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Drug Catalog - Product Detail

HALOPERIDOL ORAL SOLUTION CONC. SOL 2MG/ML 118ML

NDC Mfr Size Str Form
54838-0501-40 SILARX 120 2MG/ML LIQUID
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Generic Name
HALOPERIDOL
Substance Name
HALOPERIDOL LACTATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA073364
Description
DESCRIPTION Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-( p -chlorophenyl)-4-hydroxypiperidino]-4’-fluorobutyrophenone and it has the following structural formula: Haloperidol Oral Solution, USP (concentrate) contains 2 mg haloperidol (as the lactate) per mL. Inactive ingredients: propylene glycol, methylparaben, propylparaben, lactic acid, and purified water. molec-struc
How Supplied
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 (NDC 54838-501-40), with dropper graduated at 0.5 mg, and 1 mg, 1.5 mg, 2 mg, 3 mg, 4 mg, and 15 mL bottles (NDC 54838-501-15), 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. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB72213A Rev. 09/24
Indications & Usage
INDICATIONS AND USAGE Haloperidol Oral Solution is indicated for use in the management of manifestations of psychotic disorders. Haloperidol Oral Solution is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol Oral Solution is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is 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 should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.
Dosage and Administration
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 Symptomatology 0.5 mg to 2.0 mg b.i.d. or t.i.d. Severe Symptomatology 3.0 mg to 5.0 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 2.0 mg b.i.d. or t.i.d. Chronic or Resistant Patients 3.0 mg to 5.0 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 Disorders 0.05 mg/kg/day to 0.15 mg/kg/day Non-Psychotic 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 (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.