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founder of drug haldol |
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founder of drug haldol Manufacturer: Ortho-McNeil Prescribing Information
Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is solublein most organic solvents founder of drug haldol. 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 founder of drug haldol. 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 founder of drug haldol.
Administration of haloperidol decanoate in sesame oil results in slow and sustainedrelease of haloperidol founder of drug haldol. 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 founder of drug haldol. Steady state plasma concentrationsare achieved after the third or fourth dose founder of drug haldol. The relationship between dose ofhaloperidol decanoate and plasma haloperidol concentration is roughly linearfor doses below 450 mg founder of drug haldol. It should be noted, however, that the pharmacokineticsof haloperidol decanoate following intramuscular injections can be quite variablebetween subjects founder of drug haldol.
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 founder of drug haldol.
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 founder of drug haldol. However, the syndrome can develop, although much less commonly, afterrelatively brief treatment periods at low doses founder of drug haldol. There is no known treatment for established cases of tardive dyskinesia, althoughthe syndrome may remit, partially or completely, if antipsychotic treatmentis withdrawn founder of drug haldol. Antipsychotic treatment, itself, however, may suppress (or partiallysuppress) the signs and symptoms of the syndrome and thereby may possibly maskthe underlying process founder of drug haldol. The effect that symptomatic suppression has upon thelong-term course of the syndrome is unknown founder of drug haldol. Given these considerations, antipsychotic drugs should be prescribed in a mannerthat is most likely to minimize the occurrence of tardive dyskinesia founder of drug haldol. 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 founder of drug haldol. In patients who do require chronic treatment,the smallest dose and the shortest duration of treatment producing a satisfactoryclinical response should be sought founder of drug haldol. The need for continued treatment shouldbe reassessed periodically founder of drug haldol. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics,drug discontinuation should be considered founder of drug haldol. However, some patients may requiretreatment despite the presence of the syndrome founder of drug haldol. (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 founder of drug haldol. 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) founder of drug haldol. Additional signs may include elevatedcreatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure founder of drug haldol. The diagnostic evaluation of patients with this syndrome is complicated founder of drug haldol. 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) founder of drug haldol. Other important considerations in the differential diagnosisinclude central anticholinergic toxicity, heat stroke, drug fever and primarycentral nervous system (CNS) pathology founder of drug haldol. 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 founder of drug haldol. There is no generalagreement about specific pharmacological treatment regimens for uncomplicatedNMS founder of drug haldol. If a patient requires antipsychotic drug treatment after recovery from NMS,the potential reintroduction of drug therapy should be carefully considered founder of drug haldol. The patient should be carefully monitored, since recurrences of NMS have beenreported founder of drug haldol. Hyperpyrexia and heat stroke, not associated with the above symptom complex,have also been reported with HALDOL founder of drug haldol. General-- A number of cases of bronchopneumonia, some fatal, have followedthe use of antipsychotic drugs, including HALDOL (haloperidol) founder of drug haldol. It has beenpostulated that lethargy and decreased sensation of thirst due to central inhibitionmay lead to dehydration, hemoconcentration and reduced pulmonary ventilation founder of drug haldol. Therefore, if the above signs and symptoms appear, especially in the elderly,the physician should institute remedial therapy promptly founder of drug haldol. Although not reported with HALDOL, decreased serum cholesterol and/or cutaneousand ocular changes have been reported in patients receiving chemically-relateddrugs founder of drug haldol.
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 founder of drug haldol. If both drugs are discontinuedsimultaneously, extrapyramidal symptoms may occur founder of drug haldol. The physician should keepin mind the possible increase in intraocular pressure when anticholinergic drugs,including antiparkinson agents, are administered concomitantly with haloperidoldecanoate founder of drug haldol. In patients with thyrotoxicosis who are also receiving antipsychotic medication,including haloperidol decanoate, severe neurotoxicity (rigidity, inability towalk or talk) may occur founder of drug haldol. When HALDOL is used to control mania in bipolar disorders, there may be a rapidmood swing to depression founder of drug haldol. Information for Patients The use of alcohol with this drug should be avoided due to possible additiveeffects and hypotension founder of drug haldol. |
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