Action And Clinical Pharmacology: The esterification of fluphenazine markedly prolongs its duration of effect without unduly attenuating its beneficial action. The onset of action generally appears 24 to 72 hours after injection, and the antipsychotic effects become significant within 48 to 96 hours. Amelioration of symptoms continues for 1 to 3 weeks or longer, with an average duration of effect of about 2 weeks.
Indications And Clinical Uses: A long acting parenteral antipsychotic agent indicated in the maintenance therapy of schizophrenia. There is considerable individual variability in the response and duration of action of Moditen Enanthate Injectable and, frequently, the need to control with oral medication the extrapyramidal reactions which are produced by this long acting preparation.
Depot fluphenazines are not indicated in the management of severely agitated psychotic patients, psychoneurotic patients or geriatric patients with confusion and/or agitation.
Children: The safety and efficacy of fluphenazine enanthate in children has not been established; therefore, the drug is not indicated for use in the pediatric age group.
Contraindications, Precautions and Adverse Effects: See Moditen HCl. Some adverse effects may be severe. The evaluation of tolerance and response requires stabilization of each patient under continuous and close medical observation. Local tissue reactions to the injection occur infrequently.
Depot fluphenazines produce a higher incidence of extrapyramidal reactions than the less potent piperazine derivatives or the straight chain phenothiazines such as chlorpromazine. Extrapyramidal reactions tend to occur in the first few days after injection of depot fluphenazines. Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions are often dose related and tend to subside when the dose is reduced or the drug temporarily withdrawn. However, antiparkinsonian medication may be required to control serious reactions. The evidence available tends to indicate that persistent tardive dyskinesias result from heavy drug overloading of the extrapyramidal system. Therefore, avoid overdosing of depot fluphenazines and do not exceed the optimum dosage in an attempt to decrease the frequency of injections, since this will tend to elicit marked extrapyramidal reactions.
An increase in cephalin flocculation, sometimes accompanied by alterations in other liver function tests, has been reported in patients who have had no clinical evidence of liver damage.
Dosage And Administration: Usual adult dosage is 25 mg injected every 2 weeks by the i.m. route only, not by the i.v. route. Requirements vary and may range from 12.5 to 100 mg given at intervals of 1 to 3 weeks. Doses of 75 mg or even less have caused severe reactions in some patients; therefore, a gradual increase in dosage is recommended.
It may be advisable to start with a short acting form of fluphenazine before giving the enanthate in patients who have had no history of taking phenothiazines, severely agitated patients and poor risk patients.
Availability And Storage: Each mL of injectable solution contains: fluphenazine enanthate USP 25 mg in sesame oil with benzyl alcohol 1.5% as preservative. Nonmedicinal ingredients: benzyl alcohol 1.5% w/v (preservative) and sesame oil. Vials of 5 mL.
MODITEN® ENANTHATE Squibb Fluphenazine Enanthate Antipsychotic