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Information leaflet




(and dosage form):


25 mg Fluphenazine Decanoate per mL in sesame oil preserved with 1,5% m/v benzyl alcohol.

Category A 2.6.1 Phenothiazine and derivative.

Fluphenazine decanoate is an esterified trifluoromethyl phenothiazine derivative. Its chemical name is 4-(3-[2-
(trifluoromethyl)phenothiazin-10-yl]propyl)-1 piperazine. It is an antipsychotic agent with an extended duration of
Fluphenazine has activity at all levels of the central nervous system as well as on multiple organ systems. The mechanism
whereby its therapeutic action is exerted is unknown, but may be due to competitive antagonism of dopamine, some of its
side effects can be ascribed to competitive antagonism of dopamine, and to blockade of alpha-adrenergic receptors or
muscarinic receptors. Fluphenazine is extensively metabolised, undergoing "first pass" metabolism by the liver and is
excreted in both the urine and faeces. It is highly protein-bound (>90%) in plasma. The serum half life is approximately
7-10 days.
Fluphenazine crosses the blood-brain barrier, crosses the placenta easily and cannot be removed by dialysis.

MODECATE is indicated in the management of manifestations of psychotic disorders. It is of particular value in the
treatment of chronic schizophrenia. It is not only useful in the hospital milieu, but is useful because of its long duration
of action in the long-term maintenance therapy of chronically psychotic patients who are amenable to out-patient

Patients with suspected or established parkinsonism. Phenothiazine compounds should not be used in patients receiving
large doses of hypnotics.
In comatose or severely depressed states.
The presence of blood dyscrasia or liver damage precludes the use of phenothiazines.
In patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.
Pregnancy and lactation, as safety has not been established.
Safety and efficacy in children have not been established.
Patients exposed to organophosphate insecticides.

Neuroleptic Malignant Syndrome (Hyperthermia with Extrapyramidal and Autonomic Disturbances; Neuroleptic-
induced Hyperpyrexia):
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported
in association with fluphenazine decanoate. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered
mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and
cardiac dysrhythmias). The management of NMS should include discontinuation of MODECATE and initiation of
appropriate medical treatment.
If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy
should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.
should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

The usual adequate dosage of fluphenazine decanoate is 25 mg (1 mL) every three to four weeks. If necessary,
adjustments in the amount and the dosage interval may be made in accordance with the patient's response.
The optimal amount of the drug and the frequency of administration must be determined for each patient, since dosage
requirements have been found to vary with clinical circumstances as well as with individual response to the drug.
Although in a large series of patients the optimal dose was usually 25 mg (1 mL) every three to four weeks, the amount
required ranged from 12,5 to 100 mg (0,5 to 4 mL). The interval between doses ranged from two weeks to five weeks in
most instances, but some patients required doses as often as once every three days for the first few injections, while the
response to a single dose was found to last six weeks or longer in a few patients on maintenance therapy.
For patients who have had no previous therapy, it is advisable to initiate treatment with an oral antipsychotic agent or a
quick-acting parenteral antipsychotic. When optimal response has been established, fluphenazine decanoate should be
administered every three to four weeks. In switching over to fluphenazine decanoate, the quick-acting antipsychotic
agent should be administered concurrently for 3 days, and then discontinued.
For patients on short-acting phenothiazine drugs, fluphenazine decanoate at 25 mg (1 mL) every three to four weeks
should be adequate. The previous antipsychotic agent should be administered concurrently for 3 days, and then
Severely agitated patients may be treated initially with a rapid-acting phenothiazine compound - see package insert
accompanying that product for complete information. When acute symptoms have subsided, 25 mg (1 mL) of
MODECATE (fluphenazine decanoate) may be administered; subsequent dosage may be adjusted as necessary.
In 'poor risk' patients (those with known hypersensitivity to phenothiazines, or with disorders that predispose to undue
reactions) therapy should be initiated cautiously with a quick-acting antipsychotic agent. When optimal response has
been established, fluphenazine decanoate should be administered at 25 mg every three weeks. In switching over to
fluphenazine decanoate, the quick acting antipsychotic agent should be administered concurrently for 3 days, and then
MODECATE may be administered intramuscularly or subcutaneously. A dry needle and syringe should be used. Use of a
wet needle or syringe may cause the solution to become cloudy.

The use of Modecate may impair the mental and physical abilities required for driving a car or operating machinery.
Potentiation of the effects of alcohol may occur with the use of Modecate.
Because of the possibility of cross-sensitivity, fluphenazine decanoate should be used cautiously in patients who have
developed cholestatic jaundice, dermatoses or other allergic reactions to other phenothiazine derivatives.
Psychotic patients on large doses of phenothiazine drug who are undergoing surgery should be watched carefully for
possible hypotensive phenomena. Moreover, it should be remembered that reduced amounts of anaesthetics or central
nervous system depressants may be necessary.
The effects of anticholinergics may be potentiated in some patients receiving fluphenazine because of added
anticholinergic effects.
Fluphenazine decanoate administration could be hazardous in patients exposed to extreme heat, since it may impair body
temperature regulation.
The preparation should be used with caution in patients with a history of convulsive disorders, since grand mal
convulsions have been known to occur.
Use with caution in patients with special medical disorders such as mitral insufficiency or other cardiovascular diseases as
well as pheochromocytoma.
Fluphenazine decanoate may elevate prolactin levels, which persists during chronic administration.
The possibility of liver damage, pigmentary retinopathy, lenticular and corneal deposits, and development of irreversible
dyskinesia should be remembered when patients are on prolonged therapy.
Central Nervous System: The side effects most frequently reported with phenothiazine compounds are extrapyramidal
symptoms including pseudo-parkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonus, and
hyperreflexia. Most often these extrapyramidal symptoms are reversible; however, they may be persistent (see following
text). With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual
patient sensitivity than on other factors, but dosage level and patient age are also determinants.
Extrapyramidal reactions may be controlled by administration of anticholinergic drugs and by subsequent reduction in
Other CNS Effects: Occurrences of Neuroleptic Malignant Syndrome (NMS) have been reported in some patients.
Leucocytosis, fever, elevated creatinine phosphokinase (CPK), liver function abnormalities and acute renal failure may
also occur with NMS.
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