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Fluphenazine decanoate parenteral


Solution for injection formulations of fluphenazine decanoate

Drugs List

  • fluphenazine decanoate 50mg/0.5ml oily injection
  • Therapeutic Indications


    Schizophrenia and other psychoses


    It is recommended that patients be stabilised on the injection in hospital.

    Dosage should be individually determined. Maintain as much flexibility in the dose as possible to achieve the best therapeutic response with the least side effects.

    Effective in acute states but particularly useful in chronic patients who are unreliable at taking oral medication or who do not absorb oral phenothiazines adequately.


    Patients without previous exposure to a depot fluphenazine formulation
    Initial dose of 12.5 mg (0.125 ml of 100 mg/ml or 0.5 ml of 25 mg/ml solution for injection) by deep intramuscular injection into the gluteal region.
    Subsequent injections and dosage interval are determined in accordance with the patients response. Most patients are successfully maintained within the dose range of 12.5 mg and 100 mg given at intervals of 2 to 5 weeks.

    Patients previously maintained on oral fluphenazine
    It is not possible to predict the equivalent dose of depot formulation in view of the wide variability of individual response.

    Patients previously maintained on depot fluphenazine
    Patients who have suffered a relapse following cessation of depot fluphenazine may be restarted on the same dose (as they were formerly receiving) although the frequency of injections may have to be increased until satisfactory control is obtained.


    Initial dose for patients over 60 should be 6.25 mg (0.0625 ml of 100 mg/ml or 0.25 ml of 25 mg/ml solution for injection) by deep intramuscular injection in the gluteal region.
    Elderly patients are more susceptible to extrapyramidal reactions, sedative and hypotensive effects, therefore maintenance dose may also need to be reduced. Adverse effects on temperature regulation mechanisms may particularly affect the elderly. The elderly also have an increased risk of death when treated with an anti-psychotic.

    Patients with Renal Impairment

    Increased cerebral sensitivity has been reported in renal impairment.

    The Renal Drug Handbook suggests the following doses:
    Glomerular Filtration Rate (GFR)
    GFR 10 to 50 ml/minute: Dose as in normal renal function
    GFR less than 10 ml/minute: Start with a low dose and titrate slowly.

    Additional Dosage Information

    Phenothiazines differ somewhat in predominant action and side effects. Selection is influenced by the degree of sedation required and the patient's susceptibility to extrapyramidal side effects

    The Phenothiazine derivatives can be divided into 3 main groups
    Group 1: Chlorpromazine, levomepromazine and promazine, generally characterised by pronounced sedative effects and moderate antimuscarinic and extrapyramidal side-effects.

    Group 2: Pericyazine, pipotiazine and thioridazine, generally characterised by moderate sedative effects, marked antimuscarinic effects, but fewer extrapyramidal side-effects.

    Group 3: fluphenazine, perphenazine, prochlorperazine and trifluoperazine, generally characterised by fewer sedative effects, fewer antimuscarinic effects but more pronounced extrapyramidal side-effects than group 1 and 2


    For intramuscular administration.

    Fluphenazine decanoate should be administered by deep intramuscular injection into the upper outer buttock. Correct injection technique, such as the z-track technique, and rotation of injection site are essential.

    As with all oil based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur.

    When a small volume of injection is desired, the 100 mg/ml strength should be used.


    Children under 18 years
    Central nervous system depression
    Haematological disorder
    Marked cerebral atherosclerosis
    Severe cardiac dysfunction
    Severe depression
    Severe hepatic impairment
    Severe renal impairment

    Precautions and Warnings

    Hot climates
    Predisposition to epileptic disorder
    Predisposition to long QT syndrome
    Predisposition to narrow angle glaucoma
    Predisposition to venous thromboembolism
    Alcohol withdrawal syndrome
    Brain damage
    Cardiac arrhythmias
    Cardiac disorder
    Epileptic disorder
    Hepatic impairment
    History of cardiovascular disorder
    History of narrow angle glaucoma
    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
    Use with caution in patients exposed to organophosphorous insecticides
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment should be initiated by a psychiatrist
    Use correct injection technique e.g. z-track technique
    Consider ECG before treatment
    Consider possibility of silent pneumonia on long term treatment
    Elderly more susceptible to sedation, hypotensive & temp regulatory effects
    Hypothermia may develop in the elderly
    Monitor ECG prior to and during treatment in existing cardiac abnormalities
    Monitor patients at risk for signs & symptoms of venous thromboembolism
    Perform blood counts if unexplained infection or fever develops
    Consider discontinuation if signs of tardive dyskinesia occur
    Potential for withdrawal symptoms
    Discontinue if patient develops neuroleptic malignant syndrome
    Reduce dose in elderly
    Advise that effects are potentiated by CNS depressants (including alcohol)
    Avoid direct exposure to sunlight

    There is a possibility of increased risk of cerebrovascular adverse events in the dementia population. Fluphenazine is not licensed of the treatment of dementia related behavioural disturbance.

