Haloperidol Decanoate
Generic Name: haloperidol decanoate
Brand Names:
Haloperidol Decanoate
11 DESCRIPTION Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is: The molecular formula is C 31 H 41 CIFNO 3 and has a molecular weight of 530.12.
Overview
11 DESCRIPTION Haloperidol decanoate, USP is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is: The molecular formula is C 31 H 41 CIFNO 3 and has a molecular weight of 530.12.
Uses
1 INDICATIONS AND USAGE Haloperidol decanoate is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate release oral haloperidol product. Haloperidol decanoate is a typical antipsychotic indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION • Administer haloperidol decanoate by deep intramuscular injection every 4 weeks by a healthcare provider. Do not administer intravenously ( 2.1 ). • For the recommended dosage, including the first recommended dose and the maintenance dosage, see the Dosage and Administration section ( 2.1 ). • If schizophrenia symptoms worsen during dosage modification of haloperidol decanoate, consider administering an immediate-release oral haloperidol product in addition to haloperidol decanoate therapy ( 2.2 ). 2.1 Recommended Dosage and Administration Administer haloperidol decanoate by deep intramuscular injection every 4 weeks by a health care professional. Do not administer haloperidol decanoate intravenously.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Sudden Death, Torsades de Pointes, and QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] • Tachycardia and Hypotension [see Warnings and Precautions ( 5.3 )] • Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] • Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.6 )] • Seizures [see Warnings and Precautions ( 5.8 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.9 )] • Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.13 )] • Hyperprolactinemia [see Warnings and Precautions ( 5.14 )] • Risk of Severe Neurotoxicity in Patients with Thyrotoxicosis [see Warnings and Precautions ( 5.15 )] The most...
Interactions
7 DRUG INTERACTIONS • Drugs that Prolong QTc Interval: Avoid concomitant use with haloperidol decanoate ( 7.1 ). • See full prescribing information for additional clinically significant drug interactions with haloperidol decanoate ( 7.2 ). 7.1 Drugs that Prolong the QTc Interval Avoid concomitant use of haloperidol decanoate with other drugs with a known potential to prolong the QTc interval. If concomitant use cannot be avoided [ see Warnings and Precautions ( 5.2 )]: • Obtain ECGs when initiating and during concomitant use as clinically indicated. • Obtain serum electrolytes (including potassium, calcium, phosphorus and magnesium) when initiating and during concomitant use as clinically indicated. QTc interval prolongation has been observed with haloperidol decanoate treatment.
Warnings
WARNING: 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 Warnings and Precautions ( ( 5.1 ). WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS • Sudden Death, Torsades de Pointes (TdP) and QTc Interval Prolongation: Avoid use of haloperidol decanoate in patients who are at risk of developing TdP. Avoid concomitant use of haloperidol decanoate with drugs that may increase risk of QTc interval prolongation or increase haloperidol exposure. Obtain ECG and serum electrolytes at baseline and during treatment as clinically indicated ( 5.2 ). • Tachycardia and Hypotension: Monitor orthostatic vital signs ( 5.3 ). • Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis: Use with caution in patients with schizophrenia who have risk factors for cerebrovascular adverse reactions ( 5.4 ). • Tardive Dyskinesia: Discontinue treatment if clinically appropriate ( 5.5 ). 4 CONTRAINDICATIONS Haloperidol decanoate is contraindicated in patients with: • Severe toxic central nervous system depression or comatose states from any cause. • Known hypersensitivity to haloperidol or any components of haloperidol decanoate injection.
Pregnancy
8.1 Pregnancy Risk Summary Available data from published epidemiologic studies of pregnant patients exposed to haloperidol have not established a drug-associated risk of major birth defects or miscarriage. Case reports of limb malformations in neonates have been reported in haloperidol-treated mothers; however, causal relationships were not established in these cases. There are risks to the pregnant patient from untreated schizophrenia, including increased risk of relapse, hospitalization and suicide (see Clinical Considerations).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Haloperidol decanoate injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate is a clear colorless or pink or yellow amber solution supplied as: *as haloperidol.
Frequently Asked Questions
What is Haloperidol Decanoate used for?▼
1 INDICATIONS AND USAGE Haloperidol decanoate is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate release oral haloperidol product. Haloperidol decanoate is a typical antipsychotic indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product ( 1 ).
What are the side effects of Haloperidol Decanoate?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Sudden Death, Torsades de Pointes, and QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] • Tachycardia and Hypotension [see Warnings and Precautions ( 5.3 )] • Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] • Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.6 )] • Seizures [see Warnings and Precautions ( 5.8 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.9 )] • Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.13 )] • Hyperprolactinemia [see Warnings and Precautions ( 5.14 )] • Risk of Severe Neurotoxicity in Patients with Thyrotoxicosis [see Warnings and Precautions ( 5.15 )] The most...
Can I take Haloperidol Decanoate during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from published epidemiologic studies of pregnant patients exposed to haloperidol have not established a drug-associated risk of major birth defects or miscarriage. Case reports of limb malformations in neonates have been reported in haloperidol-treated mothers; however, causal relationships were not established in these cases. There are risks to the pregnant patient from untreated schizophrenia, including increased risk of relapse, hospitalization and suicide (see Clinical Considerations).
What are the important warnings for Haloperidol Decanoate?▼
WARNING: 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 Warnings and Precautions ( ( 5.1 ). WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS • Sudden Death, Torsades de Pointes (TdP) and QTc Interval Prolongation: Avoid use of haloperidol decanoate in patients who are at risk of developing TdP. Avoid concomitant use of haloperidol decanoate with drugs that may increase risk of QTc interval prolongation or increase haloperidol exposure. Obtain ECG and serum electrolytes at baseline and during treatment as clinically indicated ( 5.2 ). • Tachycardia and Hypotension: Monitor orthostatic vital signs ( 5.3 ). • Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis: Use with caution in patients with schizophrenia who have risk factors for cerebrovascular adverse reactions ( 5.4 ). • Tardive Dyskinesia: Discontinue treatment if clinically appropriate ( 5.5 ). 4 CONTRAINDICATIONS Haloperidol decanoate is contraindicated in patients with: • Severe toxic central nervous system depression or comatose states from any cause. • Known hypersensitivity to haloperidol or any components of haloperidol decanoate injection.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.