haldol deconate

Prescribing Information

DESCRIPTION
Haloperidol decanoate is the decanoate ester of the butyrophenone, HALDOL (haloperidol) haldol deconate. It has a markedly extended duration of effect haldol deconate. It is available in sesame oilin sterile form for intramuscular (IM) injection haldol deconate. The structural formula ofhaloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4piperidinyl decanoate, is:

Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is solublein most organic solvents haldol deconate.

Each mL of HALDOL Decanoate 50 for IM injection contains 50 mg haloperidol(present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2%(w/v) benzyl alcohol as a preservative haldol deconate.

Each mL of HALDOL Decanoate 100 for IM injection contains 100 mg haloperidol(present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2%(w/v) benzyl alcohol as a preservative haldol deconate.

CLINICAL PHARMACOLOGY
HALDOL Decanoate 50 and HALDOL Decanoate 100 are the long-acting forms of HALDOL(haloperidol) haldol deconate. The basic effects of haloperidol decanoate are no different fromthose of HALDOL with the exception of duration of action haldol deconate. Haloperidol blocksthe effects of dopamine and increases its turnover rate; however, the precisemechanism of action is unknown haldol deconate.

Administration of haloperidol decanoate in sesame oil results in slow and sustainedrelease of haloperidol haldol deconate. The plasma concentrations of haloperidol gradually rise,reaching a peak at about 6 days after the injection, and falling thereafter,with an apparent half-life of about 3 weeks haldol deconate. Steady state plasma concentrationsare achieved after the third or fourth dose haldol deconate. The relationship between dose ofhaloperidol decanoate and plasma haloperidol concentration is roughly linearfor doses below 450 mg haldol deconate. It should be noted, however, that the pharmacokineticsof haloperidol decanoate following intramuscular injections can be quite variablebetween subjects haldol deconate.

INDICATIONS AND USAGE
HALDOL Decanoate 50 and HALDOL Decanoate 100 are indicated for the treatmentof schizophrenic patients who require prolonged parenteral antipsychotic therapy haldol deconate.

CONTRAINDICATIONS
Since the pharmacologic and clinical actions of HALDOL Decanoate 50 and HALDOLDecanoate 100 are attributed to HALDOL (haloperidol) as the active medication,Contraindications, Warnings, and additional information are those of HALDOL,modified only to reflect the prolonged action haldol deconate.

HALDOL is contraindicated in severe toxic central nervous system depressionor comatose states from any cause and in individuals who are hypersensitiveto this drug or have Parkinson's disease haldol deconate.

WARNINGS
Tardive Dyskinesia-- A syndrome consisting of potentially irreversible, involuntary,dyskinetic movements may develop in patients treated with antipsychotic drugs haldol deconate. Although the prevalence of the syndrome appears to be highest among the elderly,especially elderly women, it is impossible to rely upon prevalence estimatesto predict, at the inception of antipsychotic treatment, which patients arelikely to develop the syndrome haldol deconate. Whether antipsychotic drug products differ intheir potential to cause tardive dyskinesia is unknown haldol deconate.

Both the risk of developing tardive dyskinesia and the likelihood that it willbecome irreversible are believed to increase as the duration of treatment andthe total cumulative dose of antipsychotic drugs administered to the patientincrease haldol deconate. However, the syndrome can develop, although much less commonly, afterrelatively brief treatment periods at low doses haldol deconate.

There is no known treatment for established cases of tardive dyskinesia, althoughthe syndrome may remit, partially or completely, if antipsychotic treatmentis withdrawn haldol deconate. Antipsychotic treatment, itself, however, may suppress (or partiallysuppress) the signs and symptoms of the syndrome and thereby may possibly maskthe underlying process haldol deconate. The effect that symptomatic suppression has upon thelong-term course of the syndrome is unknown haldol deconate.

Given these considerations, antipsychotic drugs should be prescribed in a mannerthat is most likely to minimize the occurrence of tardive dyskinesia haldol deconate. Chronicantipsychotic treatment should generally be reserved for patients who sufferfrom a chronic illness that 1) is known to respond to antipsychotic drugs, and2) for whom alternative, equally effective, but potentially less harmful treatmentsare not available or appropriate haldol deconate. In patients who do require chronic treatment,the smallest dose and the shortest duration of treatment producing a satisfactoryclinical response should be sought haldol deconate. The need for continued treatment shouldbe reassessed periodically haldol deconate.

