Fluphenazine Decanoate - Uses, Dose, Side effects, MOA, Brands

Fluphenazine Decanoate is a typical antipsychotic medicine that is used in the treatment of patients with schizophrenia, psychosis, and tic disorders.

Fluphenazine Decanoate Uses:

  • Psychotic disorders:

    • Used for the management of manifestations of psychotic disorders; decanoate injection is intended for use in the management of patients requiring prolonged therapy.
    • Limitations of use: Fluphenazine has not been shown to be effective in the management of behavioral complications in patients with mental retardation.
  • Use: Off-Label: Adult

    • Used in the chorea of Huntington disease
    • Used in chronic tic disorders
    • Used in the psychosis/ agitation associated with dementia

Read: Olanzapine (Zyprexa)

Fluphenazine Decanoate Dose in Adults

Fluphenazine Decanoate Dose in the treatment of Psychosis:

  • Oral:
    • Initial: 2.5 to 10 mg per day in 3 or 4 divided doses;
    • Maintenance: 1 to 5 mg per day (may be given as a daily dose);
    • Note: Some patients may require up to 40 mg per day for symptom control (long-term safety of higher doses not established)
    • PORT guidelines:
      • Acute therapy: 6 to 20 mg/day for up to 6 weeks;
      • Maintenance: 6 to 12 mg per day.
  • IM (hydrochloride):
    • Initial: 1.25 mg as a single dose; depending on severity and duration, may need 2.5 to 10 mg per day in divided doses at 6- to 8-hour intervals (IM fluphenazine HCl is approximately equivalent to 33 percent to 50 percent  of the oral fluphenazine HCl dose);
    • Use caution with doses more than 10 mg per day; once symptoms stabilized, the transition to oral maintenance therapy
    • Long-acting maintenance injections (decanoate):
      • Prior to initiation consider establishing response, the appropriate dose, and tolerability with a short-acting form of fluphenazine.
  • IM, SubQ (decanoate):
    • 6.25 to 25 mg every 2 weeks.
    • Once at a steady-state, the effects of a single injection may last 4 to 6 weeks;
    • Titrate dose cautiously, if doses more than 50 mg are needed, increase in 12.5 mg increments (maximum dose: 100 mg).
  • Conversion from hydrochloride dosage forms to decanoate IM:

    • 5 mg of decanoate every 3 weeks is approximately equivalent to 10 mg of oral hydrochloride per day

Note: Decrease the oral fluphenazine (or current antipsychotic) dose by half after the initial injection; consider discontinuation of oral therapy after the second injection.

Fluphenazine Decanoate Dose in the treatment of Chorea of Huntington disease (off-label):

  • Oral: Initial:
    • 2 mg daily; increase the dose gradually based on response and tolerability; doses as high as 7 mg/day have been reported.
  • IM (decanoate):
    • Initial: 25 mg; after the initial injection, the dose can be increased based on response and tolerability in increments of 12.5 to 25 mg up to 75 mg every 3 weeks.
  • Additional data may be necessary to further define the role of fluphenazine in this condition.

Fluphenazine Decanoate Dose in the treatment of Chronic tic disorders (off-label):

  • Oral:
    • Initial: 0.5 to 1 mg once in a day;
    • increase in 0.5 mg to 1 mg increments every week based on response and tolerability.
    • Doses up to 24 mg divided 1 to 3 times daily have been studied.
    • The usual dose range: 2.5 to 10 mg per day.
    • Additional data may be necessary to further define the role of fluphenazine in this condition.

