Fluphenazine Decanoate 25 mg/mL
Fluphenazine Decanoate · INJECTION · Hikma Pharmaceuticals USA Inc.
Fluphenazine Decanoate is a injection containing fluphenazine decanoate at 25 mg/mL, taken intramuscular. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Fluphenazine Decanoate
- Generic Name
- Fluphenazine Decanoate
- NDC Code (Product)
0143-9529- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 25 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA074531
- Marketing Start
- 08/30/1996
Recall History
AuroMedics Pharma LLC
Discoloration; Hazy solution found in one vial instead of a clear solution.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Fresenius Kabi USA, LLC
Subpotent Drug
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION: 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 …
Warnings
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. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of neuroleptic treatment, which patients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of neuroleptic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after r…
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 Injection is not intended for use in children under 12 years of age. Fluphenazine Decanoate Injection is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.
Adverse Reactions
ADVERSE REACTIONS: 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. With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level and patient age are also determinants. Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions can usually be controlled by administration of antiparkinsonian drugs such as Benztropine Mesylate or Intravenous Caffeine and Sodium Benzoate Injection, and by subs…
Frequently Asked Questions
What is Fluphenazine Decanoate used for?
Fluphenazine Decanoate contains Fluphenazine Decanoate. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Fluphenazine Decanoate a controlled substance?
Fluphenazine Decanoate is not classified as a controlled substance by the DEA.
What is the generic name for Fluphenazine Decanoate?
The generic name for Fluphenazine Decanoate is Fluphenazine Decanoate. There are 2 other brand versions of Fluphenazine Decanoate.
What is the NDC code for Fluphenazine Decanoate 25 mg/mL?
The NDC (National Drug Code) for Fluphenazine Decanoate 25 mg/mL is 0143-9529, listed by Hikma Pharmaceuticals USA Inc..