Zuredel Full Prescribing Information, Dosage & Side Effects

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Haloperidol.

Description

Each tablet contains 5 mg Haloperidol.
Each tablet contains 20 mg Haloperidol.

Action

Pharmacology: Pharmacokinetics: Haloperidol is readily absorbed from the gastrointestinal tract. It is metabolized in the liver and excreted in the urine and, via the bile, in the feces there is evidence of enterohepatic recycling. Owing to the first-pass effect of metabolism in the liver, plasma concentrations following oral administration are lower than those following intramuscular administration. Haloperidol is about 92% bound plasma proteins. It is widely distributed in the body and crosses the blood-brain barrier. The decanoate ester of Haloperidol is very slowly absorbed from the site of injection, it is gradually released into the bloodstream where it is rapidly hydrolysed to haloperidol.

Indications/Uses

Haloperidol is indicated in the management of manifestations of acute and chronic psychosis, including schizophrenia and manic states. Management of severe behavior problems in children who have combative, explosive hyperexcitability and in the symptomatic control of Gilles de la Tourette's syndrome.

Dosage/Direction for Use

Adult: The usual initial dose for the treatment of psychoses and associated behaviour disorders is 0.50 mcg to 5 mcg two to three times daily. In severe psychoses or resistant patients doses of up to 100 mcg daily may be required. The dose should be reduced gradually according to response, maintenance dose as low as 3 to 10 mcg daily may be sufficient.
Children: A suggested initial dose is 23 to 50 mcg per kg body-weight daily in 2 divided doses, increase cautiously if necessary.

Overdosage

Symptoms: The symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, most prominent of which would be severe extrapyramidal reactions, hypotension or sedation. The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like statement.
Treatment: Gastric lavage or induction of emesis should be carried out immediately, followed by administration of the universal antidote. Respiratory depression may be counteracted by artificial respiration and mechanical respirators.

Contraindications

Contraindicated in patients in severe depressive states or comatose states; those who have Parkinson's disease or pre-existing Parkinson-like symptoms and has sensitivity to haloperidol.

Warnings

Tardive Dyskinesia: A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalance of the syndrome appears to be highest among the elderly, especially elder women.
Neuoleptic Malignant Syndrome (NMS): A potentially fatal symptom complex has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, cardiac dysrhythmias).
Generally patients receiving short-term therapy experience no problems with abrupt discontinuation of antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. Sedation may occur in some patients, use cautions when driving, operating machinery, or performing other hazardous activities.

Special Precautions

In very rare instances, it has been felt that haloperidol was contributory to the precipitation of attacks in angina prone patients. Moderate hypotension may occur with excessive oral doses of haloperidol; however, vertigo and syncope occur only rarely.
Haloperidol may lower the convulsive threshold and has been reported to trigger seizures in previously controlled known epileptics.
As with other antipsychotic agents, haloperidol should be administered cautiously to patients with severe impairment of liver or kidney function, and to patients with known allergies to other neuroleptic drugs.

Use In Pregnancy & Lactation

Safety for use in pregnancy and lactation has not been established; do not administer to women of childbearing potential or nursing mothers unless the expected benefits outweigh the potential hazard to the fetus or child.
Haloperidol is excreted in breast milk.

Adverse Reactions

Neurological: Neuromuscular (extrapyramidal) effects such as Parkinson-like symptoms, akathisia, dyskinesia, dystonia, hyperreflexia, rigidity.
Behavioral: Insomnia, depressive reactions and toxic confusional states are the more common effects encountered.
Autonomic: Blurred vision, urinary retention, dry mouth, incontinence, priapism.
Cardiovascular: Hypertension, tachycardia & ECG changes.
Hematologic: Mild and usually transient leukopenia and leukocytosis, decreases in blood cell counts, anemia.
Endocrine: Mastalgia, lactation, menstrual irregularities, breast enlargement.
Gastrointestinal: Nausea, vomiting, heartburn, weight loss, constipation, diarrhea and hypersalivation have been reported.
Respiratory: Bronchospasm, increase depth of respiration and stasis pneumonia.

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Storage

Store at a temperatures not exceeding 30°C.

MIMS Class

Antipsychotics

ATC Classification

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

Regulatory Classification

Presentation/Packing

Tab 5 mg x 100's. 20 mg x 100's.

Zuredel

haloperidol

Manufacturer:

Psychotropics India

Distributor:

JF Draf