Discontinuation of therapy:

  • The American Psychiatric Association (APA), Canadian Psychiatric Association (CPA), and World Federation of Societies of Biological Psychiatry (WFSBP) guidelines recommend gradually tapering antipsychotics to avoid withdrawal symptoms and minimize the risk of relapse.
  • The risk for withdrawal symptoms may be highest with highly anti-cholinergic or dopaminergic antipsychotics.
  • Continuing anti-parkinsonism agents for a brief period after discontinuation may prevent withdrawal symptoms.
  • When stopping antipsychotic therapy in patients with schizophrenia, the CPA guidelines recommend a gradual taper over 6 to 24 months, and the APA guidelines recommend reducing the dose by 10% each month.
  • When switching antipsychotics, 3 strategies have been suggested:
    • Cross-titration (gradually discontinuing the first antipsychotic while gradually increasing the new antipsychotic),
    • overlap and taper (maintaining the dose of the first antipsychotic while gradually increasing the new antipsychotic, then tapering the first antipsychotic), and
    • abrupt change (abruptly discontinuing the first antipsychotic and either increasing the new antipsychotic gradually or starting it at a treatment dose).
  • Evidence supporting ideal switch strategies and taper rates is limited, and results are conflicting.

Fluphenazine Decanoate Dose in Childrens

Fluphenazine Decanoate Dose in the treatment of Chronic tic disorders (off-label):

  • Children and Adolescents:

    • Oral: Initial:
      • 0.5 to 1 mg once in a day;
      • Increase in 0.5 mg to 1 mg increments every week based on response and tolerability.
      • Doses up to 24 mg divided 1 to 3 times daily have been studied in adult and pediatric patients
      • The usual dose range: 0.25 to 10 mg per day.
    • Additional data may be necessary to further define the role of fluphenazine in this condition.

Fluphenazine Decanoate Pregnancy Category: N

  • Both oxcarbazepine as well as its monohydroxy metabolite, (MHD), have pharmacological activity.
  • It is not known what the mechanism behind anticonvulsant effects works.
  • MHD and Oxcarbazepine block voltage-sensitive sodium channel, stabilizing hyperexcited neuronal membranes and inhibiting repetitive firing and decreasing the spread of synaptic impulses.
  • These actions can be used to stop the spread of seizures.
  • MHD and Oxcarbazepine also increase potassium conductance, and modulate activity of high-voltage activated Calcium channels.

Dose in Kidney Disease:

The manufacturer's labeling doesn't provide any dosage adjustments; Use with caution.

Dose in Liver disease:

Manufacturer's labeling doesn't provide any dosage adjustments

Side effects of Fluphenazine Decanoate:

  • Cardiovascular:

    • Cardiac Arrhythmia
    • Edema
    • Variable Blood Pressure
    • Hypertension
    • Hypotension
    • Tachycardia
  • Central Nervous System:

    • Akathisia
    • Drowsiness
    • Dystonia
    • EEG Pattern Changes
    • Excitement
    • Headache
    • Hyperreflexia
    • Lethargy
    • Bizarre Dream
    • Cerebral Edema
    • Depression
    • Disruption Of Body Temperature Regulation
    • Dizziness
    • Neuroleptic Malignant Syndrome
    • Parkinsonian-Like Syndrome
    • Restlessness
    • Seizure
    • Tardive Dyskinesia
  • Dermatologic:

    • Dermatitis
    • Pruritus
    • Seborrhea
    • Skin Photosensitivity
    • Skin Pigmentation
    • Skin Rash
    • Eczema
    • Erythema
    • Urticaria
  • Endocrine & Metabolic:

    • Galactorrhea
    • Gynecomastia
    • Increased Serum Prolactin
    • Menstrual Disease
    • Amenorrhea
    • Change In Libido
    • SIADH (Syndrome Of Inappropriate Antidiuretic Hormone Secretion)
    • Weight Gain
  • Gastrointestinal:

    • Anorexia
    • Xerostomia
    • Constipation
    • Paralytic Ileus
    • Salivation
  • Genitourinary:

    • Bladder Paralysis
    • Urinary Incontinence
    • Ejaculatory Disorder
    • Impotence
    • Mastalgia
  • Hematologic & Oncologic:

    • Agranulocytosis
    • Eosinophilia
    • Thrombocytopenia
    • Leukopenia
    • Nonthrombocytopenic Purpura
    • Pancytopenia
  • Hepatic:

    • Cholestatic Jaundice
    • Hepatotoxicity
  • Neuromuscular & Skeletal:

