The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Fluphenazine decanoate is not indicated for the management of severely agitated psychotic patients, psychoneurotic patients or geriatric patients with confusion andor agitation. Fluphenazine decanoate injection, usp par sterile products. A twentyweek doubleblind study was conducted to compare the efficacy and sideeffect profile of haloperidol decanoate and fluphenazine decanoate, both given fourweekly, in fiftyone chronic schizophrenic patients. In patients with chronic schizophrenic disorder, usual initial dose is 12. S, age 39, with a 15year history of schizophrenia and severe paranoid delusions, is admitted after physically assaulting a staff member at a group home. To learn about fluphenazine decanoate side effects, drug interactions or safety concerns, read either the drug label or the drugs package insert. Haloperidol is the first of the butyrophenone series of major antipsychotics. Greater increases in body mass index bmi and prolactin were observed in the risperidone lai group. Feb 05, 2020 do not stop taking fluphenazine decanoate injection all of a sudden without calling your doctor. Haloperidol injection, usp is available as a sterile parenteral form. The ester ification of fluphenazine markedly prolongs the drugs duration of effect without unduly attenuating its bene ficial action. The prolixin decanoate fluphenazine decanoate fda package insert doesnt have numbers about how common side effects are. The basic effects of fluphenazine decanoate appear to be no different from those of fluphenazine hydrochlo ride, with the exception of duration of action.
Immune globulin intravenous human, 10% liquid privigen. Fluphenazine decanoate section after pearls for dosing and use continued fluphenazine 291 pharmacokinetics mean halflife of oral formulation approximately 15 hours mean halflife of intramuscular formulation approximately 6. Drug information fluphenazine decanoate fluphenazine decanoate install pdr s official, free drug information and comparison app today. The basic effects of fluphenazine decanoate appear to be no different from those of fluphenazine. Fluphenazine decanoate timing of administration for people with schizophrenia. Fluphenazine decanoate api dmfs us drug master file dmf. Mar 16, 2020 avinza package insert pdf please refer to your supplemental new drug application snda dated approved package insert into the physicians labeling rule plr. Fluphenazine decanoate medicinal forms bnf content. Csl behring immune globulin intravenous human, 10% liquid privigen us package insert july 2007 page 4 version 10. The specific effects will vary from person to person, depending on how much prolixin was taken and whether it was taken with other drugs or alcohol. Administer 21 consecutive days of oral aripiprazole. Labelingpackage insert label is not available on this site. Prescribing information prfluphenazine fluphenazine hydrochloride tablets usp 1 mg, 2 mg, and 5 mg therapeutic classification antipsychotic pharmacology phenothiazine derivatives appear to act on the hypothalamus, depressing various components of the.
Fluphenazine is a prescription drug that is licensed for treating psychotic disorders. The chemical designation is 44pchlorophenyl4hydroxypiperidino4fluorobutyrophenone and it has the following structural formula. Aug 26, 2019 haloperidol decanoate is almost insoluble in water 0. Drug name active ingredients strength dosage formroute marketing status rld te code application no. Use of a wet needle or syringe may cause the solution to become cloudy. Prescribing information prfluphenazine fluphenazine. A comparative trial of haloperidol decanoate and fluphenazine. Dailymed fluphenazine hydrochloride solution, concentrate. List of approved drug products containing fluphenazine decanoate in the fda orange book on. For psychotic patients who have been stabilized on a fixed daily dosage of orally administered fluphenazine hydrochloride dosage forms, conversion to the longacting injectable fluphenazine decanoate may be indicated see package insert for fluphenazine decanoate injection for conversion information.