    Response to treatment may be delayed. If treatment is withdrawn recurrence of symptoms may not become apparent for several weeks or months.

    Pregnancy and Lactation


    Use fluphenazine with caution in pregnancy.

    Data on pregnancy outcomes are conflicting. Safety has not been established for the use of fluphenazine during pregnancy, therefore the potential hazards should be weighed against the benefits when administering this product to pregnant patients. Fluphenazine is a phenothiazine. Phenothiazines are known to cross the placenta. Schaefer (2007) considers that treatment with phenothiazines, such as fluphenazine, is not an indication for termination of pregnancy. Regular psychiatric and obstetric care will be required (Schaefer, 2007). NICE (2007) states that depot antipsychotics should not routinely be prescribed to pregnant women because there is relatively little information on their safety and their infants may show extra-pyramidal symptoms (usually self limiting) several months after administration of the depot (NICE, 2007). 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 may consider reduction of the dose or even interruption to treatment in the days immediately preceding delivery.

    NICE advises that anticholinergic dugs should not be prescribed routinely for the extra-pyramidal side effects of antipsychotic drugs except for acute short term use. Instead the dose and timing of the antipsychotic drug should be adjusted, or the drug changed (NICE, 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 ( ).


    Fluphenazine is contraindicated in breastfeeding.

    Breastfeeding is not recommended during treatment with depot fluphenazine due to the possibility that it may be excreted in breast milk.

    Infants of mothers who are breastfeeding while taking psychotropic medication, or following earlier depot therapy, 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

    Side Effects

    Abnormal liver function
    Abnormal liver function tests
    Acute dystonias
    Acute renal failure
    Altered consciousness
    Anaphylactic reaction
    Autonomic instability
    Blood dyscrasias
    Blurred vision
    Cardiac arrhythmias
    Corneal opacities
    Creatine phosphokinase increased
    Deep vein thrombosis (DVT)
    Dry mouth
    ECG changes
    Epileptiform attacks
    False pregnancy test results
    Glaucoma (closed angle)
    Hypersensitivity reactions
    Impaired consciousness
    Impairment of judgement
    Impairment of mental skills
    Inappropriate secretion of antidiuretic hormone
    Increase in antinuclear antibodies (ANA)
    Increase in serum cholesterol (transient)
    Interference with temperature regulation
    Lens opacities
    Menstrual disturbances
    Nasal stuffiness
    Neuroleptic malignant syndrome
    Oculogyric crisis
    Prolongation of QT interval
    Pulmonary embolism
    Purplish pigmentation of cornea, conjunctiva, retina
    Purplish pigmentation of skin
    Rhythmic protrusion of tongue
    Sexual dysfunction
    T-wave changes
    Tardive dyskinesia
    Urinary hesitancy
    Urinary incontinence
    Venous thrombosis
    Ventricular fibrillation
    Ventricular tachycardia


    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: September 2013

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    BNF for Children (2013-2014) Pharmaceutical Press, London.

    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.

    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: Modecate Injection 25mg/ml. Sanofi. Revised February 2013.

    Summary of Product Characteristics: Modecate Concentrate Injection 100mg/ml. Sanofi. Revised January 2013.

    Summary of Product Characteristics: Fluphenazine Decanoate Injection BP 25mg/ml, 0.5ml, 1ml and 2ml. Mercury Pharma international Ltd. Revised August 2013.

    Summary of Product Characteristics: Fluphenazine Decanoate Injection BP 100mg/ml, 0.5ml and 1ml. Mercury Pharma international Ltd. Revised August 2012.

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

    Antenatal and postnatal mental health
    National Institute for Health and Care Excellence (NICE) 4th February 2008
    Available at:
    Last accessed: September 5, 2013

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Fluphenazine Last revised: November 1, 2010
    Last accessed: September 5, 2013

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