    • Muscle Spasm (Neck)
    • Systemic Lupus Erythematosus
    • Tremor (Fingers)
  • Ophthalmic:

    • Blurred Vision
    • Corneal Changes
    • Glaucoma
    • Lens Disease
    • Retinitis Pigmentosa
  • Renal:

    • Polyuria
  • Respiratory:

    • Asthma
    • Laryngeal Edema
    • Nasal Congestion

Contraindications to Fluphenazine Decanoate:

  • Hypersensitivity to fluphenazine and any component of the formulation (cross-reactivity among phenothiazines) may occur.
  • Grave CNS Depression
  • coma
  • Subcortical brain injury;
  • Blood dyscrasias
  • Hepatic disease
  • Patients who have received large amounts of hypnotics.
  • Children younger than 12 years old (fluphenazine canoate only)

Canadian labeling: Additional contraindications not in US labeling

  • Fluphenazine decanoate
    • Cerebral atherosclerosis is a common condition.
    • Renal insufficiency is a serious cardiovascular disorder.
    • Pheochromocytoma.

Warnings and precautions

  • Modified cardiac conduction

    • May cause cardiac conduction to be altered (life-threatening arrhythmias have been reported with therapeutic doses antipsychotics).
  • Anticholinergic effects

    • Anticholinergic effects may occur (constipation, urinary retention, xerostomia and blurred vision).
    • Patients with reduced gastrointestinal motility, paralytic and ileus, urinary retentions, BPH, xerostomia, and visual impairments should be cautious.
    • Fluphenazine is a lower-potency antipsychotic than other antipsychotics.
  • Blood dyscrasias

    • In clinical trials and postmarketing reports, there have been reports of leukopenia, neutropenia, and sometimes fatal agranulocytosis in antipsychotic use.
    • Periodic blood count assessments should be done if there are any risk factors, such as low WBC or a history of drug-induced neutropenia/neutropenia.
    • Stop treatment if you experience blood dyscrasias, or if your absolute neutrophil count is 1000/mm3.
  • Depression in the CNS:

    • CNS depression can lead to mental or physical impairments. Patients should be cautious about driving or operating machinery that requires mental alertness.
  • Esophageal dysmotility/aspiration

    • Antipsychotic use has been linked to esophageal dysmotility, aspiration, and increased risk with age.
    • Patients at high risk of aspiration pneumonia (ie Alzheimer's disease) should be treated with caution, especially if they are older than 75 years.
  • Extrapyramidal symptoms

    • Extrapyramidal symptoms (EPS).
      • Extrapyramidal symptoms may include tardive dyskinesia, pseudo-parkinsonism and akathisia.
    • Higher doses of antipsychotics and use of conventional antipsychotics may increase the risk of dystonia (and other EPS), in younger patients.
    • There are several factors that increase the vulnerability to tardive dyskinesia, including older age, female gender, postmenopausal status and pseudo-parkinsonism symptoms. Parkinson disease, affective disorders (particularly major depression disorder), concurrent medical conditions such as diabetes, prior brain damage, alcoholism, poor response to treatment, and high doses antipsychotics.
    • You may consider discontinuing therapy if you experience tardive dyskinesia symptoms.
  • Falls

    • Patients with certain diseases or medications that can increase fall risk should have their fall risk assessed at baseline and again periodically throughout treatment.
    • May increase the chance of falling due to somnolence and orthostatic hypotension.
  • Hepatic effects

    • Use has been associated with liver damage and jaundice in the cholestatic type hepatitis.
  • Hyperprolactinemia

    • Hyperprolactinemia is a condition that results in an increase in prolactin levels. Clinical significance of hyperprolactinemia for patients with breast cancer or other prolactin dependent tumors is not known.
  • Neuroleptic malignant Syndrome (NMS).

