Opsonil100 mg

Opsonil is a first-generation (typical) phenothiazine antipsychotic. Its evidence-based uses include:

• Established/FDA-approved uses:
  • Management of manifestations of psychotic disorders, including schizophrenia.
  • Control of nausea and vomiting.
  • Relief of restlessness and apprehension before surgery.
  • Treatment of intractable hiccups.
  • Management of acute intermittent porphyria.
  • Management of severe behavioral problems in children (combativeness, explosive hyperexcitable behavior), and for short-term treatment of hyperactive children who show excessive motor activity.
  • Presurgical apprehension and as an adjunct in the treatment of tetanus.
• Guideline-supported / adjunct uses: Adjunctive treatment of manic episodes of bipolar disorder (as add-on to a mood stabilizer, since Opsonil alone is not a first-line agent for bipolar maintenance).
• Off-label use (not FDA-approved, used in clinical practice): Adjunct for acute agitation in emergency settings when other options are unsuitable.

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

Each tablet or injectable formulation contains Chlorpromazine Hydrochloride as the active pharmaceutical ingredient. Chlorpromazine Hydrochloride is available in oral tablet, oral concentrate/solution, and injectable formulations, along with standard pharmaceutical excipients.

Opsonil is a phenothiazine derivative and one of the earliest developed typical antipsychotic agents. It has been used since the 1950s for management of psychotic disorders and several non-psychiatric indications such as intractable hiccups and severe nausea/vomiting. Chemically it belongs to the aliphatic phenothiazine subclass.

Opsonil belongs to the phenothiazine class of typical (first-generation) antipsychotics. It is also used as an antiemetic and for management of intractable hiccups.

Chlorpromazine Hydrochloride acts primarily as a dopamine D2 receptor antagonist in the mesolimbic pathway, which underlies its antipsychotic effect. It also blocks histamine H1 receptors (sedative effect), alpha-1 adrenergic receptors (orthostatic hypotension), muscarinic cholinergic receptors (anticholinergic effects), and serotonin 5-HT2 receptors.

Blockade of dopamine receptors in the chemoreceptor trigger zone accounts for its antiemetic activity, while its central antidopaminergic and sedative properties contribute to control of hiccups and behavioral agitation.

Opsonil can be administered orally (tablet or oral concentrate) or by deep intramuscular injection. The oral concentrate should be diluted with a suitable liquid immediately before administration. Doses should be taken/given exactly as directed by the physician.

• CNS depressants (alcohol, barbiturates, opioids, sedative-hypnotics, general anesthetics): Additive CNS and respiratory depression; concurrent doses of these agents should be reduced when combined with Opsonil.
• Antihypertensive agents: Increased risk of orthostatic hypotension due to additive alpha-adrenergic blockade.
• Anticholinergic drugs: Additive anticholinergic effects (dry mouth, constipation, urinary retention) and may reduce antipsychotic efficacy.
• Lithium: Rare reports of neurotoxicity/encephalopathic syndrome with combined use; monitor closely.
• Oral anticoagulants: May reduce anticoagulant effect; monitor coagulation parameters if co-administered.
• Propranolol and other beta-blockers: Mutual increase in plasma concentrations of both drugs, increasing risk of hypotension and arrhythmia.
• Drugs that prolong QT interval: Additive risk of QT prolongation and arrhythmia when combined with Opsonil.
• CYP2D6 inhibitors/substrates: May alter plasma levels of Opsonil or co-administered drugs metabolized through this pathway.

Common side effects of Opsonil include:

• Sedation and drowsiness
• Orthostatic hypotension
• Extrapyramidal symptoms (dystonia, akathisia, pseudo-parkinsonism)
• Anticholinergic effects (dry mouth, blurred vision, constipation, urinary retention)
• Weight gain
• Photosensitivity (advise sun protection)

Less common but clinically important effects include tardive dyskinesia (risk increases with duration of therapy), neuroleptic malignant syndrome (rare but potentially life-threatening — see Precautions and Warnings), agranulocytosis and other blood dyscrasias (rare), cholestatic jaundice, QT interval prolongation and cardiac arrhythmias, and corneal/lenticular pigment deposits with long-term high-dose therapy.

