- Side Effects
- Drug Interactions
- Pregnancy & Breastfeeding
- What Else to Know
Generic Name: fluphenazine
Brand Names: Modecate, Modecate Concentrate, Moditen, Prolixin, RhoFluphenazine
Drug Class: Antipsychotics, 1st Generation; Antipsychotics, Phenothiazine
What is fluphenazine, and what is it used for?
First generation antipsychotics are less commonly prescribed after the advent of second generation antipsychotics which are more effective in treating the negative symptoms of schizophrenia and have better safety profiles.
Fluphenazine works by reducing the activity of dopamine, a chemical (neurotransmitter) released in the brain by nerve cells (neurons) to transmit signals. Dopamine has many functions including regulation of movement, memory, motivation, and pleasure. Overactivity of dopamine in certain pathways of the brain appears to lead to positive symptoms of schizophrenia such as hallucinations and delusions.
Fluphenazine belongs to a group of antipsychotics derived from a compound known as phenothiazine. Fluphenazine inhibits dopamine activity by blocking dopamine D1 and D2 receptors, protein molecules on neurons that respond to dopamine and initiate excitatory action. Fluphenazine also depresses the release of hormones by the hypothalamus and pituitary gland, which results in its side effects.
The limitation of fluphenazine is that it does not have efficacy in the management of behavioral complications in patients with intellectual disabilities. Fluphenazine is used off-label in the management of Tourette syndrome that causes involuntary muscle twitches (tics) and unintended sounds (phonic tics).
- Fluphenazine is not approved for use in patients with dementia-related psychosis. Controlled trials show that fluphenazine treatment increases the risk for death from cardiovascular conditions or infections such as pneumonia, in patients with dementia-related psychosis.
- Do not use fluphenazine in patients with documented hypersensitivity to fluphenazine. Cross-sensitivity to other phenothiazine derivatives may also occur.
- Do not use fluphenazine in patients with the following conditions:
- Do not use fluphenazine decanoate injection in children under 12 years of age.
- Do not use phenothiazine compounds including fluphenazine in patients receiving large doses of hypnotics.
- Antipsychotic drugs including fluphenazine can cause drug-related movement disorders known as extrapyramidal symptoms, including potentially irreversible tardive dyskinesia, with prolonged treatment with high doses.
- Antipsychotic drugs including fluphenazine can cause neuroleptic malignant syndrome (NMS), a life-threatening reaction with high fever, irregular pulse and heart rate, muscle rigidity, changes in blood pressure and an altered state of mind.
- Fluphenazine may cause anticholinergic effects such as constipation, dry mouth, blurred vision, and urinary retention. Use with caution in patients with reduced gastrointestinal motility, paralytic ileus, urinary retention, prostate enlargement, dry mouth, or visual problems such as glaucoma.
- Use with caution in patients with:
- Stenosing peptic ulcer disease (PUD)
- History of NMS
- Parkinson’s disease
- Low calcium levels (hypocalcemia)
- Liver or kidney function impairment
- History of severe reaction to insulin
- History of severe reaction to electroconvulsive therapy (ECT)
- History of seizures, asthma, respiratory tract infections, or cardiovascular disease
- May disturb the heart conduction, which may result in life-threatening arrhythmia.
- May cause blood disorders such as neutropenia, leukopenia, and agranulocytosis. Monitor blood count and discontinue therapy if counts drop.
- Antipsychotic use can affect esophageal motility and lead to aspiration. Patients over 75 years of age are at a higher risk for aspiration pneumonia.
- May cause CNS depression, which may impair physical or mental abilities. Caution patients appropriately.
- Fluphenazine can cause drowsiness, orthostatic hypotension, and motor and sensory instability that may lead to falls and, consequently, fractures and other injuries. Perform fall risk assessment, especially in patients with other predisposing factors such as medications or diseases.
- Fluphenazine may impair core body temperature regulation. Patient should be cautioned about strenuous exercise, dehydration, heat/cold exposure, and concomitant medication possessing anticholinergic effects.
- May cause eye disorders such as pigmentary retinopathy, and lenticular and corneal deposits, especially with prolonged therapy.
- Fluphenazine use may increase prolactin levels (hyperprolactinemia), however, the clinical significance in patients with breast cancer or other prolactin-dependent tumors is unknown.
What are the side effects of fluphenazine?
