Drugs List

Therapeutic Indications

Uses

Nausea and vomiting
Nausea and/or vomiting in migraine
Vertigo

Contraindications

Children under 12 years
Benign prostatic hyperplasia
Central nervous system depression
Coma
Epileptic disorder
Haematological disorder
Hepatic impairment
Hereditary fructose intolerance
Long QT syndrome
Narrow angle glaucoma
Parkinson's disease
Phaeochromocytoma
Torsade de pointes

Precautions and Warnings

Children aged 12 to 18 years
Elderly
Family history of long QT syndrome
Predisposition to venous thromboembolism
Prolonged starvation
Alcoholism
Bradycardia
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Cerebrovascular disorder
Dementia
Depression
Diabetes mellitus
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of agranulocytosis
History of jaundice
History of narrow angle glaucoma
History of seizures
History of torsade de pointes
Hypothyroidism
Hypovolaemia
Myasthenia gravis
Organic brain syndrome
Pregnancy
Renal impairment
Severe respiratory disease

Correct electrolyte disorders before treatment
May mask nausea and vomiting associated with organic disease
Advise patient ability to drive or operate machinery may be impaired
May reduce seizure threshold
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Preparation contains sucrose
Elderly more susceptible to sedation, hypotensive & temp regulatory effects
Examine eyes for defects in prolonged use
Monitor ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Perform blood counts if unexplained infection or fever develops
Consider discontinuation if signs of tardive dyskinesia occur
Increased risk for venous thromboembolism - take preventive measures
May cause postural hypotension especially in elderly
Avoid abrupt withdrawal
Discontinue at first signs of jaundice
Discontinue if fever occurs
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient that photosensitivity possible
Advise patient to avoid exposure to direct sunlight

It has been reported that patients with AIDS may be particularly susceptible to antipsychotic-induced extrapyramidal effects

There is an increased susceptibility to CNS side effects, postural hypotension, hypothermia, hyperthermia and drug-induced Parkinsonism in the elderly. Care should be taken not to confuse the adverse effects of prochlorperazine with the effects due to the underlying disorder.

Prolonged high doses may lead to the occurrence of tardive dyskinesia. Dosage should be kept low wherever possible.

Pregnancy and Lactation

Pregnancy

Prochlorperazine should be used with caution in pregnancy.

Prochlorperazine crosses the placenta. According to Briggs (2011), short courses of low dose prochlorperazine may be considered as safe for both mother and foetus despite isolated reports of congenital defects in children who had been exposed to prochlorperazine in utero. UK licensed product information however, recommends that prochlorperazine should be avoided during pregnancy. Product information further mentions possible adverse effects on the neonate exposed during the third trimester including extrapyramidal and withdrawal symptoms. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.

Consequently, when neuroleptics have been used up to delivery, observation of neonate for at least 2 days is recommended. In order to prevent neonatal adaptation disorders, prescribers are advised to reduce the dose or even interrupt treatment in the days immediately preceding delivery.

Neuroleptics may occasionally prolong labour. It is then recommended that treatment is withheld until the cervix is dilated 3 to 4 cm.

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

Prochlorperazine should be used with caution in breastfeeding.

It is suspected that prochlorperazine, in line with other phenothiazines, will appear in breast milk. It cannot be excluded that the nursing infant would be exposed to prochlorperazine. However based on minimal excretion of other phenothiazine derivatives, it appears that occasional short-term use of prochlorperazine for the treatment of nausea and vomiting poses little risk to the breastfed infant.

Use of prochlorperazine has been associated with galactorrhoea and hyperprolactinaemia.

NICE advises that Infants of mothers who are breastfeeding while taking psychotropic medication should be monitored for adverse reactions.

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

Agitation
Agranulocytosis
Akathisia
Apathy
Arrhythmias
Autonomic instability
Blood dyscrasias
Blurred vision
Cholestatic jaundice
Confusion
Constipation
Contact sensitisation
Convulsions
Corneal opacities
Decrease in bone mineral density
Deep vein thrombosis (DVT)
Diabetes
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dystonia
Excitement
Extrapyramidal effects
Galactorrhoea
Gastro-intestinal disturbances
Gum irritation
Gynaecomastia
Headache
Hyperglycaemia
Hyperprolactinaemia
Hyperthermia
Hypotension
Impaired concentration
Increased prolactin
Insomnia
Interference with temperature regulation
Jaundice
Lens opacities
Leucopenia
Menstrual disturbances
Mouth irritation
Narrow angle glaucoma
Neuroleptic malignant syndrome
Parkinsonism
Photosensitivity
Postural hypotension
Prolongation of QT interval
Pulmonary embolism
Purplish pigmentation of cornea, conjunctiva, retina
Purplish pigmentation of skin
Rash
Reflex tachycardia
Respiratory depression
Rigidity
Sexual dysfunction
Skin reactions
Syncope
Tachycardia
Tardive dyskinesia
Tremor
Venous thrombosis
Weight gain
Withdrawal symptoms

Presentation

Buccal tablets containing prochlorperazine maleate

Drugs List

Therapeutic Indications

Uses

Nausea and vomiting
Nausea and/or vomiting in migraine
Vertigo

Dosage

Adults

Elderly

Children

Contraindications

Children under 12 years
Benign prostatic hyperplasia
Central nervous system depression
Coma
Epileptic disorder
Haematological disorder
Hepatic impairment
Hereditary fructose intolerance
Long QT syndrome
Narrow angle glaucoma
Parkinson's disease
Phaeochromocytoma
Torsade de pointes

