Fluphenazine decanoate package insert pdf file

She is receiving paliperidone palmitate, 234 mg every 4 weeks. Fluphenazine decanoate generic drug details drugpatentwatch. Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. Have blood work checked as you have been told by the doctor. Fluphenazine decanoate injection is contraindicated in comatose or severely depressed states. Prescribing information prfluphenazine fluphenazine. The chemical designation is 44pchlorophenyl4hydroxypiperidino4fluorobutyrophenone and it has the following structural formula. 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. Patients who have shown hypersensitivity to other phenothiazines, including fluphenazine, should not be given fluphenazine decanoate.

Find patient medical information for fluphenazine decanoate injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. 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. Thrombosis, renal dysfunction and acute renal failure measles exposurethrombosis may occur with immune globulin products, including privigen. To learn about fluphenazine decanoate side effects, drug interactions or safety concerns, read either the drug label or the drugs package insert. Fluphenazine decanoate api dmfs us drug master file dmf. No personal respiratory protective equipment is normally required when this product is being usedadministered by a licensed healthcare practitioner i. May 22, 2019 use fluphenazine hydrochloride dosages 10 mg daily with caution. Our products are available from authorized distributors. Fluphenazine hydrochloride monograph for professionals. If you need to stop fluphenazine decanoate injection, you will want to slowly stop it as ordered by your doctor.

Fluphenazine decanoate to 25 mg have no history of fluphenazine decanoate injection. Fluphenazine decanoate fda orange book approved drug. Fluphenazine decanoate injection auromedics pharma llc. Prolixin decanoate fda prescribing information, side effects and. List of drug master files dmf of fluphenazine decanoate active pharmaceutical ingredient api submitted to the u. It is used to find the right dose for you before moving to a longacting injection. Fluphenazine decanoate exerts its actions by blocking postsynaptic dopamine d2 receptors in the limbic, cortical system and basal ganglia. Capitals indicate lifethreatening, underlines indicate most frequent. The products dosage form is injection, and is administered via intramuscular. A comparative trial of haloperidol decanoate and fluphenazine decanoate in chronic schizophrenic patients. The basic effects of fluphenazine decanoate appear to be no different from those of fluphenazine. Modecate, modecate concentrate fluphenazine dosing. Fluphenazine decanoate timing of administration for people with schizophrenia.

Fluphenazine decanoate injection is a longacting parenteral antipsychotic drug intended for use in the management of patients. Store at 20 to 25c 68 to 77f see usp controlled room temperature. Hyoscyamine may cause drowsiness, dizziness or blurred vision. When and how to use longacting injectable antipsychotics.

See full prescribing information for complete boxed warning. 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. Fluphenazine decanoate injection is not intended for use in children under 12 years of age. 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. 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. 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. Prolixin fda prescribing information, side effects and uses. Administration of haloperidol decanoate in sesame oil results in slow and. 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. Fluphenazine decanoate drug bnf content published by nice. Use our prescription price comparison tool to find the best prescription drug price for fluphenazine decanoate in your area, then use our prescription discount card to save even more. 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. 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 is not indicated for the management of severely agitated psychotic patients, psychoneurotic patients or geriatric patients with confusion andor agitation. List of the 8 ndc products with the active ingredient fluphenazine decanoate. Fluphenazine decanoate injection may be given im or sc. 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. Conversion from hydrochloride dosage forms to decanoate i. To begin therapy with fluphenazine decanoate injection, the following regimens are suggested. The ndc code 0143952901 is assigned to fluphenazine decanoate also known as. The prolixin decanoate fluphenazine decanoate fda package insert doesnt have numbers about how common side effects are. 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. For complete ordering information, please contact your local pharmaceutical distributor. As with all medicines, it is possible for a person to take too much prolixin. Fluphenazine is a phenothiazine and antipsychotic agent which is no longer in common use. In patients with chronic schizophrenic disorder, usual initial dose is 12. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine decanoate.

Fluphenazine decanoate fluphenazine decanoate dose. Drug name active ingredients strength dosage formroute marketing status rld te code application no. Oral fluphenazine dosing the recommended dose when starting the drug is fluphenazine 2. 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. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for prolixin decanoate fluphenazine decanoate. Over the course of a typical 10 week controlled trial, the rate of death in drugtreated patients was about 4. Plasma levels of fluphenazine in patients receiving fluphenazine decanoate. Fluphenazine decanoate injection, usp par sterile products. Fluphenazine decanoate has activity at all levels of. You may also want to speak with your pharmacist or healthcare provider. It is a highly potent behavior modifier with a markedly extended duration of effect. 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. Fluphenazine depot injection solutions must be drawn up using a dry syringe and a needle of at least 21gauge. It is a highly potent behavior modifier with a markedly extended dura tion of effect and has the following structural formula.