Common side effects of fluphenazine include:
- Irregular heart rhythms (cardiac arrhythmia)
- Rapid heart rate (tachycardia)
- High or low blood pressure (hypertension/hypotension)
- Swelling (edema)
- Cerebral edema
- EEG pattern changes
- Overactive reflexes (hyperreflexia)
- Muscle spasm (neck)
- Tremor (fingers)
- Decreased gag reflex
- Extrapyramidal symptoms, which are drug-induced movement disorders such as:
- Restlessness (akathisia)
- Involuntary muscle contractions (dystonia)
- Involuntary movements (dyskinesia)
- Loss or impairment of voluntary movements (akinesia)
- Muscle stiffness
- Parkinson's disease-like symptoms (parkinsonism)
- Tardive dyskinesia from long-term therapy
- Neuroleptic malignant syndrome (rare, life-threatening reaction)
- Anticholinergic effects such as:
- Eye conditions such as:
- Disruption of body temperature regulation mechanism
- Systemic lupus erythematosus (SLE)
- Skin reactions including:
- Nasal congestion
- Laryngeal edema
- Abnormal dreams
- Toxicity to the liver (hepatotoxicity)
- Jaundice from impaired bile flow (cholestatic jaundice)
- Paralysis of the intestinal muscles (paralytic ileus)
- Loss of appetite (anorexia)
- Excessive urination (polyuria)
- Urinary incontinence
- Bladder paralysis
- Blood disorders including:
- Increased prolactin levels in blood
- Abnormal breast tissue growth in males (gynecomastia)
- Abnormal milk secretion (galactorrhea)
- Breast pain (mastalgia)
- Reduced or absent menstruation (oligomenorrhea or amenorrhea)
- Menstrual disorders
- Ejaculatory disorder
- Erectile dysfunction
- Change in libido
- Weight gain
Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:
- Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
- Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
- Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
- Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.
What are the dosages of fluphenazine?
- 1 mg
- 2.5 mg
- 5 mg
- 10 mg
- 2.5 mg/5 mL
- 5 mg/mL
- 2.5 mg/mL (fluphenazine hydrochloride)
- 25 mg/mL (fluphenazine decanoate)
- 2.5-10 mg/day orally divided every 6-8 hours initially; maintenance: 1-5 mg orally/intramuscularly divided every 6-8 hours; not to exceed 40 mg/day
- 12.5-25 mg (25 mg/mL) intramuscularly/subcutaneously (IM/SC) every 2-4 weeks
- Conversion from hydrochloride salt to decanoate: 10 mg/day orally HCl salt = approximately 12.5 mg intramuscularly/subcutaneously (IM/SC) every 3 weeks of decanoate salt
- Renal impairment: Use with caution; monitor
- Hepatic impairment: Use with caution; monitor
- 1-2.5 mg/day orally; dosage titrated according to response
- Safety and efficacy not established
What drugs interact with fluphenazine?
Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.
- Severe interactions of fluphenazine include:
- Fluphenazine has serious interactions with at least 91 different drugs.
- Fluphenazine has moderate interactions with at least 339 different drugs.
- Fluphenazine has mild interactions with at least 59 different drugs.
The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.
It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.
Pregnancy and breastfeeding
- Fluphenazine treatment during pregnancy should be individualized and used only if clearly needed, based on benefits of treatment to the mother and potential risks to the mother and fetus.
- Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms) and/or withdrawal symptoms in newborns following delivery.
- Fluphenazine is present in breast milk, avoid use in nursing mothers.
What else should I know about fluphenazine?
- Take fluphenazine exactly as prescribed.
- Fluphenazine can cause movement disorders, particularly with prolonged therapy. Notify your physician if you develop symptoms such as muscle twitches or tightness.
- Report immediately to your physician if you develop flu-like illness, fever, lethargy, weakness or infections.
- Fluphenazine may impair body temperature regulating mechanism. Exercise caution to avoid overexercising, dehydration and getting exposed to extreme cold or heat.
- Fluphenazine is associated with risks of drowsiness and seizure. Avoid potentially hazardous activities such as driving or operating heavy machinery while on therapy.
- Store safely away from the reach of children.
- In case of overdose, seek medical help immediately or contact Poison Control.
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Fluphenazine is a first generation antipsychotic medication used for symptomatic management of psychotic disorders in patients with chronic schizophrenia who require prolonged therapy. Fluphenazine is not approved for use in patients with dementia-related psychosis. Common side effects of fluphenazine include irregular heart rhythms (cardiac arrhythmia), rapid heart rate (tachycardia), high or low blood pressure (hypertension/hypotension), swelling (edema), cerebral edema, EEG pattern changes, headache, dizziness, drowsiness, sedation, overactive reflexes (hyperreflexia), lethargy, and others. Consult your doctor if pregnant or breastfeeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.