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Prochlorperazine maleate oromucosal


Buccal tablets containing prochlorperazine maleate

Drugs List

  • BUCCASTEM M 3mg buccal tablets
  • prochlorperazine 3mg buccal tablets
  • Therapeutic Indications


    Nausea and vomiting
    Nausea and/or vomiting in migraine



    3 to 6 mg (one or two buccal tablets) twice a day.


    3 to 6 mg (one or two buccal tablets) twice a day.


    Children 12 years and older

    3 to 6 mg (one or two buccal tablets) twice a day.


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

    Precautions and Warnings

    Children aged 12 to 18 years
    Family history of long QT syndrome
    Predisposition to venous thromboembolism
    Prolonged starvation
    Cardiac arrhythmias
    Cardiovascular disorder
    Cerebrovascular disorder
    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
    Myasthenia gravis
    Organic brain syndrome
    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


    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 ( ) or if this is unavailable at the backup site ( ).


    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


    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

    Autonomic instability
    Blood dyscrasias
    Blurred vision
    Cholestatic jaundice
    Contact sensitisation
    Corneal opacities
    Decrease in bone mineral density
    Deep vein thrombosis (DVT)
    Difficulty in micturition
    Dry mouth
    Extrapyramidal effects
    Gastro-intestinal disturbances
    Gum irritation
    Impaired concentration
    Increased prolactin
    Interference with temperature regulation
    Lens opacities
    Menstrual disturbances
    Mouth irritation
    Narrow angle glaucoma
    Neuroleptic malignant syndrome
    Postural hypotension
    Prolongation of QT interval
    Pulmonary embolism
    Purplish pigmentation of cornea, conjunctiva, retina
    Purplish pigmentation of skin
    Reflex tachycardia
    Respiratory depression
    Sexual dysfunction
    Skin reactions
    Tardive dyskinesia
    Venous thrombosis
    Weight gain
    Withdrawal symptoms


    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 ( ) or if this is unavailable at the backup site ( ).

    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 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:
    Accessed: February 18, 2014.

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

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