Finished product reference
Fluphenazine Decanoate
Injection · Parenteral · 25 mg/1mL
- List code
- 555
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…
Indications
INDICATIONS AND USAGE Fluphenazine Decanoate Injection, USP 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, USP has not been shown effective in the management of behavioral complications in patients with mental retardation.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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 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.
Contraindications
CONTRAINDICATIONS 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 is not intended for use in children under 12 years of age.
Warnings and precautions
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.
Storage and supply
HOW SUPPLIED Fluphenazine Decanoate Injection, USP, 25 mg/mL is available in 5 mL multiple dose vials, packaged in individual cartons. NDC 0143-9529-01. Protect from light. Store at 20° to 25°C (68° to 77°F) ; avoid freezing and excessive heat. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.
Source: Fluphenazine Decanoate (Fluphenazine Decanoate) — US FDA prescribing information, 2025-01-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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