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Haloperidol

Haloperidol
Tablets 2 mg;
Tablets 10 mg;
ATC N05A D01
Prescription-only medicine
Medicine reimburse by Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION

Haloperidol tablets are administered orally.

The dose for all indications should be individually adjusted, for each patient. It is important when the initial dose is determined, as well as for dosage titration, the patient should be under clinical monitoring.

To determine the initial dose, consideration should be given to the patient’s age, the severity of symptoms and previous response to neuroleptic drugs

Lower doses of haloperidol should be used in older patients, debilitated and in patients with previously reported adverse reactions to neuroleptic drugs. In these cases, it is required the initial dose should be divided in half and gradually increased until an optimal therapeutic effect is achieved.

It is required to use the lowest dose that is clinically effective.

Adults

Schizophrenia, psychosis, mania and hypomania, mental and behavioral problems, psychomotor agitation, excitement, violent and dangerously impulsive behavior, organic brain damage.

Initial dose: Moderate symptomatology: 1.5 – 3.0 mg two to three times a day.

Severe symptomatology/resistant patients: 3.0-5.0 mg two to three times a day. The same initial dose should be used in adolescents and patients with resistant schizophrenia, but these patients may require a dose of up to 30 mg a day.

Maintenance dose: Once satisfactory control of symptoms has been achieved, the dosage should be gradually reduced to the lowest effective maintenance dose, usually 5 mg a day or 10 mg a day. Too rapid dose reduction should be avoided.

Anxiety and agitation in elderly: Initial dose: 1.5-3.0 mg two or three times a day titrate until efficient maintenance dose is achieved (1.5 mg-30 mg a day).

Gilles-de-la Tourette syndrome, a severe case of ticks and uninterruptible hiccups: Initial dose is 1.5 mg three times a day, depending on the therapeutic answer. A daily maintenance dose of 10 mg may be required in Gilles-de-la Tourette syndrome.

Children

Childhood behavioral disorders and schizophrenia: Total maintenance daily dose is 0.025-0.05 mg/kg/day. Half of the dose is given in the morning, the other half in the evening, up to a maximum daily dose of 10 mg a day.

Gilles-de-la Tourette syndrome: For most patients, the oral maintenance dose is up to 10 mg a day.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

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COMPOSITION

Each tablet contains 2 mg haloperidol, excipients.
Each tablet contains 10 mg haloperidol, excipients.

THERAPEUTIC INDICATIONS

Adults:
• Schizophrenia: treatment of symptoms and prevention of relapse.
• Other psychoses: especially paranoid.
• Mania and hypomania.
• Mental or behavioral problems such as aggression, hyperactivity and self-mutilation in the mentally retarded and in patients with organic brain damage.
• As an adjunct to short term management of moderate to severe psychomotor agitation, excitement, violent or dangerously impulsive behavior.
• Intractable hiccup.
• Anxiety and agitation in the elderly.
• Gilles-de-la Tourette syndrome and severe tics.
Children:
• Childhood behavioral disorders, especially when associated with hyperactivity and aggression.
• Gilles-de-la Tourette syndrome.
• Childhood schizophrenia.

CONTRAINDICATIONS

Comatose states, CNS depression, Parkinson's disease, known hypersensitivity to haloperidol, lesions of basal ganglia.
In common with other neuroleptics, haloperidol has the potential to cause rare prolongation of the QT interval. Use of haloperidol is, therefore, contraindicated in patients with clinically significant cardiac disorders e.g. recent acute myocardial infarction, uncompensated heart failure, arrhythmias treated with class IA and III antiarrhythmic medicinal products, QTc interval prolongation, history of ventricular arrhythmia or torsade de pointes clinically significant bradycardia, second or third-degree heart block and uncorrected hypokalaemia. Haloperidol should not be used concomitantly with other QT-prolonging drugs.


PACKAGING

Box with 25 tablets of 2 mg in a plastic container
Box with 30 tablets of 10 mg (3 blisters x 10 tablets).