Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
For the treatment and maintenance of schizophrenic patients and those with paranoid psychoses.
While Modecate concentrate injection has been shown to be effective in acute states, it is particularly useful in the maintenance treatment of chronic patients who are unreliable at taking their oral medication, and also of those who do not absorb their oral phenothiazine adequately.
It is recommended that patients be stabilised on the injection in hospital.
Recommended dosage regimes for all indications:
A. Patients without previous exposure to a depot fluphenazine formulation:
Initially 0.125ml ie. 12.5mg (0.0625ml ie 6.25mg for patients over 60) by deep intramuscular injection into the gluteal region.
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 maintain as much flexibility 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 0.125ml (12.5mg) to 1ml (100mg) given at a dose interval 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.
B. Patients previously maintained on depot fluphenazine:
Patients who have suffered a relapse following cessation of depot fluphenazine therapy may be restarted on the same dose (as they were receiving formerly), although the frequency of injections may need to be increased in the early weeks of treatment until satisfactory control is obtained.
Elderly patients may be particularly susceptible to extrapyramidal reactions. Therefore reduced maintenance dosage may be required and a smaller initial dose (See above).
Not recommended for children.
* Where a very small volume/low concentration of fluphenazine is required patients may be transferred to the equivalent dose of Modecate Injection 25mg/ml on the basis that 1ml Modecate Concentrate (100mg/ml) is equivalent to 4ml Modecate Injection.
Note:
The dosage should not be increased without close supervision and it should be noted that there is a variability in individual response.
The response to antipsychotic drug treatment may be delayed. If drugs are withdrawn, recurrence of symptoms may not become apparent for several weeks or months.
Intramuscular.
Overdosage should be treated symptomatically and supportively, extrapyramidal reactions will respond to oral or parenteral anti-parkinsonian drugs such as procyclidine or benzatropine. In cases of severe hypotension, all procedures for the management of circulatory shock should be instituted, eg. vasoconstrictors and/or intravenous fluids. However, only the vasoconstrictors metaraminol or noradrenaline should be used, as adrenaline may further lower the blood pressure through interaction with the phenothiazine.
Shelf life: 2 years.
Store below 25°C. Keep the ampoules in the outer carton in order to protect from light.
Colourless type I glass ampoules with an OPC (one point cut) breaking system containing 0.5ml (packs of 10) and 1ml (packs of 5).
Prefilled syringe with neoprene or pharma-gummi rubber plunger and stopper containing 0.5ml (packs of 10).
Not all pack sizes may be marketed.
No special requirements.
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