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Pericyazine oral formulations

Updated 2 Feb 2023 | Antipsychotics

Presentation

Oral formulations containing pericyazine

Drugs List

  • pericyazine 10mg tablets
  • pericyazine 10mg/5ml oral solution
  • pericyazine 2.5mg tablets
  • Therapeutic Indications

    Uses

    Schizophrenia
    Short term adjunctive management of anxiety
    Short term adjunctive management of violent/dangerously impulsive behaviour
    Short term moderate-severe psychomotor agitation (adjunctive management)

    Dosage

    Dosage requirement depends on individual variations and the severity of the condition. Initial dosage should be low with progressive increases until desired response is obtained, after which dose should be adjusted to maintain control of symptoms.

    Adults

    Schizophrenia and other psychoses
    Initial dose: 75mg daily in divided doses. Increase at weekly intervals by 25mg daily until optimum response is achieved.
    Maximum dose: 300mg daily.

    Anxiety, psychomotor agitation, violent or dangerously impulsive behaviour
    Initial dose: 15mg to 30mg daily in two divided doses. Larger dose to be administered in the evening

    Elderly

    Caution, the elderly are at risk of hyper-hypothermia during very hot or very cold weather and are particularly susceptible to hypotension.

    Schizophrenia and other psychoses
    Initial dose: 15mg to 30mg daily in divided doses. Increase if necessary for optimal effect.

    Anxiety, psychomotor agitation, violent or dangerously impulsive behaviour
    Initial dose: 5mg to 10mg daily, divided if necessary with the larger dose being administered in the evening.
    Half or one quarter of the normal adult dose may be sufficient for maintenance.

    Children

    Only the oral solution formulation is licensed for children under 12 years of age.

    Schizophrenia and other psychoses
    Children aged 12 to 18 years
    (See Dosage; Adult).
    Children 1 year to 18 years
    Initial dose: 500micrograms daily for a child of 10 kg. For heavier children, the initial dose is increased by 1mg for each additional 5kg
    Maximum dose: 10mg daily.
    Dose may be gradually increased according to response but maintenance should not exceed twice the initial dose.

    Contraindications

    Children under 1 year
    Breastfeeding
    Central nervous system depression
    Coma
    Phaeochromocytoma

    Precautions and Warnings

    Elderly
    Family history of long QT syndrome
    Family history of narrow angle glaucoma
    Prolonged starvation
    Risk of cerebrovascular accident
    Bradycardia
    Cardiac arrhythmias
    Cardiac failure
    Diabetes mellitus
    Epileptic disorder
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    Haematological disorder
    Hepatic impairment
    Hereditary fructose intolerance
    History of agranulocytosis
    History of alcohol abuse
    History of jaundice
    History of narrow angle glaucoma
    History of seizures
    History of torsade de pointes
    History of venous thromboembolism
    Hyperglycaemia
    Hypocalcaemia
    Hypokalaemia
    Hypomagnesaemia
    Hypothyroidism
    Lactose intolerance
    Long QT syndrome
    Myasthenia gravis
    Parkinson's disease
    Pregnancy
    Prostate disorder
    Renal impairment
    Severe respiratory disease

    Advise ability to drive/operate machinery may be affected by side effects
    Combine with antidepressant therapy if depression & psychosis coexist
    May reduce seizure threshold
    Not all formulations are suitable for use in children under 18 years
    Not to be used as sole treatment where depression is predominant
    Some formulations contain lactose
    Some formulations contain sucrose
    Avoid contact of product with skin
    Monitor blood counts regularly
    Monitor ECG in patients at risk of QT prolongation
    Monitor for signs and symptoms of glucose intolerance
    Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
    Monitor patients at risk for signs & symptoms of venous thromboembolism
    Monitor patients with existing or tendency towards diabetes mellitus
    Perform blood counts if unexplained infection or fever develops
    Increased risk for venous thromboembolism - take preventive measures
    May cause postural hypotension especially in elderly
    Potential for withdrawal symptoms
    Avoid abrupt withdrawal
    Discontinue at first signs of jaundice
    Discontinue if fever occurs
    Discontinue if patient develops neuroleptic malignant syndrome
    Reduce dose in elderly
    Advise patient that photosensitivity possible
    Advise patient to avoid exposure to direct sunlight

    Pregnancy and Lactation

    Pregnancy

    Use pericyazine with caution in pregnancy.

    The safety of pericyazine in human pregnancy has not been established. There is no data available on the use of pericyazine in human pregnancy or in animal reproductive studies. Possible adverse effects on the new born include lethargy or paradoxical hyperexcitability, tremor and low Apgar score.

    Pericyazine may cause labour to be prolonged so it is recommended to withhold therapy during labour until the cervix is 3 to 4 cm dilated.

    Although occasional published reports have attempted to link various phenothiazine compounds with congenital defects, the bulk of the evidence suggests that the therapeutic use of these drugs are safe for the mother and foetus. However, animal studies of other phenothiazines have shown some evidence of harmful effects.

    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 to 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 ).

    Lactation

    Pericyazine is contraindicated in breastfeeding.

    The safety of pericyazine in breast feeding has not been established. The manufacturer advises breastfeeding is suspended during treatment.

    Phenothiazines are excreted into human milk in small amounts. The effects on the nursing infant are unknown but may be of concern because of the potential for toxicity and galactorrhoea.

    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

    Side Effects

    Acute dystonias
    Agitation
    Agranulocytosis
    Akathisia
    Amenorrhoea
    Antimuscarinic effects
    Apathy
    Atrial arrhythmia
    Atrioventricular block
    Blurred vision
    Confusion
    Constipation
    Contact sensitisation
    Convulsions
    Corneal opacities
    Decreased glucose tolerance
    Deep vein thrombosis (DVT)
    Difficulty in micturition
    Dizziness
    Drowsiness
    Dry mouth
    Dyskinesia
    Eosinophilia
    Excitement
    Extrapyramidal effects
    Galactorrhoea
    Gastro-intestinal symptoms
    Gynaecomastia
    Headache
    Hyperglycaemia
    Hyperprolactinaemia
    Hypotension
    Impotence
    Insomnia
    Interference with temperature regulation
    Jaundice
    Lens opacities
    Leukopenia
    Liver damage
    Narrow angle glaucoma
    Nasal stuffiness
    Neuroleptic malignant syndrome
    Parkinsonism
    Photosensitivity
    Priapism
    Prolongation of QT interval
    Pulmonary embolism
    Purplish pigmentation of cornea, conjunctiva, retina
    Purplish pigmentation of skin
    Rash
    Respiratory depression
    ST depression
    Sudden unexplained death
    T-wave changes
    Tardive dyskinesia
    U-wave changes
    Venous thrombosis
    Ventricular arrhythmias
    Ventricular fibrillation
    Ventricular tachycardia
    Weight gain

    Overdosage

    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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: January 2015

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summary of Product Characteristics. Pericyazine 2.5 mg tablets. Winthrop Pharmaceuticals UK Limited. Revised January 2012.

    Summary of Product Characteristics. Pericyazine 10 mg tablets. Winthrop Pharmaceuticals UK Limited. Revised January 2012.

    Summary of Product Characteristics. Pericyazine 10 mg/5ml syrup. Winthrop Pharmaceuticals UK Limited. Revised January 2012.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 September 2017

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