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Drug Catalog - Product Detail

FLUPHENAZINE DECANOATE INJECTION INJECT. 125MG/5ML 5MLX1

NDC Mfr Size Str Form
42023-0129-01 PAR STERILE PRODUCTS 5 25MG/ML SOLUTION
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PACKAGE FILES

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Generic Name
FLUPHENAZINE DECANOATE
Substance Name
FLUPHENAZINE DECANOATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAMUSCULAR
Application Number
ANDA203732
Description
DESCRIPTION Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect and has the following structural formula: Fluphenazine Decanoate Injection, USP is available as a clear, pale yellow solution for intramuscular (IM) or subcutaneous (SC) use providing 25 mg fluphenazine decanoate per mL in a sesame oil vehicle with 12 mg benzyl alcohol as a preservative. Chemical Structure
How Supplied
HOW SUPPLIED Fluphenazine Decanoate Injection, USP NDC 42023-129-01: 25 mg/mL in 5 mL multiple dose, flip-top vial individually packaged. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Retain vial in carton until ready for use. Vial stoppers do not contain natural rubber latex. Rx Only
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 and Administration
DOSAGE AND ADMINISTRATION Fluphenazine Decanoate Injection may be given IM or SC. 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, USP or Fluphenazine Hydrochloride Elixir, USP conversion of therapy from these short-acting oral forms to the long-acting Fluphenazine Decanoate Injection may be indicated. Appropriate dosage of Fluphenazine Decanoate Injection should be individualized for each patient and responses carefully monitored. No precise formula can be given to convert to use of Fluphenazine Decanoate Injection; however, a controlled multicentered study, Schooler, N.R.: The Initiation of Long-Term Pharmacotherapy in Schizophrenia: Dosage and Side Effect Comparisons between Oral and Depot Fluphenazine. Pharmakopsych. 9:159-169, 1976. in patients receiving oral doses from 5 to 60 mg fluphenazine hydrochloride daily, showed that 20 mg fluphenazine hydrochloride daily was equivalent to 25 mg (1 mL) of Fluphenazine Decanoate Injection every three weeks. This represents an approximate conversion ratio of 12.5 mg (0.5 mL) of decanoate every three weeks for every 10 mg of fluphenazine hydrochloride daily. Once conversion to Fluphenazine Decanoate Injection is made, careful clinical monitoring of the patient and appropriate dosage adjustment should be made at the time of each injection. Severely agitated patients may be treated initially with a rapid-acting phenothiazine compound such as Fluphenazine Hydrochloride Injection—see Package Insert accompanying that product for complete information. When acute symptoms have subsided, 25 mg (1 mL) of Fluphenazine Decanoate Injection may be administered; subsequent dosage is adjusted as necessary. "Poor risk" patients (those with known hypersensitivity to phenothiazines, or with disorders that predispose to undue reactions): Therapy may be initiated cautiously with oral or parenteral fluphenazine hydrochloride (see Package Inserts accompanying these products for complete information). When the pharmacologic effects and an appropriate dosage are apparent, an equivalent dose of fluphenazine decanoate may be administered. Subsequent dosage adjustments are made in accordance with the response of the patient. The optimal amount of the drug and the frequency of administration must be determined for each patient, since dosage requirements have been found to vary with clinical circumstances as well as with individual response to the drug. Dosage should not exceed 100 mg. If doses greater than 50 mg are deemed necessary, the next dose and succeeding doses should be increased cautiously in increments of 12.5 mg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.