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Levomepromazine

Updated 2 Feb 2023 | Antipsychotics

Presentation

Solution for injection containing 25mg per ml levomepromazine hydrochloride

Drugs List

  • levomepromazine 25mg/1ml injection
  • NOZINAN 25mg/1ml injection
  • Therapeutic Indications

    Uses

    Pain and accompanying restlessness or distress in the terminally ill patient.

    Unlicensed Uses

    Nausea and vomiting in palliative care.

    Dosage

    Adults

    Pain and accompanying restlessness or distress in the terminally ill patient
    Intramuscular and intravenous injection
    12.5mg to 25mg by intramuscular injection or intravenous injection, increased up to 50mg in cases of severe agitation. Repeated every 6 to 8 hours.

    Continuous subcutaneous infusion
    25mg to 200mg over 24 hours by continuous subcutaneous infusion.

    The following alternative dose schedules may be suitable:
    Restlessness and confusion in palliative care
    6.25mg by subcutaneous injection every 2 hours as required.
    Alternatively, 12.5mg to 50mg over 24 hours by subcutaneous infusion. Doses above 100mg per 24 hours should be given under specialist supervision.

    Nausea and vomiting in palliative care (unlicensed)
    6.25mg by subcutaneous injection at bedtime, increased if necessary to 12.5mg to 25mg by subcutaneous injection twice a day.
    Alternatively, 5mg to 25mg over 24 hours by continuous subcutaneous infusion. Sedation can limit the dose.

    Children

    Pain and accompanying restlessness or distress in the terminally ill patient
    0.35mg/kg/day to 3.0mg/kg/day.

    The following alternative dose schedules may be suitable:
    Restlessness and confusion in palliative care
    Children aged 12 to 18 years
    12.5mg to 200mg over 24 hours by continuous subcutaneous infusion.

    Children aged 1 to 12 years
    0.35mg/kg to 3mg/kg over 24 hours by continuous subcutaneous infusion.

    Nausea and vomiting in palliative care (unlicensed)
    Children aged 12 to 18 years
    5mg to 25mg over 24 hours by subcutaneous infusion or by continuous intravenous infusion.

    Children aged 1 month to 12 years
    100micrograms/kg to 400micrograms/kg over 24 hours by subcutaneous infusion or by continuous intravenous infusion.

    Patients with Renal Impairment

    Alternative sources recommend starting with small doses in severe renal impairment due to increased cerebral sensitivity.

    Administration

    For intramuscular injection, intravenous injection and continuous subcutaneous infusion.
    Alternative sources also recommend dose schedules via subcutaneous injection and continuous intravenous infusion for some indications/patient groups (see Dosage; Adult and Dosage; Children).

    Contraindications

    Pregnancy (see Pregnancy section)

    There are no absolute contraindications to the use of levomepromazine in terminal care.

    Precautions and Warnings

    Levomepromazine should be avoided, or used with caution in hepatic impairment.

    Cardiac disease and arrhythmias (levomepromazine may cause QT prolongation). Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Use with caution in patients with hypocalcaemia, hypokalaemia or hypomagnesaemia, a history of cardiovascular disorders, history of, family history of or predisposition to QT prolongation, bradycardia, second or third degree atrioventricular block, history of ventricular arrhythmias or history of Torsade de Points. Discontinue if Torsade de Pointes occurs during treatment.

    Before starting treatment with levomepromazine, consider an ECG with measurement of serum calcium, potassium and magnesium levels. Periodic serum electrolyte levels should be monitored and corrected if necessary, especially during long-term chronic usage. Monitor ECG prior to increasing the dose.

    Discontinue treatment if neuroleptic malignant syndrome occurs.

    Severe respiratory disease.

    Breastfeeding (see Lactation).

    Severe renal impairment (see Dosage; Renal impairment).

    Epilepsy and conditions predisposing to epilepsy.

    Parkinson's disease.

    Prostatic hypertrophy.

    Dementia. There is a possibility of increased risk of cerebrovascular adverse events in the dementia population.

    Depression.

    Prolonged starvation.

    Alcohol misuse.

    Myasthenia gravis.

    Predisposition to angle-closure glaucoma.

    History of jaundice.

    Elderly.

    Debilitation.

    Patients are advised to avoid alcohol.

