Haloperidol Decanoate Is the Long-Acting Form CLINICAL PHARMACOLOGY: Alcohol Asapreservative

For IM Injection Only INJECTION HALOPERIDOL DECANO 45803 I /Revised: October 2012 A Rx only TE comatose states from any cause and in indi in and cause any from states comatose or depression system nervous central toxic modified only to reflect the prolonged action. additional information are those of haloperidol, CONTRA medication, active the as haloperidol to uted of HaloperidolDecanoateInjectionare attrib actions clinical and pharmacologic the Since CONTRAINDICATIONS: antipsy chotic therapy. parenteral prolonged require patients who schizophrenic of treatment the for indicated is Injection Decanoate Haloperidol INDICATIONS ANDUSAGE: be quitevariablebetweensubjects. anoate following intramuscular injections can that the pharmacokinetics of haloperidol dec however, noted, be should It mg. 450 below doses for linear roughly is concentration dol haloperi plasma and decanoate haloperidol fourth dose. The relationship between dose of plasma or third the after achieved are concentrations Steady-state weeks. 3 about of life half- apparent an with thereafter, falling and ing a peak at about 6 days after the injection, - reach rise, gradually haloperidol of trations concen plasma The haloperidol. of release sustained and slow in results oil sesame in the precise mechanism of action is unknown. mine and increases its turnover rate; however, action. Haloperidol blocks the effects of dopa of duration of exception the with haloperidol of those from different no are decanoate dol haloperi of effects basic The haloperidol. of Haloperidol decanoate is the long-acting form CLINICAL PHARMACOLOGY: alcohol asapreservative. in a sesame oil vehicle, with 1.2% (w/v) benzyl (present as haloperidol decanoate 141.04 mg) tion, 100 mg/mL, contains 100 mg haloperidol alcohol asapreservative. in a sesame oil vehicle, with 1.2% (w/v) benzyl (present as haloperidol decanoate 70.52 mg) haloperidol mg 50 contains mg/mL, 50 tion, organic solvents. most in soluble is but mg/mL), (0.01 water in C decanoate, is: 1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl of haloperidol decanoate, 4-(4-chlorophenyl)- muscular (IM) injection. The structural formula intra for form sterile in oil sesame in solution is It amber yellow effect. to colorless/pink a as available of duration extended markedly a has It haloperidol. butyrophenone, the of Haloperidol decanoate is the decanoate ester DESCRIPTION: psychosis (see WARNINGS). treatment of patientsthe for approved withnot is dementia-relatedInjection anoate the patients is not clear. Haloperidol Dec ofcharacteristic(s) some to opposed as may be attributed to the in- antipsychotic of creased findings drugmortality the inobservational which studies to extent The mortality. increase may drugs psychotic antipsychotic anti- conventional with treatment atypical drugs, to similar that, Observationalsuggestnature.studies in den death)sud or infectiousfailure, (e.g.,heart pneumonia) (e.g., cardiovascular deathstheappearedmosteitherof be to Although the causes of death were varied,group. placebo the in 2.6%about of rate a to compared4.5%, about was patients trolled trial, the rate Over theof course of a typicaldeath 10-week con in drug-treatedplacebo-treated inpatients. death of risk the times 1.7 to 1.6 between drugs, of patients drug-treated in death of risk antipsychotic a revealed atypical taking patientsweeks),largelyin10duration of seventeen placebo-controlled trials (modalat an increased risk of death. Analyses of – chosis Psychosis treated with antipsychotic drugsElderly arepatients with Dementia-Related dementia-related Patients psy with Elderly in Mortality Increased 31 Haloperidol is contraindicated in severe severe in contraindicated is Haloperidol decanoate haloperidol of Administration Injec Decanoate Haloperidol of mL Each Each mL of Haloperidol Decanoate Injec Decanoate Haloperidol of mL Each insoluble almost is decanoate Haloperidol H 41 CIFNO INDICATIONS, WARNINGS, INDICATIONS, 3

WARNING M.W. 530.12 and and ------

QT-syndrome).fami and hypothyroidism, malities, underlying QT, prolong to known drugs hypomagnesemia], and lemia hypoka [particularly imbalance electrolyte (including conditions with QT-prolonging other patients treating in advised is caution the absence of predisposing in factors, even particularreported been have cases Although Pointes. de Torsades and QT-prolongation haloperidol of risk higher of a with associated be to appear administration intravenous and formulation any of doses recommended than Higher haloperidol. receiving patients in reported been have Pointes de Torsades Cases of sudden death, QT-prolongation, and Cardiovascular Effects psychosis (seeBOXEDWARNING). treatment of patients with dementia-related Decanoate Injection is not approved for the Haloperidol death. of risk increased an at chosis treated with antipsychotic drugs are Elderly patients with dementia-related psy Dementia-Related Psychosis Increased Mortality in Elderly Patients with WARNINGS: have Parkinson’sdisease. viduals who are hypersensitive to this drug or this syndrome is complicated. In arriving at at arriving In complicated. is syndrome this renal failure. acute and (rhabdomyolysis) phosphokinase, myoglobinuria creatine elevated and include diaphoresis, may signs Additional dysrhythmias). cardiac tachycardia, blood or pulse pressure, (irregular instability auto of nomic evidence and signs) catatonic ing (includ status mental altered rigidity, muscle in hyperpyrexia, are NMS of manifestations cal Clini reported drugs. been antipsychotic with has association (NMS) Malignant Syndrome Neuroleptic as to referred times some complex symptom fatal potentially A Neuroleptic MalignantSyndrome(NMS) refer toADVERSEREACTIONS.) please detection, clinical its and dyskinesia tardive of description the about information further (For syndrome. the of presence the despite treatment require may patients some continuation should be considered. However, appear in a patient on antipsychotics, drug dis should bereassessedperiodically. treatment continued for need The sought. be pro ducing a satisfactory clinical treatment response shouldof duration shortest the and dose smallest the treatment, chronic require do who patients In appropriate. or available but potentially less harmful treatments are and 2) for whom alternative, equally effective, 1) is known to respond to antipsychotic drugs, patients who for suffer from a chronic illness that reserved be generally antipsychotic should treatment Chronic dyskinesia. tardive of occurrence the minimize to likely most is that manner a in prescribed be should drugs is unknown. syndrome the of course long-term the upon The effect that symptomatic suppression has process. underlying the mask possibly may signs the thereby and syndrome the of symptoms and suppress) may partially (or however, suppress itself, treatment, Anti psychotic withdrawn. is treatment antipsychotic if completely, or partially remit, may drome cases of tardive dyskinesia, although the syn doses. low at periods treatment brief relatively after can develop, although much less commonly, syndrome the However, increase. patient the to administered drugs antipsychotic of dose the as duration of treatment and the total increase cumulative to believed are irreversible become will it that likelihood the and nesia dive dyskinesiaisunknown. tar- cause to potential their in differ products drug antipsychotic Whether syndrome. the treatment, which patients antipsychotic are likely of to develop inception the at predict, to is it women, impossible to rely upon prevalence estimates elderly especially elderly, the among highest be to appears syndrome the anti with of prevalence the Although drugs. treated psychotic patients in develop may movements dyskinetic involuntary, versible, A syndrome consisting of consisting syndrome A Tardive Dyskinesia INTRAVENOUSLY. ADMINISTERED BE NOT MUST INJECTION The diagnostic evaluation of patients with with patients of evaluation diagnostic The If signs and symptoms of tardive dyskinesia antipsychotic considerations, these Given There is no known treatment for established Both the risk of developing tardive dyski tardive developing of risk the Both HALOPERIDOL

