Class: Phenothiazines
Note: This monograph also contains information on fluphenazine hydrochloride
VA Class: CN701
CAS Number: 5002-47-1
Brands: Prolixin
Special Alerts:
[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.
RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .
[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: , and .
Introduction
Phenothiazine antipsychotic agent.a b c d f g i
Uses for fluphenazine decanoate
Psychotic Disorders
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Symptomatic management of psychotic disorders (i.e., schizophrenia).a b c f g i
The long-acting decanoate ester is used mainly for maintenance therapy in patients with chronic schizophrenic disorder who cannot be relied on to take oral antipsychotic drugs; do not use for acute management of severely agitated patients.a b
Mental Retardation
Efficacy not established for management of behavioral complications in mental retardation.a b c f g i
fluphenazine decanoate Dosage and Administration
General
Use shorter-acting fluphenazine hydrochloride formulations in patients with acute schizophrenic reactions so that dosage can be readily adjusted according to patient’s tolerance and therapeutic response.a b
Administration
Administer fluphenazine hydrochloride orally or IM.a b c f g i
Administer fluphenazine decanoate IM or sub-Q.a b If used outside of psychiatric institutions, administer under direction of clinician experienced in use of psychotropic drugs, particularly phenothiazine derivatives.b
Avoid skin contact with elixir, oral concentrate solution, or injection since contact dermatitis rarely occurs.a d
Oral Administration
Fluphenazine hydrochloride: Administer orally every 6–8 hours initially; maintenance therapy can often be administered as a single daily dose.a c f g
When oral concentrate solution is used, dilute dose with at least 60 mL of suitable diluent (e.g., water; uncaffeinated soft drinks [e.g., Seven-Up]; carbonated orange beverage; sodium chloride; milk; V-8; or pineapple, apricot, prune, orange, tomato, or grapefruit juice) just before administration.a f (See Compatibility under Stability.)
IM or Sub-Q Administration
Fluphenazine hydrochloride: Administer IM every 6–8 hours.a f
Fluphenazine decanoate: Administer IM or sub-Q using a dry syringe and needle of at least 21 gauge; use of a wet needle or syringe may cause solution to become cloudy.b
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Available as fluphenazine hydrochloride or fluphenazine decanoate; dosage expressed in terms of the salt.b c f g i
Carefully adjust dosage according to individual requirements and response, using lowest possible effective dosage.a c f g
Because of risk of adverse reactions associated with cumulative effects of phenothiazines, periodically evaluate patients with a history of long-term therapy with fluphenazine and/or other antipsychotic agents to determine whether maintenance dosage may be decreased or drug therapy discontinued.a
Conversion from oral fluphenazine hydrochloride to long-acting decanoate injection may be indicated for psychotic patients stabilized on a fixed daily oral dosage.a c f g In patients without a history of therapy with phenothiazines, administer shorter-acting form for several weeks prior to instituting therapy with fluphenazine decanoate in order to determine patient’s approximate dosage requirements and susceptibility to adverse effects.a b
Precise formula for converting therapy from fluphenazine hydrochloride to fluphenazine decanoate not established.a An approximate conversion ratio of 12.5 mg every 3 weeks of fluphenazine decanoate for every 10 mg daily of fluphenazine hydrochloride has been used.a
Adults
Psychotic Disorders
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Oral
Fluphenazine hydrochloride: Initially, 2.5–10 mg daily given in divided doses every 6–8 hours.a c f g Dosage may be gradually increased, if necessary, until desired clinical effects are obtained.a c f g
Optimum therapeutic effect often occurs with oral fluphenazine hydrochloride dosages <20 mg daily.a c f g Dosages up to 40 mg may be required in severely disturbed patients, but safety of prolonged administration of such dosages not established.a c f g Use dosages >20 mg daily with caution.a
