Myung In Haloperidol

Haloperidol.

Each tablet contains Haloperidol 1.5 mg.

Schizophrenia, mania, manifestations of psychotic disorders, Gilles de la Tourette's syndome, vomiting, and hiccup.

Adult and children (over 14 years of age): Initial daily doses of 1~1.5 mg bid or tid in oral haloperidol is recommended. (Oral dose for severe patients may be given to a maximum of 100mg daily). Maintenance daily doses of 2~8 mg in oral haloperidol is recommended. The dosage should be adjusted properly according to the age and the symptom, and the dosage in patients who are elderly and debilitated, should be recommended with downward titration.

Manifestations: In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be severe extrapyramidal reactions, hypotension, or sedation. The extrapyramidal reactions would be manifested by muscular weakness or rigidity and a generalized or localized tremor. Hypertension rather than hypotension occurred. The patient may appear comatose with respiratory depression and hypotension, which could be severe enough to produce a shock-like state. The risk of ventricular arrhythmias, possibly associated with QT-prolongation should be considered.
Treatment: Since there is no specific antidote, treatment is primarily symptomatic and supportive. Activated charcoal should be administered after gastric lavage and emesis. A patient airway must be established by use of an oropharyngeal airway or endotracheal tube on in prolonged cases of coma, by tracheostomy. Respiratory depression may be counteracted by artificial respiration ECG and vital signs should be monitored and monitoring should continue until the ECG is normal. Severe arrhythmias should be treated with appropriate antiarrhythmic measures. Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as dopamine, norepinephrine. Epinephrine should not be used since it may cause profound hypotension in the presence of haloperidol. In case of severe extrapyramidal reactions, antiparkinson (benztropine mesylate 1-2 mg IM or IV) medication should be administered.

Hypersensitivity to haloperidol, butyrophenone and the similar compounds; Comatose states; Alcoholism; Enhanced response to barbiturate, anesthetic and other CNS depressants; Severe heart failure (myocardial disorder and lowering of the blood pressure have been reported); Parkinson's disease (extrapyramidal reactions may occur); Bronchopneumonia; Lesions of the basal ganglia; Patient receiving epinephrine; Pregnant women and women of childbearing potential, nursing mother.

Patients with liver disease and renal failure; Patients with phaeochromocytoma, cardiovascular disease, hypotension or conditions predisposing to this symptom (transient lowering of the blood pressure may occur); Patients with convulsive disease such as seizure etc. or patients with a history of seizure (haloperidol may lower the convulsive threshold); Patients with hyperthyroidism or hypothyroidism (extrapyramidal reactions may occur); Patients receiving anticoagulants; Hypersensitivity or with a history of hypersensitivity to drugs; Infant-child; Patients with physical damage accompanied with dehydration and malnutririon; Depression; Patients with QT syndrome and hypokalaemia, patients receiving drugs to prolong the QT interval; patients with prolactin-dependent tumor; Patient with narrow angle glaucoma; Patient with severe myasthenia gravis; Patient with prostatomegaly; The elderly.
General Precautions: Sudden and unexpected deaths have been reported in association with the administration of antipsychotic drug including haloperidol. Because QT-interval prolongation may occur by taking this agent, it should be used with caution in patients with QT-prolongation conditions (QT syndrome, hypokalemia, prolonged QT-interval).
It has been reported that seizures can be triggered by haloperidol. Caution is advised in patients suffering from epilepsy and in conditions predisposing to convulsions such as alcohol withdrawal and brain damage.
Haloperidol should be used with great caution in patients with hyperthyroidism, because this agent increases toxicity of tyrosine.
Haloperidol should not be used alone where depression is predominant. It may be combined with antidepressants to treat those conditions in which depression and psychosis coexist.
It should be used with caution in patients on long-term therapy. Liver and renal function and blood cells should be monitored.
Because drowsiness, the reduction of attention, concentration, and reflex movement may occur, patients taking haloperidol should be warned against engaging in hazardous occupation requiring mental alertness such as operating machinery or driving a motor vehicle.
Acute withdrawal symptoms including nausea, vomiting, and insomnia have been described after abrupt cessation of high doses of antipsychotic drugs. Gradual reduction of the dose is therefore recommended.
Because haloperidol has an effect on antiemetic action, this agent can conceal emesis causing by other medicinal poisoning, intestinal obstruction and encephaloma. Therefore it should be used with caution in patients.
On initial therapy, orthostatic hypotension may occur. Appropriate supportive care including reduction or discontinuance of dose should be used.
Others: Sudden and unexpected deaths have been reported in association with the administration of haloperidol.
On long-term treatment of rats (
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), mammary rumors (more than 10 times maximum usual dosage-1.25 mg/kg/day) and pituitary tumors (more than 40 times maximum than usual dosage-5mg/kg/day) have been reported.
Pediatric use: Extrapyramidal reactions, especially dyskinesia, may occur easily.
Geriatric use: Orthostatic hypotension, extrapyramidal reactions, ataxia, and excretion disorder may occur easily. It should be used appropriate supportive care including reduction.

There have been reports of birth defects. Haloperidol has been shown to be teratogenic and fetotoxic in animal study. It should, therefore, not be administered to women of childbearing potential or nursing mothers.
The lethargy, tremor, and hypexcitability may occur in the neonate of the mother taking the antipsychotic drug during the end of pregnancy of labour.
Haloperidol is excreted in breast milk. If the use of haloperidol is considered essential, breast-feeding should be discontinued.