potentially irre potentially cardiac abnor cardiac

DECANOATE lial long long lial 5AV not ------

Class Effect: Agranulocytosis Leukopenia, Neutropenia,and PRECAUTIONS: in patients receiving chemically-related drugs. reported been have changes ocular and ous cutane- and/or cholesterol serum decreased institute remedialtherapypromptly. especially in the elderly, the physician should fore, There if the above signsventilation. and symptoms pulmonary appear, reduced and inhibition may lead to dehydration, hemoconcentration central to due thirst of sensation has It been postulated that lethargy and decreased haloperidol. including drugs, chotic antipsy of use the followed have fatal, some broncho of cases of number A General discontinued promptly if such signs appear. evidence of neurological toxicity and treatment therapy should be monitored closely for early combined such receiving patients however, established; been not has haloperidol and and the concomitant administration of lithium events these between relationship causal A haloperidol. plus lithium with treated patients irre by few a in occurred has damage followed brain versible sugar) blood fasting and symptoms, leukocytosis, elevated serum enzymes, BUN, extrapyramidal confusion, and tremulousness fever, lethargy, weakness, by An encephalopathic syndrome (characterized Combined UseofHaloperidolandLithium also beenreportedwithhaloperidol. have complex, symptom above the with ated fully monitored, since recurrences of NMS NMS of have beenreported. recurrences since monitored, fully care- be should patient The considered. fully reintroduction of drug therapy should be potential care the NMS, from recovery after ment mens foruncomplicatedNMS. about specific pharmacological treatment regi agreement general no is There available. are treatments specific which for problems cal medi serious 3) concomitant and any of treatment monitoring, medical and symptomatic treatment intensive 2) therapy, current con to essential not drugs other and drugs 1) immediate discontinuation of antipsychotic (CNS) pathology. drug feverstroke, and heat primary centraltoxicity, nervous system anticholinergic central include diagnosis differential the in consid erations important Other (EPS). and symptoms signs extrapyramidal treated equately inad or untreated and etc.) infection, temic serious medical illness (e.g., pneumonia, sys both includes presentation clinical the where cases identify to important is it diagnosis, a • • tered cautiouslytopatients: adminis be should decanoate Haloperidol Other WBC followeduntilrecovery. continue haloperidol decanoate and have their lute neutrophil count occur. Patients with severe signs neutropenia or symptoms (abso such if promptly treated and infection of signs or symptoms other or fever for monitored carefully be should penia the absenceofothercausativefactors. sign of a clinically significant first the decline at in considered WBC be in should decanoate haloperidol of discontinuation and therapy of months few first the during frequently tored have their complete blood count (CBC) moni a or drug-induced leukopenia/neutropenia WBC should low significant clinically a of tory - his a with Patients leukopenia/neutropenia. cell count (WBC) and history of drug-induced blood white low pre-existing include tropenia Agranulocytosis hasalsobeenreported. to antipsychotic agents, including haloperidol. related temporally reported been have penia leukopenia/neutro of events experience, ing a history of seizures, or with EEG abnor EEG with or seizures, of history a with medications, anticonvulsant receiving epinephrine should beused. Instead, metaraminol, phenylephrine or nor further occur. may pressure blood the of lowering paradoxical and activity, pressor vaso its block may haloperidol since used be not should epinephrine required, be sor Should hypotension occur and a vasopres disorders, tension and/or precipitation of anginal pain. because cardiovascular of the possibility of transient hypo severe with Although not reported with haloperidol, haloperidol, with reported not Although Hyperpyrexia and heat stroke, not associ not stroke, heat and Hyperpyrexia If a patient requires antipsychotic drug treat include should NMS of management The Patients with clinically significant neutro significant clinically with Patients Possible risk factors for leukopenia/neu for factors risk Possible In clinical trial and/or postmarket < 1000/mm 3 pneumonia, pneumonia, ) should dis ------Inhibitors or Inducers of CYP3A4, CYP2D6 required, it may have to be continued after hal • • in haloperidol concentrations. of rifampin produced a mean 3.3-fold increase oral haloperidol and rifampin, discontinuation In 5 other schizophrenic patients treated with ric Rating Scale were increased from baseline. of 70% and mean scores on the Brief Psychiat haloperidol levels were decreased by a mean plasma rifampin, and haloperidol oral istered In a study of 12 schizophrenicRifampin patients coadmin of haloperidol plasma levels. reduction significant haloperidol a in results this therapy, to added is carbamazepine or with enzyme-inducing drugs such as rifampin chlorpromazine, and promethazine. sertraline, fluoxetine, quinidine, alprazolam, fluvoxamine, venlafaxine, buspirone, done, nefazo itraconazole, as, such isoenzymes, as substrates or inhibitors of characterized CYP3A4 or CYP2D6 drugs with concomitantly given was haloperidol when reported been have concentrations haloperidol increased In pharmacokinetic studies, mild to moderately or Glucuronidation Drugs Characterized as Substrates, adverse events, including QT-prolongation. tions and potentially increase the risk of certain may result in increased haloperidol drug concentraanother by metabolism of routes these of Inhibition system. enzyme P450 chrome cyto the and glucuronidation the including Haloperidol is metabolized by several routes, Decanoate The Effect of Other Drugs on Haloperidol Pharmacokinetic Interactions dosage. haloperidol the reduce to necessary be may It mg/day). (20 paroxetine and mg/day) (400 thetics, opiatesandalcohol. anes as such depressants CNS potentiating of capable be may haloperidol that noted be electrolyte cause imbalance. to known or QT-interval the prolong to known medications receiving patients to or imbalance) electrolyte kalemia, hypo QT-syndrome, (long conditions gation QT-prolon with patient to prescribing when advised is caution treatment, haloperidol ing Since QT-prolongation has been observed durPharmacodynamic Interactions described below. combina in tion with other drugs have been evaluated as haloperidol using of risks The pharmacokinetic (alteration of plasma levels). or effects) pharmacologic (combined namic pharmacody be can interactions Drug-drug Drug Interactions hypotension. and effects additive possible to due avoided warned be accordingly. should patient ambulatory The vehicle. motor a driving or machinery ating oper as such tasks hazardous of formance per the for required abilities physical and/or Haloperidol decanoate may impair the mental Information forPatients medication, including haloperidol. toxicosis who are also receiving antipsychotic walk or talk) may occur in patients with thyro rapid moodswingtodepression. trol mania in cyclic disorders, there may be a haloperidol decanoate. with concomitantly administered are agents, anticholinergic drugs, when including antiparkinson pressure intraocular in increase sible pos the mind in keep should physician The occur. may symptoms extrapyramidal ously, ate. If both drugs are discontinued simultane of the prolonged action of haloperidol decano because discontinued is decanoate operidol with the metabolic inhibitors ketoconazole ketoconazole inhibitors metabolic the with combination in given was haloperidol when CYP3A4. Increases in QTc have been observed effects of one anticoagulant (phenindione). the with occurred interference of instance isolated an since anticoagulants, receiving of history allergic reactionstodrugs. a with or allergies, known with tantly maintained. anticonvulsant therapy should be concomi convulsive threshold. If indicated, adequate malities, because haloperidol may lower the If concomitant antiparkinson medication is medication antiparkinson concomitant If When prolonged treatment (1 to 2 weeks) 2 to (1 treatment prolonged When of inhibitor potent a is Ketoconazole As with other antipsychotic agents, it should The use of alcohol with this drug should be to inability (rigidity, neurotoxicity Severe When haloperidol decanoate is used to con

