Prolixin

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of fluphenazine.

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

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking fluphenazine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with fluphenazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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.

No information provided.

Fluphenazine is an anti-psychotic medicine in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.

Fluphenazine 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, bone marrow 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 psychotic conditions related to dementia. Fluphenazine may increase the risk of death in older adults with dementia-related conditions.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Taking fluphenazine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with fluphenazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Prolixin 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.

General

Because of the possibility of cross-sensitivity, fluphenazine hydrochloride should be used cautiously in patients who have developed cholestatic jaundice, dermatoses or other allergic reactions to phenothiazine derivatives.

Prolixin Tablets (Fluphenazine Hydrochloride Tablets) 5 mg only contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Psychotic patients on large doses of a phenothiazine drug who are undergoing surgery should be watched carefully for possible hypotensive phenomena. Moreover, it should be remembered that reduced amounts of anesthetics or central nervous system depressants may be necessary.

The effects of atropine may be potentiated in some patients receiving fluphenazine because of added anticholinergic effects.

Fluphenazine hydrochloride should be used cautiously in patients exposed to extreme heat or phosphorus insecticides; in patients with a history of convulsive disorders, since grand mal convulsions have been known to occur; and in patients with special medical disorders, such as mitral insufficiency or other cardiovascular diseases and pheochromocytoma.

The possibility of liver damage, pigmentary retinopathy, lenticular and corneal deposits, and development of irreversible dyskinesia should be remembered when patients are on prolonged therapy.

Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.

Information for Patients

Given the likelihood that some patients exposed chronically to neuroleptics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.

Abrupt Withdrawal

In general, phenothiazines do not produce psychic dependence; however, gastritis, nausea and vomiting, dizziness, and tremulousness have been reported following abrupt cessation of high dose therapy. Reports suggest that these symptoms can be reduced if concomitant antiparkinsonian agents are continued for several weeks after phenothiazine is withdrawn.

Facilities should be available for periodic checking of hepatic function, renal function and the blood picture. Renal function of patients on long-term therapy should be monitored; if BUN (blood urea nitrogen) becomes abnormal, treatment should be discontinued.

As with any phenothiazine, the physician should be alert to the possible development of “silent pneumonias” in patients under treatment with fluphenazine hydrochloride.