- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Tablets containing 250 micrograms benperidol
For the control of deviant anti-social sexual behaviour
250micrograms - 1.5mg per day in divided doses. Close clinical supervision is required for dose initiation and adjustment.
Dosage should be determined giving consideration to the patient's age, severity of symptoms and previous response to other neuroleptics. Debilitated patients or those who have suffered adverse reactions to neuroleptics previously may require lower doses, with half the usual starting dose being sufficient for a therapeutic response.
The lowest effective dose should be used.
Patients with Renal Impairment
Patients with Hepatic Impairment
For oral administration
Pregnancy (see Pregnancy section)
Breastfeeding (see Lactation section)
Children under 12 years
Precautions and Warnings
Epilepsy and conditions predisposing to epilepsy and convulsions
Elderly or debilitation (see Dosage - Elderly)
Adolescents (see Dosage - Adolescents )
Susceptibility to angle-closure glaucoma
Severe respiratory disease
History of jaundice
Blood dyscrasias - perform blood counts if unexplained infection or fever develops.
Photosensitisation may occur at higher doses avoid direct sunlight.
Some side effects may impair the ability to drive and operate machinery.
Avoid abrupt withdrawal, as there is the possibility of acute withdrawal symptoms and relapse occurring.
Monitor haematological parameters and liver function periodically, especially during long term therapy.
Discontinue treatment if patients develop neuroleptic malignant syndrome.
Consider discontinuing treatment if patients develop tardive dyskinesia. Fine vermicular movements of the tongue may be a sign of tardive dyskinesia.
Use with caution in patients with risk factors for stroke, as an approximately 3-fold increased risk of cerebrovascular adverse events has been seen in clinical trials with some atypical antipsychotics.
As with other neuroleptics, cases of QT interval prolongation may occur. Absence of the following risk factors should be verified before administration of benperidol:
family history of sudden death and/or QT prolongation
uncorrected electrolyte disturbances
history of QT interval prolongation, ventricular arrhythmias or Torsades de Pointes.
Consider an ECG with measurement of serum calcium, magnesium and potassium levels prior to treatment initiation, particularly in elderly patients and those with a history or family history of cardiac disease. Monitor serum electrolyte levels periodically during therapy, particularly during long-term treatment. An ECG may also be appropriate during dose escalation and when reaching the maximum therapeutic dose. Reduce dose if the QT interval is prolonged, and discontinue if it is greater than 500ms.
Rare cases of sudden unexplained death have been reported in patients receiving antipsychotic drugs, but benperidol has not yet been clearly implicated in any case.
The tablets contain lactose and therefore are not suitable for patients with rare hereditary problems of glucose-galactose malabsorption syndrome and lactose intolerance.
Possible risk factors for venous thromboembolism (VTE) should be identified before and during treatment with benperidol. In patients at risk of VTE preventive measures should be taken.
Use benperidol with caution in elderly patients with dementia, there may be a small increase in mortality.
May potentiate effect of alcohol.
Pregnancy and Lactation
At the time of writing, there is insufficient information on the use of benperidol in human pregnancy to establish its safety and the manufacturer does not advise administration. Animal studies have not demonstrated teratogenic effects, but data are insufficient to exclude an increased risk of malformations. Extrapyramidal symptoms and withdrawal symptoms such as sedation, feeding problems and restlessness have been reported in the neonate after chronic maternal use of high doses near term.
There is more data available for haloperidol than benperidol, and for this reason it is preferred. However, Schaefer concludes that use of benperidol is not an indication for termination. Detailed foetal ultrasonography, with special emphasis on the limbs, should be offered after maternal use in the first trimester. Regular psychiatric and obstetric care is recommended, in order to diagnose in time a relapse or pregnancy complications such as interuterine growth retardation or premature contractions.
If used up to delivery, the neonate should be observed for adaption problems for at least 2 days. Neonatal adaption disorders may be prevented by reducing or discontinuing the dose of benperidol in the days immediately preceding delivery. However, the pre-pregnancy dose should then be started immediately after delivery to prevent relapse at this vulnerable stage.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Butyrophenones, including benperidol, are excreted in breast milk and therefore their use during breastfeeding is not recommended. Whilst the amounts present in milk are probably too small to be harmful, animal studies indicate possible adverse effects on the developing nervous system. The manufacturer suggests that if the use of benperidol is considered essential, breastfeeding should be discontinued.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
May interfere with activities requiring mental alertness. Advise patients not to drive or operate machinery until their individual susceptibility is known.
Advise patients to avoid direct sunlight as photosensitisation may occur at higher doses.
Advise patient that benperidol may potentiate effect of alcohol.
Extrapyramidal effects (including tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia, oculogyric crisis and laryngeal dystonia)
Neuroleptic malignant syndrome (manifested as hyperthermia, generalised muscle rigidity, autonomic instability, altered consciousness, coma and elevated CPK levels)
Subjective feelings of mental slowness or dullness
Liver function disturbances
Interference with temperature regulation
Prolongation of QT interval
Torsades de pointes
Sudden unexplained death
Difficulty in micturition
Glaucoma (closed angle)
Purplish pigmentation of skin
Purplish pigmentation of cornea, conjunctiva, retina
Acid/base balance disturbance
Deep vein thrombosis (DVT)
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111)
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Shelf Life and Storage
Protect from light
Last Full Review Date: May 2011
British National Formulary, 61st Edition (2011) Pharmaceutical Press, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of Product Characteristics: Anquil tablets. Concord Pharmaceuticals Ltd. Revised February 2010
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