After maximum response attained, reduce fluphenazine hydrochloride dosage gradually to maintenance dosage of 1–5 mg daily, often as a single dose.a c f g To avoid recurrence of psychotic symptoms, continued therapy is required following optimum therapeutic response.a
IM
Fluphenazine hydrochloride: Generally, IM dose is approximately one-third to one-half the oral dose.a i
Usual initial fluphenazine hydrochloride dose is 1.25 mg.a i Depending on severity and duration of symptoms, initial total IM dosage may range from 2.5–10 mg daily given in divided doses every 6–8 hours; may gradually increase dosage if necessary, until symptoms are controlled.a i
Use fluphenazine hydrochloride dosages >10 mg daily with caution.a i
After symptoms are controlled, oral therapy generally should replace parenteral therapy.a i
IM or Sub-Q
Fluphenazine decanoate: In patients with chronic schizophrenic disorder, usual initial dose is 12.5–25 mg.a b
Carefully adjust subsequent fluphenazine decanoate dose and dosage interval according to patient tolerance and response;a b if doses >50 mg are deemed necessary, increase the next and succeeding doses cautiously in increments of 12.5 mg, but do not exceed 100 mg.a b
When administered as maintenance therapy, a single fluphenazine decanoate injection may be effective in controlling schizophrenic symptoms for up to 4 weeks or longer; response may persist for up to 6 weeks in some patients.a b
Prescribing Limits
Adults
Psychotic Disorders
Oral
Fluphenazine hydrochloride: Safety of prolonged administration of dosages up to 40 mg daily not established.a f g Use dosages >20 mg daily with caution.a
IM
Fluphenazine hydrochloride: Use dosages >10 mg daily with caution.a i
IM or Sub-Q
Fluphenazine decanoate: Do not exceed 100 mg.b
Special Populations
Geriatric Patients
Fluphenazine hydrochloride: Initially 1–2.5 mg orally daily.a c f g Increase dosage more gradually in debilitated, emaciated, or geriatric patients.a
Cautions for fluphenazine decanoate
Contraindications
Suspected or established subcortical brain damage.b c f g i
Comatose or severely depressed states.b c f g i
Blood dyscrasia or liver damage.b c f g i
Concomitant therapy with large doses of hypnotics.b c f g i
Known hypersensitivity to fluphenazineb c f g i or other phenothiazine derivatives (unless potential benefits outweigh possible risks).d
Warnings/Precautions
Warnings
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Tardive Dyskinesia
Tardive dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements, may develop in patients receiving antipsychotic agents, including fluphenazine.b c f g i Consider discontinuance.b c f g i
Neuroleptic Malignant Syndrome
Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, may occur in patients receiving antipsychotic agents, including fluphenazine.b c f g i
Sensitivity Reactions
Hypersensitivity
Skin disorders (e.g., pruritus, erythema, urticaria, seborrhea, photosensitivity, eczema, exfoliative dermatitis) reported with phenothiazine derivatives.b c f g i Contact dermatitis reported rarely.a
Consider possibility of anaphylactoid reactions.b c f g i
Cross-sensitivity
Possible cross-sensitivity with other phenothiazines; use with caution in patients who have developed cholestatic jaundice, dermatoses, or other allergic reactions to phenothiazine derivatives.b c f g i
General Precautions
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Use phenothiazines with caution in debilitated patients, patients with renal or hepatic disease, patients with glaucoma or prostatic hypertrophy, and patients exposed to organophosphate insecticides.b c d f g i
Use phenothiazines with caution in patients with hypocalcemia, since susceptibility to dystonic reactions may be increased.d
Abrupt Withdrawal
Gastritis, nausea, vomiting, dizziness, and tremulousness reported after abrupt discontinuance of high-dose therapy; minimize symptoms by continuing concomitant antiparkinsonian agents for several weeks after phenothiazine is withdrawn.b c f g i
Cardiovascular Effects
Hypotension occurs rarely.a b f g i Patients with pheochromocytoma, cerebral or vascular insufficiency, or severe cardiac reserve deficiency (e.g., mitral insufficiency), or psychotic patients receiving large doses of phenothiazines who are undergoing surgery may be especially prone to hypotensive effects;a b c f g i closely monitor such patients during therapy.a b c f g i
