Haloperidol decanoate

What is Haloperidol decanoate?

• Haloperidol decanoate (Haldol Decanoate) is the decanoate ester of the butyrophenone, haloperidol used to treat schizophrenia.

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Haloperidol decanoate

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Haloperidol decanoate highlighting ester group

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Haloperidol decanoate chemical structure

What are the uses of this medicine?

• Haloperidol decanoate (Haldol Decanoate) is used for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.
• Haloperidol injection is also used to control motor tics and verbal tics in people who have Tourette's disorder.

How does this medicine work?

• The decanoate ester of haloperidol, a phenylbutylpiperadine derivative with antipsychotic, neuroleptic and antiemetic effects.
• Haloperidol competitively blocks postsynaptic dopamine (D2) receptors in the mesolimbic system of the brain leading to anti-delusionary and anti-hallucinogenic effects.
• The antagonistic activity mediated through D2 dopamine receptors in the chemoreceptive trigger zone (CTZ) account for its antiemetic activity.

Who Should Not Use this medicine ?

This medicine cannot be used 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.
• Parkinson’s disease.
• Dementia with Lewy bodies

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• alprazolam (Xanax)
• amiodarone (Cordarone, Nexterone, Pacerone)
• anticoagulants (blood thinners)
• antifungals medications such as itraconazole (Onmel, Sporanox) and ketoconazole (Nizoral)
• antihistamines (in cough and cold medications)
• medications for anxiety, depression, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• buspirone
• carbamazepine (Carbatrol, Tegretol, Teril, others)
• chlorpromazine
• disopyramide (Norpace)
• diuretics ('water pills')
• epinephrine (Adrenalin, Epipen, Twinject, others)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• fluoxetine (Prozac, Sarafem, Selfemra)
• fluvoxamine (Luvox)
• lithium (Lithobid)
• moxifloxacin (Avelox)
• narcotic medications for pain
• nefazodone
• paroxetine (Brisdelle, Paxil, Pexeva)
• promethazine (Promethegan)
• quinidine (in Nuedexta)
• rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
• sedatives
• sertraline (Zoloft)
• sleeping pills
• tranquilizers
• venlafaxine (Effexor XR)

Is this medicine FDA approved?

• Haloperidol was approved for use in the United States in 1967.
• The medication is marketed in many countries throughout the world.

How should this medicine be used?

Recommended dosage: Initial Therapy:

• Conversion from oral haloperidol to haloperidol decanoate can be achieved by using an initial dose of haloperidol decanoate that is 10 to 20 times the previous daily dose in oral haloperidol equivalents.
• In patients who are elderly, debilitated, or stable on low doses of oral haloperidol, a range of 10 to 15 times the previous daily dose in oral haloperidol equivalents is appropriate for initial conversion.
• The initial dose of haloperidol decanoate should not exceed 100 mg regardless of previous antipsychotic dose requirements. If, therefore, conversion requires more than 100 mg of haloperidol decanoate as an initial dose, that dose should be administered in two injections, i.e., a maximum of 100 mg initially followed by the balance in 3 to 7 days.

Maintenance Therapy:

• The usual maintenance range is 10 to 15 times the previous daily dose in oral haloperidol equivalents.

In patients stabilized on low daily oral doses (up to 10 mg/day):

• 10 to 15 x Daily Oral Dose as intial therapy.
• 10 to 15 x Previous Daily Oral Dose as maintenance dose.

In patients with high dose, risk of relapse and tolerant to oral haloperidol:

• 20 x Daily oral dose as intial therapy.
• 10 to 15 x previous daily oral dose as maintenance dose.

Administration:

• Haloperidol injection comes as a solution to be injected into a muscle by a healthcare provider.
• Haloperidol extended-release injection comes as a solution to be injected into a muscle by a healthcare provider.
• Haloperidol extended-release injection is usually given once every 4 weeks.
• Haloperidol injection and haloperidol extended-release injection may help control your symptoms but will not cure your condition.
• Continue to keep appointments to receive haloperidol even if you feel well.
• Talk to your doctor if you do not feel like you are getting better during your treatment with haloperidol injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As decanoate 50 for IM injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate

This medicine is available in fallowing brand namesː

• Haldol Decanoate

What side effects can this medication cause?