    • This may be related to NMS. Monitor for changes in mental status, fever, rigidity of the muscles, and/or other signs that could indicate NMS.
  • Ocular effects

    • Extended therapy may cause pigmentary retinopathy and lenticular or corneal deposits.
  • Orthostatic hypotension

    • Orthostatic hypotension may occur; caution is advised in patients who are at high risk or those who cannot tolerate temporary hypotension (cerebrovascular disease and hypovolemia), or for people taking concurrent medication that could lead to hypotension/bradycardia.
  • Temperature regulation

    • It is possible to have impaired core body temperature regulation. Be aware of heat exposure, dehydration and any concomitant anticholinergic medication.
  • Cardiovascular disease

    • Patients with severe cardiovascular disease should be cautious.
  • Dementia: [US Boxed Warning]

    • Antipsychotics have a higher death rate than placebo for dementia-related psychosis in the elderly.
    • Patients with Parkinson disease dementia or Lewy body dementia should be cautious due to the increased risk of adverse effects and increased sensitivity for extrapyramidal effects. Also, there is an association with irreversible cognitive decline or death.
    • The APA recommends that second-generation antipsychotics be preferred to first generation antipsychotics for elderly patients with dementia-related schizophrenia (APA [Reus 2016]). This is because there is a greater risk of harm than second generation antipsychotics.
    • The majority of deaths were either from cardiovascular disease (eg heart failure, sudden death, etc.) or from infectious diseases (eg pneumonia).
    • For the treatment of dementia-related psychosis, fluphenazine has not been approved.
  • Hepatic impairment

    • Patients with hepatic impairment should be cautious; patients with liver damage should not be used.
  • Renal impairment

    • Patients with impaired renal function should be cautious; stop therapy if the BUN is abnormal.
  • Seizure disorder

    • Patients with seizures history should be cautious.

Fluphenazine: Drug Interaction

Risk Factor C (Monitor therapy)

Acetylcholinesterase Inhibitors

May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors.

Acetylcholinesterase Inhibitors (Central)

May enhance the neurotoxic (central) effect of Antipsychotic Agents. Severe extrapyramidal symptoms have occurred in some patients.

Ajmaline

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

Alcohol (Ethyl)

CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl).

Alizapride

May enhance the CNS depressant effect of CNS Depressants.

Amifampridine

Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine.

Aminolevulinic Acid (Topical)

Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical).

Amphetamines

Antipsychotic Agents may diminish the stimulatory effect of Amphetamines.

Antacids

May decrease the absorption of Antipsychotic Agents (Phenothiazines).

Anticholinergic Agents

May enhance the adverse/toxic effect of other Anticholinergic Agents.

Antimalarial Agents

May increase the serum concentration of Antipsychotic Agents (Phenothiazines).

Beta-Blockers

Antipsychotic Agents (Phenothiazines) may enhance the hypotensive effect of Beta-Blockers. Beta-Blockers may decrease the metabolism of Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease the metabolism of BetaBlockers. Exceptions: Atenolol; Levobunolol; Metipranolol; Nadolol.

Botulinum Toxin-Containing Products

May enhance the anticholinergic effect of Anticholinergic Agents.

Brexanolone

CNS Depressants may enhance the CNS depressant effect of Brexanolone.

Brimonidine (Topical)

May enhance the CNS depressant effect of CNS Depressants.

Cannabidiol

May enhance the CNS depressant effect of CNS Depressants.

Cannabis

May enhance the CNS depressant effect of CNS Depressants.

Chloral Betaine

May enhance the adverse/toxic effect of Anticholinergic Agents.

Chlorphenesin Carbamate

May enhance the adverse/toxic effect of Antipsychotic Agents (Phenothiazines).

Chlorphenesin Carbamate

May enhance the adverse/toxic effect of CNS Depressants.

CloBAZam

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

CNS Depressants

May enhance the adverse/toxic effect of other CNS Depressants.

Cobicistat

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

CYP2D6 Inhibitors (Moderate)

May decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors).

Darunavir

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

Deutetrabenazine

May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased.

Dimethindene (Topical)

May enhance the CNS depressant effect of CNS Depressants.

Doxylamine

May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended.

Dronabinol

May enhance the CNS depressant effect of CNS Depressants.

Esketamine

May enhance the CNS depressant effect of CNS Depressants.