Do not stop taking fluphenazine decanoate injection all of a sudden without calling your doctor. Oct 31, 2017 fluphenazine decanoate injection may be given im or sc. Fluphenazine decanoate or enanthate injections are administered via im or subcutaneous injection only, do not administer intravenously. Drug information fluphenazine decanoate fluphenazine decanoate install pdr s official, free drug information and comparison app today. Muscle weakness, an irregular heart rhythm, and difficulty breathing are some of the symptoms of a prolixin overdose. Fluphenazine decanoate monograph for professionals. Greater increases in body mass index bmi and prolactin were observed in the risperidone lai group. 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. 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. List of approved drug products containing fluphenazine decanoate in the fda orange book on. Subcutaneous injection fluphenazine decanoate or fluphenazine enanthate.

Fluphenazine decanoate injection, usp package insert. Fluphenazine decanoate is dissolved in sesame oil for long duration of action. Fluphenazine decanoate timing of administration for people with. Also, the pharmacokinetics of haloperidol in geriatric patient generally warrants the use of lower doses see dosage and administration. After symptoms are controlled, oral therapy generally should replace parenteral therapy. 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. Immune globulin intravenous human, 10% liquid privigen. Fluphenazine is a prescription drug that is licensed for treating psychotic disorders. Prolixin decanoate fluphenazine decanoate is longacting medicine for stabilizing your mood that must be given by a trained healthcare professional. Fluphenazine decanoate injection is not approved for the. 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. Fluphenazine decanoate full prescribing information. Csl behring immune globulin intravenous human, 10% liquid privigen us package insert july 2007 page 4 version 10.

Find patient medical information for fluphenazine decanoate bulk on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Qualitative and quantitative composition each 1ml contains fluphenazine decanoate bp 25mg. 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. Prolixin decanoate fluphenazine decanoate fda package. Absorption of other oral medications may be decreased during. Each ml of haldol decanoate haloperidol decanoate 50 for im injection contains 50 mg haloperidol present as haloperidol decanoate 70. Labelingpackage insert label is not available on this site. 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. Haloperidol is the first of the butyrophenone series of major antipsychotics. 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. Saphris 5 mg tablets, black cherry flavor, are round, white to offwhite sublingual tablets, with 5 on one side within a circle. The basic effects of fluphenazine decanoate appear to be no different from those of fluphenazine hydrochlo ride, with the exception of duration of action. Your healthcare provider may increase your fluphenazine dose as necessary to control your symptoms, or may attempt to decrease your dose once your symptoms are under control.

Fluphenazine decanoate api manufacturers suppliers. A dry syringe and needle of at least 21 gauge should be used. Fluphenazine decanoate injection is a longacting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy e. If side effects occur, the infusion should be slowed or stopped until the symptoms subside. Fluphenazine decanoate, a human prescription drug labeled by westward pharmaceuticals corp.

The onset of action generally appears between 24 and. With any given phenothiazine derivative, the incidence and severity of such. Aug 26, 2019 haloperidol decanoate is almost insoluble in water 0. Fluphenazine, sold under the brand names prolixin among others, is an antipsychotic medication. If this is the first time you use this feature, you will be asked to authorise cambridge core to connect with your account. Pharmacology, adverse reactions, warnings and side effects. The ester ification of fluphenazine markedly prolongs the drugs duration of effect without unduly attenuating its bene ficial action. Use of a wet needle or syringe may cause the solution to become cloudy. Fluphenazine decanoate medicinal forms bnf content. Feb 05, 2020 do not stop taking fluphenazine decanoate injection all of a sudden without calling your doctor. 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. Haloperidol decanoate is a longacting form of haloperidol. Haldol decanoate 50 haloperidol haldol decanoate 100.

When acute symptoms have subsided, 25 mg 1 ml of fluphenazine decanoate injection may be. It is given by mouth, injection into a muscle, or just under the skin. A comparative trial of haloperidol decanoate and fluphenazine. Administer 21 consecutive days of oral aripiprazole. Fluphenazine decanoate coupons save 97% with free coupons. Fluphenazine decanoate inj prescription and dosage sizes information for physicians and healthcare professionals. Pricing, sizing, legal catgories and other medicinal forms information for fluphenazine decanoate. Dailymed fluphenazine decanoate injection, solution. Haloperidol injection, usp is available as a sterile parenteral form. Fluphenazine decanoate prescription price comparison. Dailymed fluphenazine hydrochloride solution, concentrate.

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