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Fluphenazine Decanoate Oil for injection

It is used to treat the symptoms of schizophrenia and other mental disorders

Generic Name: fluphenazine  |  Brand Name: Permitil

Brand Names: Permitil, Prolixin Enanthate, Prolixin

There is an FDA Alert for this drug. Click here to view it.

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: [Web] and [Web].

[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: [Web], [Web] and [Web].

What is this medicine?

FLUPHENAZINE (floo FEN a zeen) is used to treat the symptoms of schizophrenia and other mental disorders. Not all fluphenazine injections are the same. Do not change the brand you are using without checking with your doctor or health care professional.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • blood disorders or disease
  • dementia
  • head injury
  • heart disease
  • liver disease
  • Parkinson's disease
  • Reye's syndrome
  • uncontrollable movement disorder
  • an unusual or allergic reaction to fluphenazine, other medicines foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle or under the skin. It is given by a health-care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • amoxapine
  • certain antibiotics like gatifloxacin, grepafloxacin, sparfloxacin
  • cisapride
  • clozapine
  • dofetilide
  • droperidol
  • ephedrine
  • medicines for mental depression like escitalopram, fluoxetine, paroxetine, sertraline
  • ibutilide
  • levomethadyl
  • maprotiline
  • other phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, and thioridazine
  • pimozide
  • pindolol
  • propranolol
  • risperidone
  • sotalol
  • trimethobenzamide
  • ziprasidone

This medicine may also interact with the following medications:

  • atropine
  • some medications for high blood pressure or heart problems

What should I watch for while using this medicine?

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine can reduce the response of your body to heat or cold. Dress warm in cold weather and stay hydrated in hot weather. If possible, avoid extreme temperatures like saunas, hot tubs, very hot or cold showers, or activities that can cause dehydration such as vigorous exercise.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • blurred vision
  • breast enlargement in men or women
  • breast milk in women who are not breast-feeding
  • chest pain, fast or irregular heartbeat
  • confusion, restlessness
  • dark yellow or brown urine
  • difficulty breathing or swallowing
  • dizziness or fainting spells
  • drooling, shaking
  • fever, chills, sore throat
  • involuntary or uncontrollable movements of the eyes, mouth, head, arms, and legs
  • seizures
  • stomach area pain
  • unusual bleeding or bruising
  • unusually weak or tired
  • yellowing of skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • difficulty passing urine
  • difficulty sleeping
  • headache
  • sexual dysfunction


Last Updated: May 07, 2013
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