Fluphenazine

Pronunciation: floo-FEN-uh-zeen.

Generic name: fluphenazine
Drug class: First-generation (typical) antipsychotic, phenothiazine derivative
Form: Tablets (1 mg, 2.5 mg, 5 mg, 10 mg), oral concentrate solution, and long-acting decanoate injection (25 mg/mL)
Route: Oral (tablet, concentrate solution) or long-acting intramuscular/subcutaneous injection (decanoate)
Legal status: Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · Canada

Boxed warning: Increased mortality in elderly patients with dementia-related psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs, including fluphenazine, are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to about 2.6% in the placebo group. Although the causes of death varied, most appeared to be either cardiovascular (for example, heart failure or sudden death) or infectious (for example, pneumonia) in nature. Fluphenazine is not approved for the treatment of patients with dementia-related psychosis. (1)

What fluphenazine is and how it works

Fluphenazine is a high-potency, first-generation antipsychotic used to manage psychotic disorders such as schizophrenia. It is available as oral tablets or solution for regular daily dosing, and as a long-acting decanoate injection given every few weeks for people who need prolonged antipsychotic therapy. (1)

Fluphenazine carries a genuine FDA boxed warning: it is not approved, and should not be used, for psychosis related to dementia in older adults, because of an increased risk of death in this specific group. It can also cause movement disorders (some potentially irreversible) and a rare but life-threatening reaction called neuroleptic malignant syndrome. Take only as prescribed and never stop or change the dose without your prescriber's guidance.

Mechanism of action: how fluphenazine works

Fluphenazine is a high-potency phenothiazine antipsychotic that blocks central dopamine D2 receptors, producing antipsychotic effects along with a relatively high propensity (compared with lower-potency phenothiazines) for extrapyramidal side effects. (1)

What fluphenazine is used for

Psychotic disorders (e.g. schizophrenia)

Used to manage the manifestations of psychotic disorders. It has not been shown effective for behavioural complications in people with intellectual disability, and is not approved for dementia-related psychosis in older adults. (1)

Long-acting maintenance therapy (decanoate injection)

The decanoate injection is used for people who need prolonged antipsychotic treatment, giving a steady effect over several weeks between injections instead of daily oral dosing. (2)

Before taking fluphenazine

Do not take / not appropriate for

Do not use if you have suspected or established subcortical brain damage. (all countries) (1)
Do not use together with large doses of hypnotic (sleep-inducing) medicines. (all countries) (1)
Do not use if you are in a comatose or severely depressed state (e.g. from CNS depressants). (all countries) (1)
Do not use if you have pre-existing blood cell disorders (blood dyscrasias) or liver damage. (all countries) (1)
Do not use if you have a known hypersensitivity to fluphenazine or other phenothiazine medicines. (all countries) (1)
This medicine is not approved for treating psychosis related to dementia in older adults. (all countries) (1)

Tell your clinician about

If you or a family member has had tardive dyskinesia or neuroleptic malignant syndrome with any antipsychotic before.
If you have a history of low white blood cell counts, liver disease, seizures, heart disease, or low blood pressure.
All other medicines, especially other sedating or CNS-depressant medicines and alcohol.
Whether you are pregnant, planning pregnancy, or breastfeeding.
If you are an older adult with dementia -- this medicine is not approved for dementia-related psychosis and carries a boxed warning of increased death risk in that specific situation.

(1)

How to take fluphenazine

Take exactly as prescribed by your doctor; do not change your dose or stop taking fluphenazine without medical guidance.
The decanoate injection is given by a healthcare professional as a long-acting depot, typically every few weeks -- do not attempt to self-administer.
Avoid alcohol, which can add to drowsiness and other effects.
Be careful with driving or operating machinery until you know how this medicine affects you.

(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

Contact your prescriber or care team for guidance if you miss a dose of oral fluphenazine, or if you miss a scheduled decanoate injection appointment. do not take an extra dose or adjust your own dose or schedule.

Overdose

Seek emergency medical help immediately if you think you or someone else has taken too much fluphenazine, or if severe drowsiness, muscle rigidity, high fever, very low blood pressure, an irregular heartbeat, or loss of consciousness occurs. (1)