HALOPERIDOL- haloperidol tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D)
Available from:
REMEDYREPACK INC.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics. Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any caus
Product summary:
Haloperidol Tablets, USP are available containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP. The 0.5 mg tablets are orange round tablets debossed with MYLAN over 351 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0351-01 bottles of 100 tablets NDC 0378-0351-10 bottles of 1000 tablets The 1 mg tablets are orange round tablets debossed with MYLAN over 257 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0257-01 bottles of 100 tablets NDC 0378-0257-10 bottles of 1000 tablets The 2 mg tablets are orange round tablets debossed with MYLAN over 214 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0214-01 bottles of 100 tablets NDC 0378-0214-10 bottles of 1000 tablets The 5 mg tablets are orange round tablets debossed with MYLAN over 327 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0327-01 bottles of 100 tablets NDC 0378-0327-10 bottles of 1000 tablets The 10 mg tablets are light green round tablets debossed with MYLAN over 334 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0334-01 bottles of 100 tablets The 20 mg tablets are light blue round tablets debossed with MYLAN over 335 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0335-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 11/2016 HALO:R22
Authorization status:
Abbreviated New Drug Application
Authorization number:
70518-2248-0

HALOPERIDOL- haloperidol tablet

REMEDYREPACK INC.

Reference Label Set Id: 405ee4c4-394c-47df-a6ec-9b4f4e7ca768

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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. Analyses of seventeen placebo-controlled trials (modal duration of

10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in

drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated

patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-

treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.

Although the causes of death were varied, most of the deaths appeared to be either

cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with

conventional antipsychotic drugs may increase mortality. The extent to which the findings

of increased mortality in observational studies may be attributed to the antipsychotic drug

as opposed to some characteristic(s) of the patients is not clear. Haloperidol is not

approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

DESCRIPTION

Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is

4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone and it has the following

structural formula:

Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or

20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide,

FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized

starch and sodium lauryl sulfate. In addition, the 10 mg and 20 mg tablets also contain FD&C Blue No. 1

Aluminum Lake.

CLINICAL PHARMACOLOGY

The precise mechanism of action has not been clearly established.

INDICATIONS AND USAGE

Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders.

Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette’s Disorder in

children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in

children of combative, explosive hyperexcitability (which cannot be accounted for by immediate

provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children

who show excessive motor activity with accompanying conduct disorders consisting of some or all of

the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and

poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children

only after failure to respond to psychotherapy or medications other than antipsychotics.

CONTRAINDICATIONS

Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose

states from any cause and in individuals who are hypersensitive to this drug or have Parkinson’s

disease.

WARNINGS

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 is not approved for the treatment of patients with dementia-

related psychosis (see BOXED WARNING).

Cardiovascular Effects

Cases of sudden death, QT-prolongation, and Torsades de pointes have been reported in patients

receiving haloperidol. Higher than recommended doses of any formulation of haloperidol appear to be

associated with a higher risk of QT-prolongation and Torsades de pointes. Although cases have been

reported even in the absence of predisposing factors, particular caution is advised in treating patients

with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and

hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and

familial long QT-syndrome).

Tardive Dyskinesia

A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in

patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be

highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates

to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome.

Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are

believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs

administered to the patient increase. However, the syndrome can develop, although much less

commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may

remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself,

however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may

possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term

course of the syndrome is unknown.

Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to

minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be

reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic

drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are not

available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest

duration of treatment producing a satisfactory clinical response should be sought. The need for

continued treatment should be reassessed periodically.

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. (For further information about the description of tardive dyskinesia and its clinical detection,

please refer to ADVERSE REACTIONS.)

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS)

has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are

hyperpyrexia, muscle rigidity, altered mental status (including catatonic signs) and evidence of

autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac

dysrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria

(rhabdomyolysis) and acute renal failure.

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is

important to identify cases where the clinical presentation includes both serious medical illness (e.g.,

pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and

symptoms (EPS). Other important considerations in the differential diagnosis include central

anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

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.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction

of drug therapy should be carefully considered. The patient should be carefully monitored, since

recurrences of NMS have been reported.

Hyperpyrexia and heat stroke, not associated with the above symptom complex, have also been reported

with haloperidol.

