Drugs List

Therapeutic Indications

Uses

Anxiety state - severe (adjunctive treatment)
Dangerous impulsive behaviour
Hiccough - intractable
Hypomania
Mania
Nausea,vomiting in terminal care when other drugs ineffective/unavailable
Paranoid psychosis
Schizophrenia
Schizophrenia and autism in childhood
Short term moderate-severe psychomotor agitation (adjunctive management)

Administration

Handling

Care must be taken to avoid contact of the drug with the skin due to the risk of contact sensitisation.

Contraindications

Children under 1 year
Breastfeeding
Coma
Phaeochromocytoma
Severe cardiac disorder
Severe central nervous system depression

Precautions and Warnings

Children under 12 years
Elderly
Risk of cerebrovascular accident
Tobacco smoking
Benign prostatic hyperplasia
Cardiac arrhythmias
Cardiac failure
Cardiovascular disorder
Dehydration
Dementia
Depression
Diabetes mellitus
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of haematological disorder
History of jaundice
History of narrow angle glaucoma
History of seizures
History of venous thromboembolism
Hypokalaemia
Hypomagnesaemia
Hypothyroidism
Lactose intolerance
Long QT syndrome
Myasthenia gravis
Parkinson's disease
Pregnancy
Renal impairment
Severe respiratory disease

Suppressed vomiting may mask diagnosis of GI obstruction
Advise patient drowsiness may affect ability to drive or operate machinery
Treatment to be initiated and supervised by a specialist
May contain polysorbate
May contain sodium benzoate: mild mucous membrane irritant
Oral solution contains alcohol
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some brands contain Sunset Yellow (E110) - can trigger allergic reactions
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Some formulations contain sucrose
Avoid contact of product with skin
Evaluate treatment efficacy regularly
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor full blood count regularly
Monitor liver function in patients with hepatic impairment
Monitor patients at risk for signs & symptoms of venous thromboembolism
Consider discontinuation if signs of tardive dyskinesia occur
Increased risk for venous thromboembolism - take preventive measures
May cause extrapyramidal effects in children and young adults
May cause or exacerbate extrapyramidal symptoms
May cause postural hypotension especially in elderly
Potential for withdrawal symptoms
Avoid abrupt withdrawal
Discontinue at first signs of jaundice
Discontinue if patient develops neuroleptic malignant syndrome
Dose adjustment required if patient starts/stops smoking during therapy
Maintain treatment at the lowest effective dose
Not licensed for all indications in all age groups
Reduce dose in elderly
Avoid direct exposure to sunlight

Use with caution in patients with risk factors for stroke - an approximately 3 fold increased risk of cerebrovascular adverse events have been seen with some atypical antipsychotics when used in dementia patients. Chlorpromazine is not licensed for the treatment of dementia-related behavioural disturbances.

Neuroleptic malignant syndrome (pallor, autonomic dysfunction, altered consciousness, muscle rigidity, hyperthermia or unexplained fever) may occur with all neuroleptics and requires immediate discontinuation of chlorpromazine. Signs of autonomic dysfunction, such as sweating and arterial instability, may precede the onset of hyperthermia and serve as early warning signs. Although neuroleptic malignant syndrome may be idiosyncratic in origin, dehydration and organic brains disease are predisposing factors.

Chlorpromazine inhibits the heat-regulating centre so that the subject tends to acquire the ambient temperature. Caution is required when extremes of temperature, as may lead to hypo or hyperthermia.

Signs of gastrointestinal obstruction may be masked by the anti-emetic action of chlorpromazine.

Pregnancy and Lactation

Pregnancy

Use chlorpromazine with caution in pregnancy.

Chlorpromazine readily crosses the placenta.

There is inadequate evidence of safety in human pregnancy though it has been used extensively for many years without any apparent ill effect. How ever there are conflicting reports of safety from various studies. A number of studies use significantly lower doses than those used for psychosis. Some sources state that chlorpromazine is a preferred agent for use in pregnancy.

Chlorpromazine may prolong labour and at such time should be withheld until the cervix is dilated 3 to 4 cm. Possible adverse effects on the foetus include lethargy or paradoxical hyperexcitability, tremor and low Apgar score (Briggs 2015).

Schaefer advises regular psychiatric and obstetric care to monitor for relapse or pregnancy complications. Observation of the neonate for adaptation problems, extrapyramidal or withdrawal symptoms for at least two days is recommended when antipsychotics have been used up to delivery. To prevent neonatal adaptive problems, dose reduction or treatment interruption in the days immediately preceding delivery may be considered. However, pre-pregnancy dosage should be started immediately after delivery, to prevent relapse at this vulnerable stage.

Reproductive studies in rodents have shown a potential for embryotoxicity and increased neonatal mortality.

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

Chlorpromazine is contraindicated in breastfeeding

Chlorpromazine is excreted in breast milk. Very limited long-term follow-up data indicate no adverse developmental effects when the drug is used alone. If used nursing infants should be monitored for excessive drowsiness and for developmental milestones, especially if other antipsychotics are used concurrently.