------

were not established with these cases. Since cases. these with established not were relationships Causal pregnancy. of trimester first the during potential teratogenic pected sus have which drugs other with along dol malformations haloperi- limb of use maternal following observed of cases of however, studies in pregnant women. There are reports, risk formostoftheseagents. relate this phenomenon to predictable human to evidence no is there and drugs, of variety to response a to as well as imbalance nutritional or stress non-specific a be to appears mice in palate Cleft dose. human maximum usual the times 15 at haloperidol oral given abnormalities wereobserved. tion, fetal mortality, and resorp pup mortality.of No fetal incidence in increase an showed decanoate haloperidol of dose human mum maxi usual the times 3 to up given Rodents Pregnancy CategoryC Usage inPregnancy clusive at this time. evidence is considered too limited to be con available the tumorigenesis; mammary and between chronic administration of these drugs to date, however, have shown an association studies nor epidemiologic studies conducted tration of antipsychotic drugs. Neither clinical adminis chronic after rodents in found been patients. most for unknown is levels prolactin serum elevated of significance clinical the reported, rhea, gynecomastia, and impotence amenor galactorrhea, haveas such beendisturbances a previously detected breast cancer. Although with patient a in contemplated is drugs these tor of potential importance if the prescription of cancers are prolactin dependent that indicate experiments culture Tissue istration. admin chronic during persists elevation the types werenoted. tumor specific or tumors total of incidences mice, no statistically significant differences in male In neoplasia. gland pituitary in increase significant statistically a was there dose daily same the times 20 at incidence; tumor total and neoplasia gland mammary in increase significant statistically a was there patients, resistant or chronic for dose daily initial est or resistantpatients. times the usual daily human dose for chronic 20 to up doses at rats in neoplasia of dence inci the in increase haloperidol-related a of optimal, this study does suggest the absence than control animals. tumors Therefore, although not of incidence greater a have not did dose male and female groups, these animals of rats survived to the end of the study in high- However, although a relatively greater number tumors. developing for risk at rats of number the reducing groups, dose all in optimal than less was survival study rat the In months). 18 for daily mg/kg 5 to up at (dosed mice Swiss to 5 mg/kg daily for 24 months) and in Albino dol were conducted in Wistar rats (dosed at up sistent tobeconclusiveatthistime. cytogenetic evidence is considered too incon mosome structure and number. The available effects of short-acting haloperidol on chro on haloperidol short-acting of effects inconsistent positive findings have been been have in findings obtained positive or Negative inconsistent assay. activation Salmonella Ames microsomal the in found was noate deca haloperidol of potential mutagenic No Impairment ofFertility Carcinogenesis, Mutagenesis, plasma concentrations. haloperidol affect not inhibit does to glucuronidation, known drug a valproate, Sodium Valproate necessary to reduce the dosage of haloperidol.After discontinuation of such drugs, it may be necessary. when adjusted, be should dose During combination treatment, the haloperidol or discontinued in haloperidol-treated patients. as rifampin or carbamazepine are administeredwarranted when enzyme inducing drugs such ing carbamazepine concentrations. concentrations decreased increasing linearly with and increas doses of carbamazepine, haloperidol plasma haloperidol co- administered patients schizophrenic 11 in study a In Carbamazepine such experience does not exclude the pos the exclude not does experience such There are no adequate and well-controlled and adequate no are There mice in observed been has palate Cleft has neoplasms mammary in increase An Antipsychotic drugs elevate prolactin levels; high the times 20 and 5 at mice female In Carcinogenicity studies using oral haloperi Thus, careful monitoring of clinical status is approximately one-third of human breast in vitro vitro in and and in vivo in in in vitro, studies of of studies a fac------

