Fluphenazine Decanoate

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 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.

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: 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 subsequent reduction in dosage. Tardive Dyskinesia See WARNINGS . The syndrome is characterized by involuntary choreoathetoid movements which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusion of the tongue, puffing of cheeks, puckering of the mouth, chewing movements), trunk and extremities. The severity of the syndrome and the degree of impairment produced vary widely. The syndrome may become clinically recognizable either during treatment, upon dosage reduction, or upon withdrawal of treatment. Early detection of tardive dyskinesia is important. To increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of the neuroleptic drug should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder. This maneuver is critical, since neuroleptic drugs may mask the signs of the syndrome. Other CNS Effects Occurrences of neuroleptic malignant syndrome (NMS) have been reported in patients on neuroleptic therapy (see WARNINGS , Neuroleptic Malignant Syndrome ); leukocytosis, elevated CPK, liver function abnormalities, and acute renal failure may also occur with NMS. Drowsiness or lethargy, if they occur, may necessitate a reduction in dosage; the induction of a catatonic-like state has been known to occur with dosages of fluphenazine far in excess of the recommended amounts. As with other phenothiazine compounds, reactivation or aggravation of psychotic processes may be encountered. Phenothiazine derivatives have been known to cause, in some patients, restlessness, excitement, or bizarre dreams. Autonomic Nervous System Hypertension and fluctuations in blood pressure have been reported with fluphenazine. Hypotension has rarely presented a problem with fluphenazine. However, patients with pheochromocytoma, cerebral, vascular or renal insufficiency, or a severe cardiac reserve deficiency such as mitral insufficiency appear to be particularly prone to hypotensive reactions with phenothiazine compounds, and should therefore be observed closely when the drug is administered. If severe hypotension should occur, supportive measures including the use of intravenous vasopressor drugs should be instituted immediately. Norepinephrine Bitartrate Injection is the most suitable drug for this purpose: epinephrine should not be used since phenothiazine derivatives have been found to reverse its action, resulting in a further lowering of blood pressure. Autonomic reactions including nausea and loss of appetite, salivation, polyuria, perspiration, dry mouth, headache, and constipation may occur. Autonomic effects can usually be controlled by reducing or temporarily discontinuing dosage. In some patients, phenothiazine derivatives have caused blurred vision, glaucoma, bladder paralysi …

DESCRIPTION Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. Fluphenazine Decanoate is 2-4-[3-(2-trifluoromethylphenothiazin-10-yl)-propyl]-piperazin-1 -yl]ethyl decanoate. It is a highly potent behavior modifier with a markedly extended duration of effect. Fluphenazine Decanoate Injection is a sterile solution available for intramuscular or subcutaneous administration, providing 25 mg fluphenazine decanoate per mL in a sesame oil vehicle with 1.2% (w/v) benzyl alcohol as a preservative. Fluphenazine decanoate has the following structural formula: structural formula

HOW SUPPLIED: Fluphenazine Decanoate Injection, USP is supplied in flip-top vials as follows: NDC Fluphenazine Decanoate Injection, USP (25 mg per mL) Package Factor 25021-838-05 125 mg per 5 mL Multi-Dose Vial 1 vial per carton Storage Conditions Store at 20o to 25oC (68o to 77oF); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light (keep in outer carton). Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. * 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. SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2024 Sagent Pharmaceuticals Revised: December 2024 SAGENT Pharmaceuticals ®