Cardiovascular system: ECG abnormality (QT-interval prolongation, T wave changes etc.), lowering of the blood pressure, hypertension, tachycardia, and atypical ventricular tachycardia (including torsades de pointes) may occur. Should be observed closely and then if signs of any damage occur, discontinuation or gradual dosage reductions are recommended.
Neuroleptic malignant syndrome (NMS): Akinesia, severe muscle rigidity, dysdipsia, tachycardia, irregular pulse or blood pressure, diaphoresis etc. may occur. In case of occurring hyperpyrexia with this syndrome, treatment should be withdrawn immediately and appropriate supportive therapy including hypothermia, rehydration should be used. Additional signs may include leucocytosis, elevated CPK, myoglobinuria and acute renal failure. The death has been reported in patients; in others, the cause appeared to be continuous hyperpyrexia, disturbance conciousness, dyspnea, circulatory collapse, hypohydration and acute renal failure from bad to worse.
Extrapyramidal Reactions: Acute dystonia (oculogyric crises), torticollis, movements of the mouth, dysphagia, parkinsonian rigidity, tremor, akathisia, lack of sitting in triangle ability have been reported. While all can occur at relatively low doses, they occur more frequently with greater severity at higher doses. The symptoms may be controlled with dose reductions or administration of antiparkinson drugs are administered carefully.
Tardive dyskinesia: Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may occur after short periods of treatment with low dosages or drug therapy has been discontinued. The risk appears to be greater in elder patients, especially females, patient brain damage and an emotional disorder. The treatment is discontinued if tardive dyskinesia appears. Anitparkinson drugs tend to exacerbate the symptoms of this syndrome. There is no proven or uniformly effective treatment for tardive diskinesia. This agent is administered minimum effective dosage on short-term therapy carefully. If the antiparkinson drugs are stopped at that time, short dystonia may occur.
Liver: Hepatitis, jaundice, impaired liver function may occur. These are indication for immediate withdrawal of the drug.
Eye: Paropsis including retinitis, cataract, disturbances of accommodation, and the blurred vision, impurity of cornea and crystalline lens on long-term or overdose therapy, and chromopexy of cornea.
Hypersensitivity: Edema, rash, urticaria, exfoliative dermatitis, photosensitivity, and anaphylaxis may occur. In such cases, treatment should be discontinued.
Hematologic effects: Anemia, leukocytosis, leucopenia, aglobulia, and agranulocytosis.
Gastrointestinal system: Anorexia, nausea, vomiting, constipation, and diarrhea may occur. Rarely intestinal paralysis (anorexia, nausea, vomiting, constipation, abdominal distention or atony, intestinal stasis) may occur and since paralytic intestinal obstruction should be shifted, observe sufficiently, haloperidol is contraindicated for intestinal paralysis.
Endocrine system: Hyperprolactinaemia, gynecomastia, lactation, menstrual irregularities and changes in libido, hyperglycemia, hypoglycemia, increase in weight or decrease may occur. Hyponatremia, hypotonicemia, increase in uric sodium, excretion, hypertonic urine, tremor, disturbance consciousness, syndrome of inappropriate ADH have rarely been reported. In such cases, discontinue the treatment and use appropriate supportive care including rehydrational restriction.
Respiratory effects: Bronchospasm, laryngospasm, and dyspnea may occur. In such cases, discontinue the treatment.
Nervous system: Insomnia, restlessness, drowsiness, vertigo, headache, anxiety, depression, hallucination, and agitation may occur.
Others: Dry mouth, stuffy nose, fatigue, anuresis, pyrexia, diaphoresis, and flush may occur.

Concomitant use of haloperidol and CNS depressants such as analgesics and barbiturates, hypnotics, strong anesthetics, sedative, antihistamine, hypotensive drug and anticholinergic drug, the contact of alkylphosphates, and alcohol may potentiate the interaction. Therefore, it should be used with caution and the haloperidol dose may need to be decreased.
Haloperidol may antagonize the action of epinephrine and other sympathomimetic agents and reverse the blood pressure lowering effects of adrenergic-blocking agents such as guanethidine and clonidine. Haloperidol should not be given with this agent.
Haloperidol may decrease the antiparkinson effects of levodopa. Therefore, haloperidol should not be given with levodopa.
An enhanced CNS effect, when combined with methyldopa, has been reported.
ECG pattern changes, severe extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome (NMS), irreversible brain damage during combined treatment with lithium and haloperidol have been reported. It is recommended that lithium levels should always be maintained below 1 mmol/l when combined with haloperidol. One report has suggested that ECG monitoring might be advisable. If unexplained pyrexia occurs in the presence of extrapyramidal side-effects both lithium and haloperidol should be stopped immediately.
When prolonged treatment with enzyme inducing drugs such as carbamazepine, phenobarbital, this results in a significant reduction of haloperidol plasma levels. Therefore, during combination treatment, the haloperidol dose should be adjusted.
Haloperidol inhibits the metabolism of tricyclic antidepressants, thereby increasing plasma levels of these drugs.
Prolonged QT ventricular arrhythmia during combined treatment with terfenadine, astemizole may occur.
In pharmacokinetic studies mild to moderately increased haloperidol levels have been reported when haloperidol was given concomitantly with the following drugs: quinidine, buspirone, and fluoxetine. It may be necessary to reduce the haloperidol dosage.
If an antiparkinson agent is used concomitantly with haloperidol, an increase of anticholinergic effect promotes tardive dyskinesia.
Because haloperidol is badly absorbed, when combined with antacid, caffeine, therapeutic effects may be decreased.

Store in light resistant, tight container at room temperature (1~30°C)
Shelf-life: 3 years.

Antipsychotics

N05AD01 - haloperidol ; Belongs to the class of butyrophenone derivatives antipsychotics.

POM