Fluphenazine hydrochloride is a trifluoro-methyl phenothiazine derivative intended for the management of schizophrenia. Chemically it is 4-[3-[2-(Trifluor-omethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. Its molecular formular is C₂₂H₂₆F₃N₃OS·2HCl and its molecular weight is 510.44, with structure:

Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, or 10 mg of fluphenazine hydrochloride per tablet.

Inactive ingredients are: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinzed starch, sodium lauryl sulfate and titanium dioxide. The following additional product specific inactive ingredients are employed:

1 mg- Hydroxypropyl cellulose, talc
2.5 mg- Glyceryl triacetate, lecithin, polydextrose, sodium alginate
5 mg- Hydroxypropyl cellulose
10 mg- Glyceryl triacelate, polydextrose, polyvinyl-pyrrolidone, sodium alginate

The following coloring agents are employed:

1 mg- Calcium sulfate, titanium dioxide
2.5 mg- D&C Yellow #10 Aluminum Lake. FD&C Yellow #6 Aluminum Lake
5 mg- D&C Yellow #10 Aluminum Lake. FD&C Yellow #6 Aluminum Lake, FD&C Blue #1 Aluminum Lake
10 mg- FD&C Yellow #6 Aluminum Lake

Fluphenazine hydrochloride is indicated in the management of manifestations of psychotic disorders.

Fluphenazine hydrochloride has not been shown effective in the management of behaviorial complications in patients with mental retardation.

Depending on the severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 to 10 mg and should be divided and given at six-to eight-hour intervals.

The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug vary from patient to patient. In general, the oral dose has been found to be approximately two to three times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses.

When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1 to 5 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient's requirements.

For psychotic patients who have been stabilized on a fixed daily dosage of orally administered fluphenazine hydrochloride dosage forms, conversion to the long-acting fluphenazine decanoate may be indicated (see package insert for conversion information).

For geriatric patients, the suggested starting dose is 1 to 2.5 mg daily, adjusted according to the response of the patient.

Fluphenazine hydrochloride is available as film-coated tablets containing either 1 mg, 2.5 mg, 5 mg or 10 mg of fluphenazine hydrochloride.

Solution (Prolixin Decanoate)

25 mg/mL (5)

The 1 mg tablets are film-coated white, triangular shaped tablets marked with M4. They are available as follows:

NDC 0378-6004-01 bottles of 100 tablets
NDC 0378-6004-05 bottles of 500 tablets

The 2.5 mg tablets are film-coated yellow, triangular shaped tablets marked with M9. They are available as follows:

NDC 0378-6009-01 bottles of 100 tablets
NDC 0378-6009-05 bottles of 500 tablets

The 5 mg tablets are film-coated green, triangular shaped tablets marked with M74. They are available as follows:

NDC 0378-6074-01 bottles of 100 tablets
NDC 0378-6074-05 bottles of 500 tablets

The 10 mg tablets are film-coated orange, triangular shaped tablets marked with M97. They are available as follows:

NDC 0378-6097-01 bottles of 100 tablets
NDC 0378-6097-05 bottles of 500 tablets

STORE AT CONTROLLED ROOM TEMPERATURE 15°- 30°C (59°- 86°F)

PROTECT FROM LIGHT

Dispense in a tight, light-resistant container using a child-resistant closure.

CAUTION: Federal law prohibits without dispensing prescription.

Central Nervous System

The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudo-parkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Most often these extrapyramidal symptoms are reversible; however they may be persistent (see below). With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level and patient age are also determinants.

Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions can usually be controlled by administration of antiparkinsonian drugs such as benztropine mesylate or intravenous caffeine and sodium benzoate injection, and by subsequent reduction in dosage.

Tardive Dyskinesia: See WARNINGS. The syndrome is characterized by involuntary choreoathetoid movements which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusion of the tongue, puffing of cheeks, puckering of the mouth, chewing movements), trunk and extremities. The severity of the syndrome and the degree of impairment produced vary widely.

The syndrome may become clinically recognizable either during treatment, upon dosage reduction, or upon withdrawal of treatment. Early detection of tardive dyskinesia is important. To increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of neurolelptic drug should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder. This maneuver is critical, since neuroleptic drugs may mask the signs of the syndrome.

Other CNS Effects: Occurrences of neuroleptic malignant syndrome (NMS) have been reported in patients on neuroleptic therapy (see WARNINGS: Neuroleptic Malignant Syndrome); leukocytosis, elevated CPK, liver function abnormalities, and acute renal failure may also occur with NMS.

