Afrab Haloperidol Tablets_

Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). …

• There is considerable variation from patient to patient in the amount of medication required for treatment
• As with all antipsychotic drugs, dosage should be individualized according to the needs and response of each patient
• Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control
• To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state
• Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol
• The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below
• Clinical experience suggests the following recommendations: Oral Administration Initial Dosage Range
• Adults Moderate Symptomatology - 0.5 mg to 2 mg b.i.d. or t.i.d
• Severe Symptomatology - 3 mg to 5 mg b.i.d. or t.i.d
• To achieve prompt control, higher doses may be required in some cases
• Geriatric or Debilitated Patients - 0.5 mg to 2 mg b.i.d. or t.i.d
• Chronic or Resistant Patients - 3 mg to 5 mg b.i.d. or t.i.d
• Patients who remain severely disturbed or inadequately controlled may require dosage adjustment
• Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response. …

Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson's disease.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de pointes have been reported in patients receiving haloperidol. Higher than recommended doses of any formulation of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de pointes. …

Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of Torsades de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS). Cases of sudden and unexpected death have been reported in association with the administration of haloperidol. The nature of the evidence makes it impossible to determine definitively what role, if any, haloperidol played in the outcome of the reported cases. …

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: 1) severe extrapyramidal reactions, 2) hypotension, or 3) sedation. The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. The extrapyramidal reaction would be manifest by muscular weakness or rigidity and a generalized or localized tremor as demonstrated by the akinetic or agitans types respectively. …

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