HALOPERIDOL DECANOATE 100MG/ML 10 VIALS
Generic: Haloperidol Decanoate
HALOPERIDOL DECANOATE 100MG/ML 10 VIALS
Sign up to see pricing
Licensed pharmacies, clinics, doctor's offices, and veterinary practices get instant account approval
Sign Up — Instant ApprovalDrug Information
Identification
Haloperidol Decanoate
Haloperidol Decanoate
Lifestar Pharma LLC
HUMAN PRESCRIPTION DRUG
Administration
INJECTION
INTRAMUSCULAR
ANDA216730
Active Ingredients
| Ingredient | Strength |
|---|---|
| HALOPERIDOL DECANOATE | 100 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Haloperidol decanoate injection 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 injection 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.
Dosage & Administration
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 injection 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. When injecting haloperidol decanoate, use a 21-gauge needle. The maximum volume per injection site is 3 mL. Table 1 below describes the recommended dosage for haloperidol decanoate. The maximum recommended initial dose is 100 mg. If the calculated first recommended dose of haloperidol decanoate injection is greater than 100 mg, then administer two deep intramuscular injections as follows: 100 mg on the first day Remainder of the amount 3 to 7 days later. Table 1: Haloperidol Decanoate Recommended Dosage Population First Recommended Dose Maintenance Dosage1 Adult patients less than 65 years old stabilized on ≤ 10 mg of daily immediate-release oral haloperidol with normal hepatic function. 10-15 times previous daily dose of immediate-release oral haloperidol. 10-15 times previous daily dose of immediate-release oral haloperidol administered every 4 weeks. The dosage may be increased by increments of 50 mg or less every 4 weeks until an optimal therapeutic effect is obtained. The typical effective dosage range is between 50 and 200 mg every 4 weeks. Adult patients less than 65 years old stabilized on ≤ 10 mg of daily immediate-release oral haloperidol with hepatic impairment OR Adult patients 65 years and older 10-15 times previous daily dose of immediate-release oral haloperidol. Consider starting at the low end of the dosing range [see Use in Specific Populations (8.5, 8.6) and Clinical Pharmacology (12.3)]. Adult patients less than 65 years old stabilized on >10 mg of daily immediate-release oral haloperidol 10-20 times previous daily dose of immediate-release oral haloperidol 10-15 times previous daily dose of immediate-release oral haloperidol administered every 4 weeks. The dosage may be increased by increments of 50 mg or less every 4 weeks until an optimal therapeutic effect is obtained. 1 Clinical experience with haloperidol decanoate at a dosage greater than 450 mg every 4 weeks has been limited. 2.2 Recommended Supplemental Immediate-release Oral Haloperidol Therapy If schizophrenia symptoms worsen during dosage modification of haloperidol decanoate, consider administering an immediate-release oral haloperidol product in addition to haloperidol decanoate therapy. 2.3 Preparation Instructions Visually inspect haloperidol decanoate for particulate matter and discoloration prior to administration. Do not use if the solution has debris or is not clear or not yellow to light amber in color.
Adverse Reactions
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 common adverse reactions (incidence ≥5%) were oculogyric crisis and parkinsonism. To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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. Adverse Reactions Identified in Clinical Trials with haloperidol decanoate The data described below reflect exposure to 15 mg to 500 mg (1.7 times the maximum recommended dosage) of haloperidol decanoate monthly in 13 clinical trials of 410 adult patients with schizophrenia or an unapproved condition. These clinical trials comprised of: 1 double-blind, active comparator-controlled trial with fluphenazine decanoate (Trial 1). 2 trials comparing haloperidol decanoate to oral haloperidol (Trials 2 and 3). 9 open-label trials. 1 dose-response trial. The most common adverse reactions that occurred in ≥5% of haloperidol decanoate-treated patients in Trial 1 were Parkinsonism and oculogyric crisis. Adverse reactions that occurred in ≥1% of haloperidol decanoate-treated patients in Trial 1 are shown in Table 2. Trial 1 was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the haloperidol decanoate and fluphenazine decanoate treatment groups. Table 2: Adverse Reactions that Occurred in ≥ 1% of haloperidol decanoate-treated Patients and Fluphenazine Decanoate-treated Patients in Trial 1 a Haloperidol decanoate (n=36) Fluphenazine decanoate (n=36) Extrapyramidal disorder: Parkinsonism 31% 44% Oculogyric crisis 6% 0% Akinesia 3% 22% Akathisia 3% 14% Tremor 3% 0% Abdominal pain 3% 0% Headache 3% 0% a The study was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the haloperidol decanoate and the fluphenazine decanoate treatment groups. Less common adverse reactions (<1%) that occurred in Trial 1 and other adverse reactions that occurred in Trials 2 and 3, and open-label and dose-response clinical trials of haloperidol decanoate are listed below. Cardiac Disorders: Tachycardia Endocrine Disorders: Hyperprolactinemia Eye Disorders: Vision blurred Gastrointestinal Disorders: Constipation, Dry mouth, Salivary hypersecretion General Disorders and Administration Site Conditions: Weight increased, Injection site reaction Musculoskeletal and Connective Tissue Disorders: Muscle rigidity Nervous System Disorders: Dyskinesia, Dystonia, Cogwheel rigidity, Hypertonia, Masked facies, Sedation, Somnolence Reproductive System Disorders: Erectile dysfunction Adverse Reactions Identified in Clinical Trials with Immediate-Release