HALOPERIDOL LACTATE 5 mg/mL
HALOPERIDOL LACTATE · INJECTION, SOLUTION · Mylan Institutional LLC
HALOPERIDOL LACTATE is a injection, solution containing haloperidol lactate at 5 mg/mL, taken intramuscular. Manufactured by Mylan Institutional LLC.
Key Facts
- Brand Name
- HALOPERIDOL LACTATE
- Generic Name
- HALOPERIDOL LACTATE
- NDC Code (Product)
67457-426- Manufacturer
- Mylan Institutional LLC
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- ANDA078347
- Marketing Start
- 12/18/2014
Recall History
Safecor Health, LLC
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Haloperidol Injection, USP is indicated for use in the treatment of schizophrenia.
Dosage & Administration
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. 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 mg 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 ho…
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 injection is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). Cardiovascular Effects Cases of sudden death, QTc interval-prolongation, and Torsades de Pointes have been reported in patients receiving haloperidol (see ADVERSE REACTIONS ). Higher than recommended doses of any formulation and intravenous administration of haloperidol appear to be associated with a higher risk of QTc interval-prolongation and Torsades de Pointes. Also, a QTc interval that exceeds 500 msec is associated with an increased risk of Torsades de Pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QTc-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QTc, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). HALOPERIDOL INJECTION IS NOT APPROVED FOR INTRAVENOU…
Contraindications
CONTRAINDICATIONS Haloperidol 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
ADVERSE REACTIONS 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 and Lithium •WARNINGS, General •PRECAUTIONS, Leukopenia, Neutropenia, and Agranulocytosis •PRECAUTIONS, Withdrawal Emergent Dyskinesia •PRECAUTIONS, Other Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The data described below reflect exposure to haloperidol in the following: •284 patients who participated in 3 double-blind, placebo-controlled clinical trials with haloperidol (oral formulation, 2 to 20 mg/day); two trials were in the treatment of schizophrenia and one in the treatment of bipolar disorder. •1295 patients wh…
Frequently Asked Questions
What is HALOPERIDOL LACTATE used for?
HALOPERIDOL LACTATE contains HALOPERIDOL LACTATE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is HALOPERIDOL LACTATE a controlled substance?
HALOPERIDOL LACTATE is not classified as a controlled substance by the DEA.
What is the generic name for HALOPERIDOL LACTATE?
The generic name for HALOPERIDOL LACTATE is HALOPERIDOL LACTATE. There are 7 other brand versions of HALOPERIDOL LACTATE.
What is the NDC code for HALOPERIDOL LACTATE 5 mg/mL?
The NDC (National Drug Code) for HALOPERIDOL LACTATE 5 mg/mL is 67457-426, listed by Mylan Institutional LLC.