CrossTech–70028–Proof A2 Form M01 Fresenius Kabi USA, LLC P.O. No. 4500104024–Job No. 45803I 10/29/12–bw–O–Indd4 m Fonts: Helvetica (A) Typesmiths Pi Font For IM Injection Only INJECTION HALOPERIDOL DECANO 45803 I /Revised: October 2012 A Rx only TE comatose states from any cause and in indi in and cause any from states comatose or depression system nervous central toxic modified only to reflect the prolonged action. additional information are those of haloperidol, CONTRA medication, active the as haloperidol to uted of HaloperidolDecanoateInjectionare attrib actions clinical and pharmacologic the Since CONTRAINDICATIONS: antipsy chotic therapy. parenteral prolonged require patients who schizophrenic of treatment the for indicated is Injection Decanoate Haloperidol INDICATIONS ANDUSAGE: be quitevariablebetweensubjects. anoate following intramuscular injections can that the pharmacokinetics of haloperidol dec however, noted, be should It mg. 450 below doses for linear roughly is concentration dol haloperi plasma and decanoate haloperidol fourth dose. The relationship between dose of plasma or third the after achieved are concentrations Steady-state weeks. 3 about of life half- apparent an with thereafter, falling and ing a peak at about 6 days after the injection, - reach rise, gradually haloperidol of trations concen plasma The haloperidol. of release sustained and slow in results oil sesame in the precise mechanism of action is unknown. mine and increases its turnover rate; however, action. Haloperidol blocks the effects of dopa of duration of exception the with haloperidol of those from different no are decanoate dol haloperi of effects basic The haloperidol. of Haloperidol decanoate is the long-acting form CLINICAL PHARMACOLOGY: alcohol asapreservative. in a sesame oil vehicle, with 1.2% (w/v) benzyl (present as haloperidol decanoate 141.04 mg) tion, 100 mg/mL, contains 100 mg haloperidol alcohol asapreservative. in a sesame oil vehicle, with 1.2% (w/v) benzyl (present as haloperidol decanoate 70.52 mg) haloperidol mg 50 contains mg/mL, 50 tion, organic solvents. most in soluble is but mg/mL), (0.01 water in C decanoate, is: 1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl of haloperidol decanoate, 4-(4-chlorophenyl)- muscular (IM) injection. The structural formula intra for form sterile in oil sesame in solution is It amber yellow effect. to colorless/pink a as available of duration extended markedly a has It haloperidol. butyrophenone, the of Haloperidol decanoate is the decanoate ester DESCRIPTION: psychosis (see WARNINGS). treatment of patientsthe for approved withnot is dementia-relatedInjection anoate the patients is not clear. Haloperidol Dec ofcharacteristic(s) some to opposed as may be attributed to the in- antipsychotic of creased findings drugmortality the inobservational which studies to extent The mortality. increase may drugs psychotic antipsychotic anti- conventional with treatment atypical drugs, to similar that, Observationalsuggestnature.studies in den death)sud or infectiousfailure, (e.g.,heart pneumonia) (e.g., cardiovascular deathstheappearedmosteitherof be to Although the causes of death were varied,group. placebo the in 2.6%about of rate a to compared4.5%, about was patients trolled trial, the rate Over theof course of a typicaldeath 10-week con in drug-treatedplacebo-treated inpatients. death of risk the times 1.7 to 1.6 between drugs, of patients drug-treated in death of risk antipsychotic a revealed atypical taking patientsweeks),largelyin10duration of seventeen placebo-controlled trials (modalat an increased risk of death. Analyses of – chosis Psychosis treated with antipsychotic drugsElderly arepatients with Dementia-Related dementia-related Patients psy with Elderly in Mortality Increased 31 Haloperidol is contraindicated in severe severe in contraindicated is Haloperidol Administration of haloperidol decanoate decanoate haloperidol of Administration Injec Decanoate Haloperidol of mL Each Injec Decanoate Haloperidol of mL Each insoluble almost is decanoate Haloperidol H 41 CIFNO INDICATIONS, WARNINGS, INDICATIONS, 3

WARNING M.W. 530.12 and and ------

QT-syndrome).fami and hypothyroidism, malities, underlying QT, prolong to known drugs hypomagnesemia], and lemia hypoka [particularly imbalance electrolyte (including conditions with QT-prolonging other patients treating in advised is caution the absence of predisposing in factors, even particularreported been have cases Although Pointes. de Torsades and QT-prolongation haloperidol of risk higher of a with associated be to appear administration intravenous and formulation any of doses recommended than Higher haloperidol. receiving patients in reported been have Pointes de Torsades Cases of sudden death, QT-prolongation, and Cardiovascular Effects psychosis (seeBOXEDWARNING). treatment of patients with dementia-related Decanoate Injection is not approved for the Haloperidol death. of risk increased an at chosis treated with antipsychotic drugs are Elderly patients with dementia-related psy Dementia-Related Psychosis Increased Mortality in Elderly Patients with WARNINGS: have Parkinson’sdisease. viduals who are hypersensitive to this drug or this syndrome is complicated. In arriving at at arriving In complicated. is syndrome this renal failure. acute and (rhabdomyolysis) phosphokinase, myoglobinuria creatine elevated and include diaphoresis, may signs Additional dysrhythmias). cardiac tachycardia, blood or pulse pressure, (irregular instability auto of nomic evidence and signs) catatonic ing (includ status mental altered rigidity, muscle in hyperpyrexia, are NMS of manifestations cal Clini reported drugs. been antipsychotic with has association (NMS) Malignant Syndrome Neuroleptic as to referred times some complex symptom fatal potentially A Neuroleptic MalignantSyndrome(NMS) refer toADVERSEREACTIONS.) please detection, clinical its and dyskinesia tardive of description the about information further (For syndrome. the of presence the despite treatment require may patients some continuation should be considered. However, appear in a patient on antipsychotics, drug dis should bereassessedperiodically. treatment continued for need The sought. be pro ducing a satisfactory clinical treatment response shouldof duration shortest the and dose smallest the treatment, chronic require do who patients In appropriate. or available but potentially less harmful treatments are and 2) for whom alternative, equally effective, 1) is known to respond to antipsychotic drugs, patients who for suffer from a chronic illness that reserved be generally antipsychotic should treatment Chronic dyskinesia. tardive of occurrence the minimize to likely most is that manner a in prescribed be should drugs is unknown. syndrome the of course long-term the upon The effect that symptomatic suppression has process. underlying the mask possibly may signs the thereby and syndrome the of symptoms and suppress) may partially (or however, suppress itself, treatment, Anti psychotic withdrawn. is treatment antipsychotic if completely, or partially remit, may drome cases of tardive dyskinesia, although the syn doses. low at periods treatment brief relatively after can develop, although much less commonly, syndrome the However, increase. patient the to administered drugs antipsychotic of dose the as duration of treatment and the total increase cumulative to believed are irreversible become will it that likelihood the and nesia dive dyskinesiaisunknown. tar- cause to potential their in differ products drug antipsychotic Whether syndrome. the treatment, which patients antipsychotic are likely of to develop inception the at predict, to is it women, impossible to rely upon prevalence estimates elderly especially elderly, the among highest be to appears syndrome the anti with of prevalence the Although drugs. treated psychotic patients in develop may movements dyskinetic involuntary, versible, of consisting syndrome A Tardive Dyskinesia INTRAVENOUSLY. ADMINISTERED BE NOT MUST INJECTION The diagnostic evaluation of patients with with patients of evaluation diagnostic The If signs and symptoms of tardive dyskinesia antipsychotic considerations, these Given There is no known treatment for established dyski tardive developing of risk the Both HALOPERIDOL