Falls

Haloperidol tablets may cause somnolence, postural hypotension, motor and sensory instability, which

may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or

medications that could exacerbate these effects, complete fall risk assessments when initiating

antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Usage in Pregnancy

Pregnancy

Nonteratogenic Effects

Neonates exposed to antipsychotic drugs, during the 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.

Haloperidol should be used during pregnancy only if the potential benefit justifies the potential risk to

the fetus.

Rodents given 2 to 20 times the usual maximum human dose of haloperidol by oral or parenteral routes

showed an increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality. No

teratogenic effect has been reported in rats, rabbits or dogs at dosages within this range, but cleft palate

has been observed in mice given 15 times the usual maximum human does. Cleft palate in mice appears

to be a nonspecific response to stress or nutritional imbalance as well as to a variety of drugs, and there

is no evidence to relate this phenomenon to predictable human risk for most of these agents.

There are no well controlled studies with haloperidol in pregnant women. There are reports, however,

of cases of limb malformations observed following maternal use of haloperidol along with other drugs

which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships

were not established in these cases. Since such experience does not exclude the possibility of fetal

damage due to haloperidol, this drug should be used during pregnancy or in women likely to become

pregnant only if the benefit clearly justifies a potential risk to the fetus. Infants should not be nursed

during drug treatment.

Combined Use of Haloperidol and Lithium

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and

confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and FBS) followed

by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A

causal relationship between these events and the concomitant administration of lithium and haloperidol

has not been established; however, patients receiving such combined therapy should be monitored

closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs

appear.

General

A number of cases of bronchopneumonia, some fatal, have followed the use of antipsychotic drugs,

including haloperidol. It has been postulated that lethargy and decreased sensation of thirst due to

central inhibition may lead to dehydration, hemoconcentration and reduced pulmonary ventilation.

Therefore, if the above signs and symptoms appear, especially in the elderly, the physician should

institute remedial therapy promptly.

Although not reported with haloperidol, decreased serum cholesterol and/or cutaneous and ocular

changes have been reported in patients receiving chemically-related drugs.

Haloperidol 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.

PRECAUTIONS

Leukopenia, Neutropenia and Agranulocytosis

In clinical trial and post-marketing experience, events of leukopenia/neutropenia have been reported

temporally related to antipsychotic agents, including haloperidol. Agranulocytosis (including fatal

cases) has also been reported.

Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC)

and history of drug induced leukopenia/neutropenia. Patients with a preexisting low WBC or a history

of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored

frequently during the first few months of therapy and should discontinue haloperidol at the first sign of

a decline in WBC in the absence of other causative factors.

Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of

infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia

(absolute neutrophil count < 1,000/mm

) should discontinue haloperidol and have their WBC followed

until recovery.

Haloperidol should be administered cautiously to patients:

-with severe cardiovascular disorders, because of the 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. Instead, metaraminol, phenylephrine or norepinephrine

should be used.

-receiving anticonvulsant medications, with a history of seizures, or with EEG abnormalities, because

haloperidol may lower the convulsive threshold. If indicated, adequate anticonvulsant therapy should be

concomitantly maintained.

-with known allergies, or with a history of allergic reactions to drugs.

-receiving anticoagulants, since an isolated instance of interference occurred with the effects of one

anticoagulant (phenindione).

If concomitant antiparkinson medication is required, it may have to be continued after haloperidol is

discontinued because of the difference in excretion rates. If both are discontinued simultaneously,

extrapyramidal symptoms may occur. The physician should keep in mind the possible increase in

intraocular pressure when anticholinergic drugs, including antiparkinson agents, are administered

concomitantly with haloperidol.

As with other antipsychotic agents, it should be noted that haloperidol may be capable of potentiating

CNS depressants such as anesthetics, opiates, and alcohol.

In a study of 12 schizophrenic patients coadministered haloperidol and rifampin, plasma haloperidol

levels were decreased by a mean of 70% and mean scores on the Brief Psychiatric Rating Scale were

increased from baseline. In five other schizophrenic patients treated with haloperidol and rifampin,

discontinuation of rifampin produced a mean 3.3-fold increase in haloperidol concentrations. Thus,

careful monitoring of clinical status is warranted when rifampin is administered or discontinued in

haloperidol-treated patients.

When haloperidol is used to control mania in cyclic disorders, there may be a rapid mood swing to

depression. Severe neurotoxicity (rigidity, inability to walk or talk) may occur in patients with

thyrotoxicosis who are also receiving antipsychotic medication, including haloperidol.

