Fluphenazine is a phenothiazine (FEEN-oh-THYE-a-zeen) antipsychotic medicine that is used to treat psychotic disorders such as schizophrenia.

Fluphenazine may also be used for purposes not listed in this medication guide.

You should not use fluphenazine if you have liver disease, brain damage, severe depression, a blood cell disorder, or if you are also using large amounts of alcohol or medicines that make you sleepy.

Fluphenazine is not approved for use in older adults with dementia-related psychosis.

Call your doctor at once if you have uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Fluphenazine oral is taken by mouth.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Fluphenazine oral concentrate solution must be mixed with at least 2 ounces (1/4 cup) of a liquid such as milk, tomato juice, fruit juice (but not apple juice), or a soft drink that does not contain caffeine.

Fluphenazine injection is injected into a muscle or under the skin by a healthcare provider. Fluphenazine is usually given by injection only after you have taken the medicine by mouth for a certain period of time.

Fluphenazine injection stays in your body longer than the oral form, and the injections are not given daily. Follow your doctor's dosing instructions very carefully.

You may need frequent medical tests. Your next dose may be delayed based on the results.

If you need surgery, tell the surgeon ahead of time that you are using fluphenazine.

Do not stop using fluphenazine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Do not allow liquid medicine to freeze.

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

You should not use fluphenazine if you are allergic to fluphenazine or other phenothiazines (chlorpromazine, perphenazine, prochlorperazine, promethazine, thioridazine, trifluoperazine), or if you have:

• liver disease;

• brain damage;

• severe depression; or

• a blood cell disorder (such as low platelets or low red or white blood cell counts).

Do not use fluphenazine if you have recently used large amounts of alcohol or medicine that makes you sleepy.

Fluphenazine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart problems;

• liver or kidney disease;

• low white blood cell (WBC) counts;

• breast cancer;

• glaucoma;

• Parkinson's disease;

• seizures; or

• pheochromocytoma (tumor of the adrenal gland).

Tell your doctor if you will be exposed to extreme heat or cold, or to insecticide poisons while you are using fluphenazine.

Fluphenazine is not approved for use by anyone younger than 12 years old.

Using antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop using fluphenazine without your doctor's advice.

Fluphenazine may cause false results on a pregnancy test. Tell your doctor if you think you might be pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if you miss an appointment for your fluphenazine injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Avoid driving or hazardous activity until you know how fluphenazine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Drinking alcohol with this medicine can cause side effects.

Fluphenazine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

High doses or long-term use of fluphenazine can cause a serious movement disorder that may not be reversible. The longer you use fluphenazine, the more likely you are to develop this disorder, especially if you are an older adult.

Fluphenazine may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• extreme drowsiness or light-headed feeling (like you might pass out);

• strange dreams, or if you feel restless or excited;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• painful or difficult urination;

• severe constipation, stomach pain, bloating;

• jaundice (yellowing of the skin or eyes);

• a seizure; or

• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed.

Common side effects of fluphenazine may include:

• drowsiness, headache, blurred vision;

• problems with balance or muscle movement;

• nausea, loss of appetite, constipation;

• swelling, weight changes;

• stuffy nose, dry mouth, or drooling;

• increased sweating or urination;

• breast swelling or tenderness; or

• impotence, trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using fluphenazine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect fluphenazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to fluphenazine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.