Gastrointestinal Agents (Prokinetic)

Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic).

Glucagon

Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased.

Guanethidine

Antipsychotic Agents may diminish the therapeutic effect of Guanethidine.

HydrOXYzine

May enhance the CNS depressant effect of CNS Depressants.

Imatinib

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

Itopride

Anticholinergic Agents may diminish the therapeutic effect of Itopride.

Kava Kava

May enhance the adverse/toxic effect of CNS Depressants.

Lithium

May enhance the neurotoxic effect of Antipsychotic Agents. Lithium may decrease the serum concentration of Antipsychotic Agents. Specifically noted with chlorpromazine.

Lofexidine

May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs.

Lumefantrine

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

Magnesium Sulfate

May enhance the CNS depressant effect of CNS Depressants.

Methylphenidate

Antipsychotic Agents may enhance the adverse/toxic effect of Methylphenidate. Methylphenidate may enhance the adverse/toxic effect of Antipsychotic Agents.

MetyroSINE

CNS Depressants may enhance the sedative effect of MetyroSINE.

MetyroSINE

May enhance the adverse/toxic effect of Antipsychotic Agents.

Mianserin

May enhance the anticholinergic effect of Anticholinergic Agents.

Minocycline

May enhance the CNS depressant effect of CNS Depressants.

Mirabegron

Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron.

Mirtazapine

CNS Depressants may enhance the CNS depressant effect of Mirtazapine.

Nabilone

May enhance the CNS depressant effect of CNS Depressants.

Nitroglycerin

Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption.

Panobinostat

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

Peginterferon Alfa-2b

May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

Perhexiline

CYP2D6 Substrates (High risk with Inhibitors) may increase the serum concentration of Perhexiline. Perhexiline may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

Porfimer

Photosensitizing Agents may enhance the photosensitizing effect of Porfimer.

Quinagolide

Antipsychotic Agents may diminish the therapeutic effect of Quinagolide.

QuiNINE

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

Ramosetron

Anticholinergic Agents may enhance the constipating effect of Ramosetron.

Rufinamide

May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced.

Selective Serotonin Reuptake Inhibitors

CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced.

Serotonin Modulators

May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline.

Serotonin Reuptake Inhibitor/Antagonists

Antipsychotic Agents (Phenothiazines) may enhance the adverse/toxic effect of Serotonin Reuptake Inhibitor/Antagonists. Specifically, this may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Serotonin Reuptake Inhibitor/Antagonists may enhance the hypotensive effect of Antipsychotic Agents (Phenothiazines).

Tetrabenazine

May enhance the adverse/toxic effect of Antipsychotic Agents.

Tetrahydrocannabinol

May enhance the CNS depressant effect of CNS Depressants.

Tetrahydrocannabinol and Cannabidiol

May enhance the CNS depressant effect of CNS Depressants.

Thiazide and Thiazide-Like Diuretics

Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics.

Thiopental

Antipsychotic Agents (Phenothiazines) may enhance the adverse/toxic effect of Thiopental.

Topiramate

Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate.

Trimeprazine

May enhance the CNS depressant effect of CNS Depressants.

Verteporfin

Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin.

Risk Factor D (Consider therapy modification)

Abiraterone Acetate

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. When concurrent use is not avoidable, monitor patients closely for signs/symptoms of toxicity.

Anti-Parkinson Agents (Dopamine Agonist)

May diminish the therapeutic effect of Antipsychotic Agents (First Generation [Typical]). Antipsychotic Agents (First Generation [Typical]) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Avoid concomitant therapy if possible and monitor for decreased effects of both agents when these combinations cannot be avoided. Atypical antipsychotics such as clozapine and quetiapine may be less likely to reduce the effects of anti-Parkinson agents.

Asunaprevir

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors).

Blonanserin

CNS Depressants may enhance the CNS depressant effect of Blonanserin.

Buprenorphine

CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants.

Chlormethiazole

May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used.

CYP2D6 Inhibitors (Strong)

May decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors).

