Description:

Fluphenazine Decanoate Injection BP 25mg is a long-acting injectable antipsychotic medication (depot formulation) used primarily for the maintenance treatment of chronic schizophrenia and other psychotic disorders in patients who require prolonged therapy and have difficulty adhering to oral medication. It provides sustained release over 2–5 weeks after a single intramuscular injection, helping to control symptoms such as hallucinations, delusions, disorganized thinking, and agitation. It is not used for acute psychotic episodes (where short-acting forms are preferred). In Ghana (Accra), it is a prescription-only medication commonly used in psychiatric hospitals and outpatient clinics for long-term schizophrenia management.

Prescription:

Prescription-only (requires a psychiatrist’s or physician’s prescription in Ghana; administered by healthcare professionals—intramuscular injection in hospitals/clinics or under medical supervision; not for self-administration or OTC dispensing due to serious side effects and need for monitoring).

Therapeutic Category:

Typical (First-Generation) Antipsychotic / Long-Acting Depot Neuroleptic.

Active Ingredients/Composition:

• Active ingredient: Fluphenazine decanoate BP – 25 mg per 1 ml (25 mg/ml solution). Other ingredients (excipients, typical): Sesame oil or arachis (peanut) oil (vehicle for depot release), benzyl alcohol (preservative), and other stabilizers. The solution is clear, pale yellow to yellow, sterile, and oil-based for slow intramuscular release.

Vitamins: None.

Minerals: None.

Variant:

• Fluphenazine Decanoate Injection BP 25mg/ml (standard 1 ml ampoule; common pack sizes 5 or 10 ampoules). Related variants: Fluphenazine decanoate 100mg/ml (higher strength in some markets), fluphenazine enanthate (shorter-acting depot), or short-acting fluphenazine hydrochloride (oral/injectable for acute use). The 25mg/ml is the most common depot strength.

Consume Type:

Injectable – Intramuscular (IM) injection (deep gluteal or deltoid muscle; administered only by healthcare professionals; slow injection to minimize discomfort).

Directions/Usage: Administered only by trained healthcare personnel.

• Adults: Test dose 12.5 mg (0.5 ml) IM initially to assess tolerability.
• Maintenance: 12.5–100 mg (0.5–4 ml) IM every 2–5 weeks (most patients 25–50 mg every 3–4 weeks).
• Dose adjusted individually based on response, side effects, and previous oral fluphenazine equivalent.
• Shake ampoule well before drawing (oil-based).
• Rotate injection sites to avoid tissue damage.
• Duration: Long-term (often years) for chronic schizophrenia; regular psychiatric review required.

Common Side Effects: Common (especially early or high dose):

• Extrapyramidal symptoms (tremor, rigidity, akathisia, dystonia – treat with anticholinergics like benzhexol).
• Tardive dyskinesia (late-onset involuntary movements – may be irreversible).
• Sedation, drowsiness
• Dry mouth, blurred vision, constipation (anticholinergic effects).
• Orthostatic hypotension (low BP on standing).
• Weight gain Rare/serious (seek help): Neuroleptic malignant syndrome (fever, rigidity, confusion – emergency), QT prolongation, agranulocytosis, seizures, or severe allergic reactions.

Package Type:

Glass ampoules of 1 ml (each containing 25 mg fluphenazine decanoate; packs of 5 or 10 ampoules; labelled carton with instructions and warnings).

Storage Advice: Store at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Keep out of reach of children.

Safety Advice:

• Administered only under medical supervision (high risk of extrapyramidal symptoms, tardive dyskinesia, and neuroleptic malignant syndrome – monitor closely).
• Contraindicated in hypersensitivity to phenothiazines, coma, severe CNS depression, Parkinson’s disease, severe cardiac/respiratory disease, or pheochromocytoma.
• Caution in elderly (increased sensitivity), epilepsy (lowers seizure threshold), liver/kidney impairment, glaucoma, prostate hypertrophy, or history of blood dyscrasias.
• Risk of QT prolongation – ECG monitoring in high-risk patients.
• Avoid alcohol (increases sedation).
• If fever, rigidity, confusion, severe muscle stiffness, or involuntary movements occur, seek immediate care (may indicate NMS or tardive dyskinesia).
• Regular monitoring (movement disorders, blood counts, ECG if indicated).
• Keep out of reach of children.

Product Substitutes: Similar long-acting injectable antipsychotics in Ghana include:

• Fluphenazine decanoate generics (various importers).
• Modecate (original fluphenazine decanoate brand).
• Haloperidol decanoate (Haldol Depot) – another depot typical antipsychotic.
• Risperidone long-acting injection (Risperdal Consta) or paliperidone (Invega Sustenna) – atypical depot options.
• Zuclopenthixol decanoate (Clopixol Depot). Consult psychiatrist in Accra (e.g., Accra Psychiatric Hospital) for alternatives.

Manufacturer/Marketer:

Varies by exact batch (Fluphenazine decanoate injections often by Indian manufacturers like Samarth Life Sciences, Neon Laboratories, or local Ghanaian producers for generics). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked in hospital pharmacies).

Country of Origin:

India (primary source for generic fluphenazine decanoate 25mg/ml injections imported to Ghana; BP-compliant generics common in African markets).