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ORAP is a brand name for Pimozide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Orap is an antipsychotic of the diphenylbutyl-piperidine series and is indicated in: - Chronic schizophrenia, for the treatment of symptoms and prevention of relapse. - Other psychoses, especially paranoid and monosymptomatic hypochondriacal psychoses (eg delusional parasitosis). Orap is indicated in adults and…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Orap is intended for once daily oral administration in adults and children over 12 years of age. Since individual response to antipsychotic drugs is variable, dosage should be individually determined and is best initiated and titrated under close clinical supervision.
In determining the initial dose, consideration should be given to the patient's age, severity of symptoms and previous response to other neuroleptic drugs. Dose increases should be made at weekly intervals or longer, and by increments of 2-4 mg in the daily dose.
The patient should be reviewed regularly to ensure the minimum effective dose is being used.
Chronic schizophrenia:
The dose ranges between 2 and 20 mg daily, with 2 mg as a starting dose. This may be increased according to response and tolerance to achieve an optimum response. Other psychoses, paranoid states and monosymptomatic hypochondriacal psychoses (MHP): An initial dose of 4 mg daily which may then be gradually increased, if necessary, according to response, to a maximum of 16 mg daily.
Use in elderly:
Elderly patients require half the normal starting dose of pimozide. Paediatric population (less than 12 years old) No data are available Method of Administration Oral use.
The safety of ORAP was evaluated in 165 pimozide-treated subjects who participated in seven placebo-controlled trials of patients with schizophrenia, or patients with anxiety or behavioural disorders, and in 303 pimozide-treated subjects who participated in eleven active-comparator controlled clinical trials in patients with schizophrenia (10 trials, including chronic schizophrenia) or psychic fatigability (1 trial).
Based on pooled safety data from these clinical trials, the most commonly reported (≥ 9% incidence) Adverse Drug Reactions (ADRs) were (with % incidence): Nervous System Disorders: Dizziness (11) and Somnolence (11), Extrapyramidal Disorder (9); Muscle Rigidity (9); Hyperhidrosis (13); Nocturia (12).
Including the above-mentioned ADRs, the following table (next page) displays ADRs that have been reported with the use of ORAP from either clinical-trial or post-marketing experiences.
The displayed frequency categories 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) Adverse Drug Reactions Frequency Category System Organ Class Very Commo n (≥ 1/10) Common (≥ 1/100 to < 1/10 ) Uncommon (≥ 1/1,000 to < 1/100 ) Not Known Endocrine Disorders Hyperglycaemia (in patients with pre-existing diabetes); Blood Prolactin Increased Metabolism and Nutrition Disorders Anorexia Hyponatraemia Psychiatric Disorders Depression; Insomnia; Agitation; Restlessness Libido Decreased Nervous System Disorders Dizziness; Somnolence; Extrapyramidal Disorder; Akathisia; Headache; Tremor; Lethargy; Muscle Rigidity Bradykinesia; Cogwheel Rigidity; Dyskinesia; Dystonia; Dysarthria Neuroleptic Malignant Syndrome; Grand Mal Convulsion; Tardive Dyskinesia; Neck Rigidity Eye Disorders Vision Blurred Oculogyric crisis Cardiac Disorders Torsade de Pointes; Ventricular Tachycardia; Ventricular Fibrillation Gastrointestina l Disorders Constipation; Dry Mouth; Vomiting; Salivary Hypersecretion Skin and subcutaneous tissue disorders Hyperhidrosis Sebaceous Gland Overactivity Pruritus; Rash, Urticaria Musculoskeleta l and Connective Muscle Spasms Adverse Drug Reactions Frequency Category System Organ Class Very Commo n (≥ 1/10) Common (≥ 1/100 to < 1/10 ) Uncommon (≥ 1/1,000 to < 1/100 ) Not Known Tissue Disorders Renal and urinary disorders Nocturia Urinary frequency Glycosuria Pregnancy, puerperium and perinatal conditions.
Please also refer to Drug Interactions section. 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. Orap is not licensed for the treatment of dementia-related behavioural disturbances. 3) There have been very rare reports of QT prolongation, ventricular arrhythmias, and Torsade de Pointes in patients without risk factors for QT prolongation administered therapeutic doses of pimozide, and in the setting of overdose.
Ventricular tachycardia and ventricular fibrillation (in some cases with fatal outcomes) have also been reported, in addition to very rare reports of sudden death and cardiac arrest. As with other neuroleptics, cases of sudden unexpected death have been reported with pimozide at recommended doses and in the setting of overdose.
