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Flupentixol decanoate oily injections


Oily solution for injection containing flupentixol decanoate.

Drugs List

  • DEPIXOL 20mg/1ml oily injection
  • DEPIXOL 40mg/2ml oily injection
  • DEPIXOL -CONC 100mg/1ml oily injection
  • DEPIXOL LOW VOLUME 200mg/1ml oily injection
  • flupentixol decanoate 100mg/1ml oily injection
  • flupentixol decanoate 200mg/1ml oily injection
  • flupentixol decanoate 20mg/1ml oily injection
  • flupentixol decanoate 40mg/2ml oily injection
  • flupentixol decanoate 50mg/0.5ml oily injection
  • PSYTIXOL 100mg/1ml oily injection
  • PSYTIXOL 200mg/1ml oily injection
  • PSYTIXOL 20mg/1ml oily injection
  • PSYTIXOL 40mg/2ml oily injection
  • PSYTIXOL 50mg/0.5ml oily injection
  • Therapeutic Indications


    Schizophrenia and other psychoses

    For the treatment of schizophrenia and other psychosis where patients have been stabilized on oral therapy before transferring to the injection.


    Dosage and dosage interval should be adjusted to the patients symptoms and response to treatment.

    Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be high enough to prevent relapse.


    The usual dosage of flupentixol decanoate lies between 50 mg every 4 weeks and 300 mg every 2 weeks, but some patients may require up to 400 mg weekly. Other patients may be adequately maintained on 20 to 40 mg flupentixol decanoate every 2 to 4 weeks.

    In patients who have not previously received depot antipsychotics, treatment should be initiated at a low dose (e.g. 20 mg) to assess tolerability. An interval of at least one week should be allowed before administering the second injection at a dose consistent with the patients condition.


    Initial dosage may need to be reduced to a quarter or half the normal starting dose in the elderly.

    Patients with Renal Impairment

    Use with caution in patients with renal impairment. As increased cerebral sensitivity has been reported in severe renal impairment.

    The Renal Drug Handbook suggests starting with a quarter to half of the dose and titrating slowly in patients with a glomerular filtration rate below 10 ml/minute.

    Additional Dosage Information

    When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.


    For intramuscular administration only.

    The appropriate presentation of flupentixol decanoate should be selected to achieve an injection volume not exceeding 2 ml. Volumes exceeding 2 ml should be distributed between 2 injection sites.


    Children under 18 years
    Impaired consciousness
    Circulatory failure
    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Predisposition to epileptic disorder
    Predisposition to venous thromboembolism
    Risk of cerebrovascular accident
    Suicidal ideation
    Brain damage
    Cardiac arrhythmias
    Cardiac disorder
    Diabetes mellitus
    Electrolyte imbalance
    Epileptic disorder
    Hepatic impairment
    History of alcohol abuse
    History of jaundice
    History of opioid abuse
    History of torsade de pointes
    Myasthenia gravis
    Narrow angle glaucoma
    Parkinson's disease
    Prostate disorder
    Renal impairment
    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
    Aspirate prior to injection to avoid intravascular administration
    Consider monitoring ECG in patients at risk of QT prolongation
    Diabetic control may need adjustment
    Hypothermia may develop in the elderly
    Monitor patients at risk for signs & symptoms of venous thromboembolism
    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
    Discontinue if patient develops neuroleptic malignant syndrome
    Discontinue if tardive dyskinesia occurs
    Reduce dose in elderly
    Advise patient that the effects of alcohol may be potentiated
    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.

    Other psychiatric conditions for which flupentixol is prescribed can also be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

    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.

    Potential for withdrawal symptoms. Symptoms may persist for more than a week after discontinuation of oral neuroleptics, and longer for depot formulations.

    Use with extreme caution in patients with organic brain syndrome, mental retardation and opiate or alcohol abuse, as cases of neuroleptic malignant syndrome are more likely to be fatal in these patients.

    If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered.

    Flupentixol is considered to be unsafe in patients with porphyria because it has been shown to be porphyrinogenic in animals.

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


    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

    Side Effects

    Abdominal pain
    Abnormal vision
    Altered liver function tests
    Anaphylactic reaction
    Attention disturbances
    Decreased glucose tolerance
    Deep vein thrombosis (DVT)
    Disturbances in accommodation
    Disturbances of appetite
    Dry mouth
    Erectile dysfunction
    Extrapyramidal effects
    Failure of ejaculation
    Hot flushes
    Hypersensitivity reactions
    Injection site reactions
    Micturition disorders
    Muscle rigidity
    Neuroleptic malignant syndrome
    Prolongation of QT interval
    Pulmonary embolism
    Reduced libido
    Speech disturbances
    Sudden unexplained death
    Suicidal tendencies
    Tardive dyskinesia
    Torsades de pointes
    Urinary retention
    Venous thrombosis
    Ventricular arrhythmias
    Ventricular fibrillation
    Ventricular tachycardia
    Weight gain


    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: January 2016

    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 19 August 2015.

    Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Depixol Injection and Conc Injection. Lundbeck Limited. Revised October 2014.

    Summary of Product Characteristics: Depixol Low Volume Injection. Lundbeck Limited. Revised October 2014.

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

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Flupentixol Last revised: 07 September 2013
    Last accessed: 06 January 2016

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