARNINGS

Combined Use of Haldol and Lithium
  • An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and fasting blood sugar) followed by irreversible brain damage has occurred in a few patients treated with lithium plus HALDOL. A causal relationship between these events and the concomitant administration of lithium and Haldol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.

 

PRECAUTIONS

Drug Interactions
  • Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using haloperidol in combination with other drugs have been evaluated as described below.
 
Pharmacodynamic Interactions
  • Since QT-prolongation has been observed during Haldol treatment, caution is advised when prescribing to patient with QT-prolongation conditions (long QT-syndrome, hypokalemia, electrolyte imbalance) or to patients receiving medications known to prolong the QT-interval or known to cause electrolyte imbalance. Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using haloperidol in combination with other drugs have been evaluated as described below.
  • Ketoconazole is a potent inhibitor of CYP3A4. Increases in QTc have been observed when haloperidol was given in combination with the metabolic inhibitors ketoconazole (400 mg/day) and paroxetine (20 mg/day). It may be necessary to reduce the haloperidol dosage.
 
Pharmacokinetic Interactions

The Effect of Other Drugs on Haldol

  • Haloperidol is metabolized by several routes, including the glucuronidation and the cytochrome P450 enzyme system. Inhibition of these routes of metabolism by another drug may result in increased haloperidol concentrations and potentially increase the risk of certain adverse events, including QT-prolongation.
 
Drugs Characterized as Substrates, Inhibitors or Inducers of CYP3A4, CYP2D6 or Glucuronidation
  • In pharmacokinetic studies, mild to moderately increased haloperidol concentrations have been reported when haloperidol was given concomitantly with drugs characterized as substrates or inhibitors of CYP3A4 or CYP2D6 isoenzymes, such as, itraconazole, nefazodone, buspirone, venlafaxine, alprazolam, fluvoxamine, quinidine, fluoxetine, sertraline, chlorpromazine, and promethazine. When prolonged treatment (1-2 weeks) with enzyme-inducing drugs such as rifampin or carbamazepine is added to Haldol therapy, this results in a significant reduction of haloperidol plasma levels.
 
Carbamazepine
  • In a study in 11 schizophrenic patients co-administered haloperidol and increasing doses of carbamazepine, ...
 
Valproate
  • Sodium valproate, a drug know to inhibit glucuronidation, does not affect haloperidol plasma concentrations.
  • Nursing Mothers Since haloperidol is excreted in human breast milk, infants should not be nursed during drug treatment with haloperidol