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Haloperidol Tablets

Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4''-fluorobutyrophenone. It has the following structural formula.

Haloperidol is indicated for use in the management of manifestations of psychotic disorders.Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.

Composition:	Each tablet contains: haloperidol lactate, Eq. to haloperidol USP 5 mg, excipients q s
Category:	An antipsychotic agent
Pharmacokinetics:	Haloperidol is well absorbed from the intramuscular sites. Variable bioavailability is likely due to the extent of first-pass hepatic metabolism. Metabolism is by oxidative dealkylation. The elimination half-life is approximately 20 hours. Haloperidol is extensively bound to plasma proteins, is widely distributed throughout the body and crosses the blood-brain barrier. Metabolites of haloperidol appear to be inactive and excretion occurs via urine and faeces.
Indication and usage:	Treating schizophrenia. It is also used to control symptoms associated with tourette disorder and behavioral disorders in children, psychotic disorders

Dosage and administration:
For non-psychotic behavioral problems related to dementia:	Adults: Initial dose: 0.5 mg orally 2 to 3 times daily Maintenance dose: 0.5 to 3 mg orally 2 times a day
For Mania:	Adults Initial dose: 0.5 to 5 mg orally 2 to 3 times a day Maintenance dose: 1 to 30 mg/day in 2 or 3 divided doses
For Nausea/Vomiting:	Adults: 1 to 5 mg orally every 4 to 6 hours as needed
For Psychosis:	For Adults: Initial dose: 0.5 to 5 mg orally 2 to 3 times a day Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg For 2 years or younger or less than 15 kg: Use is not recommended. For 3 to 12 years and 15 to 40 kg: Initial dose: 0.5 mg/day orally in 2 to 3 divided doses. Maintenance dose: The daily dose may be increased every 5 to 7 days in 0.25 to 0.5 mg increments. The usual range is 0.05 to 0.15 mg/kg/day in 2 to 3 divided doses. Maximum upto 6 mg/day. 13 to 18 years and greater than 40 kg: Initial dose: 0.5 to 5 mg orally 2 to 3 times a day. Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg Geriatric Dose for Psychosis: Initial dose: 0.5 to 2 mg orally 2 to 3 times a day. Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg
For tourette's syndrome:	For Adults: Initial dose: 0.5 to 2 mg orally 2 to 3 times a day Maintenance dose: May increase every 5 to 7 days to 3 to 5 mg 2 to 3 times daily for more severe or resistant cases. 3 to 12 years and 15 to 40 kg: Initial dose: 0.5 mg/day orally in 2 to 3 divided doses. Maintenance dose: The daily dose may be increased weekly in 0.25 to 0.5 mg increments up to 0.05 to 0.075 mg/kg/day For 2 years or younger or less than 15 kg: Use is not recommended.
Contraindications:	Stuporous state, coma & parkinson’s disease. Children less than 2 years
Adverse effects:	Dystonia, hallucinations, restlessness, nausea, epigastric discomfort, anaemia, blurred vision, hypersensitivity reactions, blood dyscrasia, jaundice, galactorrhoea, gynecomastia and amenorrhoea
Special precautions:	Thyrotoxicosis, epilepsy, severe cardiovascular disorders
Drug interactions:	Alcohol: CNS depression, extra-pyramidal reactions Aluminium salts: Decrease efficacy, antacids should be given 1 hour before or 2 hours after haloperidol. Anticholinergics: Decrease efficacy and increase the anticholinergic side effects of haloperidol Barbiturates: Decrease efficacy Barbiturate anaesthetics: Increase frequency and severity of neuromuscular excitation and hypotension. Bromocriptine: Efficacy decreases by haloperidol Charcoal: Prevents absorption of haloperidol Epinephrine, Norepinephrine: Pressor effect decreases, peripheral vasoconstructive effect antagonizes. Lithium: Disorientation, unconsciousness and extra-pyramidal symptoms Meperidine: Excessive sedation and hypotension may occur TCAs: Serum concentration increases by haloperidol Valproic Acid: Efficacy may potentiate Propranolol: Increase in plasma levels of both drugs MAOIs: Additive orthostatic hypotensive effect may occur Lab Tests: Pregnancy tests: False positive results Plasma Bound Iodine (PBI): Increase in PBI may occur
Storage:	Keep out of the reach of children. Store below 25℃. Protect from light.
Presentation:	100 Tablets in a container

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