Hypertension and fluctuations in BP may occur.a b c f g i
Nervous System Effects
Possible risk of seizures; phenothiazines may lower seizure threshold.d Use with caution in patients with a history of seizures or EEG abnormalities or in those receiving anticonvulsant agents.b c d f g i Maintain adequate anticonvulsant therapy.d
Drowsiness or lethargy possible; may necessitate dosage reduction.b c f g i
Because of CNS depressant effects of phenothiazines, use with caution in patients with chronic respiratory disorders (e.g., severe asthma, emphysema, acute respiratory tract infections).d
Neurologic reactions from phenothiazine therapy may be similar to CNS manifestations accompanying certain disorders (e.g., Reye’s syndrome, encephalopathy, meningitis, tetanus); diagnosis of these disorders may be obscured or disease-associated manifestations may be incorrectly diagnosed as drug induced.d
Antiemetic effect of phenothiazines may mask signs of overdosage of toxic drugs (e.g., antineoplastic agents) or may obscure cause of vomiting in various disorders (e.g., intestinal obstruction, Reye’s syndrome, brain tumor).d
Phenothiazines depress hypothalamic mechanism for body temperature regulation; use caution in patients exposed to extreme heat or cold.b c f g i
Extrapyramidal symptoms occur frequently and are usually reversible; persistent reactions can usually be controlled by concomitant therapy with an antiparkinsonian drug and subsequent dosage reduction.a b c f g i
Autonomic reactions (e.g., nausea, appetite loss, salivation, polyuria, perspiration, dry mouth, headache, constipation) may occur.a b c f g i
Hematologic Effects
Blood dyscrasias, including leukopenia, agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura, eosinophilia, and pancytopenia reported with phenothiazine derivatives.b c d f g i Perform hematologic evaluations periodically.b c d f g i
If manifestations of blood dyscrasias (e.g., sore throat, fever, weakness) occur, discontinue until possibility of adverse hematologic effect is ruled out; if evidence of cellular depression (i.e., decreased leukocyte and differential counts) occurs, discontinue and institute appropriate therapy.b c d f g i
Hepatic Effects
Liver damage, manifested by cholestatic jaundice may occur, particularly during first months of therapy;b c f g i discontinue immediately if liver damage occurs.d
Consider possibility of liver damage in patients receiving prolonged therapy.b c f g i Monitor hepatic function periodically.b c f g i
Ocular Effects
Consider possibility of pigmentary retinopathy and lenticular and corneal deposits in patients receiving prolonged therapy.b c d f g i Periodic ophthalmic examinations recommended in patients receiving prolonged phenothiazine therapy with moderate to high dosages.d
Endocrine Effects
Elevated prolactin concentrations, which persist during chronic administration, possible.b c d f g i
Galactorrhea, amenorrhea, gynecomastia, and impotence reported.b c f g i
Pulmonary Effects
Clinicians should be alert to possible development of “silent pneumonias” in patients receiving phenothiazines, including fluphenazine.b c f g i
Use with caution in patients with chronic respiratory disorders (e.g., severe asthma, emphysema, acute respiratory tract infections).d
Specific Populations
Pregnancy
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Category C.e
Lactation
Phenothiazines are distributed into milk.d e Women receiving phenothiazines should not breast-feed.d
Pediatric Use
Insufficient experience with fluphenazine hydrochloride to establish safety and efficacy.a c f g i
Safety and efficacy of fluphenazine decanoate not established in children <12 years of age.a b
Geriatric Use
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Geriatric patients appear to be particularly sensitive to adverse CNS (e.g., tardive dyskinesia, parkinsonian manifestations, akathisia, sedation), anticholinergic, and cardiovascular (e.g., orthostatic hypotension) effects of antipsychotic agents.d (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Use phenothiazines with caution in patients with hepatic disease.d Monitor hepatic function periodically.b c f g i
