The active ingredient in Prolixin is fluphenazine, either as fluphenazine hydrochloride or fluphenazine decanoate, depending on the formulation.

Prolixin’s mechanism of action involves blocking dopamine receptors in certain parts of the brain. In people with schizophrenia or other psychotic disorders, dopamine activity can be too high, leading to hallucinations or delusions. By lowering dopamine activity, Prolixin helps reduce these symptoms.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Prolixin. However, the following is a synopsis of the general guidelines for the use of Prolixin:

• Oral fluphenazine is usually taken once or twice daily with or without food.
• If you miss a dose of the oral medication, take it as soon as you remember, unless it is almost time for your next dose. Do not double up.
• Continue the medication even if you start feeling better; stopping suddenly can cause symptoms to return.
• Because Prolixin can cause drowsiness or blurred vision, avoid driving or operating machinery until you know how the medication affects you.

Some mild or common side effects of Prolixin include:

• Drowsiness or sedation.
• Dry mouth.
• Constipation.
• Blurred vision.
• Loss of appetite.
• Weight gain.
• Dizziness or low blood pressure (hypotension).
• Increased prolactin levels can cause breast tenderness, milk production (galactorrhea), or gynecomastia (breast enlargement in males).

Some individuals may experience serious side effects while using Prolixin. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Tardive dyskinesia, which is repetitive, uncontrolled movements of the face, tongue, or body.
• Neuroleptic Malignant Syndrome (NMS) is a rare but life-threatening reaction with fever, muscle stiffness, confusion, and irregular heartbeat.
• Severe allergic reactions such as rash, hives, sore throat, swelling, or trouble breathing.
• Extreme muscle stiffness, tremor, or Parkinson‘s-like symptoms (extrapyramidal symptoms).
• Severe constipation or intestinal blockage.
• Seizures or chest pain.
• Confusion, fainting, or very low blood pressure.

These are not all of the possible side effects of fluphenazine. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Prolixin, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

Glaucoma.

Liver disease or kidney disease.

Heart problems or low blood pressure.

Seizure disorders or epilepsy.

Parkinson’s disease.

A history of brain damage or head injury.

Prostate problems or urinary blockage.

Are pregnant, planning pregnancy, or breastfeeding.

Do not use Prolixin if you:

Are allergic to fluphenazine hydrochloride, fluphenazine decanoate, or other phenothiazines.

Have severe central nervous system depression, such as coma or unresponsiveness.

Have blood disorders, severe liver disease, or bone marrow suppression.

Are taking large doses of central nervous system depressants such as strong sedatives or alcohol.

Have dementia-related psychosis.

Prolixin begins to have noticeable effects within several days to two weeks of starting treatment, though full benefits may take several weeks.

When Prolixin is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other antipsychotic medications, such as risperidone, perphenazine, or chlorpromazine.
• Antidepressants, especially fluoxetine, or mood stabilizers.
• Anticholinergic drugs, such as benztropine which may increase the risk of dry mouth, constipation, and blurred vision.
• Antihistamines or sleep aids can increase drowsiness.
• Drugs for blood pressure or heart conditions, which may cause hypotension.
• Supplements or herbal products that affect brain chemistry or sedation.
• Alcohol and other central nervous system depressants increase drowsiness and risk of overdose.

Prolixin is available as tablets containing 1 mg, 2.5 mg, 5 mg, or 10 mg of fluphenazine hydrochloride. The generic fluphenazine is available in the following dosage forms and strengths:

Oral elixir containing 2.5 mg of fluphenazine hydrochloride per 5 mL solution.

Injectable forms, including fluphenazine hydrochloride for short-acting intramuscular or intravenous use, and fluphenazine decanoate, the long-acting injectable form, for maintenance therapy.

It should be stored at room temperature, away from the reach of children or pets.

It is manufactured by Eli Lilly and Company.

Yes, it is available from many manufacturers of generic drugs.

Do not stop taking Prolixin suddenly unless instructed by your doctor. Abruptly stopping can cause withdrawal symptoms or the return of psychosis.

Use during pregnancy should be limited to cases where benefits outweigh risks. Babies exposed to antipsychotics like fluphenazine in the third trimester may experience movement or withdrawal symptoms after birth.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Fluphenazine passes into breast milk during lactation. Because of the potential for serious side effects in nursing infants, women who are breastfeeding should not take Prolixin unless clearly needed.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.