Oral fluphenazine dosing the recommended dose when starting the drug is fluphenazine 2. See full prescribing information for complete boxed warning. Mar 29, 2020 what are the generic sources for fluphenazine decanoate and what is the scope of freedom to operate fluphenazine decanoate is the generic ingredient in two branded drugs marketed by aurobindo pharma ltd, fresenius kabi usa, hospira, mylan labs ltd, par sterile products, teva parenteral, westward pharms int, and bristol myers squibb, and is included in eight ndas. List of the 8 ndc products with the active ingredient fluphenazine decanoate. Dec 18, 2017 for psychotic patients who have been stabilized on a fixed daily dosage of orally administered fluphenazine hydrochloride dosage forms, conversion to the longacting injectable fluphenazine decanoate may be indicated see package insert for fluphenazine decanoate injection for conversion information. No personal respiratory protective equipment is normally required when this product is being usedadministered by a licensed healthcare practitioner i. Have blood work checked as you have been told by the doctor. Fluphenazine, sold under the brand names prolixin among others, is an antipsychotic medication. Fluphenazine decanoate is dissolved in sesame oil for long duration of action. Fluphenazine decanoate coupons save 97% with free coupons. If side effects occur, the infusion should be slowed or stopped until the symptoms subside.
Fluphenazine decanoate injection auromedics pharma llc. Fluphenazine decanoate to 25 mg have no history of fluphenazine decanoate injection. Prolixin fda prescribing information, side effects and uses. Fluphenazine can cause mild and transient serum enzyme elevations and has been linked to rare instances of clinically apparent cholestatic liver injury. Pdf fluphenazine decanoate timing of administration for people. It is used to find the right dose for you before moving to a longacting injection. Other hazards fluphenazine decanoate is a longacting antipsychotic drug of the phenothiazine. It is a highly potent behavior modifier with a markedly extended dura tion of effect and has the following structural formula. Plasma levels of fluphenazine in patients receiving fluphenazine decanoate. Fluphenazine decanoate injection is not approved for the. Patients who have shown hypersensitivity to other phenothiazines, including fluphenazine, should not be given fluphenazine decanoate. Pricing, sizing, legal catgories and other medicinal forms information for fluphenazine decanoate. When and how to use longacting injectable antipsychotics. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for prolixin decanoate fluphenazine decanoate.
Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. May 22, 2019 use fluphenazine hydrochloride dosages 10 mg daily with caution. Fluphenazine decanoate injection, usp is a sterile injection, available for intramuscular or subcutaneous administration, providing 25 mg fluphenazine decanoate per ml in a sesame oil vehicle with 1. Fluphenazine decanoate fda orange book approved drug. Thrombosis, renal dysfunction and acute renal failure measles exposurethrombosis may occur with immune globulin products, including privigen. To begin therapy with fluphenazine decanoate injection, the following regimens are suggested. It is given by mouth, injection into a muscle, or just under the skin. Fluphenazine hydrochloride monograph for professionals.
Fluphenazine decanoate injection may be given im or sc. A comparative trial of haloperidol decanoate and fluphenazine decanoate in chronic schizophrenic patients. Fluphenazine decanoate injection is a longacting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy e. Fluphenazine decanoate drug bnf content published by nice. Hyoscyamine may cause drowsiness, dizziness or blurred vision. Over the course of a typical 10 week controlled trial, the rate of death in drugtreated patients was about 4. The decanoate salt form of fluphenazine, a phenothiazine with antipsychotic activity. Prolixin decanoate fluphenazine decanoate fda package. You may also want to speak with your pharmacist or healthcare provider. Fluphenazine decanoate, a human prescription drug labeled by westward pharmaceuticals corp. Prolixin decanoate fluphenazine decanoate is longacting medicine for stabilizing your mood that must be given by a trained healthcare professional. Fluphenazine depot injection solutions must be drawn up using a dry syringe and a needle of at least 21gauge. Capitals indicate lifethreatening, underlines indicate most frequent.
Dailymed fluphenazine decanoate injection, solution. If you need to stop fluphenazine decanoate injection, you will want to slowly stop it as ordered by your doctor. Fluphenazine decanoate timing of administration for people with. Haloperidol decanoate injection package insert haloperidol decanoate injection for im injection only rx only descpription haloperidol decanoate is the decanoate ester of the butyrophenone, haloperidol. The onset of action generally appears between 24 and. Haloperidol decanoate is a longacting form of haloperidol.