No mutagenic potential of haloperidol was found in the Ames Salmonella microsomal activation assay.

Negative or inconsistent positive findings have been obtained in in vitro and in vivo studies of effects of

haloperidol on chromosome structure and number. The available cytogenetic evidence is considered

too inconsistent to be conclusive at this time.

Carcinogenicity studies using oral haloperidol were conducted in Wistar rats (dosed at up to 5 mg/kg

daily for 24 months) and in Albino Swiss mice (dosed at up to 5 mg/kg daily for 18 months). In the rat

study, survival was less than optimal in all dose groups, reducing the number of rats at risk for

developing tumors. However, although a relatively greater number of rats survived to the end of the

study in high dose male and female groups, these animals did not have a greater incidence of tumors than

control animals. Therefore, although not optimal, this study does suggest the absence of a haloperidol

related increase in the incidence of neoplasia in rats at doses up to 20 times the usual daily human dose

for chronic or resistant patients.

In female mice at 5 and 20 times the highest initial daily dose for chronic or resistant patients, there was

a statistically significant increase in mammary gland neoplasia and total tumor incidence; at 20 times the

same daily dose there was a statistically significant increase in pituitary gland neoplasia. In male mice,

no statistically significant differences in incidences of total tumors or specific tumor types were noted.

Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration.

Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin

dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a

patient with a previously detected breast cancer. Although disturbances such as galactorrhea,

amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated

serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found

in rodents after chronic administration of antipsychotic drugs. Neither clinical studies nor

epidemiologic studies conducted to date, however, have shown an association between chronic

administration of these drugs and mammary tumorigenesis; the available evidence is considered too

limited to be conclusive at this time.

There are no well controlled studies with haloperidol in pregnant women. There are reports, however,

of cases of limb malformations observed following maternal use of haloperidol along with other drugs

which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships

were not established in these cases. Since such experience does not exclude the possibility of fetal

damage due to haloperidol, this drug should be used during pregnancy or in women likely to become

pregnant only if the benefit clearly justifies a potential risk to the fetus. Infants should not be nursed

during drug treatment.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of haloperidol did not include sufficient numbers of subjects aged 65 and over to

determine whether they respond differently from younger subjects. Other reported clinical experience

has not consistently identified differences in responses between the elderly and younger patients.

However, the prevalence of tardive dyskinesia appears to be highest among the elderly, especially

elderly women (see WARNINGS: Tardive Dyskinesia). Also, the pharmacokinetics of haloperidol in

geriatric patients generally warrants the use of lower doses (see DOSAGE AND

ADMINISTRATION).

ADVERSE REACTIONS

Cardiovascular Effects

Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular

arrhythmias have also been reported, in addition to ECG pattern changes compatible with the

polymorphous configuration of Torsades de pointes, and may occur more frequently with high doses

and in predisposed patients (see WARNINGS and PRECAUTIONS).

Cases of sudden and unexpected death have been reported in association with the administration of

haloperidol. The nature of the evidence makes it impossible to determine definitively what role, if any,

haloperidol played in the outcome of the reported cases. The possibility that haloperidol caused death

cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in

psychotic patients when they go untreated or when they are treated with other antipsychotic drugs.

CNS Effects

Extrapyramidal Symptoms (EPS)

EPS during the administration of haloperidol have been reported frequently, often during the first few

days of treatment. EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia

(including opisthotonos and oculogyric crisis). While all can occur at relatively low doses, they occur

more frequently and with greater severity at higher doses. The symptoms may be controlled with dose

reductions or administration of antiparkinson drugs such as benztropine mesylate, USP or

trihexyphenidyl hydrochloride, USP. It should be noted that persistent EPS have been reported; the drug

may have to be discontinued in such cases.

Dystonia

Class Effect

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible

individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck

muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing,

and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more

frequently and with greater severity with high potency and at higher doses of first generation

antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Withdrawal Emergent Neurological Signs

Generally, patients receiving short-term therapy experience no problems with abrupt discontinuation of

antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic

signs after abrupt withdrawal. In certain of these cases the dyskinetic movements are indistinguishable

from the syndrome described below under “Tardive Dyskinesia” except for duration. It is not known

whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal

emergent neurological signs but until further evidence becomes available, it seems reasonable to

gradually withdraw use of haloperidol.