Drowsiness or lethargy, if they occur, may necessitate a reduction in dosage; the induction of a catatonic-like state has been known to occur with dosages of fluphenazine far in excess of the recommended amounts. As with other phenothiazine compounds, reactivation or aggravation of psychotic processes may be encountered.

Phenothiazine derivatives have been known to cause, in some patients, restlessness, excitement, or bizarre dreams.

Autonomic Nervous System

Hypertension and fluctuations in blood pressure have been reported with fluphenazine hydrochloride.

Hypotension has rarely presented a problem with fluphenazine. However, patients with pheochromocytoma, cerebral vascular or renal insufficiency, or a severe cardiac reserve deficiency such as mitral insufficiency appear to be particularly prone to hypotensive reactions with phenothiazine compounds, and should therefore be observed closely when the drug is administered. If severe hypotension should occur, supportive measures including the use of intravenous vasopressor drugs should be instituted immediately. Norepinephrine bitartrate injection is the most suitable drug for this purpose; epinephrine should not be used since phenothiazine derivatives have been found to reverse its action, resulting in a further lowering of blood pressure.

Autonomic reactions including nausea and loss of appetite, salivation, polyuria, perspiration, dry mouth, headache, and constipation may occur. Autonomic effects can usually be controlled by reducing or temporarily discontinuing dosage.

In some patients, phenothiazine derivatives have caused blurred vision, glaucoma, bladder paralysis, fecal impaction, paralytic ileus, tachycardia, or nasal congestion.

Metabolic and Endocrine

Weight change, peripheral edema, abnormal lactation, gynecomastia, menstrual irregularities, false results on pregnancy tests, impotency in men and increased libido in women have all been known to occur in some patients on phenothiazine therapy.

Allergic REACTIONS

Skin disorders such as itching, erythema, urticaria, seborrhea, photosensitivity, eczema and even exfoliative dermatitis have been reported with phenothiazine derivatives. The possibility of anaphylactoid reactions occurring in some patients should be borne in mind.

Hematologic

Routine blood counts are advisable during therapy since blood dyscrasias including leukopenia, agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura, eosinophilia, and pancytopenia have been observed with phenothiazine derivatives. Furthermore, if any soreness of the mouth, gums, or throat, or any symptoms of upper respiratory infection occur and confirmatory leukocyte count indicates cellular depression, therapy should be discontinued and other appropriate measures instituted immediately.

Hepatic

Liver damage as manifested by cholestatic jaundice may be encountered, particularly during the first months of therapy; treatment should be discontinued if this occurs. An increase in cephalin flocculation, sometimes accompanied by alterations in other liver function tests, has been reported in patients receiving fluphenazine hydrochloride who have had no clinical evidence of liver damage.

Others

Sudden, unexpected and unexplained deaths have been reported in hospitalized psychotic patients receiving phenothiazines. Previous brain damage or seizures may be predisposing factors; high doses should be avoided in known seizure patients. Several patients have shown sudden flareups of psychotic behavior patterns shortly before death. Autopsy findings have usually revealed acute fulminating pneumonia or pneumonitis, aspiration of gastric contents, or intramyocardial lesions.

Although this is not a general feature of fluphenazine, potentiation of central nervous system depressants (opiates, analgesics, antihistamines, barbiturates, alcohol) may occur.

The following adverse reactions have also occurred with phenothiazine derivatives: systemic lupus erythematosus-like syndrome, hypotension severe enough to cause fatal cardiac arrest, altered electrocardiographic and electroencephalographic tracings, altered cerebrospinal fluid proteins, cerebral edema, asthma, laryngeal edema, and angioneurotic edema; with long-term use-skin pigmentation, and lenticular and corneal opacities.

No information provided.

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with neuroleptic (antipsychotic) drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of neuroleptic treatment, which patients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown.

Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of neuroleptic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if neuroleptic treatment is withdrawn. Neuroleptic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, neuroleptics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic neuroleptic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to neuroleptic drugs and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a safisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on neuroleptics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.

(For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on PATIENT INFORMATION and ADVERSE REACTIONS, Tardive Dyskinesia.)

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association wi th antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include:

1. immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy,
2. intensive symptomatic treatment and medical monitoring, and
3. treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatmemt regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

The use of this drug may impair the mental and physical abilities required for driving a car or operating heavy machinery.

