haloperidol (Rx)

Brand and Other Names:Haldol, Haldol Decanoate, more...Haloperidol LA, Peridol
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 0.5mg
  • 1mg
  • 2mg
  • 5mg
  • 10mg
  • 20mg

oral concentrate

  • 2mg/mL

injectable solution, lactate

  • 5mg/mL

injectable solution, decanoate

  • 50mg/mL
  • 100mg/mL

Schizophrenia, Psychosis

PO

  • Moderate disease, 0.5-2 mg q8-12hr initially
  • Severe disease, 3-5 mg q8-12hr initially; not to exceed 30 mg/day

IM lactate (prompt-acting)

  • 2-5 mg q4-8hr PRN; may require q1hr in acute agitation; not to exceed 20 mg/day

IM decanoate (depot)

  • Initial: IM dose 10-20 times daily PO dose administered monthly; not to exceed 100 mg; if conversion requires initial dose >100 mg, administer in 2 injections (eg, 100 mg initially, then remainder in 3-7 days)
  • Maintenance: Monthly dose 10-15 times daily PO dose

IV (Off-label)

  • May be needed for ICU delirium; use only haloperidol lactate for IV administration; do not use haloperidol decanoate
  • 2-10 mg initially, depending on degree of agitation; if response inadequate, may repeat bolus q15-30min, sequentially doubling initial bolus dose; when calm achieved, administer 25% of last bolus dose q6hr; taper dose after patient is controlled
  • Monitor ECG and QT interval (QT prolongation may occur with cumulative doses ≥35 mg; torsades de pointes reported with single doses ≥20 mg)

Tourette Disorder

0.5-2 mg PO q8-12hr initially; if severe symptoms necessitate increased dosage, titrate upward to 3-5 mg PO q8-12hr; if patient remains inadequately controlled, daily doses up to 100 mg have been used (safety not determined)

Dosage Forms & Strengths

tablet

  • 0.5mg
  • 1mg
  • 2mg
  • 5mg
  • 10mg
  • 20mg

oral concentrate

  • 2mg/mL

injectable solution, lactate

  • 5mg/mL

injectable solution, decanoate

  • 50mg/mL
  • 100mg/mL

Schizophrenia, Psychosis/Sedation

<3 years: Safety and efficacy not established

3-12 years (15-40 kg): 0.25-0.5 mg/day PO divided q8-12hr initially; may be increased by 0.5 mg/day every 5-7 days PRN; maintenance: 0.05-0.15 mg/kg/day PO divided q8-12hr  

6-12 years: Lactate (prompt-acting): 1-3 mg IM q4-8hr PRN; not to exceed 0.15 mg/kg/day

>12 years: Moderate disease, 0.5-2 mg PO q8-12hr initially; severe disease, 3-5 mg PO q8-12hr; not to exceed 30 mg/day

Tourette Disorder

<3 years: Safety and efficacy not established

3-12 years: 0.5 mg/day PO initially; dose increased by 0.5 mg every 5-7 days until therapeutic effect achieved, then reduced to lowest effective maintenance level of 0.05-0.075 mg/kg/day PO divided q8-12hr  

>12 years: 0.5-2 mg PO q8-12hr initially; if severe symptoms necessitate increased dosage, titrate upward to 3-5 mg PO q8-12hr; if patient remains inadequately controlled, daily doses up to 100 mg have been used (safety not determined)

Behavioral Disorders

<3 years: Safety and efficacy not established

3-12 years: 0.5 mg/day PO initially; dose increased PRN by 0.5 mg every 5-7 days until therapeutic effect achieved, then reduced to lowest effective maintenance level of 0.05-0.075 mg/kg/day PO divided q8-12hr  

Acute Agitation

<12 years: Safety and efficacy not established

>12 years: 0.5-3 mg PO, repeated in 1 hour PRN; alternatively, 2-5 mg IM, repeated in 1 hr PRN

Schizophrenia, Psychosis

PO: Lower initial doses and more gradual adjustments recommended; 0.25-0.5 mg PO q8-12hr initially

IM lactate (prompt-acting): Lower adult doses and longer dosing intervals recommended compared with typical adult doses