Dacomitinib

May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Management: Avoid concurrent use of dacomitinib with CYP2D6 subtrates that have a narrow therapeutic index.

Droperidol

May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs.

Flunitrazepam

CNS Depressants may enhance the CNS depressant effect of Flunitrazepam.

HYDROcodone

CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.

Iohexol

Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants.

Iomeprol

Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants.

Iopamidol

Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants.

Mequitazine

Antipsychotic Agents may enhance the arrhythmogenic effect of Mequitazine. Management: Consider alternatives to one of these agents when possible. While this combination is not specifically contraindicated, mequitazine labeling describes this combination as discouraged.

Methotrimeprazine

CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established.

Opioid Agonists

CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.

OxyCODONE

CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.

Perampanel

May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination.

Pramlintide

May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract.

Secretin

Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin.

Sodium Oxybate

May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated.

Suvorexant

CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended.

Tapentadol

May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.

Zolpidem

CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol.

Risk Factor X (Avoid combination)

Aclidinium

May enhance the anticholinergic effect of Anticholinergic Agents.

Aminolevulinic Acid (Systemic)

Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic).

Amisulpride

Antipsychotic Agents may enhance the adverse/toxic effect of Amisulpride. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs.

Azelastine (Nasal)

CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal).

Bromopride

May enhance the adverse/toxic effect of Antipsychotic Agents.

Bromperidol

May enhance the CNS depressant effect of CNS Depressants.

Cimetropium

Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium.

Dronedarone

Antipsychotic Agents (Phenothiazines) may enhance the arrhythmogenic effect of Dronedarone.

Eluxadoline

Anticholinergic Agents may enhance the constipating effect of Eluxadoline.

Glycopyrrolate (Oral Inhalation)

Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation).

Glycopyrronium (Topical)

May enhance the anticholinergic effect of Anticholinergic Agents.

Ipratropium (Oral Inhalation)

May enhance the anticholinergic effect of Anticholinergic Agents.

Levosulpiride

Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride.

Metoclopramide

May enhance the adverse/toxic effect of Antipsychotic Agents.

Orphenadrine

CNS Depressants may enhance the CNS depressant effect of Orphenadrine.

Oxatomide

May enhance the anticholinergic effect of Anticholinergic Agents.

Oxomemazine

May enhance the CNS depressant effect of CNS Depressants.

Paraldehyde

CNS Depressants may enhance the CNS depressant effect of Paraldehyde.

Piribedil

Antipsychotic Agents may diminish the therapeutic effect of Piribedil. Piribedil may diminish the therapeutic effect of Antipsychotic Agents. Management: Use of piribedil with antiemetic neuroleptics is contraindicated, and use with antipsychotic neuroleptics, except for clozapine, is not recommended.

Potassium Chloride

Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride.

Potassium Citrate

Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate.

Revefenacin

Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin.

Saquinavir

Antipsychotic Agents (Phenothiazines) may enhance the arrhythmogenic effect of Saquinavir. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs.

Sulpiride

Antipsychotic Agents may enhance the adverse/toxic effect of Sulpiride.

Thalidomide

CNS Depressants may enhance the CNS depressant effect of Thalidomide.

Tiotropium

Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium.

Umeclidinium

May enhance the anticholinergic effect of Anticholinergic Agents.

 

Monitoring parameters:

  • Mental health;
  • Vital signs (as indicated by a doctor);
  • Weight, height, waist circumference, and BMI (baseline) at each visit for the first six months. Visits are made quarterly with stable antipsychotic medication.
  • CBC (as indicated by the doctor; patients who have a history of drug-induced leukopenia/neutropenia or low WBC should be monitored frequently in the first few months.
  • Electrolytes, renal function and liver function (yearlyly and as indicated by the doctor; discontinue treatment if BUN is abnormal).
  • Fasting plasma glucose level/HbA
  • lipid panel (baseline, repeat every 2 years if your LDL level has not increased; repeat every 6 month if it is higher than 130 mg/dL).
  • Changes in menstruation, galactorrhea development, libido and ejaculatory functions (at each visit during the first 12 weeks following the antipsychotic's administration or until the dose becomes stable; thereafter, annually).
  • Parkinsonian signs or abnormal involuntary movements (baseline; continue weekly until dose stabilization for at least 2 week after introduction, and 2 weeks after any significant dose rise);
  • Visual changes (enquire annually);
  • Lateive dyskinesia occurs every 6 months
  • High-risk patients should be seen every 3 months
  • Ocular examinations (annually for patients over 40 years old; once every 2 years for younger patients).