Potentiation of the effects of alcohol may occur with the use of this drug.

Since there is no adequate experience in children who have received this drug, safety and efficacy in children have not been established.

Usage in Pregnancy

The safety for the use of this drug during pregnancy has not been established; therefore the possible hazards should be weighed against the potential benefits when administering this drug to pregnant patients.

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.

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 the phenothiazine is with-drawn.

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.

Symptoms include deep sleep, hypotension, hypertension, dystonia, seizures, extrapyramidal symptoms, and respiratory failure. Following initiation of essential overdose management, toxic symptom and supportive treatment should be initiated. Hypotension usually responds to I.V. fluids or Trendelenburg positioning. If unresponsive to these measures, the use of a parenteral inotrope may be required. Seizures commonly respond to diazepam (I.V. 5-10 mg bolus in adults every 15 minutes, if needed, up to a total of 30 mg; I.V. 0.25-0.4 mg/kg/dose up to a total of 10 mg in children) or to phenytoin or phenobarbital. Cardiac arrhythmias often respond to I.V. lidocaine while other antiarrhythmics can be used. Neuroleptics often cause extrapyramidal symptoms (eg, dystonic reactions) requiring management with anticholinergic agents such as benztropine mesylate I.V. 1-2 mg (adults) may be effective. These agents are generally effective within 2-5 minutes.

Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. Fluphenazine hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

Mechanism for action:

Blocks postsynaptic mesolimbic dopaminergic D1 and D2 receptors in the brain; depresses the release of hypothalamic and hypophyseal hormones; believed to depress the reticular activating system thus affecting basal metabolism, body temperature, wakefulness, vasomotor tone, and emesis.

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.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

FLUPHENAZINE - ORAL

(flew-FEN-uh-zeen)

COMMON BRAND NAME(S): Prolixin

WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (e.g., pneumonia, heart failure) when this medication is used in older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

USES: This medication is used to treat symptoms of a certain type of mental/mood condition (schizophrenia). Fluphenazine belongs to a class of medications called phenothiazines and is also referred to as a neuroleptic. It works by affecting the balance of natural chemicals (neurotransmitters) in the brain.

Some of the benefits of continued use of this medication include reduced episodes of hallucinations, delusions, or bizarre behaviors that occur in patients with schizophrenia.

This medication is not recommended for use in children under 12 years of age. Also, it should not be used to manage behavioral problems in patients with mental retardation.

HOW TO USE: Take with food or milk if stomach upset occurs unless directed otherwise by your doctor.

This medication must be taken as prescribed. Do not stop taking this drug suddenly without consulting your doctor. Some conditions may worsen if the medication is suddenly stopped.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Dosage is based on your medical condition and response to therapy.

It may take up to two weeks for the full benefit of this medication to take effect. Inform your doctor if your condition does not improve or worsens.

SIDE EFFECTS: Drowsiness, lethargy, dizziness, nausea, loss of appetite, sweating, dry mouth, blurred vision, headache, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call 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 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 may cause blurred vision. Use caution engaging in activities requiring alertness or clear vision such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of side effects.

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.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It should not be used during the first three months of pregnancy. Liver problems, birth defects, or side effects involving involuntary muscle movements may occur in infants exposed to this type of medication in the womb. Tell your doctor immediately if you notice yellowing of the eyes/skin, dark urine, unusual muscle movements, or muscle stiffness in your infant.

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.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., atropine), dopamine agonists (e.g., cabergoline, pergolide), guanadrel, guanethidine, lithium, sibutramine.

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with fluphenazine decanoate, such as isoniazid (INH), theophylline, bupropion, or tramadol, among others. Consult your doctor or pharmacist for more details.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), other psychiatric medicines (e.g., other phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers.

Check the labels on all your medicines (e.g., cold-and-cough products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This drug may interfere with certain laboratory tests (pregnancy test, phenylketonuria test, some urine tests). Make sure laboratory personnel and your doctors know you use this drug.

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.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: loss of consciousness, seizures, fast/irregular heartbeat, or slow/shallow breathing.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., liver function, kidney function, complete blood counts, eye exams, AIMS test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose and take 1 dose daily: take as soon as remembered unless it is almost time for the next dose. In that case, skip the missed dose and resume your usual schedule. If you take more than 1 dose daily: take as soon as possible if it is within an hour or so of the missed dose. If not remembered within an hour, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze. Keep tightly closed. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.