Generic Name: Fluphenazine Brand Name(s): Fluphenazine.

Uses

What is Fluphenazine used for?

Fluphenazine is commonly used to treat symptoms of a certain type of mental/mood condition (schizophrenia). Fluphenazine belongs to a class of medications called phenothiazines and is also referred to as a neuroleptic. It works by affecting the balance of natural chemicals (neurotransmitters) in the brain.

Some of the benefits of continued use of this medication include reduced episodes of hallucinations, delusions, or bizarre behaviors that occur in patients with schizophrenia.

This medication is not recommended for use in children under 12 years of age. Also, it should not be used to manage behavioral problems in patients with mental retardation.

How should I take Fluphenazine?

Take with food or milk if stomach upset occurs unless directed otherwise by your doctor.

Measure carefully and dilute (mix) with 4 ounces (120 milliliters) or more of water, milk, juice or non-caffeinated carbonated drink. Do not dilute with coffee, tea, caffeinated colas or apple juice as the drug may lose its effectiveness.

Take immediately after diluting. Do not dilute drug for later use.

Avoid getting the medication on your skin because allergic reactions (contact dermatitis) may occur.

This medication must be taken as prescribed. Do not stop taking this drug suddenly without consulting your doctor. Some conditions may worsen if the medication is suddenly stopped.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Dosage is based on your medical condition and response to therapy.

It may take up to two weeks for the full benefit of this medication to take effect. Inform your doctor if your condition does not improve or worsens.

How do I store Fluphenazine?

Fluphenazine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Fluphenazine in the bathroom or the freezer. There may be different brands of Fluphenazine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Fluphenazine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Fluphenazine?

Before taking fluphenazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (such as chlorpromazine, perphenazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain damage, nervous system problems (such as CNS depression, cerebrovascular insufficiency, brain tumors, encephalitis, encephalopathy), blood problems (such as leukopenia, thrombocytopenia, agranulocytosis), liver problems, breast cancer, eye problems (such as glaucoma), heart problems (such as very high or very low blood pressure, mitral valve insufficiency), kidney problems, certain types of tumors (pheochromocytoma), seizures, exposure to phosphorus insecticides, chronic breathing problems (such as asthma, emphysema, frequent infections), low blood calcium, enlarged prostate, drug or alcohol dependency, Reye’s syndrome, dehydration.

Before having surgery or any diagnostic testing, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Avoid being exposed to very cold temperatures (such as swimming in cold water). Severe lowering of your body temperature may occur.

Children may be more sensitive to the side effects of this drug, especially the side effect of uncontrolled movements. This is especially true if the child is sick (such as has chickenpox, measles, stomach flu).

Older adults may be more sensitive to the side effects of this drug, especially to facial or muscle twitching, muscle spasms/stiffness, uncontrolled movements (tardive dyskinesia), drowsiness, dizziness, lightheadedness, confusion, and possible effects on blood pressure. Drowsiness, dizziness, lightheadedness, and confusion can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Liver problems or birth defects may occur in infants exposed to this type of medication in the womb. Tell the doctor right away if you notice yellowing of the eyes/skin or dark urine in your infant. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.

Since untreated mental/mood problems (such as schizophrenia) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Fluphenazine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Fluphenazine. Fluphenazine is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Fluphenazine?

Drowsiness, lethargy, dizziness, lightheadedness, nausea, loss of appetite, sweating, dry mouth, blurred vision, headache, and constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: feelings of restlessness, mask-like facial expression, greatly increased saliva, tremors, unusual mental/mood changes (such as depression, worsening of psychosis), confusion, unusual dreams, frequent urination or difficulty urinating, vision problems, weight change, swelling of the feet/ankles, fainting, skin discoloration, butterfly-shaped facial rash, joint pain, seizures.

In rare instances, this medication may increase your level of a certain hormone (prolactin). For females, this rare increase in prolactin may result in unwanted breast milk, missing/stopped menstrual periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

Fluphenazine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

This drug may rarely cause serious blood problems (such as agranulocytosis, leukopenia) or liver problems. Get medical help right away if you notice any of the following rare but very serious side effects: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, severe stomach/abdominal pain, yellowing of the eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Fluphenazine?

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., atropine), dopamine agonists (e.g., cabergoline, levodopa, pergolide), guanadrel, guanethidine, lithium.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This drug may interfere with certain laboratory tests (pregnancy test, phenylketonuria test, some urine tests). Make sure laboratory personnel and your doctors know you use this drug.

Fluphenazine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Fluphenazine?

Fluphenazine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Fluphenazine?

