Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol 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.
CONTRAINDICATIONS
Haloperidol is 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
CONTRAINDICATIONS
Haloperidol is 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
Directions And Dosage
OVERDOSAGE
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:
Other Label Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 87441-037-01 Haloperidol Tablets USP, 5 mg Rx only
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.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
The precise mechanism of action has not been clearly established.
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol 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.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Haloperidol is 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
WARNINGS SECTION
PRECAUTIONS
PRECAUTIONS SECTION
Leukopenia, Neutropenia and Agranulocytosis In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including haloperidol tablets USP. 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 tablets USP 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
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
OVERDOSAGE
OVERDOSAGE SECTION
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
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:
HOW SUPPLIED
HOW SUPPLIED SECTION
Haloperidol Tablets USP, 5 mg are green, capsule-shaped, flat-faced, beveled-edge tablets debossed with the logo of 'ZC', '07' and partial bisect, on one side and plain on the other side and are supplied as follows: NDC 87441-037-01 in blister pack of 30 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 11/24 Repackaged By: Unit Dose Solutions, Inc. Raleigh, NC 27604
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 87441-037-01 Haloperidol Tablets USP, 5 mg Rx only
