Levomepromazine 25mg and 50mg oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of high strength levomepromazine (25mg and 50mg).
Drugs List
Therapeutic Indications
Uses
Schizophrenia
Terminal disease (adjunctive therapy)
Adjunct therapy in the relief of pain and the accompanying distress in terminal illness.
Alternative treatment to chlorpromazine in schizophrenia especially when it is desirable to reduce psychomotor activity.
Dosage
Adults
Terminal illness
12.5mg to 50mg every 4 to 8 hours.
Psychiatric conditions
Ambulant patients:
Initially up to 25mg to 50mg per day, usually in 3 divided doses. Gradually increased as required. The larger portion of the dose may be taken at bedtime.
Bed patients:
Initially 100mg to 200mg per day, usually in 3 divided doses. Gradually increased to 1g daily if necessary. Dosage should be reduced in stable patients to an adequate maintenance level.
Children
Psychiatric conditions
Total daily dose of 37.5mg should not be exceeded.
The average effective daily intake for a ten year old is 12.5mg to 25mg.
Patients with Renal Impairment
Alternative sources recommend starting with small doses in severe renal impairment due to increased cerebral sensitivity.
Contraindications
Breastfeeding
Long QT syndrome
Pregnancy
Torsade de pointes
Precautions and Warnings
Debilitation
Elderly
Family history of long QT syndrome
Predisposition to diabetes mellitus
Predisposition to epileptic disorder
Predisposition to prolongation of QT interval
Predisposition to venous thromboembolism
Prolonged starvation
Risk of cerebrovascular accident
Alcoholism
Bradycardia
Cardiovascular disorder
Dementia
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of long QT syndrome
History of torsade de pointes
History of ventricular arrhythmias
Lactose intolerance
Second degree atrioventricular block
Severe renal impairment
Third degree atrioventricular block
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
Some formulations contain lactose
Keep patient supine when receiving large initial doses
Perform ECG before and during treatment
Diabetic control may need adjustment
Monitor ECG prior to increasing dosage
Monitor patients at risk for signs & symptoms of venous thromboembolism
Monitor serum electrolytes
May cause postural hypotension especially in elderly
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Discontinue if Torsade de Pointes should occur during treatment
Advise patient to avoid alcohol during treatment
Male & female: May cause infertility
Female: Ensure adequate contraception during treatment
Levomepromazine is not recommended in ambulant patients over 50 years of age unless the risk of a hypotensive reaction has been assessed.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic medication. All possible risk factors for VTE should be identified before and during treatment and preventative measures taken.
Pregnancy and Lactation
Pregnancy
Levomepromazine is contraindicated during pregnancy.
The manufacturer does not recommend using levomepromazine during pregnancy or in women of childbearing potential not using contraception. At the time of writing there is no published information regarding the use of levomepromazine during pregnancy. Safety in pregnancy has not been established.
Levomepromazine may cause dose-dependant withdrawal symptoms or transient extrapyramidal symptoms in neonates. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder and newborns should be monitored carefully.
Lactation
Levomepromazine is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues levomepromazine or discontinues breastfeeding. Available data indicates that levomepromazine is excreted in human breast milk in low amounts. Effects on exposed infants are unknown.
Side Effects
Accelerated erythrocyte sedimentation
Acid/base balance disturbance
Agranulocytosis
Akathisia
Allergic dermatitis
Asthenia
Blurred vision
Cardiac arrest
Cardiac arrhythmias
Cholestatic liver changes
Confusion
Constipation
Convulsions
Corneal opacities
Decreased glucose tolerance
Deep vein thrombosis (DVT)
Delirium
Difficulty in micturition
Dry mouth
ECG changes
Electrolyte disturbances
Extrapyramidal effects
Heat stroke
Hepatocellular damage
Hyperglycaemia
Hyponatraemia
Hypotension
Hypoxia
Inappropriate secretion of antidiuretic hormone
Intestinal colic
Jaundice
Keratopathy
Lens opacities
Melanosis
Necrotising enterocolitis
Neuroleptic malignant syndrome
Paralytic ileus
Parkinson-like symptoms
Photosensitivity
Pigmented retinopathy
Precipitation of diabetes
Priapism
Prolongation of QT interval
Pulmonary embolism
Somnolence
Sudden unexplained death
Tardive dyskinesia
Thrombocytopenia
Torsades de pointes
Venous thrombosis
Ventricular arrhythmias
Ventricular fibrillation
Ventricular tachycardia
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: January 2021
Reference Sources
Summary of Product Characteristics: Levomepromazine Maleate 50mg Tablets. Morningside Healthcare Ltd. Revised July 2020.
Summary of Product Characteristics: Nozinan 25mg Tablets. Sanofi-Aventis. Revised November 2019.
The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 14 January 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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