IM decanoate (depot): Lower initial doses and more gradual adjustments recommended; monthly dose 10-15 times daily PO dose

IV (off-label): 0.25-0.5 mg IV q4hr; use only lactate (not decanoate) for IV administration; monitor with ECG for prolonged QT interval

Not approved for dementia-related psychosis, because of increased risk of cardiovascular or infectious related deaths (see Black Box Warnings)

Tourette Disorder

Lower initial doses and more gradual adjustments recommended; 0.25-0.5 mg PO q8-12hr initially

Dosing Considerations

Elderly at higher risk for tardive dyskinesia associated with higher-potency antipsychotic agents such as haloperidol because of higher ratios of dopaminergic blockage to adrenergic/anticholinergic blockade

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Interactions

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            Adverse Effects

            Frequency Not Defined

            Extrapyramidal symptoms

            • Akathisia
            • Dystonia
            • Muscle stiffness
            • Neuroleptic malignant syndrome (NMS; infrequent but serious)
            • Parkinsonism
            • Tardive dyskinesia

            Common

            • Anticholinergic effects
            • Sedation
            • Weight gain
            • Erectile dysfunction
            • Oligomenorrhea or amenorrhea

            Less common

            • Orthostatic hypotension (after IM injection), tachycardia
            • Agitation, anxiety, cerebral edema, depression, dizziness, euphoria, headache, insomnia, poikilothermia, restlessness, weakness, confusion
            • Anorexia, constipation, dyspepsia, ileus, decreased gag reflex
            • Lens opacities (prolonged use)

            Uncommon

            • ECG changes
            • Photosensitivity
            • Pruritus
            • Diarrhea
            • Blood dyscrasia
            • Ejaculatory disorder
            • Galactorrhea

            Rare

            • Seizure
            • Cholestatic jaundice
            • Priapism

            Postmarketing Reports

            Rhabdomyolysis

            Falls

            Hypersensitivity

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            Warnings

            Black Box Warnings

            Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk for death, as shown in short-term controlled trials; deaths in trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

            Not approved for treatment of patients with dementia-related psychosis

            Contraindications

            Documented hypersensitivity

            Severe toxic central nervous system depression or comatose states from any cause

            Parkinson disease

            Dementia with Lewy bodies

            Cautions

            Risk of sudden death, torsades de pointes, and prolonged QT interval from off-label IV administration of higher than recommended dose: monitor ECG if administering IV

            Conditions or drugs that prolong QT interval, congenital long QT syndrome

            Safety of prolonged administration of 100 mg/day PO not established

            Avoid use in narrow-angle glaucoma, bone marrow suppression, and severe hypotension

            FDA warning regarding off-label use for dementia in elderly

            Cerebrovascular adverse reactions (eg, stroke, transient ischemic attack), including fatalities reported in elderly patients with dementia-related psychosis; mechanism for increased risk is not known; an increased risk cannot be excluded for antipsychotics; use with caution in patients with risk factors for cerebrovascular adverse reactions

            Leukopenia/neutropenia and agranulocytosis reported; possible risk factors include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia

            If patient has history of clinically significant presence of either risk factor, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/μL in absence of other causative factors, and continue monitoring WBC count until recovery

            Severe neurotoxicity manifesting as rigidity or inability to walk or talk may occur in patients with thyrotoxicosis also receiving antipsychotics

            If administering IV or IM, watch for hypotension; use with caution in diagnosed CNS depression, subcortical brain damage, or cardiac disease; if history of seizures, benefits must outweigh risks; significant increase in body temperature may indicate intolerance to antipsychotics (discontinue if this occurs)

            Use caution in patients at risk of pneumonia (eg, Alzheimer's patients); antipsychotic use reported to be associated with esophageal dysmotility and aspiration

            Extrapyramidal symptoms may occur including acute dystonic reactions, akathisia, tardive dyskinesia, and pseudoparkinsonism; some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal; in certain cases dyskinetic movements are indistinguishable from tardive dyskinesia except for duration; not known whether gradual withdrawal will reduce rate of occurrence of withdrawal emergent neurological signs but until further evidence becomes available, gradually withdraw therapy

