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Nyumbani / Registered in Nigeria / Fluphenazine Decanoate Injection

Fluphenazine Decanoate Injection

NAFDAC Reg. No. A4-0863 · Drug

Registered with NAFDAC. Registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Fluphenazine Decanoate Injection
NAFDAC number
A4-0863
Active ingredient
Fluphenazine decanoate
Strength
25 mg/mL
Form
Emulsion for injection/infusion
Pack size
1 x 10's
Manufacturer
Not listed
Applicant (holder)
Alpha Pharmacy and Stores (Nig) Ltd
Approved
28 Sep 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
25 Sep 2026
WHO alerts
None found
Community reports
None
Times checked
0

About the medicine: Fluphenazine decanoate: uses, dosage and brands worldwide

What we found

  • Fluphenazine Decanoate Injection is on the NAFDAC register with an active registration (A4-0863). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

How to use Fluphenazine Decanoate Injection

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Serious warning: Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs 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. …
Who it is for

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.

How to take it and how often
  • Fluphenazine Decanoate Injection may be given intramuscularly or subcutaneously
  • A dry syringe and needle of at least 21 gauge should be used
  • Use of a wet needle or syringe may cause the solution to become cloudy
  • To begin therapy with Fluphenazine Decanoate Injection, the following regimens are suggested: For most patients , a dose of 12.5 to 25 mg (0.5 to 1 mL) 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
  • The response to a single dose has been found to last as long as six weeks in a few patients on maintenance therapy
  • 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
  • For psychotic patients who have been stabilized on a fixed daily dosage of Fluphenazine Hydrochloride Tablets or Fluphenazine Hydrochloride Elixir conversion of therapy from these short-acting oral forms to the long-acting Fluphenazine Decanoate Injection may be indicated. …
Talk to a doctor first if
  • Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage
  • Phenothiazine compounds should not be used in patients receiving large doses of hypnotics
  • Fluphenazine Decanoate Injection is contraindicated in comatose or severely depressed states
  • The presence of blood dyscrasia or liver damage precludes the use of fluphenazine decanoate
  • Fluphenazine Decanoate Injection is not intended for use in children under 12 years of age. …
Warnings

Increased Mortality in Elderly Patients with Dementia-Related Psychosis 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 (see BOXED WARNING ). Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with neuroleptic (antipsychotic) drugs. …

Possible side effects

Central Nervous System The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Muscle rigidity sometimes accompanied by hyperthermia has been reported following use of fluphenazine decanoate. Most often these extrapyramidal symptoms are reversible; however, they may be persistent (see below). The frequency of such reactions is related in part to chemical structure: one can expect a higher incidence with fluphenazine decanoate than with less potent piperazine derivatives or with straight-chain phenothiazines such as chlorpromazine. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-05-06.

Label for fluphenazine decanoate, the active ingredient registered with NAFDAC.

Check your pack of Fluphenazine Decanoate Injection

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3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

About Fluphenazine Decanoate Injection

What is in Fluphenazine Decanoate Injection?

Fluphenazine Decanoate Injection contains Fluphenazine decanoate (25 mg/mL), as emulsion for injection/infusion, according to its NAFDAC registration record.

Is Fluphenazine Decanoate Injection registered with NAFDAC?

Yes. Fluphenazine Decanoate Injection is listed on the NAFDAC register under registration number A4-0863, and its registration is active as of 5 November 2026.

Has Fluphenazine Decanoate Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Fluphenazine Decanoate Injection in our automatically synced alert list.

How can I check that my pack of Fluphenazine Decanoate Injection is genuine?

Run a free authenticity scan with the NAFDAC number A4-0863, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

How do I take Fluphenazine Decanoate Injection?

Follow your prescription or the leaflet in your pack. The official label says: Fluphenazine Decanoate Injection may be given intramuscularly or subcutaneously. A dry syringe and needle of at least 21 gauge should be used. Use of a wet needle or syringe may cause the solution to become cloudy. To begin therapy with Fluphenazine Decanoate Injection, the following regimens are suggested: For most patients , a dose of 12.5 to 25 mg (0.5 to 1 mL) may be given …

What is Fluphenazine Decanoate Injection used for?

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. (Summarised from the official U.S. FDA label for fluphenazine decanoate. Always follow your doctor or pharmacist.)

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