Zuredel 5mg, 20mg

FORMULATION
Each tablet contains 5 mg Haloperidol.
Each tablet contains 20 mg Haloperidol.
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
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.
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 prevalence of the syndrome appears to be highest among the elderly, especially elder women.
Neuroleptic 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 caution when driving, operating machinery, or performing other hazardous activities.
ADVERSE REACTIONS
Neurological: Neuromuscular (extrapyamidal) 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 leucopenia 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 statis pneumonia.
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.
Pregnancy and 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.
OVERDOSAGE
Symptom
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 state.
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.
DOSAGE AND ADMINISTRATION
Adult. The usual initial dose for the treatment of psychoses and associated behavior 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 25 to 50 mcg per kg body-weight daily in 2 divided doses, increase cautiously if necessary. Or as prescribed by the physician.
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
AVAILABILITY
Zuredel foil strips 5 mg X 10’s (Box of 100’s)
Zuredel foil strips 20 mg X 10’s (Box of 100’s)
STORE AT TEMPERATURES NOT EXCEEDING 30° C

Manufactured for:
JFDraf Pharmaceuticals Corp.
Suite 407 Greenhills Mansion,
37 Annapolis St., North East Greenhills,
San Juan, Metro Manila, Philippines

By:
P.I. Pharmaceuticals Pvt. Ltd.
141-DLF Industrial Area, Mathura Road,
Faridabad 121003 India

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