warnings precautions haldol side effects overdose

Prescribing Information

DESCRIPTION
Haloperidol decanoate is the decanoate ester of the butyrophenone, HALDOL (haloperidol) warnings precautions haldol side effects overdose. It has a markedly extended duration of effect warnings precautions haldol side effects overdose. It is available in sesame oilin sterile form for intramuscular (IM) injection warnings precautions haldol side effects overdose. 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 warnings precautions haldol side effects overdose.

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 warnings precautions haldol side effects overdose.

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 warnings precautions haldol side effects overdose.

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

Administration of haloperidol decanoate in sesame oil results in slow and sustainedrelease of haloperidol warnings precautions haldol side effects overdose. 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 warnings precautions haldol side effects overdose. Steady state plasma concentrationsare achieved after the third or fourth dose warnings precautions haldol side effects overdose. The relationship between dose ofhaloperidol decanoate and plasma haloperidol concentration is roughly linearfor doses below 450 mg warnings precautions haldol side effects overdose. It should be noted, however, that the pharmacokineticsof haloperidol decanoate following intramuscular injections can be quite variablebetween subjects warnings precautions haldol side effects overdose.

INDICATIONS AND USAGE
HALDOL Decanoate 50 and HALDOL Decanoate 100 are indicated for the treatmentof schizophrenic patients who require prolonged parenteral antipsychotic therapy warnings precautions haldol side effects overdose.

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 warnings precautions haldol side effects overdose.

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 warnings precautions haldol side effects overdose.

WARNINGS
Tardive Dyskinesia-- A syndrome consisting of potentially irreversible, involuntary,dyskinetic movements may develop in patients treated with antipsychotic drugs warnings precautions haldol side effects overdose. 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 warnings precautions haldol side effects overdose. Whether antipsychotic drug products differ intheir potential to cause tardive dyskinesia is unknown warnings precautions haldol side effects overdose.

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 warnings precautions haldol side effects overdose. However, the syndrome can develop, although much less commonly, afterrelatively brief treatment periods at low doses warnings precautions haldol side effects overdose.

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

Given these considerations, antipsychotic drugs should be prescribed in a mannerthat is most likely to minimize the occurrence of tardive dyskinesia warnings precautions haldol side effects overdose. 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 warnings precautions haldol side effects overdose. In patients who do require chronic treatment,the smallest dose and the shortest duration of treatment producing a satisfactoryclinical response should be sought warnings precautions haldol side effects overdose. The need for continued treatment shouldbe reassessed periodically warnings precautions haldol side effects overdose.

If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics,drug discontinuation should be considered warnings precautions haldol side effects overdose. However, some patients may requiretreatment despite the presence of the syndrome warnings precautions haldol side effects overdose. (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 warnings precautions haldol side effects overdose. 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) warnings precautions haldol side effects overdose. Additional signs may include elevatedcreatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure warnings precautions haldol side effects overdose.

The diagnostic evaluation of patients with this syndrome is complicated warnings precautions haldol side effects overdose. 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) warnings precautions haldol side effects overdose. Other important considerations in the differential diagnosisinclude central anticholinergic toxicity, heat stroke, drug fever and primarycentral nervous system (CNS) pathology warnings precautions haldol side effects overdose.

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 warnings precautions haldol side effects overdose. There is no generalagreement about specific pharmacological treatment regimens for uncomplicatedNMS warnings precautions haldol side effects overdose.

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

Hyperpyrexia and heat stroke, not associated with the above symptom complex,have also been reported with HALDOL warnings precautions haldol side effects overdose.

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

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

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 warnings precautions haldol side effects overdose. 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 warnings precautions haldol side effects overdose. Instead, metaraminol, phenylephrine or norepinephrineshould be used warnings precautions haldol side effects overdose.
receiving anticonvulsant medications, with a history of seizures, or with EEGabnormalities, because HALDOL may lower the convulsive threshold warnings precautions haldol side effects overdose. If indicated,adequate anticonvulsant therapy should be concomitantly maintained warnings precautions haldol side effects overdose.
with known allergies, or with a history of allergic reactions to drugs warnings precautions haldol side effects overdose.
receiving anticoagulants, since an isolated instance of interference occurredwith the effects of one anticoagulant (phenindione) warnings precautions haldol side effects overdose.

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 warnings precautions haldol side effects overdose. If both drugs are discontinuedsimultaneously, extrapyramidal symptoms may occur warnings precautions haldol side effects overdose. The physician should keepin mind the possible increase in intraocular pressure when anticholinergic drugs,including antiparkinson agents, are administered concomitantly with haloperidoldecanoate warnings precautions haldol side effects overdose.

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

When HALDOL is used to control mania in bipolar disorders, there may be a rapidmood swing to depression warnings precautions haldol side effects overdose.

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 warnings precautions haldol side effects overdose. The ambulatory patient should be warned accordingly warnings precautions haldol side effects overdose.

The use of alcohol with this drug should be avoided due to possible additiveeffects and hypotension warnings precautions haldol side effects overdose.

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