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Name:Fluphenazine Hydrochloride
Manufacturer:Remedyrepack Inc.
Category:Prescription Marketed Drugs


FLUPHENAZINE HYDROCHLORIDE  - fluphenazine hydrochloride tablet 
REMEDYREPACK INC.

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DESCRIPTION

DESCRIPTIONFluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Chemicallyit is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl]propyl]-1-piperazine-ethanol dihydrochloride which may be represented by thefollowing structural formula: C22H26F3N3OS2252HClM.W. 510.44Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, or 10 mg of fluphenazine hydrochloride, USP per tablet. Inactiveingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodiumlauryl sulfate and titanium dioxide. The following additional product specific

INACTIVE INGREDIENT

inactive ingredients are employed:1 mg 226 calcium sulfate, hydroxypropyl cellulose and talc2.5 mg 226 lecithin, polydextrose, sodium alginate and triacetin5 mg 226 hydroxypropyl cellulose10 mg 226 lecithin, polydextrose, sodium alginate and triacetinThe following coloring agents are employed:2.5 mg 226 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake5 mg 226 FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake10 mg 226 FD&C Yellow No. 6 Aluminum Lake.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGYFluphenazine hydrochloride has activity at all levels of the central nervous system as well as on multiple organ systems. Themechanism whereby its therapeutic action is exerted is unknown.INDICATIONS AND USAGEFluphenazine hydrochloride is indicated in the management of manifestations of psychotic disorders.Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mentalretardation.

CONTRAINDICATIONS

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

WARNINGS

WARNINGSTardive DyskinesiaTardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patientstreated 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, whichpatients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia isunknown.Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration oftreatment 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 andsymptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppressionhas 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 tardivedyskinesia. Chronic neuroleptic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) isknown to respond to neuroleptic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are page 2 of 5 not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatmentproducing a satisfactory 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

PRECAUTIONS

PRECAUTIONS:

INFORMATION FOR PATIENTS

Information for Patients and

ADVERSE REACTIONS

ADVERSE REACTIONS: Tardive Dyskinesia.)Neuroleptic Malignant Syndrome (NMS)A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported inassociation with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status andevidence 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 caseswhere the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated orinadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis includecentral 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 toconcurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medicalproblems for which specific treatments are available. There is no general agreement about specific pharmacological treatmentregimens for uncomplicated NMS.If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should becarefully 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 beenestablished.Usage in

PREGNANCY

PregnancyThe safety for the use of this drug during pregnancy has not been established; therefore, the possible hazards should be weighedagainst the potential benefits when administering this drug to pregnant patients.PRECAUTIONSGeneralBecause of the possibility of cross-sensitivity, fluphenazine hydrochloride should be used cautiously in patients who have developedcholestatic 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 possiblehypotensive phenomena. Moreover, it should be remembered that reduced amounts of anesthetics or central nervous systemdepressants 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 patientswith a history of convulsive disorders, since grand mal convulsions have been known to occur; and in patients with special medicaldisorders, 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 dyskinesiashould be remembered when patients are on prolonged therapy.Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicatethat approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if theprescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such asgalactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactinlevels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration ofneuroleptic drugs. Neither

CLINICAL STUDIES

clinical studies nor epidemiologic studies conducted to date, however, have shown an association betweenchronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive atthis time.Information for PatientsGiven the likelihood that some patients exposed chronically to neuroleptics will develop tardive dyskinesia, it is advised that allpatients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patientsand/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand theinformation provided. page 3 of 5 Abrupt WithdrawalIn general, phenothiazines do not produce psychic