Renal Impairment
Use phenothiazines with caution in patients with renal disease.d Monitor renal function periodically; if BUN becomes abnormal, discontinue therapy.b c f g i
Common Adverse Effects
Extrapyramidal reactions (e.g., pseudo-parkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, hyperreflexia), drowsiness, lethargy, weight gain.a b c d f g i
Interactions for fluphenazine decanoate
Specific Drugs and Laboratory Tests
Drug or Test | Interaction | Comments |
|---|---|---|
Anticonvulsants | Phenothiazines may lower seizure threshold, but CNS depressant effects do not potentiate anticonvulsant activity of anticonvulsantsd | Dosage adjustment of anticonvulsant may be necessary to maintain seizure control during concomitant used |
Atropine | Possible potentiated effects of atropine in some patients receiving fluphenazine because of added anticholinergic effectsb c f g i | |
CNS depressants (e.g., alcohol, analgesics, antihistamines, barbiturates, general anesthetics, opiates) | Possible additive effects or potentiated action of other CNS depressantsb c d f g i | Use concomitantly with caution to avoid excessive sedation or CNS depressionb c d During surgery in patients receiving high fluphenazine dosages, may need to reduce dosages of anesthetics or other CNS depressantsb c f g i |
Epinephrine | Reversal of epinephrine actionb c f g i | Do not use epinephrine for phenothiazine-induced hypotension; further lowering of BP may resultb c f g i |
Lithium | An acute encephalopathic syndrome reported occasionally, especially when high serum lithium concentrations presentd | Observe patients receiving combined therapy for evidence of adverse neurologic effects; promptly discontinue if such signs or symptoms appeard |
Test for phenylketonuria (PKU) | False-positive test results may occur during phenothiazine used | |
Tests for pregnancy | False-positive results reported in some patients receiving phenothiazinesb c d f g i | |
Tests for urobilinogen, amylase, uroporphyrins, porphobilinogens, 5-hydroxyindolacetic acid | Urinary metabolites of phenothiazines may cause urine to darken and result in false-positive test resultsd |
fluphenazine decanoate Pharmacokinetics
Absorption
Bioavailability
Rapidly absorbed from GI tract and from parenteral sites.a Peak serum concentrations were attained within 1.5–2 or 0.5 hours after IM or oral administration, respectively, of fluphenazine hydrochloride.a
Onset
Fluphenazine hydrochloride: Usually occurs within 1 hour following oral or IM administration.a
Fluphenazine decanoate: Within 24–72 hours.a b
Duration
Fluphenazine hydrochloride: 6–8 hours following oral or IM administration.a
Fluphenazine decanoate: Usually 1–6 weeks (average: 2 weeks).a
Distribution
Extent
Not fully elucidated; reportedly crosses blood-brain barrier.a
Phenothiazines cross the placenta and are distributed into milk.e
Elimination
Metabolism
Metabolic fate not fully elucidated.a
Elimination Route
Excreted in feces and urine as unchanged drug, fluphenazine sulfoxide, and 7-hydroxyfluphenazine following IM administration of fluphenazine decanoate in 1 patient studied; also excreted in urine as metabolite conjugates.a
Half-life
Fluphenazine hydrochloride: 14.7–15.3 hours following IM or oral administration.a
Fluphenazine decanoate: 6.8–9.6 days following IM administration.a
Stability
Storage
Oral
Tablets
15–30°C.c Protect from light.c Avoid excessive heat.c
Elixir
Tightly closed containers at 15–30°C, unless otherwise specified by manufacturer; a d g avoid freezing.g Protect from light.a g
Solution, concentrate
Tightly closed containers at <40°C, preferably 15–30°C, unless otherwise specified by manufacturer;a d f avoid freezing.d f Protect from light.a f
Parenteral
Injection
Fluphenazine decanoate: 15–30°C.b Avoid freezing and excessive heat.b Protect from light.b
Fluphenazine hydrochloride: 15–30°C.d i Avoid freezing.a Protect from light.a i
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Oral
Do not mix oral concentrate solution with beverages containing caffeine (e.g., coffee, cola), tannic acid (e.g., tea), or pectinates (e.g., apple juice), since physical incompatibility may result.a f (See Oral Administration under Dosage and Administration.)