Tardive Dyskinesia

As with all antipsychotic agents, haloperidol has been associated with persistent dyskinesias. Tardive

dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may

appear in some patients on long-term therapy or may occur after drug therapy has been discontinued.

The risk appears to be greater in elderly patients on high dose therapy, especially females. The

symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by

rhythmical involuntary movements of tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of

cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary

movements of extremities and the trunk.

There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not

alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if

these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the

agent, or switch to a different antipsychotic agent, this syndrome may be masked.

It has been reported that fine vermicular movement of the tongue may be an early sign of tardive

dyskinesia and if the medication is stopped at that time, the full syndrome may not develop.

Tardive Dystonia

Tardive dystonia, not associated with the above syndrome, has also been reported. Tardive dystonia is

characterized by delayed onset of choreic or dystonic movements, is often persistent, and has the

potential of becoming irreversible.

Other CNS Effects

Insomnia, restlessness, anxiety, euphoria, agitation, drowsiness, depression, lethargy, headache,

confusion, vertigo, grand mal seizures, exacerbation of psychotic symptoms including hallucinations

and catatonic-like behavioral states which may be responsive to drug withdrawal and/or treatment with

anticholinergic drugs.

Body as a Whole: Neuroleptic malignant syndrome (NMS), hyperpyrexia and heat stroke have been

reported with haloperidol. (See WARNINGS for further information concerning NMS.)

Hematologic Effects: Reports have appeared citing the occurrence of mild and usually transient

leukopenia and leukocytosis, minimal decreases in red blood cell counts, anemia, or a tendency toward

lymphomonocytosis. Agranulocytosis has rarely been reported to have occurred with the use of

haloperidol, and then only in association with other medication.

Liver Effects: Impaired liver function and/or jaundice have been reported.

Dermatologic Reactions: Maculopapular and acneiform skin reactions and isolated cases of

photosensitivity and loss of hair.

Endocrine Disorders: Lactation, breast engorgement, mastalgia, menstrual irregularities,

gynecomastia, impotence, increased libido, hyperglycemia, hypoglycemia and hyponatremia.

Gastrointestinal Effects: Anorexia, constipation, diarrhea, hypersalivation, dyspepsia, nausea and

vomiting.

Autonomic Reactions: Dry mouth, blurred vision, urinary retention, diaphoresis and priapism.

Respiratory Effects: Laryngospasm, bronchospasm and increased depth of respiration.

Special Senses: Cataracts, retinopathy and visual disturbances.

Post-marketing Events

Hyperammonemia has been reported in a 51⁄2 year old child with citrullinemia, an inherited disorder of

ammonia excretion, following treatment with haloperidol.

OVERDOSAGE

Manifes tations

In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and

adverse reactions, the most prominent of which would be: 1) severe extrapyramidal reactions, 2)

hypotension, or 3) sedation. The patient would appear comatose with respiratory depression and

hypotension which could be severe enough to produce a shock-like state. The extrapyramidal reaction

would be manifest by muscular weakness or rigidity and a generalized or localized tremor as

demonstrated by the akinetic or agitans types respectively. With accidental overdosage, hypertension

rather than hypotension occurred in a 2 year old child. The risk of ECG changes associated with

Torsades de pointes should be considered. (For further information regarding Torsades de pointes,

please refer to ADVERSE REACTIONS.)

Treatment

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.

DOSAGE AND ADMINISTRATION

There is considerable variation from patient to patient in the amount of medication required for

treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and

response of each patient. Dosage adjustments, either upward or downward, should be carried out as

rapidly as practicable to achieve optimum therapeutic control.

To determine the initial dosage, consideration should be given to the patient’s age, severity of illness,

previous response to other antipsychotic drugs, and any concomitant medication or disease state.

Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to

antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually

obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below.

Clinical experience suggests the following recommendations:

Oral Administration

Initial Dosage Range

Adults

Moderate Symptomatology - 0.5 mg to 2 mg b.i.d. or t.i.d.

Severe Symptomatology - 3 mg to 5 mg b.i.d. or t.i.d.

To achieve prompt control, higher doses may be required in some cases.

Geriatric or Debilitated Patients - 0.5 mg to 2 mg b.i.d. or t.i.d.

Chronic or Resistant Patients - 3 mg to 5 mg b.i.d. or t.i.d.

