Fluphenazine

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

Fluphenazine may also be used for other reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. 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 given 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.

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

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.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble 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 go away. 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 right away if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• extreme drowsiness or feeling light-headed (like you might faint);
• 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.

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/dayOral 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/injectionFluphenazine 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/dayParenteral 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 mgComments:-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

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

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.

Avoid driving or doing anything dangerous until you know how fluphenazine will affect you. Dizziness or drowsiness can lead to falls, accidents, or serious injuries.

Avoid standing up too quickly from a sitting or lying position, or you may feel dizzy.

Drinking alcohol with this medicine can lead to side effects.

Fluphenazine could make you more prone to sunburn. Stay away from sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Using fluphenazine with other drugs that cause drowsiness can make you feel even more tired. Talk to your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs can affect how fluphenazine works, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any new medicine you start or stop using.