Parenteral
Drug Compatibility (for Fluphenazine Hydrochloride)
Compatible |
|---|
Benztropine mesylate |
Diphenhydramine HCl |
Hydroxyzine HCl |
ActionsActions
Precise mechanism(s) of antipsychotic action not determined but may be principally related to antidopaminergic effects.d
Exhibits weak anticholinergic and sedative effects and strong extrapyramidal effects; has weak antiemetic activity.a
Advice to Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Risk of drowsiness and impairment of mental and physical abilities required for driving a car or operating heavy machinery.a b c f g i
Importance of avoiding alcohol during fluphenazine therapy.a b c f g i
Importance of clinicians informing patients in whom chronic use is contemplated of risk of tardive dyskinesia, taking into account clinical circumstances and competency of patient to understand information provided.a b c f g i
Importance of clinicians informing patients of risk of extrapyramidal reactions and providing reassurance that these reactions usually can be controlled by administration of antiparkinsonian drugs (e.g., benztropine) and by subsequent dosage reduction.b c f g i
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.a b c f g i
Importance of avoiding exposure to temperature extremes.b c d f g i
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b c f g i
Importance of informing patients of other important precautionary information.a b c f g i (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection | 25 mg/mL | Fluphenazine Decanoate Injection (with benzyl alcohol 1.2% in sesame oil) | Abraxis, Apotex, Bedford, Sicor |
Prolixin Decanoate (with benzyl alcohol 1.2% in sesame oil) | Sandoz |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Elixir | 2.5 mg/5 mL | Fluphenazine Hydrochloride Elixir | Pharmaceutical Associates, Teva |
Solution, concentrate | 5 mg/mL | Fluphenazine Hydrochloride Concentrate | Pharmaceutical Associates, Teva | |
Tablets | 1 mg* | Fluphenazine Hydrochloride Tablets | Mylan, Par, Sandoz, UDL | |
2.5 mg* | Fluphenazine Hydrochloride Tablets | Mylan, Par, Sandoz, UDL | ||
5 mg* | Fluphenazine Hydrochloride Tablets | Mylan, Par, Sandoz, UDL | ||
10 mg* | Fluphenazine Hydrochloride Tablets | Mylan, Par, Sandoz, UDL | ||
Parenteral | Injection, for IM use only | 2.5 mg/mL | Fluphenazine Hydrochloride Injection (with parabens) | Abraxis |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Fluphenazine Decanoate 25MG/ML Solution (APP PHARMACEUTICAL): 5/$69.99 or 10/$130
Fluphenazine HCl 1MG Tablets (SANDOZ): 90/$17.99 or 180/$23.98
Fluphenazine HCl 10MG Tablets (SANDOZ): 60/$24.99 or 180/$74.98
Fluphenazine HCl 2.5MG Tablets (MYLAN): 60/$15.99 or 180/$38.98
Fluphenazine HCl 5MG Tablets (SANDOZ): 60/$18.99 or 180/$45.98
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
a. AHFS drug information 2004. McEvoy GK, ed. Fluphenazine. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2314-5.
b. Gensia Sicor Pharmaceuticals, Inc. Fluphenazine decanoate injection prescribing information. Irvine, CA; 1998 Aug.
c. Par Pharmaceutical, Inc. Fluphenazine hydrochloride tablets prescribing information. Spring Valley, NY; 2003 Jul.
d. AHFS drug information 2004. McEvoy GK, ed. Phenothiazines general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004: 2301-11.
e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Baltimore, MD: Williams & Wilkins; 2002:574-5.
f. Pharmaceutical Associates, Inc. Fluphenazine hydrochloride oral solution prescribing information. Greenville, SC; 2000 Oct.
g. Pharmaceutical Associates, Inc. Fluphenazine hydrochloride elixir prescribing information. Greenville, SC; 2002 Nov.
h. Trissel LA. Handbook on injectable drugs. 12th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2003:622-3.
i. American Pharmaceutical Partners. Fluphenazine hydrochloride injection prescribing information. Schaumburg, IL; 2002 Jul.
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