Flupentixol tabs 1mg & 500 mcg
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Tablets containing flupentixol dihydrochloride
For the symptomatic treatment of depression with or without anxiety
The usual starting dose is 1 mg as a single morning dose. After one week the dose may be increased to 2 mg if there is inadequate clinical response.
Daily dosage of more than 2 mg should be in divided doses.
Maximum daily dose is 3 mg.
The usual starting dose is 500 micrograms as a single morning dose. After one week the dose may be increased to 1 mg if there is inadequate clinical response.
Caution should be exercised if further increasing the dosage, but occasionally patients may require up to 1.5 mg daily in divided doses.
Patients with Renal Impairment
Use with caution in patients with renal failure, increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment.
The renal drug handbook suggests starting with quarter to half the dose in patients with a glomerular filtration rate of <10 ml/minute
Patients with Hepatic Impairment
Use with caution in patients with hepatic impairment. May precipitate coma. Consider serum flupentixol concentration monitoring.
Patients often respond within 2 to 3 days. If no effect has been observed within one week at maximum dosage the drug should be withdrawn
Additional Dosage Information
Although flupentixol may cause drowsiness, it can also have an alerting effect so should not be taken in the evening.
Children under 18 years
Long QT syndrome
Severe depression requiring ECT or hospitalisation
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Predisposition to epileptic disorder
Risk of cerebrovascular accident
Benign prostatic hyperplasia
Glucose-galactose malabsorption syndrome
History of alcohol abuse
History of herpes gestationis
History of jaundice
History of opioid abuse
History of torsade de pointes
Narrow angle glaucoma
Severe respiratory disease
Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Advise ability to drive/operate machinery may be affected by side effects
Hepatic Impairment: Discontinue if no response after 1 week at max dosage
Consider monitoring ECG in patients at risk of QT prolongation
Diabetic control may need adjustment
Hypothermia may develop in the elderly
Monitor serum electrolytes
Perform blood counts if signs of persistent infection exist
Risk of cerebrovascular events
Advise patients/carers to seek medical advice if suicidal intent develops
Increased risk for venous thromboembolism - take preventive measures
May cause postural hypotension especially in elderly
Potential for withdrawal symptoms
Reduce dose +/or add antiparkinsonian drug if extrapyramidal symptoms occur
Avoid abrupt withdrawal
Discontinue if patient develops neuroleptic malignant syndrome
Discontinue if tardive dyskinesia occurs
Reduce dose in elderly
Advise patient to avoid alcohol during treatment
May cause impaired fertility
Advise patient that photosensitivity possible
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm.
Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.
Patients (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.
Concomitant treatment with antipsychotics should be avoided.
An increased risk of cerebrovascular events was identified in clinical trials when elderly patients with dementia were treated with certain antipsychotics. The pharmacological mechanisms involved have not been identified. Therefore similar risks with flupentixol cannot be excluded, even when treating other patient populations. Use with caution in patients with risk factors for stroke.
Potential for withdrawal symptoms, gradual withdrawal is therefore recommended. Symptoms may persist for more than a week after discontinuation of oral neuroleptics.
If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered.
Pregnancy and Lactation
Flupentixol should be used with caution in pregnancy.
Data describing the use of flupentixol in pregnancy is highly limited. Flupentixol crosses the placental barrier. The manufacturer suggests avoid the use of flupentixol during pregnancy, particularly during the first and last trimesters. Postulated risks to the newborn include lethargy, tremor, hyperexcitability and low apgar scores.
When neuroleptics have been used up to delivery, observation of the 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 (Schaefer 2007).
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 ).
Flupentixol is contraindicated in breastfeeding.
Flupentixol is excreted into breast milk. Although the effects of long-term exposure have not been studied it has been suggested that extended exposure to flupentixol may affect the nursing infant's neurobehavioral mechanisms. Currently no adverse effects have been reported in breast-feeding infants whose mothers were receiving flupentixol.
LactMed suggests that if flupentixol is used during breastfeeding careful monitoring of the infant should be conducted.
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
Patients and caregivers should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour and the need to seek medical advice immediately if they present.
Advise patients that flupentixol may impair alertness, particularly at the start of treatment or following the consumption of alcohol. Patients should be advised not to drive or operate machinery until their individual susceptibility is known. Patients should not drive if they have blurred vision.
Advise patients that flupentixol may cause an increased susceptibility to sunburn.
Altered liver function tests
Decreased glucose tolerance
Deep vein thrombosis (DVT)
Disturbances in accommodation
Disturbances of appetite
Failure of ejaculation
Neuroleptic malignant syndrome
Prolongation of QT interval
Sudden unexplained death
Torsades de pointes
Withdrawal Symptoms and Signs
Acute withdrawal symptoms include nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesia, insomnia, restlessness, anxiety and agitation. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders has been reported. Therefore gradual withdrawal is recommended.
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 ).
Last Full Review Date: September 2015
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 19 August 2015.
Summary of Product Characteristics: Fluanxol tablets. Lundbeck Limited. Revised May 2014.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Flupentixol Last revised: 07 September 2013
Last accessed: 04 September 2015
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