Haloperidol Products Based on clinical trials with immediate-release haloperidol products that included 1,579 patients, the following adverse reactions were reported: Musculoskeletal and Connective Tissue Disorders: Torticollis, Trismus, Muscle twitching Nervous System Disorders: Neuroleptic malignant syndrome, Tardive dyskinesia, Bradykinesia, Hyperkinesia, Hypokinesia, Dizziness, Nystagmus Psychiatric Disorders: Loss of libido, Restlessness Reproductive System and Breast Disorders: Amenorrhea, Galactorrhea, Dysmenorrhea, Menorrhagia, Breast discomfort Skin and Subcutaneous Tissue Disorders: Acneiform skin reactions Vascular Disorders: Hypotension, Orthostatic hypotension 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of haloperidol, including haloperidol decanoate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: Pancytopenia, Agranulocytosis, Thrombocytopenia, Leukopenia, Neutropenia Cardiac Disorders: Ventricular fibrillation, Torsade de pointes, Ventricular tachycardia, Extrasystoles, QTc interval prolongation Endocrine Disorders: Inappropriate antidiuretic hormone secretion Gastrointestinal Disorders: Vomiting, Nausea General Disorders and Administration Site Conditions: Sudden death, Face edema, Edema, Hyperthermia, Hypothermia, Injection site abscess, Weight decreased Hepatobiliary Disorders: Acute hepatic failure, Hepatitis, Cholestasis, Jaundice, Liver function test abnormal Immune System Disorders: Anaphylactic reaction, Hypersensitivity Metabolic and Nutritional Disorders: Hypoglycemia Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis Nervous System Disorders: Convulsion, Opisthotonus, Tardive dystonia Pregnancy, Puerperium and Perinatal Conditions: Neonatal drug withdrawal syndrome Psychiatric Disorders: Agitation, Confusional state, Depression, Insomnia Renal and Urinary Disorders: Urinary retention Reproductive System and Breast Disorders: Priapism, Gynecomastia Respiratory, Thoracic and Mediastinal Disorders: Laryngeal edema, Bronchospasm, Laryngospasm, Dyspnea Skin and Subcutaneous Tissue Disorders: Angioedema, Dermatitis exfoliative, Hypersensitivity vasculitis, Photosensitivity reaction, Urticaria, Pruritus, Rash, Hyperhidrosis
Information for Patients
17 PATIENT COUNSELING INFORMATION Sudden Death, Torsades de Pointes, and QTc Interval Prolongation Inform patients that there have been reports of sudden death, torsades de Pointes, and QTc interval prolongation in haloperidol-treated patients. Advise patients or caregivers to seek immediate medical attention if they suspect or develop signs or symptoms associated with the clinical consequences of QTc interval prolongation [see Warnings and Precautions (5.2)] . Tardive Dyskinesia Inform patients that tardive dyskinesia (TD) may develop with haloperidol decanoate. Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and Precautions (5.5)] . Neuroleptic Malignant Syndrome Counsel patients about a potentially fatal adverse reaction, Neuroleptic Malignant Syndrome (NMS), that has been reported with administration of antipsychotic drugs. Advise patients, family members, or caregivers to contact the health care provider or to report to the emergency room if they experience signs and symptoms of NMS [see Warnings and Precautions (5.6)] . Hypersensitivity Reactions Inform patients of the potential risk of hypersensitivity reactions. Advise patients to stop taking haloperidol decanoate and seek immediate attention if signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.9)] . Falls Inform patients that haloperidol decanoate can cause somnolence, orthostatic hypotension, motor instability and sensory abnormality that may lead to falls. Advise patients to notify their healthcare provider if any of these symptoms occur [see Warnings and Precautions (5.10)]. Potential for Cognitive and Motor Impairment Inform patients of the risk and advise them to not drive a motor vehicle or operate hazardous machinery until they are reasonably certain that treatment with haloperidol decanoate does not impair their cognitive and motor functions [see Warnings and Precautions (5.11)]. Leukopenia/Neutropenia Advise patients with a pre-existing low WBC or a history of drug induced leukopenia or neutropenia that they should have their CBC monitored while taking haloperidol decanoate [see Warnings and Precautions (5.13)] . Hyperprolactinemia Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of haloperidol decanoate. Advise the patients to seek medical attention if they experience any of the following: amenorrhea, galactorrhea, erectile dysfunction or gynecomastia [see Warnings and Precautions (5.14)]. Pregnancy Advise pregnant patients to notify their health care provider if they become pregnant or intend to become pregnant during treatment with haloperidol decanoate. Advise patients that haloperidol decanoate exposure during the third trimester of pregnancy may cause adverse effects in the neonate, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and decreased feeding [see Use in Specific Populations (8.1)] . Lactation Advise breastfeeding patients using haloperidol decanoate to monitor infants for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)] . Infertility Advise females and males of reproductive potential that haloperidol decanoate may impair fertility due to an increase in serum prolactin levels [see Use in Specific Populations (8.3)] . Drug Interactions Advise patients to inform their health care provider before starting or discontinuing a prescription drug, nonprescription drug, or supplement [see Warnings and Precautions (5.2) and Drug Interactions (7)] . Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd Mahwah, NJ 07430 USA Made in India Revised: April 2026, V-08
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.