haloperidol decanoate 500 mg/5mL
haloperidol decanoate · INJECTION, SOLUTION · Sagent Pharmaceuticals
haloperidol decanoate is a injection, solution containing haloperidol decanoate at 500 mg/5mL, taken intramuscular. Manufactured by Sagent Pharmaceuticals.
Key Facts
- Brand Name
- haloperidol decanoate
- Generic Name
- haloperidol decanoate
- NDC Code (Product)
25021-834- Manufacturer
- Sagent Pharmaceuticals
- Strength
- 500 mg/5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- ANDA205241
- Marketing Start
- 11/15/2017
Recall History
Somerset Therapeutics Private Limited
Lack of Assurance of Sterility: Media fill with bacterial contamination
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
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
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.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Amerisource Health Services LLC
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Amerisource Health Services LLC
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
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 decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
Dosage & Administration
DOSAGE AND ADMINISTRATION Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL should be administered by deep intramuscular injection. A 21 gauge needle is recommended. The maximum volume per injection site should not exceed 3 mL. DO NOT ADMINISTER INTRAVENOUSLY. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are intended for use in schizophrenic patients who require prolonged parenteral antipsychotic therapy. These patients must be previously stabilized on antipsychotic medication before considering a conversion to haloperidol decanoate. Furthermore, it is recommended that patients being considered for haloperidol decanoate therapy have been treated with, and tolerate well, short-acting haloperidol in order to reduce the possibility of an unexpected adverse sensitivity to haloperidol. Close clinical supervision is required during the initial period of dose adjustment in order to minimize the risk of overdosage or reappearance of psychotic symptoms…
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 decanoate 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 DECANOATE MUST NOT BE ADMINISTERED INTRAV…
Contraindications
CONTRAINDICATIONS Since the pharmacologic and clinical actions of haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are attributed to haloperidol as the active medication, Contraindications, Warnings, and additional information are those of haloperidol, modified only to reflect the prolonged action. 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, Combined Use of Haloperidol and Lithium WARNINGS, General PRECAUTIONS, Leukopenia, Neutropenia, and Agranulocytosis PRECAUTIONS, Other PRECAUTIONS, Usage in Pregnancy 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 410 patients who participated in 13 clinical trials with haloperidol decanoate (15 to 500 mg/month) in the treatment of schizophrenia or schizoaffective disorder. These clinical trials comprised: 1 double-blind, active comparator-controlled trial with fluphenazine decanoate. 2 trials comparing the decanoate formulatio…
Frequently Asked Questions
What is haloperidol decanoate used for?
haloperidol decanoate contains haloperidol decanoate. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is haloperidol decanoate a controlled substance?
haloperidol decanoate is not classified as a controlled substance by the DEA.
What is the generic name for haloperidol decanoate?
The generic name for haloperidol decanoate is haloperidol decanoate. There are 11 other brand versions of haloperidol decanoate.
What is the NDC code for haloperidol decanoate 500 mg/5mL?
The NDC (National Drug Code) for haloperidol decanoate 500 mg/5mL is 25021-834, listed by Sagent Pharmaceuticals.
Other Haloperidol Brands
See all →- HALOPERIDOL DECANOATE50 mg/mL68001-578
- HALOPERIDOL DECANOATE50 mg/mL68001-580
- HALOPERIDOL DECANOATE100 mg/mL70069-867
- HALOPERIDOL DECANOATE100 mg/mL70069-868
- Haloperidol decanoate50 mg/mL70771-1852
- Haloperidol Decanoate50 mg/mL10147-0921
- HALOPERIDOL DECANOATE50 mg/mL70069-030
- HALOPERIDOL DECANOATE100 mg/mL70069-031
- Haloperidol decanoate100 mg/mL70710-1463
- Haloperidol Decanoate100 mg/mL70756-616
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)