Opsonil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under close medical supervision. Neonates exposed to antipsychotics including Opsonil during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms following delivery.

Opsonil is excreted in breast milk. Breastfeeding is not generally recommended during treatment; a decision should be made 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 Opsonil, are at increased risk of death compared with placebo. Opsonil is not approved for the treatment of dementia-related psychosis.

Other Precautions

• Neuroleptic malignant syndrome (NMS): A rare but potentially fatal reaction characterized by hyperthermia, muscle rigidity, altered mental status, and autonomic instability. Discontinue Opsonil immediately if NMS is suspected.
• Tardive dyskinesia: May develop with prolonged use; risk and irreversibility increase with duration of therapy and total cumulative dose.
• QT prolongation and cardiac arrhythmias: Use with caution in patients with cardiac disease or risk factors for QT prolongation.
• Seizure threshold: Opsonil may lower the seizure threshold; use cautiously in patients with seizure disorders.
• Agranulocytosis and blood dyscrasias: Monitor blood counts during prolonged therapy; discontinue if significant suppression occurs.
• Cholestatic jaundice: Monitor liver function; discontinue if jaundice occurs.
• Photosensitivity: Advise patients to avoid excessive sun exposure and use sun protection.
• Ocular changes: Long-term, high-dose therapy has been associated with corneal and lens pigment deposits; periodic eye examinations are advised.
• Anticholinergic and sedative effects: Use caution in patients with glaucoma, prostatic hypertrophy, or urinary retention, and when operating machinery or driving.
• Use with caution in patients with cardiovascular disease, hepatic impairment, or Parkinson's disease.

Overdose with Opsonil may cause deep CNS depression, hypotension, extrapyramidal symptoms, agitation, seizures, cardiac arrhythmias, and coma. Overdose is a medical emergency.

If overdose is suspected, seek immediate medical attention or contact emergency services/poison control right away. Treatment is supportive and symptomatic; management should be carried out by trained medical personnel and should not be attempted at home.

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

Pediatric Use

Opsonil is not recommended in children under 6 months of age except when potentially life-saving. In children 6 months to 12 years, it may be used for severe behavioral problems or as an antiemetic, with weight-based dosing and close monitoring, as safety data in young children are limited.

Geriatric Use

Elderly patients are more sensitive to the sedative, hypotensive, and anticholinergic effects of Opsonil and should be started on lower doses with careful titration. Elderly patients with dementia-related psychosis have an increased risk of death with antipsychotic use (see boxed warning in Precautions and Warnings); Opsonil is not approved for this use.

Hepatic Impairment

Use with caution in patients with hepatic impairment; Opsonil is contraindicated in severe liver disease.

Renal Impairment

No well-established dose adjustment guidelines exist; use with caution and monitor clinical response.

Duration of treatment with Opsonil depends on the indication and clinical response. Short-term use (days) is typical for nausea/vomiting, hiccups, or preoperative sedation, while treatment of psychotic disorders is generally long-term and should be reviewed periodically by the prescribing physician, weighing benefits against risks such as tardive dyskinesia.

Chlorpromazine Hydrochloride belongs to the phenothiazine class of typical antipsychotics, and is also classified as an antiemetic agent.

Chlorpromazine Hydrochloride exerts its therapeutic effects primarily through antagonism of dopamine D2 receptors, along with antagonism of histaminergic, adrenergic, muscarinic cholinergic, and serotonergic receptors, producing antipsychotic, antiemetic, sedative, and anxiolytic effects.

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Opsonil is approved for use in children 6 months to 12 years of age for severe behavioral problems and as an antiemetic, using weight-based dosing (approximately 0.55 mg/kg every 4–6 hours as needed). It is not recommended in infants under 6 months of age except when potentially life-saving. Safety and efficacy for long-term use in children have not been fully established, and use should be under close pediatric or psychiatric supervision.