            Hyperprolactinemia may occur

            Monitor for mental status changes, muscle rigidity, fever, and/or autonomic instability; neuroleptic malignant syndrome may occur

            Motor instability, somnolence, and orthostatic hypotension reported, which may lead to falls and, consequently, fractures or other fall-related injuries; assess risk of falls when initiating treatment and recurrently for patients receiving repeated doses, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects

            Association with increased risk of pigmentary retinopathy reported

            Impairment of core body temperature regulation reported; use caution with activities that may increase body temperature including strenuous exercise, heat exposure, dehydration, and concomitant medications with anticholinergic effects

            Caution in patients receiving anticoagulants; isolated instance of interference occurred with effects of one anticoagulant (phenindione)

            When used to control mania in cyclic disorders, there may be rapid mood swing to depression

            May cause anticholinergic effects; use caution in patients with xerostomia, urinary retention, BPH, decreased gastrointestinal motility, paralytic ileus, or visual problems

            May cause CNS depression; may impair ability to operate heavy machinery or driving

            Decreased sensation of thirst due to central inhibition may lead to dehydration, hemoconcentration and reduced pulmonary ventilation; a number of cases of bronchopneumonia, some fatal, reported; if signs and symptoms appear, especially in the elderly, institute remedial therapy promptly

            Use caution in patients with severe cardiovascular disorders, because of possibility of transient hypotension and/or precipitation of anginal pain; should hypotension occur and a vasopressor be required, epinephrine should not be used since haloperidol may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur; use metaraminol, phenylephrine or norepinephrine instead

            Use caution in patients receiving anticonvulsant medications, with a history of seizures, or with EEG abnormalities; haloperidol may lower convulsive threshold; if indicated, adequate anticonvulsant therapy should be concomitantly maintained

            Patients with Parkinson’s disease or dementia with Lewy Bodies are reported to have increased sensitivity to antipsychotic medication; manifestations include severe extrapyramidal symptoms, confusion, sedation, and falls; therapy may impair antiparkinson effects of levodopa and other dopamine agonists

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            Pregnancy & Lactation

            Pregnancy

            There are no well controlled studies in pregnant women; there are reports of cases of limb malformations observed following maternal use with drug along with other drugs which have suspected teratogenic potential during first trimester of pregnancy; causal relationships were not established in these cases; however, such experience does not exclude possibility of fetal damage due to therapy; drug should be used during pregnancy or in women likely to become pregnant only if benefit clearly justifies a potential risk to fetus; infants should not be nursed during drug treatment

            Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery; there have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates; these complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization

            Animal data

            • Rodents given 2- 20 times usual maximum human dose by oral or parenteral routes showed increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality; no teratogenic effect reported in rats, rabbits or dogs at dosages within this range, but cleft palate has been observed in mice given 15 times usual maximum human dose
            • Rats or rabbits administered oral haloperidol at doses of 0.5 to 7.5 mg/kg, which are approximately 0.2 to 7 times maximum recommended human dose (MRHD) of 20 mg/day based on mg/m2 body surface area, showed increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality; no fetal abnormalities were observed at these doses in rats or rabbits
            • Cleft palate observed in mice administered oral haloperidol at dose of 0.5 mg/kg, which is approximately 0.1 times MRHD based on mg/m2 body surface area

            Lactation

            Drug is excreted in human breast milk; infants should not be nursed during drug treatment

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Phenylbutylpiperadine; antagonizes dopamine D1 and D2 receptors in brain; depresses reticular activating system and inhibits release of hypothalamic and hypophyseal hormones

            Absorption

            Bioavailability: 60-70%

            Onset: 30-60 min (IM/IV)

            Duration: 2-4 weeks (decanoate)

            Peak plasma time: 2-6 hr (PO); 10-20 minutes(IM); 6-7 days (decanoate)

            Distribution

            Protein bound: 90%

            Vd: 8-18 L/kg

            Metabolism

            Metabolized by hepatic P450 enzyme CYP3A4

            Metabolites: Hydroxyhaloperidol

            Enzymes inhibited: CYP2D6

            Elimination

            Half-life: 18 hr; 3 weeks (decanoate)

            Excretion: Urine (30%), feces (15%)

