Adult Dosing

Psychotic disorders (fluphenazine hydrochloride)

• Start 1.25 mg IM; initial total daily dose may range from 2.5-10 mg IM given in divided doses q6-8 hrs depending on severity and duration of symptoms
• May increase the dosage, if necessary, until therapeutic effect is achieved
• Dosage >10 mg/day should be used with caution
• Initiate oral maintenance therapy once symptoms are controlled

Note:

• Therapy must be started with lowest possible dose and individualized as per severity of symptoms

Prolonged parenteral neuroleptic therapy (fluphenazine decanoate)

• Start 12.5-25 mg IM/SC
• Max: 100 mg/day
• Subsequent dose and dosage interval to be decided as per patient’s response
• Maintenance therapy: Single injection IM/SC q4-6 wks

• Therapy must be started with lowest possible dose and individualized as per severity of symptoms and patient response
• Patients with no history of phenothiazine use should be initially treated with a short-acting form of fluphenazine before administering the decanoate to evaluate therapeutic response and establish suitable dosage
• If a patient is severely agitated, initiate treatment with a rapid-acting phenothiazine (fluphenazine hydrocloride injection); administer fluphenazine decanoate once acute symptoms subside and adjust subsequent doses as necessary
• Increase the dosage in increments of 12.5 mg using caution, if doses >50 mg are indicated

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of manifestations of psychotic disorders (fluphenazine hydrochloride)
• Management of patients requiring prolonged parenteral neuroleptic therapy (fluphenazine decanoate)

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to phenothiazine derivatives
• Dementia-related psychosis in elderly patients
• Subcortical brain damage
• Concurrent administration of large doses of hypnotics
• Blood dyscrasias
• Hepatic damage
• Coma
• Severe CNS depression
• Severe bone marrow depression
• Severe respiratory depression

• Fluphenazine is not indicated for treatment of dementia-related psychosis
• Geriatric patients with dementia-related psychosis are at an increased risk of death when treated with antipsychotic agents
• Clinical studies have revealed increased mortality in patients treated with either atypical or conventional antipsychotic drugs
• Causes of death were mostly cardiovascular (heart failure, sudden death) or infectious (pneumonia) in nature. However, the extent to which these findings may be attributed to the antipsychotic drug as opposed to some patient characteristic(s) is not clear

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined; caution advised

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

See Supplemental Patient Information

• Fluphenazine is not approved for treatment of dementia-related psychosis [US Black Box Warning]
• Elderly patients with dementia-related psychosis using antipsychotics are at an increased risk of death [US Black Box Warning]
• Patients treated with antipsychotics, especially elderly women, may develop tardive dyskinesia, a condition characterized by involuntary, dyskinetic movements
• Tardive dyskinesia is irreversible and progressive with chronic administration of antipsychotics. If symptoms worsen, discontinue the therapy
• To reduce the occurrence of tardive dyskinesia, the dose of fluphenazine should be kept minimum for shortest possible duration or alternative treatments should be considered
• Potentially fatal neuroleptic malignant syndrome (NMS), characterized by hyperpyrexia, muscle rigidity, altered mental status and autonomic instability, has been reported with fluphenazine use. If NMS is observed, discontinue drug and initiate appropriate treatment
• Exposure to fluphenazine during pregnancy may cause extrapyramidal and withdrawal symptoms in neonates. Use of fluphenazine in pregnancy is advised only if potential benefit to the mother outweighs the risk to the fetus
• Use with caution in patients with cholestatic jaundice, dermatoses or allergic reactions to phenothiazines due to the possibility of cross-sensitivity
• Monitor patients treated with large doses of fluphenazine who are undergoing surgery due to an increased risk of developing hypotension
• Prolonged use of fluphenazine may cause liver damage, pigmentary retinopathy, lenticular/corneal deposits and irreversible dyskinesia
• Increase in serum prolactin levels, manifested by galactorrhea, amenorrhea, gynecomastia, and impotence, has been reported with use of fluphenazine
• Hematological abnormalities like leukopenia, neutropenia and agranulocytosis have been reported in clinical trial and postmarketing experience with fluphenazine
• Patients with preexisting low WBC and a history of drug-induced leukopenia/neutropenia are at higher risk of such hematological abnormalities. Monitor CBC regularly during the first few months of therapy; if there is a decline in WBC, discontinue the drug
• Fluphenazine may potentiate the effects of atropine in certain patients due to added anticholinergic effects
• Psychic dependence is not seen with fluphenazine; however, abrupt discontinuation of the drug may cause withdrawal symptoms such as gastritis, nausea and vomiting, dizziness, and tremulousness
• Regularly monitor renal and hepatic function during prolonged therapy. If BUN levels are abnormal, discontinue the drug
• Physicians should be alert to the possibility of silent pneumonias occurring in patients treated with fluphenazine
• Fluphenazine decanoate should be administered under the supervision of a qualified physician experienced in the clinical use of psychotropic drugs, especially phenothiazine derivatives

Cautions: Use cautiously in

• Allergic reactions to phenothiazines
• Exposure to extreme heat
• Exposure to organophosphates
• History of convulsive disorders
• Mitral insufficiency
• Cardiovascular diseases
• Pheochromocytoma
• Severe hypotension
• Parkinson disease
• Myasthenia gravis
• History of glaucoma
• Pulmonary disease
• Elderly patients
• Dementia
• Obstructive GI disease

Supplemental Patient Information

• Advise patients to avoid performing tasks like driving or operating machinery, as the drug may impair mental and physical abilities
• Instruct patients to avoid drinking alcohol during therapy

Pregnancy Category:C

Breastfeeding: Safety unknown. An alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 22 June 2011).