potentially irre potentially cardiac abnor cardiac

DECANOATE lial long long lial 5AV not ------

Class Effect: Agranulocytosis Leukopenia, Neutropenia,and PRECAUTIONS: in patients receiving chemically-related drugs. reported been have changes ocular and ous cutane- and/or cholesterol serum decreased institute remedialtherapypromptly. especially in the elderly, the physician should fore, There if the above signsventilation. and symptoms pulmonary appear, reduced and inhibition may lead to dehydration, hemoconcentration central to due thirst of sensation has It been postulated that lethargy and decreased haloperidol. including drugs, chotic antipsy of use the followed have fatal, some broncho of cases of number A General discontinued promptly if such signs appear. evidence of neurological toxicity and treatment therapy should be monitored closely for early combined such receiving patients however, established; been not has haloperidol and and the concomitant administration of lithium events these between relationship causal A haloperidol. plus lithium with treated patients irre by few a in occurred has damage followed brain versible sugar) blood fasting and symptoms, leukocytosis, elevated serum enzymes, BUN, extrapyramidal confusion, and tremulousness fever, lethargy, weakness, by An encephalopathic syndrome (characterized Combined UseofHaloperidolandLithium also beenreportedwithhaloperidol. have complex, symptom above the with ated NMS of have beenreported. recurrences since monitored, fully care- be should patient The considered. fully reintroduction of drug therapy should be potential care the NMS, from recovery after ment mens foruncomplicatedNMS. about specific pharmacological treatment regi agreement general no is There available. are treatments specific which for problems cal medi serious 3) concomitant and any of treatment monitoring, medical and symptomatic treatment intensive 2) therapy, current con to essential not drugs other and drugs 1) immediate discontinuation of antipsychotic (CNS) pathology. drug feverstroke, and heat primary centraltoxicity, nervous system anticholinergic central include diagnosis differential the in consid erations important Other (EPS). and symptoms signs extrapyramidal treated equately inad or untreated and etc.) infection, temic serious medical illness (e.g., pneumonia, sys both includes presentation clinical the where cases identify to important is it diagnosis, a • • tered cautiouslytopatients: adminis be should decanoate Haloperidol Other WBC followeduntilrecovery. continue haloperidol decanoate and have their lute neutrophil count occur. Patients with severe signs neutropenia or symptoms (abso such if promptly treated and infection of signs or symptoms other or fever for monitored carefully be should penia the absenceofothercausativefactors. sign of a clinically significant first the decline at in considered WBC be in should decanoate haloperidol of discontinuation and therapy of months few first the during frequently tored have their complete blood count (CBC) moni a or drug-induced leukopenia/neutropenia WBC should low significant clinically a of tory - his a with Patients leukopenia/neutropenia. cell count (WBC) and history of drug-induced blood white low pre-existing include tropenia Agranulocytosis hasalsobeenreported. to antipsychotic agents, including haloperidol. related temporally reported been have penia leukopenia/neutro of events experience, ing a history of seizures, or with EEG abnor EEG with or seizures, of history a with medications, anticonvulsant receiving epinephrine should beused. Instead, metaraminol, phenylephrine or nor further occur. may pressure blood the of lowering paradoxical and activity, pressor vaso its block may haloperidol since used be not should epinephrine required, be sor Should hypotension occur and a vasopres disorders, tension and/or precipitation of anginal pain. because cardiovascular of the possibility of transient hypo severe with Although not reported with haloperidol, haloperidol, with reported not Although associ not stroke, heat and Hyperpyrexia If a patient requires antipsychotic drug treat include should NMS of management The Patients with clinically significant neutro significant clinically with Patients leukopenia/neu for factors risk Possible In clinical trial and/or postmarket < 1000/mm 3 pneumonia, pneumonia, ) should dis ------in haloperidol concentrations. of rifampin produced a mean 3.3-fold increase oral haloperidol and rifampin, discontinuation In 5 other schizophrenic patients treated with ric Rating Scale were increased from baseline. of 70% and mean scores on the Brief Psychiat haloperidol levels were decreased by a mean plasma rifampin, and haloperidol oral istered In a study of 12 schizophrenicRifampin patients coadmin of haloperidol plasma levels. reduction significant haloperidol a in results this therapy, to added is carbamazepine or with enzyme-inducing drugs such as rifampin chlorpromazine, and promethazine. sertraline, fluoxetine, quinidine, alprazolam, fluvoxamine, venlafaxine, buspirone, done, nefazo itraconazole, as, such isoenzymes, as substrates or inhibitors of characterized CYP3A4 or CYP2D6 drugs with concomitantly given was haloperidol when reported been have concentrations haloperidol increased In pharmacokinetic studies, mild to moderately or Glucuronidation Inhibitors or Inducers of CYP3A4, CYP2D6 Drugs Characterized as Substrates, adverse events, including QT-prolongation. tions and potentially increase the risk of certain may result in increased haloperidol drug concentraanother by metabolism of routes these of Inhibition system. enzyme P450 chrome cyto the and glucuronidation the including Haloperidol is metabolized by several routes, Decanoate The Effect of Other Drugs on Haloperidol Pharmacokinetic Interactions dosage. haloperidol the reduce to necessary be may It mg/day). (20 paroxetine and mg/day) ketoconazole (400 inhibitors metabolic the with combination in given was haloperidol when CYP3A4. Increases in QTc have been observed thetics, opiatesandalcohol. anes as such depressants CNS potentiating of capable be may haloperidol that noted be electrolyte cause imbalance. to known or QT-interval the prolong to known medications receiving patients to or imbalance) electrolyte kalemia, hypo QT-syndrome, (long conditions gation QT-prolon with patient to prescribing when advised is caution treatment, haloperidol ing Since QT-prolongation has been observed durPharmacodynamic Interactions described below. combina in tion with other drugs have been evaluated as haloperidol using of risks The pharmacokinetic (alteration of plasma levels). or effects) pharmacologic (combined namic pharmacody be can interactions Drug-drug Drug Interactions hypotension. and effects additive possible to due avoided warned be accordingly. should patient ambulatory The vehicle. motor a driving or machinery ating oper as such tasks hazardous of formance per the for required abilities physical and/or Haloperidol decanoate may impair the mental Information forPatients medication, including haloperidol. toxicosis who are also receiving antipsychotic walk or talk) may occur in patients with thyro rapid moodswingtodepression. trol mania in cyclic disorders, there may be a • • haloperidol decanoate. with concomitantly administered are agents, anticholinergic drugs, when including antiparkinson pressure intraocular in increase sible pos the mind in keep should physician The occur. may symptoms extrapyramidal ously, ate. If both drugs are discontinued simultane of the prolonged action of haloperidol decano because discontinued is decanoate operidol required, it may have to be continued after hal effects of one anticoagulant (phenindione). the with occurred interference of instance isolated an since anticoagulants, receiving of history allergic reactionstodrugs. a with or allergies, known with tantly maintained. anticonvulsant therapy should be concomi convulsive threshold. If indicated, adequate malities, because haloperidol may lower the When prolonged treatment (1 to 2 weeks) 2 to (1 treatment prolonged When of inhibitor potent a is Ketoconazole As with other antipsychotic agents, it should The use of alcohol with this drug should be to inability (rigidity, neurotoxicity Severe When haloperidol decanoate is used to con is medication antiparkinson concomitant If