DEPENDENCE

dependence; however, gastritis, nausea and vomiting, dizziness, and tremulousnesshave been reported following abrupt cessation of high dose therapy. Reports suggest that these symptoms can be reduced ifconcomitant antiparkinsonian agents are continued for several weeks after the phenothiazine is withdrawn.Facilities should be available for periodic checking of hepatic function, renal function and the blood picture. Renal function of patientson 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 undertreatment with fluphenazine hydrochloride.ADVERSE REACTIONSCentral Nervous SystemThe side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms includingpseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Most often theseextrapyramidal symptoms are reversible; however, they may be persistent (see below). With any given phenothiazine derivative, theincidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level andpatient age are also determinants.Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions can usually becontrolled by administration of antiparkinsonian drugs such as benztropine mesylate or intravenous caffeine and sodium benzoateinjection, and by subsequent reduction in dosage.Extrapyramidal SymptomsDystoniaClass Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals duringthe first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of thethroat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses,they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. Anelevated risk of acute dystonia is observed in males and younger age groups.Tardive DyskinesiaSee 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 andextremities. 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 neuroleptic 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 EffectsOccurrences 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 occurwith NMS.Drowsiness or lethargy, if they occur, may necessitate a reduction in dosage; the induction of a catatonic-like state has been known tooccur with dosages of fluphenazine far in excess of the recommended amounts. As with other phenothiazine compounds, reactivationor aggravation of psychotic processes may be encountered.Phenothiazine derivatives have been known to cause, in some patients, restlessness, excitement, or bizarre dreams.Autonomic Nervous SystemHypertension 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 orrenal insufficiency, or a severe cardiac reserve deficiency such as mitral insufficiency appear to be particularly prone to hypotensivereactions with phenothiazine compounds, and should therefore be observed closely when the drug is administered. If severehypotension 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 phenothiazinederivatives 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 constipationmay 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. page 4 of 5 Metabolic and EndocrineWeight 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 ReactionsSkin disorders such as itching, erythema, urticaria, seborrhea, photosensitivity, eczema and even exfoliative dermatitis have beenreported with phenothiazine derivatives. The possibility of anaphylactoid reactions occurring in some patients should be borne inmind.HematologicRoutine blood counts are advisable during therapy since blood dyscrasias including leukopenia, agranulocytosis, thrombocytopenicor nonthrombocytopenic purpura, eosinophilia, and pancytopenia have been observed with phenothiazine derivatives. Furthermore, ifany soreness of the mouth, gums, or throat, or any symptoms of upper respiratory infection occur and confirmatory leukocyte countindicates cellular depression, therapy should be discontinued and other appropriate measures instituted immediately.HepaticLiver damage as manifested by cholestatic jaundice may be encountered, particularly during the first months of therapy; treatmentshould be discontinued if this occurs. An increase in cephalin flocculation, sometimes accompanied by alterations in other liverfunction tests, has been reported in patients receiving fluphenazine hydrochloride who have had no clinical evidence of liver damage.OthersSudden, unexpected and unexplained deaths have been reported in hospitalized psychotic patients receiving phenothiazines. Previousbrain damage or seizures may be predisposing factors; high doses should be avoided in known seizure patients. Several patients haveshown sudden flare-ups of psychotic behavior patterns shortly before death. Autopsy findings have usually revealed acute fulminatingpneumonia 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 use226skinpigmentation, and lenticular and corneal opacities.DOSAGE AND ADMINISTRATIONDepending on the severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 mgto 10 mg and should be divided and given at 6 to 8 hour intervals.The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosagelevels of this potent drug vary from patient to patient. In general, the oral dose has been found to be approximately 2 to 3 times theparenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage, which may be increased, if necessary, until thedesired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severelydisturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlledclinical 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 mg to 5 mg, often givenas a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may benecessary 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 dosageforms, 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 mg to 2.5 mg daily, adjusted according to the response of the patient.

HOW SUPPLIED

HOW SUPPLIEDFluphenazine Hydrochloride Tablets, USP are available containing either 1 mg, 2.5 mg, 5 mg or 10 mg of fluphenazine hydrochloride,USP.The 1 mg tablets are white film-coated, triangular shaped tablets debossed with M on one side of the tablet and 4 on the other side.They are available as follows:NDC 0378-6004-01bottles of 100 tabletsNDC 0378-6004-05bottles of 500 tabletsThe 2.5 mg tablets are yellow film-coated, triangular shaped tablets debossed with M on one side of the tablet and 9 on the other side.They are available as follows:NDC 0378-6009-01bottles of 100 tablets page 5 of 5 NDC 0378-6009-05bottles of 500 tabletsThe 5 mg tablets are green film-coated, triangular shaped tablets debossed with M on one side of the tablet and 74 on the other side.They are available as follows:NDC 0378-6074-01bottles of 100 tabletsNDC 0378-6074-05bottles of 500 tabletsThe 10 mg tablets are orange film-coated, triangular shaped tablets debossed with M on one side of the tablet and 97 on the other side.They are available as follows:NDC 0378-6097-01bottles of 100 tabletsNDC 0378-6097-05bottles of 500 tabletsStore at 20260 to 25260C (68260 to 77260F). [See USP for Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED FEBRUARY 2008FPHZ:R8

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Fluphenazine Hydrochloride
GENERIC: Fluphenazine Hydrochloride
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-005-02
STRENGTH:1 mg
COLOR: white
SHAPE: TRIANGLE
SCORE:
SIZE: 6 mm
IMPRINT: 30
QTY: 30

IMAGE OF PRODUCT LABEL
IMAGE OF CARTON

FLUPHENAZINE HYDROCHLORIDE 
fluphenazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-005(NDC:0378-6004-01)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 1 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
CETETH-10  
SODIUM LAURYL SULFATE  
TITANIUM DIOXIDE  
CALCIUM SULFATE  
HYDROXYPROPYL CELLULOSE  
TALC  
Product Characteristics
Color white Score no score
Shape TRIANGLE (TABLET) Size 6mm
Flavor Imprint Code M;4
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49349-005-02 30 TABLET ( TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075659 07/29/2010

Labeler - REMEDYREPACK INC. (829572556)

Revised: 07/2010 REMEDYREPACK INC.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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