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
Akinesia
Alteration of autonomic nervous system
Altered consciousness
Amenorrhoea
Anaphylactic reaction
Angioedema
Antimuscarinic effects
Apathy
Atrial arrhythmia
Atrioventricular block
Blurred vision
Bronchospasm
Cardiac arrest
Cardiac arrhythmias
Confusion
Constipation
Contact sensitisation
Convulsions
Corneal opacities
Depression
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dystonia
ECG changes
Eosinophilia
Excitement
Faecal impaction
Galactorrhoea
Gastrointestinal disorder
Glaucoma (closed angle)
Gynaecomastia
Headache
Hepatic damage
Hypercholesterolaemia
Hyperglycaemia
Hyperprolactinaemia
Hyperthermia
Hypotension
Hypothermia
Impotence
Insomnia
Interference with temperature regulation
Jaundice
Lens opacities
Leucopenia
Menstrual disturbances
Nasal stuffiness
Neuroleptic malignant syndrome
Nightmares
Oculogyric crisis
Oedema
Oligomenorrhoea
Pallor
Paralytic ileus
Parkinsonism
Photosensitivity
Postural hypotension
Priapism
Prolongation of QT interval
Pulmonary embolism
Purplish pigmentation of cornea, conjunctiva, retina
Rash
Respiratory depression
Rigidity
Sedation
Sexual dysfunction
Slate-grey skin discolouration
ST depression
Sudden unexplained death
Systemic lupus erythematosus
T-wave changes
Tardive dyskinesia
Torsades de pointes
Toxic megacolon
Tremor
U-wave changes
Urticaria
Venous thrombosis
Ventricular fibrillation
Ventricular tachycardia
Weight gain

Presentation

Oral formulations containing chlorpromazine hydrochloride.

Drugs List

Therapeutic Indications

Uses

Anxiety state - severe (adjunctive treatment)
Dangerous impulsive behaviour
Hiccough - intractable
Hypomania
Mania
Nausea,vomiting in terminal care when other drugs ineffective/unavailable
Paranoid psychosis
Schizophrenia
Schizophrenia and autism in childhood
Short term moderate-severe psychomotor agitation (adjunctive management)

Dosage

Initial dose should be low, increased under close supervision until optimum dosage is reached. Individual response and dosage requirements may vary greatly.

Chlorpromazine is not licensed for use in all groups in all indications.

Adults

Elderly

Children

Patients with Renal Impairment

Administration

Handling

Care must be taken to avoid contact of the drug with the skin due to the risk of contact sensitisation.

Contraindications

Children under 1 year
Breastfeeding
Coma
Phaeochromocytoma
Severe cardiac disorder
Severe central nervous system depression

Precautions and Warnings

Children under 12 years
Elderly
Risk of cerebrovascular accident
Tobacco smoking
Benign prostatic hyperplasia
Cardiac arrhythmias
Cardiac failure
Cardiovascular disorder
Dehydration
Dementia
Depression
Diabetes mellitus
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of haematological disorder
History of jaundice
History of narrow angle glaucoma
History of seizures
History of venous thromboembolism
Hypokalaemia
Hypomagnesaemia
Hypothyroidism
Lactose intolerance
Long QT syndrome
Myasthenia gravis
Parkinson's disease
Pregnancy
Renal impairment
Severe respiratory disease

Suppressed vomiting may mask diagnosis of GI obstruction
Advise patient drowsiness may affect ability to drive or operate machinery
Treatment to be initiated and supervised by a specialist
May contain polysorbate
May contain sodium benzoate: mild mucous membrane irritant
Oral solution contains alcohol
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some brands contain Sunset Yellow (E110) - can trigger allergic reactions
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Some formulations contain sucrose
Avoid contact of product with skin
Evaluate treatment efficacy regularly
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor full blood count regularly
Monitor liver function in patients with hepatic impairment
Monitor patients at risk for signs & symptoms of venous thromboembolism
Consider discontinuation if signs of tardive dyskinesia occur
Increased risk for venous thromboembolism - take preventive measures
May cause extrapyramidal effects in children and young adults
May cause or exacerbate extrapyramidal symptoms
May cause postural hypotension especially in elderly
Potential for withdrawal symptoms
Avoid abrupt withdrawal
Discontinue at first signs of jaundice
Discontinue if patient develops neuroleptic malignant syndrome
Dose adjustment required if patient starts/stops smoking during therapy
Maintain treatment at the lowest effective dose
Not licensed for all indications in all age groups
Reduce dose in elderly
Avoid direct exposure to sunlight

Use with caution in patients with risk factors for stroke - an approximately 3 fold increased risk of cerebrovascular adverse events have been seen with some atypical antipsychotics when used in dementia patients. Chlorpromazine is not licensed for the treatment of dementia-related behavioural disturbances.

