Pericyazine oral formulations
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing pericyazine
Drugs List
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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