Haloperidol 5 mg/mL
Haloperidol lactate · INJECTION · Hikma Pharmaceuticals USA Inc.
Haloperidol is a injection containing haloperidol lactate at 5 mg/mL, taken intramuscular. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Haloperidol
- Generic Name
- Haloperidol lactate
- NDC Code (Product)
0143-9501- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- ANDA075858
- Marketing Start
- 06/19/2001
Recall History
Somerset Therapeutics Private Limited
Lack of Assurance of Sterility: Media fill with bacterial contamination
Safecor Health, LLC
Defective Container: Confirmed customer complaints of leaking bottles.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Safecor Health, LLC
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
SOMERSET THERAPEUTICS LLC
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Mylan Institutional LLC
Lack of Assurance of Sterility; due to leaking vials
Amerisource Health Services LLC
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mylan Institutional LLC
Lack of Assurance of Sterility; due to leaking vials
Fresenius Kabi USA LLC
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.
Dosage & Administration
DOSAGE AND ADMINISTRATION There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, 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. Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below. Clinical experience suggests the following recommendations: Oral Administration Initial Dosage Range Adults Moderate Symptomatology - 0.5 mg to 2 mg b.i.d. or t.i.d. Severe Symptomatology - 3 mg to 5 mg b.i.d. or t.i.d. To achieve prompt control, higher doses may be required in some cases. Geriatric or Debilitat…
Warnings
WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de pointes have been reported in patients receiving haloperidol. Higher than recommended doses of any formulation of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). Tardive Dyskinesia A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, e…
Contraindications
CONTRAINDICATIONS Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson's disease.
Adverse Reactions
ADVERSE REACTIONS Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of Torsades de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS). Cases of sudden and unexpected death have been reported in association with the administration of haloperidol. The nature of the evidence makes it impossible to determine definitively what role, if any, haloperidol played in the outcome of the reported cases. The possibility that haloperidol caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs. CNS Effects Extrapyramidal Symptoms (EPS) EPS during the administration of haloperidol have been reported frequently, often during the first few days of treatment. EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia (including opisthotonos and oculogyric crisis). Whil…
Frequently Asked Questions
What is Haloperidol used for?
Haloperidol contains Haloperidol lactate. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Haloperidol a controlled substance?
Haloperidol is not classified as a controlled substance by the DEA.
What is the generic name for Haloperidol?
The generic name for Haloperidol is Haloperidol lactate. There are 3 other brand versions of Haloperidol lactate.
What is the NDC code for Haloperidol 5 mg/mL?
The NDC (National Drug Code) for Haloperidol 5 mg/mL is 0143-9501, listed by Hikma Pharmaceuticals USA Inc..