Neuroleptic malignant syndrome (pallor, autonomic dysfunction, altered consciousness, muscle rigidity, hyperthermia or unexplained fever) may occur with all neuroleptics and requires immediate discontinuation of chlorpromazine. Signs of autonomic dysfunction, such as sweating and arterial instability, may precede the onset of hyperthermia and serve as early warning signs. Although neuroleptic malignant syndrome may be idiosyncratic in origin, dehydration and organic brains disease are predisposing factors.

Chlorpromazine inhibits the heat-regulating centre so that the subject tends to acquire the ambient temperature. Caution is required when extremes of temperature, as may lead to hypo or hyperthermia.

Signs of gastrointestinal obstruction may be masked by the anti-emetic action of chlorpromazine.

Pregnancy and Lactation

Pregnancy

Use chlorpromazine with caution in pregnancy.

Chlorpromazine readily crosses the placenta.

There is inadequate evidence of safety in human pregnancy though it has been used extensively for many years without any apparent ill effect. How ever there are conflicting reports of safety from various studies. A number of studies use significantly lower doses than those used for psychosis. Some sources state that chlorpromazine is a preferred agent for use in pregnancy.

Chlorpromazine may prolong labour and at such time should be withheld until the cervix is dilated 3 to 4 cm. Possible adverse effects on the foetus include lethargy or paradoxical hyperexcitability, tremor and low Apgar score (Briggs 2015).

Schaefer advises regular psychiatric and obstetric care to monitor for relapse or pregnancy complications. Observation of the neonate for adaptation problems, extrapyramidal or withdrawal symptoms for at least two days is recommended when antipsychotics have been used up to delivery. To prevent neonatal adaptive problems, dose reduction or treatment interruption in the days immediately preceding delivery may be considered. However, pre-pregnancy dosage should be started immediately after delivery, to prevent relapse at this vulnerable stage.

Reproductive studies in rodents have shown a potential for embryotoxicity and increased neonatal mortality.

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

Chlorpromazine is contraindicated in breastfeeding

Chlorpromazine is excreted in breast milk. Very limited long-term follow-up data indicate no adverse developmental effects when the drug is used alone. If used nursing infants should be monitored for excessive drowsiness and for developmental milestones, especially if other antipsychotics are used concurrently.

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
Akinesia
Alteration of autonomic nervous system
Altered consciousness
Amenorrhoea
Anaphylactic reaction
Angioedema
Antimuscarinic effects
Apathy
Atrial arrhythmia
Atrioventricular block
Blurred vision
Bronchospasm
Cardiac arrest
Cardiac arrhythmias
Confusion
Constipation
Contact sensitisation
Convulsions
Corneal opacities
Depression
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dystonia
ECG changes
Eosinophilia
Excitement
Faecal impaction
Galactorrhoea
Gastrointestinal disorder
Glaucoma (closed angle)
Gynaecomastia
Headache
Hepatic damage
Hypercholesterolaemia
Hyperglycaemia
Hyperprolactinaemia
Hyperthermia
Hypotension
Hypothermia
Impotence
Insomnia
Interference with temperature regulation
Jaundice
Lens opacities
Leucopenia
Menstrual disturbances
Nasal stuffiness
Neuroleptic malignant syndrome
Nightmares
Oculogyric crisis
Oedema
Oligomenorrhoea
Pallor
Paralytic ileus
Parkinsonism
Photosensitivity
Postural hypotension
Priapism
Prolongation of QT interval
Pulmonary embolism
Purplish pigmentation of cornea, conjunctiva, retina
Rash
Respiratory depression
Rigidity
Sedation
Sexual dysfunction
Slate-grey skin discolouration
ST depression
Sudden unexplained death
Systemic lupus erythematosus
T-wave changes
Tardive dyskinesia
Torsades de pointes
Toxic megacolon
Tremor
U-wave changes
Urticaria
Venous thrombosis
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: October 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

Summary of Product Characteristics: Chlorpromazine hydrochloride 25mg/5ml oral solution. Pinewood Healthcare. Revised April 2015.
Summary of Product Characteristics: Chlorpromazine hydrochloride 25mg tablets. Dr Reddy's Laboratories. Revised December 2016.
Summary of Product Characteristics: Chlorpromazine hydrochloride 50mg tablets. Dr Reddy's Laboratories. Revised December 2016.
Summary of Product Characteristics: Chlorpromazine hydrochloride 100mg tablets. Dr Reddy's Laboratories. Revised December 2016.
Summary of Product Characteristics: Chlorpromazine hydrochloride 25mg/5ml oral syrup. Rosemont Pharmaceuticals Limited. Revised July 2013.
Summary of Product Characteristics: Chlorpromazine hydrochloride 100mg/5ml oral syrup. Rosemont Pharmaceuticals Limited. Revised July 2013.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 June 2017

Specialist Pharmacy Service (SPS)
Available at: https://www.sps.nhs.uk/
What are the clinically significant drug interactions with tobacco smoking? Last revised: July 2020
Last accessed: 07 December 2020

UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: 17 October 2016

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Chlorpromazine Last revised: 16 January 2014
Last accessed: 17 October 2016