An ECG should be performed prior to initiation of treatment with pimozide, as well as periodically during treatment. If repolarization changes (prolongation of QT interval, T-wave changes or U-wave development) appear or arrhythmias develop, the need for treatment with pimozide in these patients should be reviewed.
They should be closely monitored and their dose of pimozide should be reduced or the drug discontinued. If QT or QTc exceeds 500 msec, pimozide should be discontinued. 5) and periodic electrolyte monitoring is recommended. 5) Venous Thromboembolism (VTE) Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs.
Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Orap and preventive measures undertaken. Liver disease Caution is advised in patients with liver disease because pimozide is metabolized in the liver.
In common with several other neuroleptics, pimozide has been reported to prolong the QT interval. It is, therefore, contra-indicated in patients with a pre-existing congenital prolongation of QT, or with a history or family history of this syndrome, and in patients with a history of cardiac arrhythmias and a history of Torsades de pointes.
5), known uncorrected hypokalaemia or hypomagnesaemia, or clinically significant cardiac disorders (eg recent acute myocardial infarction, uncompensated heart failure, arrhythmias treated with class IA and III antiarrhythmic medicinal products) or clinically significant bradycardia.
1. It should not be used in patients with depression or Parkinson’s syndrome. The concomitant use of orally or parenterally administered cytochrome P450 CYP 3A4 inhibiting drugs such as azole antimycotics, antiviral protease inhibitors, macrolide antibiotics and nefazodone is contra-indicated.
The concomitant use of CYP 2D6 inhibiting drugs such as quinidine is also contra-indicated. The inhibition of either or both of these cytochrome P450 systems may result in the elevation of pimozide blood concentration and increase the possibility of QT-prolongation.
5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6) Reproductive System and Breast Disorders Erectile Dysfunction Amenorrhoea Galactorrhoea; Gynaecomastia General Disorders and Administration Site Conditions Extreme exhaustion Face oedema Body Temperature Dysregulation; Hypothermia Investigations Weight increased Electrocardiogram QT Interval Prolonged; Electroencephalogra m Abnormal In addition to the above, cardiac arrest and sudden unexplained death have been reported with the use of pimozide.
These events should be considered ADRs associated with the class of medicinal products, the D2, dopamine-antagonist neuroleptics. Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs (frequency unknown).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard
Kinetics of response/withdrawal In schizophrenia, the response to antipsychotic drug treatment may be delayed. If drugs are withdrawn, recurrence of symptoms may not become apparent for several weeks or months. Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia, have been described after abrupt cessation of antipsychotic drugs.
Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable. 8). Antiparkinson drugs of the anticholinergic type may be prescribed as required, but should not be prescribed routinely as a preventive measure (see tardive dyskinesia below).
Tardive dyskinesia As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or after drug discontinuation. The syndrome is mainly characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw.
The manifestations may be permanent in some patients. The syndrome may be masked when treatment is reinstituted, when the dosage is increased or when a switch is made to a different antipsychotic drug. Treatment should be discontinued as soon as possible.
There is no known treatment for tardive dyskinesia. The antipsychotic drug may mask it, as may anticholinergic agents. Although the latter do not predispose to tardive dyskinesia, they should not be used routinely to mask the Parkinsonian effects of antipsychotic drugs as they may mask the early signs of tardive dyskinesia.
Neuroleptic malignant syndrome In common with other antipsychotic drugs, pimozide has been associated with neuroleptic malignant syndrome: an idiosyncratic response characterized by hyperthermia, generalised muscle rigidity, autonomic instability, altered consciousness.
Hyperthermia is often an early sign of this syndrome. Antipsychotic treatment should be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted. g. alcohol withdrawal or brain damage). In addition, grand mal convulsions have been reported in association with pimozide.
Body Temperature Regulation Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. , exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity or being subject to dehydration.
Endocrine Effects Hormonal effects of antipsychotic neuroleptic drugs include hyperprolactinaemia, which may cause galactorrhoea, gynaecomastia, oligomenorrhoea or amenorrhoea, and erectile dysfunction. Pimozide should only be used with great caution in patients with thyrotoxicosis.
Other Caution is also advised in patients with renal failure, Parkinson’s disease and phaeochromocytoma. Concomitant use of pimozide with other neuroleptics should be avoided.