Composition:

Each 1ml Solution contains 25mg Fluphenazine decanoate.

Mechanism of action:

Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect.

Indications:

Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics).

Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation.

Contraindication:

•  Patients with suspected or established subcortical brain damage.
•  Patients receiving large doses of hypnotics.
•  Comatose or severely depressed states.
•  The presence of blood dyscrasia or liver damage precludes the use of fluphenazine decanoate.
•  Not intended for use in children under 12 years of age.
•  Patients who have shown hypersensitivity to fluphenazine.

Dosage & Method of administration:

- Fluphenazine Decanoate Injection may be given IM or SC.

- For most patients, a dose of 12.5 to 25 mg may be given to initiate therapy. The onset of action generally appears between 24 and 72 hours after injection and the effects of the drug on psychotic symptoms becomes 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 up to four weeks or longer.

- It may be advisable that patients who have no history of taking phenothiazines should be treated initially with a shorter-acting form of fluphenazine before administering the decanoate to determine the patient's response to fluphenazine and to establish appropriate dosage.

- Severely agitated patients may be treated initially with a rapid-acting phenothiazine compound such as Fluphenazine Hydrochloride Injection.

When acute symptoms have subsided, 25 mg of Fluphenazine Decanoate Injection maybe administered; subsequent dosage is adjusted as necessary.

- Poor risk" patients (those with known hypersensitivity to phenothiazines, or with disorders that predispose to undue reactions): Therapy may be initiated cautiously with oral or parenteral fluphenazine Hydrochloride. When the pharmacologic effects and an appropriate dosage are apparent, an equivalent dose of fluphenazine decanoate may be administered. Subsequent dosage adjustments are made in accordance with the response of the patient.

- Dosage should not exceed 100 mg. If doses greater than 50 mg are deemed necessary, the next dose and succeeding doses should be increased cautiously in increments of 12.5mg.

Side effects:

•  Central Nervous System: pseudoparkinsonism, dystonia, dyskinesia, hyperreflexia. Muscle rigidity sometimes accompanied by hyperthermia. Most often these extrapyramidal symptoms are reversible; however, they may be persistent.
• Tardive Dyskinesia: to increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of the neuroleptic drug should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder. This maneuver is critical, since neuroleptic drugs may mask the signs of the syndrome.
•  Drowsiness or lethargy, restlessness, excitement, or bizarre dreams.

•  Hypertension and fluctuations in blood pressure have been reported with fluphenazine, Hypotension has rarely presented a problem with fluphenazine. Autonomic reactions including nausea and loss of appetite, salivation, polyuria, perspiration, dry mouth, headache, and constipation may occur.

•  Weight change, peripheral edema, abnormal lactation, gynecomastia, menstrual irregularities, false results on pregnancy tests.
•  Skin disorders such as itching, erythema, urticaria, seborrhea, photosensitivity, eczema and even exfoliative dermatitis.

•  Blood dyscrasias, Liver damage as manifested by cholestatic jaundice may be encountered, particularly during the first months of therapy.
• Sudden, unexpected and unexplained deaths have been reported in hospitalized psychotic patients receiving phenothiazines.
• Systemic lupus, hypotension severe enough to cause fatal cardiac arrest, altered electrocardiographic and electroencephalographic tracings, altered cerebrospinal fluid proteins, cerebral edema, asthma.

Precautions:

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Fluphenazine decanoate injection is not approved for the treatment of patients with dementia-related psychosis.
• Tardive dyskinesia may develop in patients treated with neuroleptic. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women.
• Fluphenazine Decanoate Injection may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs.
• The use of this drug may impair the mental and physical abilities.
• 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 phenothiazine derivatives.

• Psychotic patients on large doses of a phenothiazine drug who are undergoing surgery should be watched carefully for possible hypotensive phenomena. Moreover, it should be remembered that reduced amounts of anesthetics.
• The preparation should be used with caution in patients with a history of convulsive disorders.
• Use with caution in patients with special medical disorders such as mitral insufficiency or other cardiovascular disease and pheochromocytoma.
• As with any phenothiazine, the physician should be alert to the possible development of "silent pneumonias" in patients under treatment with fluphenazine decanoate.
• Potentiation of the effects of alcohol may occur with the use of this drug.

Use during Pregnancy:

The safety for the use of this drug during pregnancy has not been established.

Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates.

These complications have varied in severity; while in some cases symptoms have been self- limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Fluphenazine Decanoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.