Patients who remain severely disturbed or inadequately controlled may require dosage

adjustment. Daily dosages up to 100 mg may be necessary in some cases to achieve an

optimal response. Infrequently haloperidol has been used in doses above 100 mg for

severely resistant patients; however the limited clinical usage has not demonstrated the

safety of prolonged administration of such doses.

Children

The following recommendations apply to children between the ages of 3 and 12 years (weight range 15

kg to 40 kg). Haloperidol is not intended for children under 3 years old. Therapy should begin at the

lowest dose possible (0.5 mg per day). If required, the dose should be increased by an increment of 0.5

mg at 5 to 7 day intervals until the desired therapeutic effect is obtained. (See chart below.)

The total dose may be divided, to be given b.i.d. or t.i.d.

Psychotic Disorders - 0.05 mg/kg/day to 0.15 mg/kg/day

Nonpsychotic Behavior Disorders and Tourette’s Disorder - 0.05 mg/kg/day to 0.075 mg/kg/day

Severely disturbed psychotic children may require higher doses. In severely disturbed,

non-psychotic children or in hyperactive children with accompanying conduct disorders,

who have failed to respond to psychotherapy or medications other than antipsychotics, it

should be noted that since these behaviors may be short lived, short term administration of

haloperidol may suffice. There is no evidence establishing a maximum effective dosage.

There is little evidence that behavior improvement is further enhanced in dosages beyond 6

mg per day.

Maintenance Dosage

Upon achieving a satisfactory therapeutic response, dosage should then be gradually reduced to the

lowest effective maintenance level.

Switchover Procedure

The oral form should supplant the injectable as soon as practicable. In the absence of bioavailability

studies establishing bioequivalence between these two dosage forms the following guidelines for

dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose

administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is

recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy,

sedation, and adverse effects, be carried out periodically for the first several days following the

initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly

accomplished. Depending on the patient’s clinical status, the first oral dose should be given within 12 to

24 hours following the last parenteral dose.

HOW SUPPLIED

Haloperidol Tablets, USP are available containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of

haloperidol, USP.

The 0.5 mg tablets are orange round tablets debossed with MYLAN over 351 on one side of the tablet

and scored on the other side. They are available as follows:

NDC 0378-0351-01

bottles of 100 tablets

NDC 0378-0351-10

bottles of 1000 tablets

The 1 mg tablets are orange round tablets debossed with MYLAN over 257 on one side of the tablet

and scored on the other side. They are available as follows:

NDC 0378-0257-01

bottles of 100 tablets

NDC 0378-0257-10

bottles of 1000 tablets

The 2 mg tablets are orange round tablets debossed with MYLAN over 214 on one side of the tablet

and scored on the other side. They are available as follows:

NDC 0378-0214-01

bottles of 100 tablets

NDC 0378-0214-10

bottles of 1000 tablets

The 5 mg tablets are orange round tablets debossed with MYLAN over 327 on one side of the tablet

and scored on the other side. They are available as follows:

NDC 0378-0327-01

bottles of 100 tablets

NDC 0378-0327-10

bottles of 1000 tablets

The 10 mg tablets are light green round tablets debossed with MYLAN over 334 on one side of the

tablet and scored on the other side. They are available as follows:

NDC 0378-0334-01

bottles of 100 tablets

The 20 mg tablets are light blue round tablets debossed with MYLAN over 335 on one side of the

tablet and scored on the other side. They are available as follows:

NDC 0378-0335-01

bottles of 100 tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Revised: 11/2016

HALO:R22

DRUG: Haloperidol

GENERIC: haloperidol

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2248-0

COLOR: orange

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 7 mm

IMPRINT: MYLAN;257

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

HALOPERIDOL 1mg in 1

INACTIVE INGREDIENT(S):

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

STARCH, CORN

FD&C YELLOW NO. 6

SILICON DIOXIDE

SODIUM LAURYL SULFATE

HALOPERIDOL

haloperidol tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:70 518 -2248 (NDC:0 378 -0 257)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HALO PERIDO L (UNII: J6 29 2F8 L3D) (HALOPERIDOL - UNII:J6 29 2F8 L3D)

HALOPERIDOL

1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

REMEDYREPACK INC.

Product Characteristics

Color

o ra nge

S core

2 pieces

S hap e

ROUND

S iz e

Flavor

Imprint Code

MYLAN;257

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:70 518 -2248 -0

30 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 70 278

0 8 /0 2/20 19

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 8/2019

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