Fluphenazine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

 

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Fluphenazine.

What is the dose of Fluphenazine for an adult?

Usual Adult Dose for Psychosis

Oral:

-Initial dose: 2.5 to 10 mg orally in divided doses every 6 to 8 hours

-Maintenance dose: 1 to 5 mg/day

-Maximum dose: Up to 40 mg/day

Oral Comments:

-Maintenance doses may be given as single daily doses.

-Many patients achieve therapeutic effect with doses of less than 20 mg. Patients who are severely disturbed or inadequately controlled may require a dose of up to 40 mg/day.

Parenteral:

Fluphenazine Decanoate for Injection:

-Initial dose: 12.5 to 25 mg deep IM injection into the gluteal region

-Maintenance dose: 12.5 to 100 mg IM, usually every 3 to 4 weeks

-Maximum dose: 100 mg/injection

Fluphenazine HCl for Injection:

-Initial dose: 2.5 to 10 mg IM, given as divided doses every 6 to 8 hours

-Maximum dose: Up to 10 mg/day

Parenteral Comments:

-Patients may switch from Fluphenazine HCl for Injection to oral formulations when symptoms are controlled. The dose of an oral formulation is approximately 2 to 3 times the dose of fluphenazine HCl for injection.

-Fluphenazine decanoate for injection may be given subcutaneously.

Uses:

-Management of manifestations of schizophrenia

-Management of patients requiring prolonged parenteral neuroleptic therapy (e.g., patients with chronic schizophrenia)

Usual Geriatric Dose for Psychosis

Oral:

-Initial dose: 1 to 2.5 mg orally, given in divided doses every 6 to 8 hours

-Maintenance dose: 1 to 5 mg/day

-Maximum dose: Up to 40 mg

Comments:

-Maintenance doses may be given as a single dose.

-Many patients achieve therapeutic effect with doses less than 20 mg. Patients who are severely disturbed or inadequately controlled may require a dose of up to 40 mg/day.

Use: Management of manifestations of schizophrenia

Renal Dose Adjustments

Renal insufficiency: Use with caution.

Abnormal BUN: Discontinue treatment

Liver Dose Adjustments

Liver damage: Contraindicated

Development of cholestatic jaundice during treatment: Discontinue use

Dose Adjustments

-Severe neutropenia (absolute neutrophil count less than 1000 mm3): Discontinue treatment and follow WBC counts until recovery occurs

Other Comments

Administration advice:

-Decanoate formulations: Dry needles and syringes should be used to prevent cloudiness observed when wet needles and/or syringes are used. The dose should be given as a deep IM injection into the gluteal region.

-Oral solution formulations: The oral solution should be diluted in at least 60 mL (2 fluid ounces) of tomato/fruit juice, milk, and/or uncaffeinated soft drinks prior to administration. Dilution with caffeinated beverages, tannics (e.g., tea), and pectinates (e.g., apple juice) should be avoided.

Storage requirements:

-See manufacturer product information.

Reconstitution/preparation techniques:

-See manufacturer product information.

IV compatibility:

-See manufacturer product information.

General:

-This drug should not be used in non-psychotic disorders.

-Treatment has not been effective in managing behavioral complications in patients with mental disabilities.

-Patients should be started on a short-acting formulation before administering long-acting parenteral formulations.

Monitoring:

-ECG monitoring for patients at risk of QT prolongation or with/with a family history of cardiovascular disease

-Periodic WBC with differential tests, especially in patients with signs/symptoms of infection/sore throat, at increased risk of blood dyscrasias, and/or with a history of low WBCs or drug-induced neutropenia/leukopenia

-Periodic liver function tests

-Blood pressure, especially in patients with impaired cardiovascular systems

-Eye examinations, especially in patients on prolonged treatment with moderate to high doses

-Heart rate, especially in patients with arrhythmias and/or taking QT prolonging drugs concurrently

-Periodic renal function tests, especially in patients on prolonged treatment

Patient advice:

-Patients should be warned to avoid abrupt discontinuation of this drug.

-Patients should be instructed to immediately report any signs/symptoms of neutropenia/leukopenia, neuroleptic malignant syndrome, or tardive dyskinesia.

-Patients should be warned about extrapyramidal reaction signs/symptoms before beginning treatment.

-Patients should be advised to speak to a healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.

-Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are seen.

What is the dose of Fluphenazine for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Fluphenazine available?

Fluphenazine is available in the following dosage forms and strengths:

  • Injectable solution
  • Oral concentrate
  • Oral elixir
  • Oral tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Fluphenazine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: February 1, 2018 | Last Modified: February 1, 2018

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