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Prolixin^® (fluphenazine)

All FDA warnings are at the end of this fact sheet. Please consult them before taking this medication.

Brand/Generic Names

Brand name: Prolixin®
- Tablets: 1 mg, 2.5 mg, 5 mg, and 10 mg
- Liquid: 0.5 mg/ml (2.5 mg/5 ml teaspoon) and 5 mg/ml (concentrate) 60 ml and 473 ml bottles
- Injection: Fluphenazine HCL (short acting injection) 2.5 mg/ml 10 ml vials; Fluphenazine decanoate (long acting injection) 25 mg/ml 5 ml vials
Generic name: Fluphenazine

What is Prolixin® and what does it treat?

Fluphenazine is a first generation antipsychotic (FGA) medication approved for the treatment of schizophrenia. Fluphenazine can improve symptoms of schizophrenia such as: hallucinations, delusions, and disorganized thinking; in some people, improvement in social isolation, reduced speech, productivity and motivation also occur.

What is the most important information I should know about Prolixin®?

Relapse is very common in schizophrenia and the most frequent cause is that patients stop taking their medication. Even when medication is taken exactly as prescribed, relapse may still occur for some people. Therefore it is recommended that you take your medication exactly as prescribed by your healthcare provider as this has been shown to decrease relapse.

Schizophrenia requires long-term treatment. Only your healthcare provider can determine the length of fluphenazine treatment that is right for you.
Do not stop taking fluphenazine or change your dose, without talking to your healthcare provider first.
Some people may develop side effects on fluphenazine such as extrapyramidal effects (restlessness, tremor, stiffness) or tardive dyskinesia (slow or jerky movements that one cannot control, often starting in the mouth with tongue rolling or chewing movements). If you develop movements that you cannot control, call your healthcare provider immediately.
Fluphenzine treatment may be associated with strokes and/or transient ischemic attacks (TIAs) in elderly people with dementia and accompanying behavior problems. This safety concern has not been proven confidently, but there is some evidence. Talk with your healthcare provider if you are concerned or have questions.
Antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular conduction of an electrical impulse in the heart). To minimize this possibility, antipsychotic medications should be used in the smallest effective dose in situations where the benefits outweigh the risks, such as schizophrenia or bipolar disorder. Often an EKG tracing may be ordered to monitor for conduction changes.
Fluphenazine treatment must be monitored by a healthcare provider. Be sure to keep all of your scheduled appointments so that you stay healthy while on fluphenazine.
You should not take illegal drugs or drink alcohol while taking fluphenazine.

Are there specific concerns about Prolixin® and pregnancy?

If you are planning to become pregnant, notify your healthcare provider so that he/she can best manage your medications. People living with schizophrenia who wish to become pregnant face important decisions, each with risks and benefits related to how the illness, medications and the risks to the fetus may interact. This is a complex decision as untreated schizophrenia has risks to the fetus as well as the mother. There are many dimensions to these choices, so be sure to confer with your doctor and caregivers.

Regarding breast-feeding, caution is advised since fluphenazinedoes pass into breast milk. Fluphenazine may affect breast milk production. Fluphenazine may increase drowsiness and tiredness in infants and interfere with infant development.

What should I discuss with my healthcare provider before taking Prolixin®?

Symptoms of schizophrenia which are bothersome to you.
If you had any serious side effects with other antipsychotic medications like muscle stiffness, muscle cramping, shaking, tardive dyskinesia, neuroleptic malignant syndrome, weight gain, or diabetes. (See the NAMI Hearts and Minds Program.)
If you have had an allergic reaction to fluphenazine or any other medication.
History of heart problems, such as heart rhythm problems, long QT syndrome, or heart attacks. These illnesses may make fluphenazine unsafe for you to take
Medical problems you have, especially diabetes, high cholesterol or triglycerides, increased body weight, seizures, or kidney disease or impairment.

How should I take Prolixin®?

Fluphenazine can be taken with or without food but should be taken with a full glass of water.
Only your doctor can determine the correct dose for you. Typically patients begin at a low dose of medicine and the dose is increased slowly over several weeks.
Use a calendar or pill box to help you remember to take your medication. Or, have a family member or friend remind you or check in with you to be sure you are taking your medication.

What happens if I miss a dose of Prolixin®?

If you miss a dose of fluphenazine, take it as soon as you remember, if it is not too close to when your next dose is due—discuss this with your health care provider. Do not double your next dose or take more than what is prescribed.

What should I avoid while taking Prolixin®?

Fluphenazine may cause dizziness or drowsiness, especially when first starting the medication. Make sure you know how you react to the medication before you drive, operate machinery, or do other activities that may be dangerous if you are not alert.
Avoid drinking alcohol or using illegal drugs while taking fluphenazine.

What happens if I overdose with Prolixin®?