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were not established with these cases. Since cases. these with established not were relationships Causal pregnancy. of trimester first the during potential teratogenic pected sus have which drugs other with along dol malformations haloperi- limb of use maternal following observed of cases of however, studies in pregnant women. There are reports, risk formostoftheseagents. relate this phenomenon to predictable human to evidence no is there and drugs, of variety to response a to as well as imbalance nutritional or stress non-specific a be to appears mice in palate Cleft dose. human maximum usual the times 15 at haloperidol oral given abnormalities wereobserved. tion, fetal mortality, and resorp pup mortality.of No fetal incidence in increase an showed decanoate haloperidol of dose human mum maxi usual the times 3 to up given Rodents Pregnancy CategoryC Usage inPregnancy clusive at this time. evidence is considered too limited to be con available the tumorigenesis; mammary and between chronic administration of these drugs to date, however, have shown an association studies nor epidemiologic studies conducted tration of antipsychotic drugs. Neither clinical adminis chronic after rodents in found been patients. most for unknown is levels prolactin serum elevated of significance clinical the reported, rhea, gynecomastia, and impotence amenor galactorrhea, haveas such beendisturbances a previously detected breast cancer. Although with patient a in contemplated is drugs these tor of potential importance if the prescription of cancers are prolactin dependent that indicate experiments culture Tissue istration. admin chronic during persists elevation the types werenoted. tumor specific or tumors total of incidences mice, no statistically significant differences in male In neoplasia. gland pituitary in increase significant statistically a was there dose daily same the times 20 at incidence; tumor total and neoplasia gland mammary in increase significant statistically a was there patients, resistant or chronic for dose daily initial est or resistantpatients. times the usual daily human dose for chronic 20 to up doses at rats in neoplasia of dence inci the in increase haloperidol-related a of optimal, this study does suggest the absence than control animals. tumors Therefore, although not of incidence greater a have not did dose male and female groups, these animals of rats survived to the end of the study in high- However, although a relatively greater number tumors. developing for risk at rats of number the reducing groups, dose all in optimal than less was survival study rat the In months). 18 for daily mg/kg 5 to up at (dosed mice Swiss to 5 mg/kg daily for 24 months) and in Albino dol were conducted in Wistar rats (dosed at up sistent tobeconclusiveatthistime. cytogenetic evidence is considered too incon mosome chro structure and on number. The available haloperidol short-acting of effects inconsistent positive findings have been been have in findings obtained positive or Negative inconsistent assay. activation Salmonella Ames microsomal the in found was noate deca haloperidol of potential mutagenic No Impairment ofFertility Carcinogenesis, Mutagenesis, plasma concentrations. haloperidol affect not inhibit does to glucuronidation, known drug a valproate, Sodium Valproate necessary to reduce the dosage of haloperidol.After discontinuation of such drugs, it may be necessary. when adjusted, be should dose During combination treatment, the haloperidol or discontinued in haloperidol-treated patients. as rifampin or carbamazepine are administeredwarranted when enzyme inducing drugs such ing carbamazepine concentrations. concentrations decreased increasing linearly with and increas doses of carbamazepine, haloperidol plasma haloperidol co- administered patients schizophrenic 11 in study a In Carbamazepine such experience does not exclude the pos the exclude not does experience such There are no adequate and well-controlled and adequate no are There mice in observed been has palate Cleft has neoplasms mammary in increase An Antipsychotic drugs elevate prolactin levels; In female mice at 5 and 20 times the high the times 20 and 5 at mice female In Carcinogenicity studies using oral haloperi Thus, careful monitoring of clinical status is approximately one-third of human breast in vitro vitro in and and in vivo in in in vitro, studies of of studies a fac------

CrossTech–70028–Proof A2 Form M01 Fresenius Kabi USA, LLC P.O. No. 4500104024–Job No. 45803I 10/29/12–bw–O–Indd4 m Fonts: Helvetica (A) Typesmiths Pi Font 5AV