How to administer Fluphenazine Decanoate?

IM:

  • You can inject the hydrochloride/decanoate formulation intramuscularly.
  • Hypotension should be monitored.

Solution: Injection of decanoate

  • To administer fluphenazine, use a dry needle and syringe of >=21 gauge. A wet needle/syringe can cause the solution to cloudy.
  • To prevent leakage, Ztrack injection techniques should be used. Fluphenazine injection by deltoid is recommended by experts.

Oral:

  • To ensure stability and palatability, oral liquid concentrate must be dilute immediately before administration.
  • Mix at least 60mL (2 fl. oz.) of milk, tomato juice or uncaffeinated soft drink, or juices with fruit juices.
  • Do not mix caffeine-containing beverages (coffee, tea, cola), tannins or apple juice (tea), pectinate (apple cider) with any other beverage.

SubQ

  • Subcutaneous administration of the decanoate formulation is not permitted.
  • To administer fluphenazine, use a dry needle and a syringe of >=21 gauge. A wet needle/syringe could cause the solution to cloudy.

Mechanism of action of Fluphenazine Decanoate:

  • Fluphenazine, a piperazine-phenothiazine antipsychotic, blocks nonselectively postsynaptic dopaminergic D2 nerves in the brain.
  • However, fluphenazine only has limited activity at muscarinic and histaminergic receptors.

The onset of action:

  • Decanoate: 24 to 72 hours

Peak effect:

  • Decanoate: 48 to 96 hours

Duration:

  • Decanoate: ~4 to 6 weeks

Metabolism:

  • Hepatic via CYP 2D6.

Bioavailability:

  • 35 percent.

Half-life elimination (derivative dependent):

  • Oral: 14.4 to 16.4 hours.
  • Decanoate: ~14 days.

Time to peak, serum:

  • Oral: 2.8 hours;
  • Decanoate: 8 to 10 hours.

International Brand Names of Fluphenazine:

  • APO-Fluphenazine
  • FluPHENAZine Omega
  • Modecate Concentrate
  • Fenazine
  • Flenazine
  • Fludecasine
  • Fludecate
  • Fludecate Multidose
  • Flufenan
  • Fluvita
  • Funazine
  • FunazineS
  • PMS-Fluphenazine
  • PMS-Fluphenazine Decanoate
  • Anatensol
  • Anatensol Decanoate
  • Cenilene
  • Dapotum
  • Dapotum D
  • Dapotum d
  • Deca
  • Lyogen
  • Lyogen Depot
  • Modecate
  • Modicate
  • Moditen
  • Moditen Depot
  • Shrizine 1
  • Sikzonoate
  • Siqualone
  • Sydepres
  • Monasan
  • Moody
  • Omca
  • Pharnazine
  • Prolixin-D
  • Shrizine
  • Ziphen

Fluphenazine Brand Names in Pakistan:

Fluphenazine Injection 25 mg in Pakistan

Flufiwan Swan Pharmaceuticals(Pvt) Ltd
Synocate Polyfine Chempharma (Pvt) Ltd.

Fluphenazine Injection 25 mg/ml in Pakistan

Fenarax Mediceena Pharma (Pvt) Ltd.
Flitzin Fynk Pharmaceuticals
Flucate Akhai Pharmaceuticals.
Fluphan Pharmedic (Pvt) Ltd.
Fluphen Haji Medicine Co.
Gencate Genetics Pharmaceuticals
M-Kate Ophth-Pharma (Pvt) Ltd.
Modecate Glaxosmithkline
Saviget Cirin Pharmaceuticals (Pvt) Ltd.

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