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Dosage

Adults
Elderly
Children
Patients with Renal Impairment

Prevention of nausea and vomiting

5mg to 10mg two to three times daily

Treatment of nausea and vomiting

20mg initially followed by 10mg after 2 hours

Vertigo and Meniere's Syndrome

5mg three times daily. Increase gradually to a maximum of 30mg daily as necessary. After several weeks of therapy, dosage may gradually be reduced to 5mg to 10mg daily.

Schizophrenia and other psychoses

Usual dose: 75mg to 100mg daily, but patients vary widely in response.
Initial dose: 12.5mg twice daily for seven days.
Maintenance dose: Increase dose by 12.5mg increments at four to seven day intervals until a satisfactory response is obtained. After some weeks at the effective dosage level, an attempt should be made to reduce the dosage. Total daily dosages as low as 25mg to 50mg have been found to be effective.

Adjunct in the short term management of anxiety

Maintenance dose: 15mg to 20mg daily in divided doses.
Maximum dose: 40mg daily in divided doses.

Precautions and Warnings

Use with caution in:

Children 1 to 18 years
Hepatic impairment
Renal impairment
Parkinson's disease (may be exacerbated)
Pregnancy
Breastfeeding
Hypothyroidism
Cardiac failure
Myasthenia gravis
History of narrow angle glaucoma
Cardiovascular disorder
Depression - use concurrently with an antidepressant where depression is predominant
Benign prostatic hypertrophy
Haematological disorder
Severe respiratory disease
Predisposing factors for ventricular arrhythmias
Epileptic disorder or a history of seizures - (prochlorperazine may lower the seizure threshold, close monitoring is required.)
Diabetes mellitus
Hypoglycaemia

May impair alertness. Warn about driving/operating machinery

Prochlorperazine may potentiate QT prolongation which is exacerbated by the presence of bradycardia or hypokalaemia. Use with caution, monitoring biochemical status and ECG of patients with congenital or acquired predisposing factors for prolonged QT interval e.g. cardiac disease, alcohol abuse, starvation and other metabolic abnormalities such as hypokalaemia, hypocalcaemia or hypomagnesaemia, particularly during the initial phase of treatment.

Discontinue if jaundice occurs and use with caution in patients with a history of jaundice. A premonitory sign of an allergic hepato-biliary disorder manifesting as jaundice may be the sudden onset of fever after one to three weeks of treatment.

Discontinue if patient develops an unexplained fever as this may be a sign of neuroleptic malignant syndrome (pallor, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity). Signs of autonomic dysfunction such as sweating and arterial instability may precede the onset of hyperthermia and serve as early warning signs. Use with caution in organic brain disease and volume depleted patients - increased risk of neuroleptic malignant syndrome

Monitor full blood counts regularly. Agranulocytosis has been reported, occurrence of unexplained infections or fever may be evidence of blood dyscrasia and requires immediate haematological investigation. Caution should be used in patients with a history of agranulocytosis.

There is an increased susceptibility to CNS side effects, postural hypotension, hypothermia, hyperthermia and drug-induced parkinsonism in the elderly particularly after prolonged use. Use with caution in the elderly and patients with Parkinson's disease. Care should be taken not to confuse the adverse effects of prochlorperazine e.g. orthostatic hypotension, with the effects due to the underlying disorder.

Use with caution in patients with risk factors for stroke. An increased risk of cerebrovascular events was identified in clinical trials when elderly patients with dementia were treated with certain antipsychotics. Increased risk with other antipsychotics or other patient populations cannot be excluded.

Avoid abrupt termination of treatment as patients may develop such withdrawal symptoms as nausea, vomiting, insomnia and extrapyramidal reactions.

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

In schizophrenia response to prochlorperazine may be delayed. If treatment is withdrawn the recurrence of symptoms may not become apparent for some time.

Nausea and vomiting as signs of organic disease may be masked by the anti-emetic action of prochlorperazine.

Risk of photosensitisation - avoid contact of product with skin and advise patients to avoid exposure to sunlight.

Regular eye examinations advisable on prolonged use - ocular changes have occurred in some patients receiving phenothiazines for long periods.

May cause drowsiness and hypotension. Affected patients should not drive or operate machinery.

Potentiates the effects of alcohol. Advise patients to avoid alcohol while on prochlorperazine therapy.

Hyperglycaemia or intolerance to glucose had been reported in patients treated with antipsychotic phenothiazines. Patients with an established diagnosis of diabetes mellitus or with risk factors for the development of diabetes, should get appropriate glycaemic monitoring during treatment.

Tablets contain lactose and are not suitable for those with galactosaemia, use with caution in patients with glucose-galactose malabsorption syndrome or lactose intolerance.

Oral solution contains sucrose, use with caution in diabetes mellitus.

Pregnancy and Lactation

Pregnancy

Prochlorperazine should be used with caution in pregnancy.

Prochlorperazine crosses the placenta. According to Briggs and co-workers, 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. These include lethargy or paradoxical hyperexcitability, tremor and low apgar scores.

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

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.

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 is contraindicated 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. UK licensed product information advises to stop breastfeeding during treatment.

Use of prochlorperazine has been associated with galactorrhoea and hyperprolactinaemia.

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

Presentation

Oral formulations of prochlorperazine

Drugs List

prochlorperazine 5mg tablets

prochlorperazine 5mg/5ml oral solution

STEMETIL 5mg tablets

Therapeutic Indications

Uses

Treatment and prevention of nausea and vomiting
Symptomatic treatment of vertigo due to Meniere's disease, labyrinthitis and other causes
Anxiety - as adjunct in short term management
Acute mania
Schizophrenia (particularly in chronic stage) and other psychoses

Dosage

Adults

Prevention of nausea and vomiting
5mg to 10mg two to three times daily

Treatment of nausea and vomiting
20mg initially followed by 10mg after 2 hours

Vertigo and Meniere's Syndrome
5mg three times daily. Increase gradually to a maximum of 30mg daily as necessary. After several weeks of therapy, dosage may gradually be reduced to 5mg to 10mg daily.

Schizophrenia and other psychoses
Usual dose: 75mg to 100mg daily, but patients vary widely in response.
Initial dose: 12.5mg twice daily for seven days.
Maintenance dose: Increase dose by 12.5mg increments at four to seven day intervals until a satisfactory response is obtained. After some weeks at the effective dosage level, an attempt should be made to reduce the dosage. Total daily dosages as low as 25mg to 50mg have been found to be effective.

Adjunct in the short term management of anxiety
Maintenance dose: 15mg to 20mg daily in divided doses.
Maximum dose: 40mg daily in divided doses.

Elderly

(See Dosage; Adult) Use with caution, rate of metabolism and excretion of prochlorperazine decreases with age. Dosage reduction recommended based on adult dose.

Children

Children are prone to extrapyramidal symptoms, dystonic reactions in particular have been reported

Prevention and treatment of nausea and vomiting
Children aged 12 to 18 years
5mg to 10mg, up to three times a day, if necessary.
Children over 1 year and weighing over 10 kg
250micrograms/kg may be given two or three times a day.

Patients with Renal Impairment

Prochlorperazine should be avoided in patients with renal dysfunction.

The Renal Drug Handbook recommends that patients with a glomerular filtration rate below 10ml/minute be given small starting doses such as 5mg orally.

Contraindications

Children under 1 year
Children weighing less than 10 kg
Coma
Central nervous system depression
Prolactin-dependent neoplasm
Phaeochromocytoma

Tablets
Galactosaemia

Syrup
Hereditary fructose intolerance