The most common side effects of this medicine include:

• Abdominal pain
• Parkinsonism
• Oculogyric crisis
• Akinesia
• Akathisia
• Tremor
• Headache

Additional side effects may include:

• Cardiac Disorders: Tachycardia
• Endocrine Disorders: Hyperprolactinemia
• Eye Disorders: Vision blurred
• Gastrointestinal Disorders: Constipation, Dry mouth, Salivary hypersecretion
• General Disorders and Administration Site Conditions: Injection site reaction
• Investigations: Weight increased
• Musculoskeletal and Connective Tissue Disorders: Muscle rigidity
• Nervous System Disorders: Dyskinesia, Dystonia, Cogwheel rigidity, Hypertonia, Masked Facies, Sedation, Somnolence
• Reproductive System and Breast Disorders: Erectile dysfunction

What special precautions should I follow?

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haldol decanoate is not approved for the treatment of patients with dementia-related psychosis.
• Cases of sudden death, QTc interval-prolongation, and Torsades de Pointes have been reported in patients receiving haloperidol. Tachycardia and hypotension (including orthostatic hypotension) have also been reported in occasional patients.
• Haldol decanoate should be used with caution in patients with risk factors for cerebrobascular adverse reactions.
• A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs.
• The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
• Patients with Parkinson's Disease or Dementia with Lewy Bodies are reported to have an increased sensitivity to antipsychotic medication. Haldol decanoate is contraindicated in patients with Parkinson's Disease or Dementia with Lewy Bodies.
• There have been postmarketing reports of hypersensitivity reactions with haloperidol. Haldol decanoate is contraindicated in patients with hypersensitivity to this drug.
• Motor instability, somnolence, and orthostatic hypotension have been reported with the use of antipsychotics, including Haldol decanoate, which may lead to falls and, consequently, fractures or other fall-related injuries.
• An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and fasting blood sugar) followed by irreversible brain damage has occurred in a few patients treated with lithium plus Haldol. Patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.
• A number of cases of bronchopneumonia, some fatal, have followed the use of antipsychotic drugs, including Haldol (haloperidol).
• Haloperidol decanoate may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. The ambulatory patient should be warned accordingly.
• The use of alcohol with this drug should be avoided due to possible additive effects and hypotension.
• Haloperidol may impair the antiparkinson effects of levodopa and other dopamine agonists. If concomitant antiparkinson medication is required, it may have to be continued after Haldol decanoate 50 or Haldol decanoate 100 is discontinued because of the prolonged action of haloperidol decanoate.
• Severe neurotoxicity (rigidity, inability to walk or talk) may occur in patients with thyrotoxicosis who are also receiving antipsychotic medication, including Haldol.
• Since haloperidol is excreted in human breast milk, infants should not be nursed during drug treatment with haloperidol decanoate.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• extrapyramidal reactions
• hypotension
• sedation
• comatose with respiratory depression and hypotension
• hypertension rather than hypotension
• Torsades de pointes

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Gastric lavage or induction of emesis should be carried out immediately followed by administration of activated charcoal.
• Since there is no specific antidote, treatment is primarily supportive.
• A patent airway must be established by use of an oropharyngeal airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy. Respiratory depression may be counteracted by artificial respiration and mechanical respirators.
• Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine.
• Epinephrine should not be used.
• In case of severe extrapyramidal reactions, antiparkinson medication should be administered.
• ECG and vital signs should be monitored especially for signs of Q-T prolongation or dysrhythmias and monitoring should continue until the ECG is normal.
• Severe arrhythmias should be treated with appropriate antiarrhythmic measures.

Can this medicine be used in pregnancy?

• Haldol decanoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Neonates exposed to antipsychotic drugs (including haloperidol) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Can this medicine be used in children?

• Safety and effectiveness of haloperidol decanoate in children have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Haloperidol Decanoate

Inactive ingredients:

• sesame oil
• benzyl alcohol

Who manufactures and distributes this medicine?

Manufactured by:

• Janssen Pharmaceutica NV
• Beerse, Belgium

Or

• GlaxoSmithKline Manufacturing S.p.A.
• Parma, Italy

Manufactured for:

• Janssen Pharmaceuticals, Inc.
• Titusville, NJ

What should I know about storage and disposal of this medication?

• Store at controlled room temperature (15°–30° C, 59°–86° F).
• Do not refrigerate or freeze.
• Protect from light.
• Keep out of reach of children.

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Haloperidol decanoate
• FDA Haloperidol decanoate

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