If an overdose occurs, whether intentional or accidental, immediate medical attention may be necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center at 1-800-222-1222.

What are the possible side effects of Prolixin ®?

What are the common side effects seen with fluphenazine?

Common adverse effects of fluphenazine usually include sleepiness, dizziness, constipation, excessive saliva in mouth, and weight gain. An adverse effect that may occur is known as orthostatic hypotension (dizziness due to a lowering of your blood pressure when you sit up or stand up). Occasionally this can lead to fainting and falling down, therefore, people taking fluphenazine should be careful when they change positions These adverse effects are usually mild and usually go away after the first several days of starting treatment or increasing a dose.
Fluphenazine has a 30-40% incidence of extrapyramidal symptoms such as muscle spasms and cramps and side effects such as restlessness, muscle rigidity, and tremor. If you experience any of these symptoms, call your healthcare provider.

What are the more serious side effects of antipsychotics?

If you experience any of the following symptoms, call your health care provider immediately:

Jaw, neck, and back muscle spasms
Slow or difficult speech
Shuffling walk
Persistent fine tremor or inability to sit still
Fever, chills, sore throat, or flu-like symptoms
Difficulty breathing or swallowing
Severe skin rash
Yellowing of the skin or eyes
Irregular heartbeat
Neuroleptic malignant syndrome (NMS) is a rare, life-threatening, neurological disorder most often caused by an adverse reaction to antipsychotic medications. Symptoms of (NM) include sudden high fever, sweating, changing blood pressure, dizziness, fatigue, muscle stiffness, as well as changes in liver and kidney function. In most cases, the disorder develops within the first 2 weeks of medication treatment. Early identification of and treatment for individuals with neuroleptic malignant syndrome slows the progression and improves recovery from (NMS). A different antipsychotic can be started very slowly once recovery is complete, although there is a risk that the syndrome might recur. Notify your healthcare provider immediately if you suspect you are developing “NMS”. Less commonly seen, but important, is the early death/dementia risk as noted in the FDA boxed warning. In some clinical trials, it was determined that elderly people developed strokes at a higher rate than those on placebo medication (sugar pill). The SGA group has less tardive dyskinesia (TD), neuroleptic malignant syndrome, seizures, and changes in heart rhythm than FGA drugs but not zero.

What do I do about the more serious risks?

Please let your doctors know if you have any of these medical conditions prior to starting fluphenazine: history of heart problems, such as heart rhythm problems, long QT syndrome, or heart attacks; diabetes; high cholesterol or triglycerides; increased body weight; seizures; or kidney disease or impairment.

Also, obtain Abnormal Involuntary Movement testing (AIMS) to monitor for TD. Regular AIMS testing is needed for monitoring, so you can make good choices about the use of the drug when weighing the risks and benefits.

Are there any risks for taking Prolixin® for long periods of time?

Tardive dyskinesia (TD) is a side effect that may develop with prolonged use of antipsychotics. Should you develop symptoms of TD, such as grimacing, sucking and smacking of lips, and other movements that you cannot control, contact your healthcare provider immediately.

What other drugs interact with Prolixin®?

There are many other medications that may interact with fluphenazine. Any other medication that causes sleepiness may increase the same side effect of fluphenazine and increase your chance of unsteadiness and falling. Others include: opioid analgesics (for example, codeine), alcohol, antihistamines, and tricyclic antidepressants.

Fluphenazine may increase the effects of: alcohol, opioid analgesics (for example, codeine), and other central nervous system depressants.

Fluphenazine may decrease the effects of anti-Parkinson’s medications, such as levodopa/carbidopa (Sinemet®), ropinirole (Requip®).

Medications that may increase levels of fluphenazine in your body include: ketoconazole (Nizoral®), paroxetine (Paxil®), fluoxetine (Prozac®), verapamil (Calan®, Verelan®), quinidine, darunavir (Prezista®), lopinavir/ritonavir (Kaletra®), ritonavir (Norvir®).

Medications that may decrease levels of fluphenazine in your body include: carbamazepine (Tegretol®), oxcarbazepine (Trileptal®), phenytoin (Dilantin®), rifampin (Rifadin®).
Lithium may increase side effects of fluphenazine.

How long does it take for Prolixin®to work?

Fluphenazine rebalances dopamine to improve thinking, mood, and behavior. Improvement of some symptoms may be noticed in some patients within a few weeks. The full benefit of fluphenazine may not be seen for 6-12 weeks or longer.

FDA ALERT [06/06/2008]

Both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.

Antipsychotics are not indicated for the treatment of dementia-related psychosis.

Updated by
Mark Schneiderhan, Pharm.D., BCPP
(July 2010)

NAMI wishes to thank the College of Psychiatric and Neurologic Pharmacists for producing this fact sheet.

Reviewed by Dr. Ken Duckworth, NAMI Medical Director

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Prolixin® (fluphenazine)