PROLIXIN (fluphenazine) is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Fluphenazine hydrochloride is described chemically as 4-[3-[2-(Trifluoromethyl)phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride and its molecular formula is C₂₂H₂₈F₃N₃OS₂HCl. The molecular structure is shown below:

PROLIXIN Tablets (Fluphenazine Hydrochloride Tablets) contain 5 and 10 mg fluphenazine hydrochloride per tablet. Inactive ingredients: Aluminum Lakes of the following colorants: [D&C Red No. 27 and D&C Red No. 30 for 10 mg only; FD&C Blue No. 1 for 5 mg only; FD&C Blue No.2 for 10 mg only; FD&C Yellow No. 5 (tartrazine) for 5 mg only; FD&C Yellow No. 6 for 10 mg only], croscarmellose sodium; hydroxypropyl methylcellulose, lactose monohydrate; polyethylene glycol; polysorbate 80, povidone, stearic acid, and titanium dioxide.

PROLIXIN Elixir (Fluphenazine Hydrochloride Elixir) contains 0.5 mg fluphenazine hydrochloride per mL. Inactive ingredients: alcohol [14% v/v], colorant (FD&C Yellow No. 6), flavors, glycerin, polysorbate 40, purified water, sodium benzoate, and sucrose.

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 immediately if any of these unlikely but serious side effects occur: feelings of restlessness, mask-like facial expression, greatly increased saliva, tremors, unusual mental/mood changes (e.g., depression, worsening of psychosis), confusion, unusual dreams, frequent urination or difficulty urinating, vision problems, weight change, swelling of the feet/ankles, fainting, skin discoloration.

Tell your doctor immediately if any of these rare but very serious side effects occur: butterfly-shaped facial rash, joint/muscle 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 immediately.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, 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 immediately if you develop any unusual/uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).

This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following: fever, muscle stiffness, severe confusion, increased sweating, fast or irregular heartbeat.

This drug may infrequently cause serious blood problems (e.g., agranulocytosis, leukopenia) or liver problems. Seek immediate medical attention if you notice any of the following rare but very serious side effects: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, severe stomach/abdominal pain, dark urine, yellowing of the eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking fluphenazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (e.g., 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.

This medication should not be given to patients who are unconscious.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: brain damage, severe nervous system problems (severe CNS depression).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., leukopenia, thrombocytopenia, agranulocytosis), liver problems, breast cancer, eye problems (e.g., glaucoma), heart problems (e.g., 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 (e.g., asthma, emphysema, frequent infections), low blood calcium, enlarged prostate, drug or alcohol dependency, Reye's syndrome, other nervous system problems (e.g., cerebrovascular insufficiency, brain tumors, encephalitis, encephalopathy), dehydration.

Before having surgery or any diagnostic testing, tell your doctor or dentist that you are taking fluphenazine.

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.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

The medication can reduce sweating, making you more susceptible to heat stroke. Avoid strenuous work or exercise in hot weather.

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

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially the side effect of uncontrolled movements. This is especially true if the child is sick (e.g., has chickenpox, measles, stomach flu).

Caution is advised when using this drug in the elderly, because they may be more sensitive to its effects, especially to facial or muscle twitching, muscle spasms/stiffness, uncontrolled movements (tardive dyskinesia) and possible effects on blood pressure.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. 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 infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

Based on information for similar drugs, fluphenazine may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.