sibility of fetal damage due to haloperidol, low doses, they occur more frequently and Autonomic Reactions response to previous antipsychotic therapy. Store at 20° to 25°C (68° to 77°F) [see USP haloperidol decanoate should be used dur- with greater severity with high potency and at Dry mouth, blurred vision, urinary retention, The preferred approach to determining the Controlled Room Temperature]. ing pregnancy or in women likely to become higher doses of first generation antipsychotic diaphoresis and priapism. minimum effective dose is to begin with lower Do not refrigerate or freeze. pregnant only if the benefit clearly justifies a drugs. An elevated risk of acute dystonia is initial doses and to adjust the dose upward as Respiratory Effects PROTECT FROM LIGHT. potential risk to the fetus. observed in males and younger age groups. Laryngospasm, bronchospasm and increased needed. For patients previously maintained on Non-teratogenic Effects Withdrawal Emergent Neurological Signs depth of respiration. low doses of antipsychotics (e.g., up to the Keep in carton until empty. equivalent of 10 mg/day oral haloperidol), it Neonates exposed to antipsychotic drugs Generally, patients receiving short-term ther- Special Senses (including haloperidol) during the third tri- apy experience no problems with abrupt dis- is recommended that the initial dose of halo- Cataracts, retinopathy and visual distur- peridol decanoate be 10 to 15 times the previ- mester of pregnancy are at risk for extrapyra- continuation of antipsychotic drugs. However, bances. midal and/or withdrawal symptoms following some patients on maintenance treatment ous daily dose in oral haloperidol equivalents; Postmarketing Events limited clinical experience suggests that lower delivery. There have been reports of agitation, experience transient dyskinetic signs after 1 hypertonia, hypotonia, tremor, somnolence, abrupt withdrawal. In certain of these cases the Hyperammonemia has been reported in a 5 ⁄2 initial doses may be adequate. respiratory distress, and feeding disorder in year old child with citrullinemia, an inherited dyskinetic movements are indistinguishable Initial Therapy these neonates. These complications have from the syndrome described below under disorder of ammonia ex cretion, following treat- varied in severity; while in some cases symp- ment with haloperidol. Conversion from oral haloperidol to haloperi- “Tardive Dyskinesia” except for duration. dol decanoate can be achieved by using an toms have been self-limited, in other cases Although the long-acting properties of halo- OVERDOSAGE: neonates have required intensive care unit While overdosage is less likely to occur with a initial dose of haloperidol decanoate that is peridol decanoate provide gradual withdrawal, 10 to 20 times the previous daily dose in oral support and prolonged hospitalization. it is not known whether gradual withdrawal parenteral than with an oral medication, infor- Haloperidol decanoate should be used dur- mation pertaining to haloperidol is presented, haloperidol equivalents. of antipsychotic drugs will reduce the rate of In patients who are elderly, debilitated, or ing pregnancy only if the potential benefit occurrence of withdrawal emergent neurologi- modified only to reflect the extended duration justifies the potential risk to the fetus. of action of haloperidol decanoate. stable on low doses of oral haloperidol (e.g., cal signs. up to the equivalent of 10 mg/day oral halo- Nursing Mothers Tardive Dyskinesia Manifestations peridol), a range of 10 to 15 times the previous Since haloperidol is excreted in human breast As with all antipsychotic agents haloperidol In general, the symptoms of overdosage daily dose in oral haloperidol equivalents is milk, infants should not be nursed during drug has been associated with persistent dyski- would be an exaggeration of known phar- appropriate for initial conversion. treatment with haloperidol decanoate. nesias. Tardive dyskinesia, a syndrome con- macologic effects and adverse reactions, the In patients previously maintained on higher Pediatric Use sisting of potentially irreversible, involuntary, most prominent of which would be: 1) severe doses of antipsychotics for whom a low dose Safety and effectiveness of haloperidol deca- dyskinetic movements, may appear in some extrapyramidal reactions, 2) hypotension, or 3) approach risks recurrence of psychiatric noate in children have not been established. patients on long-term therapy with haloperidol sedation. The patient would appear comatose decompensation and in patients whose long- Geriatric Use decanoate or may occur after drug therapy with respiratory depression and hypotension term use of haloperidol has resulted in a toler- Clinical studies of haloperidol did not include has been discontinued. The risk appears to which could be severe enough to produce ance to the drug, 20 times the previous daily sufficient numbers of subjects aged 65 and be greater in elderly patients on high-dose a shock-like state. The extrapyramidal reac- dose in oral haloperidol equivalents should be over to determine whether they respond dif- therapy, especially females. The symptoms tions would be manifested by muscular weak- considered for initial conversion, with down- ferently from younger subjects. Other reported are persistent and in some patients appear ness or rigidity and a generalized or localized ward titration on succeeding injections. clinical experience has not consistently iden- irreversible. The syndrome is characterized by tremor, as demonstrated by the akinetic or The initial dose of haloperidol decanoate tified differences in responses between the rhythmical involuntary movements of tongue, agitans types, respectively. With accidental should not exceed 100 mg regardless of previ- elderly and younger patients. However, the face, mouth, or jaw (e.g., protrusion of tongue, overdosage, hypertension rather than hypo- ous antipsychotic dose requirements. If, there- prevalence of tardive dyskinesia appears to be puffing of cheeks, puckering of mouth, chew- tension occurred in a two-year old child. The fore, conversion requires more than 100 mg of highest among the elderly, especially elderly ing movements). Sometimes these may be risk of ECG changes associated with Torsades haloperidol decanoate as an initial dose, that women (see WARNINGS, Tardive Dyskine- accompanied by involuntary movements of de Pointes should be considered. dose should be administered in two injections, sia). Also, the pharmacokinetics of haloperidol extremities and the trunk. (For further information regarding Tors- i.e., a maximum of 100 mg initially followed by in geriatric patients generally warrants the use There is no known effective treatment for ades de Pointes, please refer to ADVERSE the balance in 3 to 7 days. of lower doses (see DOSAGE AND ADMIN- tardive dyskinesia; antiparkinson agents usu- REACTIONS.) ISTRATION). ally do not alleviate the symptoms of this syn- Treatment Maintenance Therapy m ADVERSE REACTIONS: drome. It is suggested that all antipsychotic Since there is no specific antidote, treatment The maintenance dosage of haloperidol dec- Adverse reactions following the administra- agents be discontinued if these symptoms is primarily supportive. A patent airway must anoate must be individualized with titration tion of Haloperidol Decanoate Injection are appear. Should it be necessary to reinsti- be established by use of an oropharyngeal upward or downward based on therapeutic those of haloperidol. Since vast experience tute treatment, or increase the dosage of the airway or endotracheal tube or, in prolonged response. The usual maintenance range is has accumulated with haloperidol, the adverse agent, or switch to a different antipsychotic cases of coma, by tracheostomy. Respiratory 10 to 15 times the previous daily dose in oral reactions are reported for that compound as agent, this syndrome may be masked. depression may be counteracted by artificial haloperidol equivalents dependent on the well as for haloperidol decanoate. As with all It has been reported that fine vermicular respiration and mechanical respirators. Hypo- clinical response of the patient. injectable medications, local tissue reactions movement of the tongue may be an early sign tension and circulatory collapse may be coun- HALOPERIDOL DECANOATE have been reported with haloperidol decanoate. of tardive dyskinesia and if the medication is teracted by use of intravenous fluids, plasma, DOSING RECOMMENDATIONS Cardiovascular Effects stopped at that time the full syndrome may or concentrated albumin, and vasopressor not develop. Monthly Tachycardia, hypotension, and hypertension agents such as metaraminol, phenylephrine Patients 1st Month Maintenance have been reported. QT-prolongation and/ Tardive Dystonia and norepinephrine. Epinephrine should not or ventricular arrhythmias have also been Tardive dystonia, not associated with the be used. In case of severe extrapyramidal Stabilized on low 10 to 15 x Daily 10 to 15 x Previous reported, in addition to ECG pattern changes above syndrome, has also been reported. reactions, antiparkinson medication should daily oral doses Oral Dose Daily Oral Dose compatible with the polymorphous configura- Tardive dystonia is characterized by delayed be administered, and should be continued for (up to 10 mg/day) tion of Torsades de Pointes, and may occur onset of choreic or dystonic movements, several weeks, and then withdrawn gradually Elderly or Debilitated more frequently with high doses and in pre- is often persistent, and has the potential of as extrapyramidal symptoms may emerge. High dose 20 x Daily Oral 10 to 15 x Previous disposed patients (see WARNINGS and PRE- becoming irreversible. ECG and vital signs should be monitored Dose Daily Oral Dose CAUTIONS). Other CNS Effects especially for signs of QT-prolongation or Cases of sudden and unexpected death have Insomnia, restlessness, anxiety, euphoria, dysrhythmias and monitoring should continue Risk of relapse been reported in association with the adminis- agitation, drowsiness, depression, lethargy, until the ECG is normal. Severe arrhythmias Tolerant to oral haloperidol tration of Haloperidol Decanoate Injection. The headache, confusion, vertigo, grand mal sei- should be treated with appropriate anti- Close clinical supervision is required dur- nature of the evidence makes it impossible zures, exacerbation of psychotic symptoms arrhythmic measures. ing initiation and stabilization of haloperidol to determine definitively what role, if any, including hallucinations, and catatonic-like DOSAGE AND ADMINISTRATION: decanoate therapy. Haloperidol decanoate Haloperidol Decanoate Injection played in behavioral states which may be responsive Haloperidol Decanoate Injection should be is usually administered monthly or every 4 the outcome of the reported cases. The pos- to drug withdrawal and/or treatment with anti- administered by deep intramuscular injec- weeks. However, variation in patient response sibility that Haloperidol Decanoate Injection cholinergic drugs. tion. A 21 gauge needle is recommended. The may dictate a need for adjustment of the dos- caused death cannot, of course, be excluded, Body as a Whole maximum volume per injection site should not ing interval as well as the dose (see CLINICAL but it is to be kept in mind that sudden and Neuroleptic malignant syndrome (NMS), exceed 3 mL. DO NOT ADMINISTER INTRA- PHARMACOLOGY). unexpected death may occur in psychotic hyperpyrexia and heat stroke have been VENOUSLY. Clinical experience with haloperidol decano- patients when they go untreated or when they reported with haloperidol (see WARNINGS Parenteral drug products should be ate at doses greater than 450 mg per month are treated with other antipsychotic drugs. for further information concerning NMS). inspected visually for particulate matter and has been limited. CNS Effects Hematologic Effects discoloration prior to administration, whenever Extrapyramidal Symptoms (EPS) Reports have appeared citing the occurrence solution and container permit. HOW SUPPLIED: EPS during the administration of haloperidol of mild and usually transient leukopenia and Haloperidol Decanoate Injection is intended Product NDC have been reported frequently, often dur- leukocytosis, minimal decreases in red blood for use in schizophrenic patients who require No. No. ing the first few days of treatment. EPS can cell counts, anemia, or a tendency toward prolonged parenteral antipsychotic therapy. 436901 63323-469-01 Haloperidol Decanoate be categorized generally as Parkinson-like lymphomonocytosis. Agranulocytosis has These patients should be previously stabilized Injection, 50 mg*/mL, symptoms, akathisia, or dystonia (including rarely been reported to have occurred with on antipsychotic medication before consider- 1 mL fill, in a 2 mL opisthotonos and oculogyric crisis). While all flip-top vial, packaged the use of haloperidol, and then only in ing a conversion to haloperidol decanoate. I can occur at relatively low doses, they occur association with other medication (see PRE- Furthermore, it is recommended that patients individually. more frequently and with greater severity at CAUTIONS, Leukopenia, Neutropenia, and being considered for haloperidol decanoate 436905 63323-469-05 Haloperidol Decanoate higher doses. The symptoms may be con- Agranulocytosis). therapy have been treated with, and toler- Injection, 50 mg*/mL, trolled with dose reductions or administration Liver Effects ate well, short-acting haloperidol in order 5 mL fill, in a 5 mL of antiparkinson drugs such as benztropine Impaired liver function and/or jaundice have to reduce the possibility of an unexpected multiple dose, flip-top mesylate USP or trihexyphenidyl hydrochlo- been reported. adverse sensitivity to haloperidol. Close clini- vial, packaged ride USP. It should be noted that persistent cal supervision is required during the initial individually. EPS have been reported; the drug may have Dermatologic Reactions period of dose adjustment in order to minimize 437101 63323-471-01 Haloperidol Decanoate to be discontinued in such cases. Maculopapular and acneiform skin reactions the risk of overdosage or reappearance of Injection, 100 mg*/mL, Dystonia and isolated cases of photosensitivity and psychotic symptoms before the next injec- 1 mL fill, in a 2 mL Class Effect: Symptoms of dystonia, pro- loss of hair. tion. During dose adjustment or episodes of flip-top vial, packaged longed abnormal contractions of muscle Endocrine Disorders exacerbation of symptoms of schizophrenia, individually. groups, may occur in susceptible individu- Lactation, breast engorgement, mastalgia, haloperidol decanoate therapy can be supple- 437105 63323-471-05 Haloperidol Decanoate als during the first few days of treatment. menstrual irregularities, gynecomastia, impo- mented with short-acting forms of haloperidol. Injection, 100 mg*/mL, Fresenius Kabi USA, LLC tence, increased libido, hyperglycemia, hypo- Schaumburg, IL 60173 Dystonic symptoms include: spasm of the The dose of haloperidol decanoate should 5 mL fill, in a 5 mL neck muscles, sometimes progressing to glycemia and hyponatremia. be expressed in terms of its haloperidol con- multiple dose, flip-top

