Fluphenazine

Fluphenazine is a phenothiazine, also called a neuroleptic, used to treat symptoms of a certain type of mental/mood condition (schizophrenia).

Fluphenazine is available under the following different brand names: Modecate, Modecate Concentrate, Moditen, Prolixin (discontinued brand), and RhoFluphenazine.

Dosage Forms and Strengths

Tablet

• 1 mg
• 2.5 mg
• 5 mg
• 10 mg

Elixir

• 2.5mg/5mL

Oral concentrate

• 5mg/mL

Injectable solution

• 2.5mg/mL (fluphenazine hydrochloride)
• 25mg/mL (fluphenazine decanoate)

Dosage Considerations – Should be Given as Follows:

Psychotic Disorders

Fluphenazine hydrochloride

• 2.5-10 mg/day orally divided every 6-8 hours initially; maintenance: 1-5 mg orally/intramuscularly divided every 6-8 hours; not to exceed 40 mg/day

Fluphenazine decanoate

• 12.5-25 mg (25 mg/mL) intramuscularly/subcutaneously (IM/SC) every 2-4 weeks

Dosing considerations

• Conversion from hydrochloride salt to decanoate: 10 mg/day orally HCl salt = approximately 12.5 mg intramuscularly/subcutaneously (IM/SC) every 3 weeks of decanoate salt

Dosing Modifications

Renal impairment: Use with caution; monitor

Hepatic impairment: Use with caution; monitor

Pediatric: Safety and efficacy not established

Geriatric: 1-2.5 mg/day orally; dosage titrated according to response

Side effects of fluphenazine include:

• Confusion
• Decreased gag reflex
• Extrapyramidal symptoms
•  Restlessness
•  Involuntary muscle contractions
• Involuntary movements
• Muscle stiffness
• Neuroleptic malignant syndrome (NMS; infrequent but serious)
• Parkinsonism
• Slow movements (tardive dyskinesia)

Common side effects of fluphenazine include:

• Anticholinergic effects (dry mouth, blurred vision, constipation, dizziness, decreased sweating, difficulty urinating)
• Sedation
• Weight gain
• Erectile dysfunction
• Infrequent or missed menstrual periods
• Drowsiness

Less common side effects of fluphenazine include:

• Agitation Anxiety
• Blood dyscrasia
• Breast milk production unrelated to breastfeeding
• Cerebral edema
• Constipation
• Depression
• Diarrhea
• Dizziness
• Dizziness on standing (orthostatic hypotension) (after intramuscular injection)
• ECG changes
• Ejaculatory disorder
• Euphoria
• Fast heart rate
• Headache
• Ileus
• Inability to regulate core body temperature
• Indigestion/heartburn
• Itching
• Lens clouding (with prolonged use)
• Loss of appetite
• Nausea
• Photosensitivity
• Restlessness
• Sweating
• Weakness

Rare side effects of fluphenazine include:

• Prolonged or painful erection (priapism)
• Cholestatic jaundice

Serious side effects of fluphenazine include:

• 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 changes
• Swelling of the feet or ankles
• Fainting
• Skin discoloration
• Butterfly-shaped facial rash
• Joint pain
• Seizures

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe interactions of fluphenazine include: 

• astemizole
• cisapride
• disopyramide
• ibutilide
• indapamide
• metrizamide
• pentamidine
• pimozide
• procainamide
• quinidine
• sotalol
• terfenadine

 Fluphenazine has serious interactions with at least 76 different drugs.

Fluphenazine has moderate interactions with at least 285 different drugs.

Fluphenazine has mild interactions with at least 63 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

 This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

Patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk for death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

This drug is not approved for treatment of patients with dementia-related psychosis.

This medication contains fluphenazine. Do not take Modecate, Modecate Concentrate, Moditen, Prolixin, or RhoFluphenazine if you are allergic to fluphenazine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Documented hypersensitivity

Coma, severe hypotension, severe central nervous system (CNS) depression, concurrent use of large amounts of central nervous system (CNS) depressants, subcortical brain damage, poorly controlled seizure disorder, blood dyscrasias, severe cardiovascular disease

Narrow-angle glaucoma

Lactation

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Fluphenazine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Fluphenazine?"

Cautions

Glaucoma, prostatic hypertrophy, stenosing peptic ulcer disease (PUD), history of neuroleptic malignant syndrome (NMS), Parkinson's disease, low blood calcium (hypocalcemia), renal or hepatic impairment, history of severe reaction to insulin or electroconvulsive therapy (ECT), history of seizures, asthma, respiratory tract infections, cardiovascular disease.

Mild leukocytosis, leukopenia, and eosinophilia occasionally occur.

Dermatologic reactions are common.

Watch for urinary retention, blurred vision, dry mouth, and constipation as result of anticholinergic effects.

Risk of extrapyramidal symptoms (EPS), NMS, hypotension; hypotension may be particularly severe in patients with pheochromocytoma or mitral insufficiency. 

May need anticholinergic antiparkinsonian agent to counter extrapyramidal symptoms (EPS); in case of severe low blood pressure (hypotension), use norepinephrine or phenylepinephrine, and do not use epinephrine or dopamine.

Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia.

U.S. Food and Drug Administration (FDA) warning regarding off-label use for dementia in elderly.

Pregnancy and Lactation

• Use fluphenazine with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• Fluphenazine enters breast milk; use is not recommended while breastfeeding.