    May cause postural hypotension especially in the elderly. Patients receiving large initial doses should remain supine.

    Prolonged and or high doses may lead to the occurrence of tardive dyskinesia particularly in the elderly. Neuroleptic therapy should be withdrawn if tardive dyskinesia develops.

    Photosensitivity may occur in higher doses, patients should avoid direct sunlight.

    Cases of venous thromboembolism (VTE) have been reported with antipsychotic medication. All possible risk factors for VTE should be indentified before and during treatment and preventative measures taken.

    Use with caution in diabetic patients or those with risk factors for the development of diabetes. Appropriate glycaemic monitoring should be made during treatment.

    Haematological disorder. Perform blood counts if the patient develops signs of unexplained infection or fever. Blood dyscrasias have been reported rarely.

    May impair alertness, especially at the start of treatment or following alcohol consumption, so patients should be warned of the risk and advised not to drive or operate machinery until their individual susceptibility is known.

    Pregnancy and Lactation

    Pregnancy

    Contraindicated in pregnancy. Safety in pregnancy has not been established

    The data on pregnancy outcome are conflicting. Case reports of malformations have been reported, but most larger studies have failed to demonstrate a significant risk for congenital malformations. Most information is available from studies in which pregnant women had been treated for hyperemesis gravidarum. For this indication, smaller doses are used than those needed to treat psychosis. There is little information for use in pregnancy during palliative care.

    The phenothiazine may cause dose-dependant withdrawal symptoms or transient extrapyramidal symptoms in neonates which may last for several weeks.

    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 14-17 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

    Use with caution during breastfeeding, may be advisable to discontinue breastfeeding during treatment.

    There is little information on the use of levomepromazine during breastfeeding in palliative care. Schaefer (2007) concludes that when phenothiazine therapy is urgently required levomepromazine may be considered.

    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

    Effects on Ability to Drive and Operate Machinery

    Levomepromazine can cause drowsiness, disorientation, confusion or excessive hypotension, which may effect the patient's ability to drive or operate machinery.

    Counselling

    Patients should avoid direct sunlight.

    Patients are advised to avoid alcohol.

    Patients should be advised that levomepromazine can cause drowsiness, disorientation, confusion or excessive hypotension, which may effect the ability to drive or operate machinery.

    Side Effects

    Somnolence
    Asthenia
    Dry mouth
    Hypotension
    Agranulocytosis
    Photosensitivity
    Allergic skin reactions
    Parkinson-like symptoms
    Jaundice
    Heat stroke
    Constipation
    Paralytic ileus
    Cardiac arrhythmias
    Prolongation of QT interval
    Torsades de pointes
    Hypoxia
    Electrolyte disturbances
    Acid/base balance disturbance
    Necrotising enterocolitis
    Priapism
    Accelerated erythrocyte sedimentation
    Neuroleptic malignant syndrome
    Decreased glucose tolerance
    Precipitation of diabetes
    Hyperglycaemia
    Venous thrombosis
    Deep vein thrombosis (DVT)
    Pulmonary embolism
    Cardiac arrest
    Sudden unexplained death
    Tardive dyskinesia
    Extrapyramidal effects
    Drowsiness
    Apathy
    Agitation
    Excitement
    Insomnia
    Convulsions
    Dizziness
    Headache
    Confusion
    Gastro-intestinal symptoms
    Nasal stuffiness
    Difficulty in micturition
    Blurred vision
    Glaucoma (closed angle)
    Tachycardia
    ECG changes
    Menstrual disturbances
    Galactorrhoea
    Gynaecomastia
    Impotence
    Weight gain
    Leucopenia
    Corneal opacities
    Lens opacities
    Purplish pigmentation of skin
    Purplish pigmentation of cornea, conjunctiva, retina

    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 ).

    Shelf Life and Storage

    Protect from light

    Further Information

    Last Full Review Date: May 2011

    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, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Psychotropic Drug Directory (2009) Bazire, S. HealthComm UK Ltd, Aberdeen.

    Summary of Product Characteristics: Nozinan Injection. Sanofi-Aventis. Revised August 2017.

    The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

    UK Drugs in Lactation Advisory Service.
    Available at: https://www.ukmicentral.nhs.uk/drugpreg/qrg_p1.asp
    Last accessed: April 20, 2011

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 01 November 2018.

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