SERENACE

There is considerable variation from patient to patient in the response to treatment and the dosage required. As with all antipsychotics, dosage should be individualised according to the needs and response of each patient. To determine the initial dosage, consideration should be given to the patient’s age, severity of symptoms and previous response to other antipsychotic therapy.

Oral dosage may be given in single or divided doses. Administration twice daily is sufficient in most cases. Adults Psychotic behaviour; Mental or behavioural problems; Moderate to severe psychomotor agitation or impulsive behaviour.

5mg daily to 20mg daily, dependent on the characteristics, severity of symptoms and response of each individual patient. It may be necessary to increase the dosage gradually to obtain maximum control of symptoms. In severely disturbed or resistant patients, the maximum daily dose recommended is 30mg.

Maintenance treatment Once a satisfactory therapeutic response has been achieved, dosage should be reduced gradually to the lowest effective maintenance level which is often as low as 3 to 10mg daily dependent on the characteristics and response of each individual patient.

Gilles de la Tourette syndrome Initial dosage is usually 2mg daily. During the acute phase of treatment, dosage can be increased gradually to obtain maximum control of symptoms and may range between 6 and 30mg daily. Once a satisfactory therapeutic response has been achieved, dosage should be reduced gradually to the lowest effective maintenance level which for most patients is 4mg daily.

Nausea and vomiting 1mg daily orally has proved useful. Anxiety 500mcg twice daily. Elderly Half the recommended adult starting dose may be sufficient for therapeutic response in the elderly. The maximum and maintenance dose will generally be lower for debilitated or geriatric patients who may be more sensitive to Serenace.

Children (Oral administration) 25 to 50 micrograms per Kg body weight per day to a maximum of 10mg, although, exceptionally, adolescents may require up to 30mg daily. Route of administration Oral.

The data provided below covers all haloperidol formulations including the Haloperidol Decanoate formulations. The safety of Haloperidol was evaluated in 284 haloperidol-treated subjects who participated in 3 placebo-controlled, and in 1295 haloperidol-treated subjects who participated in sixteen double-blind active comparator-controlled clinical trials.

The safety of Haloperidol decanoate was evaluated in 410 subjects who participated in 3 comparator trials (one comparing haloperidol vs. fluphenazine and two comparing the decanoate formulation to the oral formulation), 9 open label trials and 1 dose responsive trial.

Based on pooled safety data from these clinical trials, the most commonly reported (% incidence) Adverse Drug Reactions (ADRs) were: Extrapyramidal disorder (34), Insomnia (19), Agitation (15), Hyperkinesia (13), Headache (12), Psychotic disorder (9), Depression (8), Weight increased (8), Orthostatic hypotension (7) and Somnolence (5).

Including the above mentioned ADRs, the following ADRs have been observed from clinical trials and post-marketing experiences reported with the use of Haloperidol and Haloperidol Decanoate.

Frequencies displayed use the following convention:

Very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100); rare ( 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated form the available data). 6) Reproductive system and breast disorders Common: Erectile dysfunction Uncommon: Amenorrhoea; Dysmenorrhoea; Galactorrhoea; Breast discomfort; Breast Pain; Rare: Menorrhagia; Menstrual Disorder; Sexual Dysfunction Not known: Gynaecomastia, Priapism General disorders and administration site conditions Uncommon: Gait disturbance; Hyperthermia; Oedema Not known: Sudden Death; Face Oedema; Hypothermia Investigations Common: Weight increased; Weight decreased Rare: Electrocardiogram QT prolonged Additional Information Cardiac effects such as QT-interval prolongation, torsade de pointes, ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia), and cardiac arrest have been reported.

Cases of sudden death have been reported in psychiatric patients receiving anti-psychotic drugs, including haloperidol. Increased Mortality in Elderly people with Dementia Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated.

There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. Haloperidol is not licensed for the treatment of dementia-related behavioural disturbances. Cardiovascular effects Very rare reports of QT prolongation and/or ventricular arrhythmias, in addition to rare reports of sudden death, have been reported with haloperidol.

They may occur more frequently with high doses and in predisposed patients. The risk-benefit of haloperidol treatment should be fully assessed before treatment is commenced and patients with risk factors for ventricular arrhythmias such as cardiac disease, family history of sudden death and/or QT prolongation; uncorrected electrolyte disturbances; subarachnoid haemorrhage; starvation; alcohol abuse or those receiving concomitant therapy with other drugs known to prolong the QT interval, should be monitored carefully (ECGs and potassium levels), particularly during the initial phase of treatment, to obtain steady plasma levels.

9) or with parenteral use, particularly intravenous administration. ECG monitoring should be performed for QT prolongation and for serious cardiac dysrhythmias if haloperidol is administered intravenously. Haloperidol should be used with caution in patients known to be slow metabolisers of CYP2D6, and during use of cytochrome P450 inhibitors.

Concomitant use of antipsychotics should be avoided. 3 Contraindications), especially in the elderly and patients with a positive personal or family history of cardiac disease or abnormal findings on cardiac clinical examination. g. at dose escalation) should be assessed on an individual patient basis.

Comatose states, CNS depression, lesions of basal ganglia, patients with Parkinson’s disease or known hypersensitivity to haloperidol or to any of the excipients and use during lactation. In common with other neuroleptics, haloperidol has the potential to cause rare prolongation of the QT interval.

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 Torsades de pointes, clinical significant bradycardia, second and third degree heart block and uncorrected hypokalaemia.

5).