Haloperidol

INDICATIONS AND USAGE Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP 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, USP 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, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.

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 dis orders , 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.

CONTRAINDICATIONS Haloperidol tablets, USP 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.

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, t …

DESCRIPTION Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-( p -chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone. It has the following structural formula. Each haloperidol tablet, USP intended for oral administration contains haloperidol, USP 0.5 mg or 1 mg or 2 mg or 5 mg or 10 mg or 20 mg. In addition each 0.5 mg, 1 mg, 2 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize) and each 5 mg, 10 mg, 20 mg tablet contains the following inactive ingredients: calcium stearate, dibasic calcium phosphate dihydrate, povidone (PVP K 30), sodium starch glycolate and starch. 1 mg: D&C Yellow #10 Aluminium Lake, FD&C Yellow #6 Aluminium Lake; 2 mg: D & C Red #27 Aluminum Lake; 5 mg: D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 10 mg: D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 20 mg: FD & C Yellow #6 Aluminum Lake and D & C Red #27 Aluminum Lake. Structured formula for haloperidol

OVERDOSAGE Manifestations 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 two-year old child. The risk of ECG changes associated with torsade de pointes should be considered. (For further information regarding torsade 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 anti-arrhythmic measures.

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 white to off white, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '298' on other side. They are available as follows: NDC 82619-105-01 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-105-02 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The 1 mg tablets are yellow, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '299' on other side. They are available as follows: NDC 82619-106-01 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-106-02 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The 2 mg tablets are yellow, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '297' on other side. They are available as follows: NDC 82619-107-01 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-107-02 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The 5 mg tablets are pale pink, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '300' on other side. They are available as follows: NDC 82619-108-01 bottles of 30 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-108-02 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-108-03 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The 10 mg tablets are pale pink, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '301' on other side. They are available as follows: NDC 82619-109-01 bottles of 30 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-109-02 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-109-03 bottles of 1000 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The 20 mg tablets are pale pink, round shaped flat faced beveled edge uncoated tablets functionally scored on one side and debossed with '302' on other side. They are available as follows: NDC 82619-110-01 bottles of 30 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. NDC 82619-110-02 bottles of 100 tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Protect from light. Manufactured by: V-Ensure Pharma Technologies Pvt. Ltd. Raigad, Maharashtra-410206, India. Distributed by: Creekwood Pharmaceuticals LLC. Parsippany, NJ 07054 PA1050103 Revised: 12/2025