Telazine5 mg

Telazine is a phenothiazine-class antipsychotic (typical/first-generation antipsychotic) with the following evidence-based uses:

Established/approved uses

• Schizophrenia: Management of manifestations of psychotic disorders, including acute and chronic schizophrenia (paranoid, hebephrenic, and catatonic types).
• Short-term treatment of generalized non-psychotic anxiety: Approved only for short-term use (generally not exceeding 12 weeks) at low doses, when other measures have not been adequate; not intended as first-line therapy for anxiety.

Other recognized uses (in some markets, including Bangladesh)

• Nausea and vomiting: Used at low doses as an antiemetic for nausea and vomiting of various causes, based on its antidopaminergic action at the chemoreceptor trigger zone.

Not approved: Telazine is not approved for treatment of dementia-related psychosis in elderly patients (see Precautions and Warnings for the boxed mortality warning).

Telazine is a piperazine-derivative phenothiazine and a typical (first-generation) antipsychotic agent. It has been used for decades in the management of psychotic disorders and, at lower doses, for short-term relief of severe anxiety and as an antiemetic. It is available in Bangladesh as oral tablets under several brand names.

Telazine belongs to the phenothiazine class of typical (first-generation) antipsychotics, specifically the piperazine subgroup, which also has antiemetic properties.

Trifluoperazine exerts its antipsychotic effect primarily by blocking postsynaptic dopamine D2 receptors in the mesolimbic and mesocortical pathways of the central nervous system, which reduces psychotic symptoms. Its antiemetic effect results from dopamine receptor blockade in the chemoreceptor trigger zone of the medulla.

Trifluoperazine also has weaker anticholinergic, antihistaminic, and alpha-adrenergic blocking activity compared to some other phenothiazines, contributing to its side-effect profile (e.g., orthostatic hypotension, sedation).

Telazine is administered orally as tablets, generally in divided doses (twice daily), with or without food. Doses should be taken at the same times each day as directed by the physician, and treatment should not be stopped or changed without medical advice.

Telazine has the following clinically significant drug interactions:

• CNS depressants (alcohol, sedatives, opioids, general anesthetics): Additive sedation and respiratory/CNS depression; avoid or use with caution.
• Propranolol and other beta-blockers: Mutually increased plasma concentrations of both drugs, raising the risk of hypotension and toxicity.
• Antihypertensives (e.g., guanethidine): Telazine may blunt the antihypertensive effect; combination with other antihypertensives (including thiazide diuretics) can worsen orthostatic hypotension.
• Drugs that prolong the QT interval (e.g., certain antiarrhythmics, other antipsychotics): Additive risk of QT prolongation and arrhythmia.
• Anticonvulsants: Telazine can lower the seizure threshold, potentially requiring anticonvulsant dose adjustment.
• Metrizamide (myelography contrast): Phenothiazines should be discontinued before myelography due to increased seizure risk; avoid concomitant use.
• Anticholinergic drugs: Additive anticholinergic effects (dry mouth, constipation, urinary retention).

Common side effects of Telazine include:

• Drowsiness, dizziness, and sedation
• Dry mouth and blurred vision
• Extrapyramidal symptoms: tremor, muscle rigidity, akathisia (restlessness), dystonia
• Orthostatic hypotension
• Amenorrhea and hyperprolactinemia-related effects (e.g., galactorrhea, breast changes)
• Constipation

Serious but less common effects (see Precautions and Warnings for details): neuroleptic malignant syndrome, tardive dyskinesia, blood dyscrasias (e.g., agranulocytosis), cardiac arrhythmias/QT prolongation, hepatic injury, and seizures.

Pregnancy: Telazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antipsychotic drugs (including Telazine) during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms after delivery, which may vary in severity and duration. A physician must be consulted before use in pregnancy.

Lactation: Telazine and other phenothiazines are excreted in breast milk. A decision should be made whether to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother, in consultation with a physician.

Boxed Warning

Elderly patients with dementia-related psychosis treated with antipsychotic drugs, including Telazine, are at increased risk of death compared with placebo. Telazine is not approved for the treatment of dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS)

A rare but potentially fatal reaction, presenting as hyperthermia, muscle rigidity, altered mental status, and autonomic instability. Discontinue Telazine immediately if suspected and seek emergency care.

Tardive Dyskinesia

Prolonged use of Telazine may cause tardive dyskinesia (involuntary, repetitive movements), which may be irreversible. Risk increases with dose and duration of treatment; use the lowest effective dose for the shortest duration necessary.

QT Prolongation and Cardiac Effects

Telazine may prolong the QT interval; use caution in patients with cardiac disease, electrolyte disturbances, or when combined with other QT-prolonging drugs.

Seizure Threshold

Telazine can lower the seizure threshold; use with caution in patients with a history of seizures or EEG abnormalities.

Blood Dyscrasias

Rare cases of agranulocytosis and other blood dyscrasias have been reported; monitor for signs of infection or unusual bleeding/bruising.

Other Precautions

Use with caution in patients with hepatic impairment, cardiovascular disease, glaucoma, or urinary retention. May impair mental/physical abilities required for driving or operating machinery; avoid alcohol.

Overdose of Telazine may cause deep sedation, confusion, severe extrapyramidal symptoms, hypotension, cardiac arrhythmias (including QT prolongation), and, in severe cases, coma or seizures. There is no specific antidote. In case of suspected overdose, seek emergency medical attention or contact a poison control center immediately; treatment is supportive and symptomatic under medical supervision.

Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.

Pediatric use

Telazine may be used in children aged 6 years and older for psychotic disorders under close medical supervision, starting at low doses with gradual titration (see Dosage and Administration). Safety and efficacy in children under 6 years have not been established, and use for non-psychotic anxiety in children is not generally recommended.

Elderly

Elderly patients should receive lower initial doses of Telazine with slower titration, due to increased sensitivity to hypotension, sedation, and extrapyramidal effects. Telazine is not approved for dementia-related psychosis in the elderly due to increased mortality risk (see Precautions and Warnings).

Hepatic impairment

Use with caution and reduced doses in patients with hepatic impairment; Telazine is contraindicated in severe pre-existing liver disease.

Renal impairment

No well-established specific dose adjustment is available; use with caution and clinical monitoring.

Phenothiazine derivative; typical (first-generation) antipsychotic (piperazine subgroup).

Telazine may be used in children 6 years of age and older for psychotic disorders, starting at 1 mg once or twice daily and increasing gradually as needed, usually not exceeding 15 mg per day. Safety and efficacy have not been established in children under 6 years of age. Use for non-psychotic anxiety in children is not generally recommended. Close monitoring for extrapyramidal symptoms and sedation is advised.