Haloperidol (Page 3 of 3)

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.

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:

Initial Dosage Range

Adults

Moderate Symptomatology0.5 mg to 2 mg b.i.d. or t.i.d.
Severe Symptomatology3 mg to 5 mg b.i.d. or t.i.d.
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 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 Disorders0.05 mg/kg/day to 0.15 mg/kg/day
Non-Psychotic behavior Disorders and Tourette’s Disorder0.05 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 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 (From Intramuscular Administration)
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 12-24 hours following the last parenteral dose.

HOW SUPPLIED

Haloperidol Oral Solution USP (Concentrate) 2 mg per mL (as the lactate) is colorless, odorless, and tasteless solution. This product is available in 120 mL bottles, with dropper graduated at 0.5 mg, and 1 mg, 1.5 mg, 2 mg, 3 mg, 4 mg, and 15 mL bottles, with dropper graduated at 0.5 mg, and 1 mg.

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature] Protect from freezing. Protect from light.

Dispense in a tight, light-resistant container as described in the USP.

Manufactured by:
Silarx Pharmaceuticals, Inc.
Spring Valley, NY 10977

Carton Display
(click image for full-size original)
HALOPERIDOL haloperidol solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-1290
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Haloperidol (Haloperidol) Haloperidol 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
propylene glycol
methylparaben
propylparaben
lactic acid
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-1290-54 120 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073364 09/28/1993
Labeler — Qualitest Pharmaceuticals (011103059)

Revised: 06/2011 Qualitest Pharmaceuticals

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