If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics,drug discontinuation should be considered haldol deconate. However, some patients may requiretreatment despite the presence of the syndrome haldol deconate. (For further information aboutthe description of tardive dyskinesia and its clinical detection, please referto ADVERSE REACTIONS .)

Neuroleptic Malignant Syndrome (NMS)-- A potentially fatal symptom complexsometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reportedin association with antipsychotic drugs haldol deconate. Clinical manifestations of NMS arehyperpyrexia, muscle rigidity, altered mental status (including catatonic signs)and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia,diaphoresis, and cardiac dysrhythmias) haldol deconate. Additional signs may include elevatedcreatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure haldol deconate.

The diagnostic evaluation of patients with this syndrome is complicated haldol deconate. Inarriving at a diagnosis, it is important to identify cases where the clinicalpresentation includes both serious medical illness (e.g., pneumonia, systemicinfection, etc.) and untreated or inadequately treated extrapyramidal signsand symptoms (EPS) haldol deconate. Other important considerations in the differential diagnosisinclude central anticholinergic toxicity, heat stroke, drug fever and primarycentral nervous system (CNS) pathology haldol deconate.

The management of NMS should include 1) immediate discontinuation of antipsychoticdrugs and other drugs not essential to concurrent therapy, 2) intensive symptomatictreatment and medical monitoring, and 3) treatment of any concomitant seriousmedical problems for which specific treatments are available haldol deconate. There is no generalagreement about specific pharmacological treatment regimens for uncomplicatedNMS haldol deconate.

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

Hyperpyrexia and heat stroke, not associated with the above symptom complex,have also been reported with HALDOL haldol deconate.

General-- A number of cases of bronchopneumonia, some fatal, have followedthe use of antipsychotic drugs, including HALDOL (haloperidol) haldol deconate. It has beenpostulated that lethargy and decreased sensation of thirst due to central inhibitionmay lead to dehydration, hemoconcentration and reduced pulmonary ventilation haldol deconate. Therefore, if the above signs and symptoms appear, especially in the elderly,the physician should institute remedial therapy promptly haldol deconate.

Although not reported with HALDOL, decreased serum cholesterol and/or cutaneousand ocular changes have been reported in patients receiving chemically-relateddrugs haldol deconate.

PRECAUTIONS
HALDOL Decanoate 50 and HALDOL Decanoate 100 should be administered cautiouslyto patients:

with severe cardiovascular disorders, because of the possibility of transienthypotension and/or precipitation of anginal pain haldol deconate. Should hypotension occur anda vasopressor be required, epinephrine should not be used since HALDOL (haloperidol)may block its vasopressor activity, and paradoxical further lowering of theblood pressure may occur haldol deconate. Instead, metaraminol, phenylephrine or norepinephrineshould be used haldol deconate.
receiving anticonvulsant medications, with a history of seizures, or with EEGabnormalities, because HALDOL may lower the convulsive threshold haldol deconate. If indicated,adequate anticonvulsant therapy should be concomitantly maintained haldol deconate.
with known allergies, or with a history of allergic reactions to drugs haldol deconate.
receiving anticoagulants, since an isolated instance of interference occurredwith the effects of one anticoagulant (phenindione) haldol deconate.

If concomitant antiparkinson medication is required, it may have to be continuedafter HALDOL Decanoate 50 or HALDOL Decanoate 100 is discontinued because ofthe prolonged action of haloperidol decanoate haldol deconate. If both drugs are discontinuedsimultaneously, extrapyramidal symptoms may occur haldol deconate. The physician should keepin mind the possible increase in intraocular pressure when anticholinergic drugs,including antiparkinson agents, are administered concomitantly with haloperidoldecanoate haldol deconate.

In patients with thyrotoxicosis who are also receiving antipsychotic medication,including haloperidol decanoate, severe neurotoxicity (rigidity, inability towalk or talk) may occur haldol deconate.

When HALDOL is used to control mania in bipolar disorders, there may be a rapidmood swing to depression haldol deconate.

Information for Patients
Haloperidol decanoate may impair the mental and/or physical abilities requiredfor the performance of hazardous tasks such as operating machinery or drivinga motor vehicle haldol deconate. The ambulatory patient should be warned accordingly haldol deconate.

The use of alcohol with this drug should be avoided due to possible additiveeffects and hypotension haldol deconate.

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