tightness of the throat, swallowing difficulty, Gastrointestinal Effects tent. The starting dose of haloperidol dec- vial, packaged difficulty breathing, and/or protrusion of the Anorexia, constipation, diarrhea, hypersaliva- anoate should be based on the patient’s individually. 45803I tongue. While these symptoms can occur at tion, dyspepsia, nausea and vomiting. age, clinical history, physical condition, and *as haloperidol Revised: October 2012 Typesmiths Pi Font Pi Typesmiths Helvetica (A) Helvetica P.O. No. 4500104024–Job No. 45803 No. 4500104024–Job No. P.O. CrossTech–70028–Proof A1 CrossTech–70028–Proof M02 Form LLC USA, Kabi Fresenius Fonts: 10/25/12–hc–O–Indd4 5AV

tightness of the throat, swallowing difficulty, Gastrointestinal Effects tent. The starting dose of haloperidol dec- vial, packaged difficulty breathing, and/or protrusion of the Anorexia, constipation, diarrhea, hypersaliva- anoate should be based on the patient’s individually. 45803I tongue. While these symptoms can occur at tion, dyspepsia, nausea and vomiting. age, clinical history, physical condition, and *as haloperidol Revised: October 2012 Typesmiths Pi Font Pi Typesmiths Helvetica (A) Helvetica P.O. No. 4500104024–Job No. 45803 No. 4500104024–Job No. P.O. 10/25/12–hc–O–Indd4 CrossTech–70028–Proof A1 CrossTech–70028–Proof M02 Form LLC USA, Kabi Fresenius Fonts: