Haloperidol Lactate (4 brand names, 3 dosage forms, 2 routes)
Available dosage forms: INJECTABLE, CONCENTRATE, SOLUTION.
Routes of administration: INJECTION, ORAL.
Brand Names
- HALDOL
- HALOPERIDOL
- HALOPERIDOL INTENSOL
- HALOPERIDOL LACTATE
Indications and Usage
Haloperidol injection is indicated for the treatment of patients with schizophrenia.
Dosage and Administration
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 haloperidol injection. 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. The maximum dose is 20 mg/day. 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.
Contraindications
Haloperidol injection is contraindicated in patients with: •Severe toxic central nervous system depression or comatose states from any cause. •Hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see WARNINGS, Hypersensitivity Reactions and ADVERSE REACTIONS). •Parkinson’s disease (see WARNINGS, Neurological Adverse Reactions in Patients with Parkinson’s Disease or Dementia with Lewy Bodies). •Dementia with Lewy bodies (see WARNINGS, Neurological Adverse Reactions in Patients with Parkinson’s Disease or Dementia with Lewy Bodies).
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in more detail in other sections of the labeling: • WARNINGS, Increased mortality in Elderly Patients with Dementia-Related Psychosis • WARNINGS, Cardiovascular Effects • WARNINGS, Tardive Dyskinesia • WARNINGS, Neuroleptic Malignant Syndrome • WARNINGS, Hypersensitivity Reactions • WARNINGS, Falls • WARNINGS, Usage in Pregnancy • WARNINGS, Combined Use of Haloperidol injection and Lithium • WARNINGS, General • PRECAUTIONS, Leukopenia, Neutropenia, and Agranulocytosis • PRECAUTIONS, Withdrawal Emergent Dyskinesia • PRECAUTIONS, Other
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 QTc interval-prolongation has been observed during haloperidol treatment, caution is advised when prescribing to a patient with QT-prolongation conditions or to patients receiving medications known to prolong the QTc-interval (see WARNINGS, Cardiovascular Effects). Examples include (but are not limited to): Class 1A antiarrhythmics (e.g., procainamide, quinidine, disopyramide); Class 3 antiarrhythmics (e.g., amiodarone, sotalol); and other drugs such as citalopram, erythromycin, levofloxacin, methadone, and ziprasidone. Caution is advised when haloperidol is used in combination with drugs known to cause electrolyte imbalance (e.g., diuretics or corticosteroids) because hypokalemia, hypomagnesemia, and hypocalcemia are risk factors for QT prolongation. Haloperidol may impair the antiparkinson effects of levodopa and other dopamine agonists. If concomitant antiparkinson medication is required, it may have to be continued after haloperidol is discontinued because of the difference in excretion rates. If both are discontinued simultaneously, extrapyramidal symptoms may occur. The physician should keep in mind the possible increase in intraocular pressure when anticholinergic drugs, including antiparkinson agents, are administered concomitantly with haloperidol. As with other antipsychotic agents, it should be noted that haloperidol may be capable of potentiating CNS depressants such as anesthetics, opioids, and alcohol.