Precautions and Warnings

Children aged 12 to 18 years
Elderly
Family history of long QT syndrome
Predisposition to venous thromboembolism
Prolonged starvation
Alcoholism
Bradycardia
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Cerebrovascular disorder
Dementia
Depression
Diabetes mellitus
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of agranulocytosis
History of jaundice
History of narrow angle glaucoma
History of seizures
History of torsade de pointes
Hypothyroidism
Hypovolaemia
Myasthenia gravis
Organic brain syndrome
Pregnancy
Renal impairment
Severe respiratory disease

Correct electrolyte disorders before treatment
May mask nausea and vomiting associated with organic disease
Advise patient ability to drive or operate machinery may be impaired
May reduce seizure threshold
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Preparation contains sucrose
Elderly more susceptible to sedation, hypotensive & temp regulatory effects
Examine eyes for defects in prolonged use
Monitor ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Perform blood counts if unexplained infection or fever develops
Consider discontinuation if signs of tardive dyskinesia occur
Increased risk for venous thromboembolism - take preventive measures
May cause postural hypotension especially in elderly
Avoid abrupt withdrawal
Discontinue at first signs of jaundice
Discontinue if fever occurs
Discontinue if patient develops neuroleptic malignant syndrome
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient that photosensitivity possible
Advise patient to avoid exposure to direct sunlight

It has been reported that patients with AIDS may be particularly susceptible to antipsychotic-induced extrapyramidal effects

There is an increased susceptibility to CNS side effects, postural hypotension, hypothermia, hyperthermia and drug-induced Parkinsonism in the elderly. Care should be taken not to confuse the adverse effects of prochlorperazine with the effects due to the underlying disorder.

Prolonged high doses may lead to the occurrence of tardive dyskinesia. Dosage should be kept low wherever possible.

Pregnancy and Lactation

Pregnancy

Prochlorperazine should be used with caution in pregnancy.

Prochlorperazine crosses the placenta. According to Briggs (2011), short courses of low dose prochlorperazine may be considered as safe for both mother and foetus despite isolated reports of congenital defects in children who had been exposed to prochlorperazine in utero. UK licensed product information however, recommends that prochlorperazine should be avoided during pregnancy. Product information further mentions possible adverse effects on the neonate exposed during the third trimester including extrapyramidal and withdrawal symptoms. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.

Consequently, when neuroleptics have been used up to delivery, observation of neonate for at least 2 days is recommended. In order to prevent neonatal adaptation disorders, prescribers are advised to reduce the dose or even interrupt treatment in the days immediately preceding delivery.

Neuroleptics may occasionally prolong labour. It is then recommended that treatment is withheld until the cervix is dilated 3 to 4 cm.

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

Prochlorperazine should be used with caution in breastfeeding.

It is suspected that prochlorperazine, in line with other phenothiazines, will appear in breast milk. It cannot be excluded that the nursing infant would be exposed to prochlorperazine. However based on minimal excretion of other phenothiazine derivatives, it appears that occasional short-term use of prochlorperazine for the treatment of nausea and vomiting poses little risk to the breastfed infant.

Use of prochlorperazine has been associated with galactorrhoea and hyperprolactinaemia.

NICE advises that Infants of mothers who are breastfeeding while taking psychotropic medication should be monitored for adverse reactions.

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

Counselling

Advise patients that the buccal tablets should be placed in the buccal cavity, high up along the top gum under the upper lip, until dissolved.

Increased risk of photosensitization. Advise patients to avoid direct exposure to sunlight.

Warn patients that if affected by drowsiness, they should not drive or operate machinery.

The effects of alcohol are enhanced, advise patients to avoid alcohol during treatment.

Side Effects

Agitation
Agranulocytosis
Akathisia
Apathy
Arrhythmias
Autonomic instability
Blood dyscrasias
Blurred vision
Cholestatic jaundice
Confusion
Constipation
Contact sensitisation
Convulsions
Corneal opacities
Decrease in bone mineral density
Deep vein thrombosis (DVT)
Diabetes
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dystonia
Excitement
Extrapyramidal effects
Galactorrhoea
Gastro-intestinal disturbances
Gum irritation
Gynaecomastia
Headache
Hyperglycaemia
Hyperprolactinaemia
Hyperthermia
Hypotension
Impaired concentration
Increased prolactin
Insomnia
Interference with temperature regulation
Jaundice
Lens opacities
Leucopenia
Menstrual disturbances
Mouth irritation
Narrow angle glaucoma
Neuroleptic malignant syndrome
Parkinsonism
Photosensitivity
Postural hypotension
Prolongation of QT interval
Pulmonary embolism
Purplish pigmentation of cornea, conjunctiva, retina
Purplish pigmentation of skin
Rash
Reflex tachycardia
Respiratory depression
Rigidity
Sexual dysfunction
Skin reactions
Syncope
Tachycardia
Tardive dyskinesia
Tremor
Venous thrombosis
Weight gain
Withdrawal symptoms

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: February 2014

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. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on April 06 2016.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Buccastem M. Alliance Pharmaceuticals. Revised February 2016

Summary of Product Characteristics:Prochlorperazine 3 mg Buccal Tablets. Alliance Pharmaceuticals. Revised December 2011.

NICE clinical guideline 45 - Antenatal and postnatal mental health, April 2007
Available at: https://www.nice.org.uk/nicemedia/pdf/CG045NICEGuidelineCorrected.pdf
Accessed: February 18, 2014.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov
Prochlorperazine Last revised: September 7, 2013
Last accessed: February 18, 2014