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            Administration

            IV/IM Administration

            Haloperidol lactate and haloperidol decanoate are both administered IM; haloperidol lactate has also been administered IV (off-label); haloperidol decanoate should not be administered IV

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            haloperidol oral
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            haloperidol oral
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            haloperidol oral
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            haloperidol oral
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            haloperidol oral
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            haloperidol oral
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            haloperidol oral
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            5 mg tablet
            haloperidol oral
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            5 mg tablet
            haloperidol oral
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            10 mg tablet
            haloperidol oral
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            1 mg tablet
            haloperidol oral
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            10 mg tablet
            haloperidol oral
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            haloperidol oral
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            20 mg tablet
            haloperidol oral
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            2 mg tablet
            haloperidol oral
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            2 mg tablet
            haloperidol oral
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            0.5 mg tablet
            haloperidol oral
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            20 mg tablet
            haloperidol oral
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            10 mg tablet
            haloperidol oral
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            5 mg tablet
            haloperidol oral
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            2 mg tablet
            haloperidol oral
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            1 mg tablet
            haloperidol oral
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            0.5 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            haloperidol oral

            HALOPERIDOL - ORAL

            (HAL-oh-PER-i-dol)

            COMMON BRAND NAME(S): Haldol

            WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

            USES: Haloperidol is used to treat certain mental/mood disorders (such as schizophrenia, schizoaffective disorders). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can also help prevent suicide in people who are likely to harm themselves. It also reduces aggression and the desire to hurt others. It can decrease negative thoughts and hallucinations.Haloperidol can also be used to treat uncontrolled movements and outbursts of words/sounds related to Tourette's syndrome. Haloperidol is also used for severe behavior problems in hyperactive children when other treatments or medications have not worked.Haloperidol is a psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

            HOW TO USE: Take this medication by mouth with or without food, or as directed by your doctor. If you are using the liquid form of the medication, use the measuring dropper provided in the package to measure your dose. If you do not have the dropper, ask your pharmacist for a measured oral syringe so that your dose will be correct.Dosage is based on your medical condition and response to therapy. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually reduced.Inform your doctor if your symptoms do not improve or if they worsen.

            SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, difficulty urinating, sleep disturbances, headache, and anxiety may occur. If these effects last or get worse, notify your doctor or pharmacist promptly.Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.Tell your doctor promptly if any of these side effects occur: muscle spasm/stiffness, shaking (tremor), restlessness, mask-like facial expression, drooling. Your doctor may prescribe another medication for you to take with haloperidol to decrease these side effects.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.In rare cases, haloperidol may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.For males, in the unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and get medical help right away, or permanent problems may occur.This medication may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any facial/muscle twitching such as tongue thrusting, chewing movements, puffing or puckering of your mouth, or uncontrollable shaking.This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing of eyes/skin, seizures, signs of infection (such as sore throat that doesn't go away, fever).Get medical help right away if you have any very serious side effects, including: slow heartbeat, severe dizziness, chest pain, fainting.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking haloperidol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain severe nervous system problem (severe CNS depression), Parkinson's disease, bipolar disorder, difficulty urinating (for example, due to prostate problems), glaucoma, heart problems (such as angina), overactive thyroid (hyperthyroidism), seizures, low white blood cell count.Haloperidol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using haloperidol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using haloperidol safely.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication can reduce sweating, making you more likely to get heatstroke. Avoid hard work and exercise in hot weather.Children may be more sensitive to the side effects of this drug, especially uncontrolled movements.Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, difficulty urinating, and heart effects such as QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.Since untreated mental/mood problems (such as schizophrenia, schizoaffective disorders) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: anticholinergic medications (for example, antispasmodics such as belladonna alkaloids, scopolamine), cabergoline, ketoconazole, lithium, methyldopa, drugs for Parkinson's disease (such as levodopa and carbidopa, selegiline), paroxetine, pergolide, quinupristin/dalfopristin, rifampin, saquinavir.Many drugs besides haloperidol may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, quinidine, sotalol, procainamide, macrolide antibiotics (such as erythromycin), among others. Before using haloperidol, report all medications you are currently using to your doctor or pharmacist.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

            Information last revised December 2021. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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