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 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 psychosisContraindications 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 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 treatmentPregnancy 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. 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%) 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 BRAND FORM. UNIT PRICE PILL IMAGE haloperidol oral- 5 mg tablethaloperidol oral- 5 mg tablethaloperidol oral- 1 mg tablethaloperidol oral- 2 mg tablethaloperidol oral- 0.5 mg tablethaloperidol oral- 10 mg tablethaloperidol oral- 10 mg tablethaloperidol oral- 20 mg tablethaloperidol oral- 0.5 mg tablethaloperidol oral- 1 mg tablethaloperidol oral- 0.5 mg tablethaloperidol oral- 20 mg tablethaloperidol oral- 5 mg tablethaloperidol oral- 2 mg tablethaloperidol oral- 1 mg tablethaloperidol oral- 10 mg tablethaloperidol oral- 5 mg tablethaloperidol oral- 2 mg tablethaloperidol oral- 10 mg tablethaloperidol oral- 1 mg tablethaloperidol oral- 0.5 mg tablethaloperidol oral- 10 mg tablethaloperidol oral- 5 mg tablethaloperidol oral- 20 mg tablethaloperidol oral- 2 mg tablethaloperidol oral- 2 mg tablethaloperidol oral- 20 mg tablethaloperidol oral- 10 mg tablethaloperidol oral- 5 mg tablethaloperidol oral- 2 mg tablethaloperidol oral- 1 mg tablethaloperidol oral- 0.5 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationhaloperidol 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 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.The dosage is based on your medical condition and response to treatment. 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.Tell your doctor if your symptoms do not improve or if they worsen. SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, difficulty urinating, sleep disturbances, headache, or anxiety may occur. If any of these effects last or get worse, tell 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.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.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.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).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