Fluphenazine Decanoate (Fluphenazine Decanoate)

Trade Name : Fluphenazine Decanoate

West-Ward Pharmaceuticals Corp

INJECTION

Strength 25 mg/mL

FLUPHENAZINE DECANOATE Phenothiazines [CS],Phenothiazine [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluphenazine Decanoate (Fluphenazine Decanoate) which is also known as Fluphenazine Decanoate and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 25 mg/mL per ml. Read more

Fluphenazine Decanoate (Fluphenazine Decanoate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx only
  • WARNINGu00a0
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis: n- Array
  • 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. 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 1.2% (w/v) benzyl alcohol as a preservative. At the time of manufacture, the air in the vials is replaced by nitrogen.
  • The chemical name of fluphenazine decanoate is 4-[3-[2-(Trifluoromethyl)-10-phenothiazin-10-yl]propyl]-1-piperazineethanol decanoate. It has the following structural formula:
  • Molecular Formula = CHFNOSu00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0M.W.= 591.78
  • The basic effects of fluphenazine decanoate appear to be no different from those of fluphenazine hydrochloride, with the exception of duration of action. The esterification of fluphenazine markedly prolongs the drugu2019s duration of effect without unduly attenuating its beneficial action.
  • Fluphenazine decanoate has activity at all levels of the central nervous system as well as on multiple organ systems. The mechanism whereby its therapeutic action is exerted is unknown.
  • Fluphenazine differs from other phenothiazine derivatives in several respects: it is more potent on a milligram basis, it has less potentiating effect on central nervous system depressants and anesthetics than do some of the phenothiazines and appears to be less sedating, and it is less likely than some of the older phenothiazines to produce hypotension (nevertheless, appropriate cautions should be observed - See Sections on and ).
  • Fluphenazine Decanoate Injection, USP 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, USP has not been shown effective in the management of behavioral complications in patients with mental retardation.
  • 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 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.
  • No data
  • No data
  • No data
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Fluphenazine decanoate injection may be given intramuscularly or subcutaneously. 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 the following regimens are suggested:
  • For , 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 patientu2019s 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 patientu2019s response to fluphenazine and to establish appropriate dosage. For psychotic patients who have been stabilized on a fixed daily dosage of fluphenazine hydrochloride tablets, fluphenazine hydrochloride elixir, or fluphenazine hydrochloride oral solution, conversion of therapy from these short-acting oral forms to the long-acting injectable fluphenazine decanoate 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; however, a controlled multicentered study, 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) fluphenazine decanoate every three weeks. This represents an approximate conversion ratio of 0.5 mL (12.5 mg) of decanoate every three weeks for every 10 mg of fluphenazine hydrochloride daily.
  • Once conversion to fluphenazine decanoate is made, careful clinical monitoring of the patient and appropriate dosage adjustment should be made at the time of each injection.
  • Severely agitated patients
  • u201cPoor risku201d patients
  • 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.
  • Fluphenazine Decanoate Injection, USP, 25 mg/mL is available in 5 mL multiple dose vials, packaged in individual cartons. n
  • Protect from light.
  • Store at controlled room temperature 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F); avoid freezing and excessive heat.
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .
  • For Product Inquiry call 1-877-845-0689.
  • u00a0
  • Manufactured byn
  • Distributed byn n- West-Ward Pharmaceuticalsn
  • PIN409-WES/2
  • Revised November 2016
  • NDC 0143-9529-01u00a0u00a0n 5 mL Multiple Dose Vial
  • Each mL contains 25 mgfluphenazine decanoate insesame oil with 1.2% (w/v)benzyl alcohol as apreservative.USUAL DOSAGE: See packageinsert.u00a0Store at 20u00b0 to 25u00b0 C(68u00b0 to 77u00b0 F) [See USP]. Avoidfreezing and excessive heat.
  • NDC 0143-9529-01u00a0u00a0
  • 5 mL MULTIPLE DOSE VIAL
  • FLUPHENAZINEDECANOATE INJECTION, USP125 mg/5 mL(25 mg/mL)FOR INTRAMUSCULAROR SUBCUTANEOUS USE
  • Arrayn- u00a0Rx only
  • No data

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