Fluphenazine Decanoate: Brands, Price & Uses in Bangladesh

Fluphenazine Decanoate is a long-acting (depot) injectable formulation of the first-generation (typical) antipsychotic fluphenazine, esterified with decanoic acid to allow slow release from an intramuscular or subcutaneous depot.

Established / FDA-approved use

• Maintenance treatment of schizophrenia in patients who require prolonged parenteral neuroleptic therapy, particularly patients with chronic psychotic symptoms who benefit from a long-acting formulation because of adherence difficulties with daily oral therapy.

Important scope limitations (per approved labeling)

• Fluphenazine Decanoate has not been shown to be effective for managing behavioral complications in patients with intellectual disability.
• It is not approved for treating dementia-related psychosis in elderly patients (see Precautions and Warnings for the boxed mortality warning).

Because of its delayed onset (effects generally begin 24–72 hours after injection) and long duration of action, Fluphenazine Decanoate is generally not used to treat acute psychotic agitation; patients are usually stabilised first on a shorter-acting form of fluphenazine before being converted to the decanoate depot.

Route of administration

Fluphenazine Decanoate is given by deep intramuscular or subcutaneous injection only. It must never be given intravenously. A dry syringe and needle (minimum 21-gauge) should be used, as moisture can cause the solution to become cloudy.

Adult dosing — maintenance treatment of schizophrenia

Conversion from oral fluphenazine

There is no precise conversion formula. Clinical experience suggests roughly 10 mg of oral fluphenazine hydrochloride per day corresponds approximately to 12.5 mg of Fluphenazine Decanoate given every 3 weeks, but the physician individualises the actual regimen. Patients who have not previously received fluphenazine should first be treated with a shorter-acting oral or injectable form to establish tolerability before starting Fluphenazine Decanoate.

Pediatric dosing

Fluphenazine Decanoate is not recommended for children under 12 years of age; safety and efficacy in the pediatric population have not been established (see Use in Special Populations).

Renal/hepatic impairment

No well-established dose-adjustment schedule exists for renal or hepatic impairment; Fluphenazine Decanoate is contraindicated in severe liver disease (see Contraindications), and should be used with caution and close monitoring of hepatic function in patients with any degree of hepatic impairment.

Adverse effects of Fluphenazine Decanoate are generally similar to those of oral fluphenazine, but because it is a long-acting depot injection, any reaction that occurs — including hypersensitivity and extrapyramidal reactions — may take considerably longer to resolve than with an oral dose, since the drug cannot be immediately withdrawn from the body.

Common

• Extrapyramidal symptoms — pseudoparkinsonism (tremor, rigidity), dystonia, akathisia (restlessness), oculogyric crisis
• Drowsiness, sedation, lethargy
• Dry mouth, constipation, blurred vision, nasal congestion
• Orthostatic hypotension, dizziness
• Weight gain

Less common but clinically important

• Tardive dyskinesia — potentially irreversible involuntary movements; risk rises with cumulative dose and duration of treatment (see Precautions and Warnings).
• Neuroleptic malignant syndrome (NMS) — a rare, potentially fatal reaction with hyperthermia, muscle rigidity, altered mental status, and autonomic instability; requires immediate medical attention.
• Elevated prolactin — menstrual irregularities, galactorrhea, gynecomastia, decreased libido.
• QT-interval prolongation and, rarely, serious arrhythmia.
• Leukopenia, neutropenia, or (rarely) agranulocytosis, especially in the initial months of therapy.
• Cholestatic jaundice, mainly in the first months of treatment.
• Skin reactions including photosensitivity, urticaria, and rarely exfoliative dermatitis.
• Seizures (in patients with a lowered seizure threshold).