• CV: Hypertension, orthostatic hypotension, tachycardia, intramyocardial lesions, cardiac arrest, altered EKG, arrhythmias
• CNS: Neuroleptic malignant syndrome, catatonic state, aggravation of psychosis, CNS depression, altered EEG, altered CSF proteins, cerebral edema, neonatal withdrawal symptoms (third trimester use), seizures, restlessness, excitement, headache, bizarre dreams, drowsiness
• NEURO: Extrapyramidal symptoms, pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, hyperreflexia, tardive dyskinesia, neonatal extrapyramidal symptoms (third trimester use)
• GI: Nausea, salivation, dry mouth, constipation, fecal impaction, paralytic ileus, sore mouth, sore gums, dyspepsia, anorexia
• GU: Acute renal failure, polyuria, bladder paralysis, urinary retention
• HEMA: Myelosuppression, leukocytosis, blood dyscrasias, leukopenia, neutropenia, agranulocytosis, thrombocytopenic purpura, non-thrombocytopenic purpura, eosinophilia, pancytopenia, aplastic anemia
• METABOLIC: Loss of appetite, weight change, peripheral edema
• DERM: Perspiration, itching, erythema, urticaria, seborrhea, photosensitivity, eczema, exfoliative dermatitis, skin pigmentation
• EENT: Blurred vision, glaucoma, lenticular opacities, corneal opacities, pigmentary retinopathy, nasal congestion, sore throat, laryngeal edema
• RESP: Upper respiratory infection, acute fulminating pneumonia, pneumonitis, aspiration of gastric contents, asthma
• REPRODUCTIVE: False positive pregnancy test
• IMMU: SLE-like syndrome
• ENDO: Abnormal lactation, increased prolactin levels, gynecomastia, galactorrhea, menstrual irregularities, male impotency, increased libido
• LABTEST: Elevated CPK
• HEPA: Liver damage, cholestatic jaundice, liver function abnormalities
• LOCAL: Local tissue reactions
• HYPERSENSITIVITY: Anaphylactoid reactions
• MISC: Lethargy, death, angioneurotic edema, heat stroke

• Antipsychotic; exact mechanism of action is unknown. Possibly acts by blocking dopamine (D2) receptors in CNS and also exhibits anticholinergic and alpha-adrenergic blocking activity
• Metabolized extensively in liver; CYP450: 2D6
• Excreted in urine, feces/bile
• Half-life:
• Fluphenazine hydrochloride: 14.7-15.3 hrs
• Fluphenazine decanoate: 6-10 days

US Trade Name(s)

• Only generic available

US Availability

fluphenazine decanoate (generic)

• INJ: 25 mg/mL (5 mL vial)

fluphenazine hydrochloride (generic)

• INJ: 2.5 mg/mL (10 mL vial)

Canadian Trade Name(s)

• Modecate Concentrate

Canadian Availability

fluphenazine decanoate (generic)

• INJ: 25 mg/mL
• INJ: 100 mg/mL

Modecate Concentrate (fluphenazine decanoate)

• INJ: 100 mg/mL (1 mL amp)

UK Trade Name(s)

• Modecate
• Modecate Concentrate

UK Availability

fluphenazine decanoate (generic)

• INJ: 25 mg/mL (0.5, 1, 2 mL ampoules)
• INJ: 100 mg/mL (0.5, 1 mL ampoules)

Modecate (fluphenazine decanoate)

• INJ: 25 mg/mL (0.5, 1, 2 mL ampoules)

Modecate Concentrate (fluphenazine decanoate)

• INJ: 100 mg/mL (0.5, 1 mL amp)

Australian Trade Name(s)

• Modecate

Australian Availability

Modecate (fluphenazine decanoate)

• INJ: 25 mg/mL (0.5, 1, 2 mL amp)

[Outline]

Psychiatric

Antipsychotics

Phenothiazines

Pricing data from www.DrugStore.com in U.S.A.

• Fluphenazine HCl 2.5 MG TABS [Bottle] (MYLAN)
  60 mg = $15.99
  180 mg = $38.97
• Fluphenazine Decanoate 25 MG/ML SOLN [Vial] (APP PHARMACEUTICAL)
  5 ml = $82.99
  10 ml = $161.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.