Fluphenazine long acting injection

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Sanofi the manufacturer of Modecate injection (Fluphenazine decanoate) ceased production of the preparation in 2018 and all licensed stock will cease to be available by August 2020. An unlicensed version can be imported from Germany to enable treatment to be maintained for those legacy patients unable to switch to a licensed alternative long acting injection.


Fluphenazine decanoate was licensed for the treatment and maintenance of patients with schizophrenia and paranoid psychoses5.

Informed consent and documentation

Informed consent

Due to its unlicensed status, explanation for the rationale of treatment choice should be given at a suitable time during the patient’s treatment. Patient information explaining unlicensed medication in general terms is available via the Choice and Medication, as is a specific fluphenazine decanoate leaflet.



The consultant psychiatrist must make a clear record of the rationale for prescribing an unlicensed medication within the patient’s case notes and document the discussion with the patient1. Nursing staff in the ward must be informed of the medicine’s unlicensed status and ward clinical pharmacists must ensure that staff are aware of the unlicensed status.


When ordering fluphenazine decanoate injection, the patient’s initials and CHI should be included on the requisition as well as the phrase “as per protocol” for the order to be processed.


A record of administration of unlicensed medication must be kept (as per unlicensed medication policy3).  This must include drug batch numbers, patient name and CHI number. The comments section of the recording sheet may be used for the purpose of documenting the batch number. It is the responsibility of the nurse in charge to ensure this occurs.


When supplying fluphenazine decanoate injection from pharmacy, pharmacy staff must ensure that batch numbers are documented on the requisition.

Review and monitoring

Patients must be reviewed and monitored in accordance with NHS GG&C Policy, MHS 30  Good Practice Statement for the use of Depot and Long Acting Antipsychotic Injections4.

Dose range

Adults: a test dose of 12.5mg should be administered by deep intramuscular injection into the gluteal region. 

Elderly: elderly patients may be particularly susceptible to extra-pyramidal reactions. Consequently a reduced initial dose (6.25mg) and a lower maintenance dose may be required.

The onset of action generally appears between 24 and 72 hours after injection and the effects of the drug on psychotic symptoms become significant within 48 to 96 hours.

Subsequent injections and the dosage interval are determined in accordance with the patient’s response. When administered as maintenance therapy, a single injection may be effective in controlling schizophrenic symptoms for up to four weeks or longer.

It is desirable to be as flexible in the dose as possible to achieve the best therapeutic response with the least side effects. Most patients are successfully maintained within the dose range 12.5 – 100mg given at an interval of 2 to 5 weeks.

Patients suffering a relapse following cessation of fluphenazine decanoate may be restarted on their previous dose although the frequency of injections may need to be increased in the early weeks of treatment until satisfactory control is obtained.

Adverse reactions

Very common (>1 in 10) 2,5

  • Sleepiness
  • Extra-pyramidal movement disorders
  • Constipation
  • Dry mouth
  • Blurred vision
  • Weight gain
  • Pain at the injection site

Common (> 1 in 100)

  • Hyperprolactinaemia
  • Postural hypotension
  • Sexual dysfunction

Rare (> 1 in 1000)

  • Urinary retention
  • Venous thrombomembolism
  • Neuroleptic Malignant Syndrome (NMS)
  • Tardive Dykinesia
  • QTc prolongation
Contraindications and cautions


  • Hypersensitivity to fluphenazine decanoate or any other excipients in the injection.
  • Comatose states
  • Marked cerebral atherosclerosis
  • Phaeochromocytoma
  • Renal failure
  • Liver failure
  • Severe cardiac insufficiency
  • Severely depressed states
  • Existing blood dyscrasias


  • Liver disease
  • Renal impairment
  • Cardiac arrhythmias, cardiac disease
  • Thyrotoxicosis
  • Severe respiratory depression
  • Epilepsy and conditions predisposing to epilepsy (e.g. alcohol withdrawal or brain damage)
  • Parkinson’s disease
  • Patients with known sensitivity to phenothiazines
  • Personal or family history of narrow angle glaucoma
  • Hypothyroidism
  • Myasthenia gravis
  • Prostatic hypertrophy
Drug interactions


  • Other drugs that produce CNS depression e.g. alcohol, general anaesthetics, hypnotics, sedatives or strong analgesics
  • Antagonise the action adrenaline and other sympathomimetic agents
  • Impair the effect of levodopa
  • Impair the effect of anti-convulsants
  • Increase the effect of anticoagulants and antidepressants
  • Lithium
  • Other drugs known to prolong QTc
  • MAOIs
  1. GMC Good practice in prescribing and managing medicines and devices. Updated Dec14 http://www.gmc-uk.org/guidance/ethical_guidance/14316.asp
  2. Choice and Medication. Unlicensed medications handy fact sheet and fluphenazine PIL 
  3. NHS Greater Glasgow and Clyde Area Drug and Therapeutics Committee Policies Relating to the Management of Medicines Section 9.1 Acute Unlicensed Medicines Policy (ULM Policy)
  4. NHS GG&C MHS 30 Good Practice Statement for the use of Depot and Long Acting Antipsychotic Injections
  1. Electronic Medicines Compendium Modecate SPC 2015
Editorial Information

Last reviewed: 07 April 2020

Next review: 01 April 2023

Author(s): PMG-MH

Version: 1

Approved By: PMG-MH

Reviewer Name(s): Andrew Walker, Suzanne Burke