Fluphenazine decanoate injection, usp package insert. Fluphenazine decanoate inj prescription and dosage sizes information for physicians and healthcare professionals. Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in igadeficient patients with antibodies to iga and a history of hypersensitivity. Fluphenazine decanoate generic drug details drugpatentwatch. Find patient medical information for fluphenazine decanoate bulk on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. It is available in sesame oil in sterile form for intramuscular im injection. The specific effects of a prolixin overdose will vary, depending on a number of factors, including how much prolixin was taken and whether it was taken with any other. Administration of haloperidol decanoate in sesame oil results in slow and. Qualitative and quantitative composition each 1ml contains fluphenazine decanoate bp 25mg. Saphris 5 mg tablets, black cherry flavor, are round, white to offwhite sublingual tablets, with 5 on one side within a circle. The products dosage form is injection, and is administered via intramuscular.
Fluphenazine decanoate api manufacturers suppliers. Fluphenazine decanoate exerts its actions by blocking postsynaptic dopamine d2 receptors in the limbic, cortical system and basal ganglia. Fluphenazine decanoate injection is not intended for use in children under 12 years of age. As with all medicines, it is possible for a person to take too much prolixin.
Fluphenazine decanoate full prescribing information. Abilify maintena is a longacting aripiprazole formulation with 4week dosing intervals indicated for the treatment of schizophrenia and maintenance monotherapy of bipolar i disorder in adults. Prolixin decanoate fda prescribing information, side effects and. Store at 20 to 25c 68 to 77f see usp controlled room temperature. Fluphenazine decanoate or enanthate injections are administered via im or subcutaneous injection only, do not administer intravenously. Pharmacology, adverse reactions, warnings and side effects. Fluphenazine is a phenothiazine and antipsychotic agent which is no longer in common use. For psychotic patients who have been stabilized on a fixed daily dosage or orally administered prolixin fluphenazine hydrochloride dosage forms, conversion to the longacting injectable prolixin decanoate may be indicated see package insert for prolixin decanoate fluphenazine decanoate injection for conversion information. Haldol decanoate 50 haloperidol haldol decanoate 100. If this is the first time you use this feature, you will be asked to authorise cambridge core to connect with your account. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine decanoate. Muscle weakness, an irregular heart rhythm, and difficulty breathing are some of the symptoms of a prolixin overdose. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing.
Fluphenazine decanoate monograph for professionals. Find patient medical information for fluphenazine decanoate injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Our products are available from authorized distributors. Oct 31, 2017 fluphenazine decanoate injection may be given im or sc.
Conversion from hydrochloride dosage forms to decanoate i. Fluphenazine decanoate injection, usp package insert one can expect a higher incidence with fluphenazine decanoate than with less potent piperazine derivatives or with straightchain phenothiazines such as chlorpromazine. It is used in the treatment of chronic psychoses such as schizophrenia, and appears to be about equal in effectiveness to lowpotency antipsychotics like chlorpromazine. It is a highly potent behavior modifier with a markedly extended duration of effect.
List of drug master files dmf of fluphenazine decanoate active pharmaceutical ingredient api submitted to the u. She is receiving paliperidone palmitate, 234 mg every 4 weeks. A dry syringe and needle of at least 21 gauge should be used. Absorption of other oral medications may be decreased during. Fluphenazine decanoate injection is contraindicated in comatose or severely depressed states. Do not stop taking fluphenazine decanoate injection all of a sudden without calling your doctor. Modecate, modecate concentrate fluphenazine dosing. This emedtv web page further explores the effects of fluphenazine, offers general dosing information for the drug, and lists possible side effects that may occur. The ndc code 0143952901 is assigned to fluphenazine decanoate also known as. Fluphenazine decanoate prescription price comparison. Fluphenazine decanoate has activity at all levels of. Jun 27, 2017 for psychotic patients who have been stabilized on a fixed daily dosage or orally administered prolixin fluphenazine hydrochloride dosage forms, conversion to the longacting injectable prolixin fluphenazine decanoate may be indicated see package insert for prolixin decanoate fluphenazine decanoate injection for conversion information.
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