Mellaril: Stabilizing Severe Psychiatric Symptoms Effectively
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Mellaril (thioridazine hydrochloride) is a first-generation typical antipsychotic medication belonging to the phenothiazine class. It is indicated for the management of manifestations of psychotic disorders, particularly in patients who have not responded adequately to other antipsychotic agents. Its primary mechanism of action is believed to be through antagonism of postsynaptic dopaminergic receptors in the mesolimbic system of the brain, thereby helping to reduce the intensity of hallucinations, delusions, and agitation. While its use has become more restricted due to the risk of certain adverse effects, it remains a potent option in specific clinical scenarios under careful supervision. This agent requires a thorough understanding of its pharmacokinetics, side effect profile, and necessary monitoring parameters for safe and effective use.
Features
- Active Ingredient: Thioridazine hydrochloride
- Drug Class: Phenothiazine antipsychotic (neuroleptic)
- Available Formulations: Oral tablets in various strengths (e.g., 10 mg, 25 mg, 50 mg, 100 mg)
- Mechanism of Action: Dopamine D2 receptor antagonist with additional anticholinergic and antiadrenergic properties
- Bioavailability: Significant first-pass metabolism; extensive protein binding
- Half-life: Approximately 21-24 hours, allowing for once or twice-daily dosing in maintenance phases
- Metabolism: Hepatic, primarily via CYP2D6 isoenzyme, producing active metabolites including mesoridazine
Benefits
- Provides effective reduction of positive psychotic symptoms such as hallucinations and thought disorder in treatment-resistant cases.
- Offers sedative properties that can be beneficial for managing acute agitation and anxiety associated with psychotic episodes.
- May be considered for patients who experience extrapyramidal side effects (EPS) with other typical antipsychotics due to its lower EPS propensity relative to high-potency neuroleptics.
- Can contribute to overall behavioral stabilization, facilitating patient engagement in adjunctive psychosocial therapies.
- Historically used for severe behavioral problems in certain pediatric populations, though this use is now highly restricted and off-label.
Common use
Mellaril is primarily used in the treatment of schizophrenia in adults who have not achieved satisfactory response with other antipsychotic medications. It may be employed for the management of psychotic symptoms occurring in the context of other disorders, such as bipolar disorder during manic phases with psychotic features, though this is less common. Its use has declined significantly due to the associated risk of QTc prolongation and torsades de pointes, and it is generally considered a second or third-line agent. Off-label historical uses included severe behavioral disturbances in children and elderly patients with dementia-related psychosis, though these are now strongly discouraged due to increased mortality risks in elderly patients with dementia-related psychosis and heightened sensitivity in pediatric populations.
Dosage and direction
Dosage must be individualized based on severity of symptoms, patient response, and tolerance. Therapy should be initiated at the lowest possible dose and titrated gradually.
Adults (Schizophrenia):
- Initial dose: 50-100 mg three times daily; may increase gradually to a maximum of 800 mg daily in divided doses for severe cases.
- Maintenance dose: Once symptoms are controlled, reduce gradually to the lowest effective dose, often between 200-800 mg daily in divided doses. Some patients may be maintained on once-daily dosing.
Elderly/Debilitated Patients:
- Use lower initial doses (e.g., 25-50 mg once or twice daily) and titrate even more slowly due to increased susceptibility to adverse effects.
Administration:
- Administer orally with food or water to minimize gastric upset.
- Tablets should be swallowed whole; not for chewing or crushing.
- Regular monitoring of ECG (particularly QTc interval), blood pressure, and periodic reassessment of continued need is mandatory.
Dosage above 800 mg daily is not recommended. Treatment should be periodically reevaluated to determine the need for continued therapy.
Precautions
- Cardiac Effects: Mellaril is associated with dose-related QTc prolongation and risk of potentially fatal arrhythmias, including torsades de pointes. Baseline ECG is required before initiation and periodically during treatment, especially after dose increases.
- Neuroleptic Malignant Syndrome (NMS): A rare but life-threatening reaction characterized by hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability. Discontinue immediately if suspected.
- Tardive Dyskinesia: May develop after prolonged use, characterized by involuntary movements of tongue, face, or jaw. Risk appears greater in elderly patients, especially women.
- Sedation and Impairment: Can cause significant drowsiness and impaired cognitive or motor performance; caution patients against driving or operating machinery until response is known.
- Hematologic Effects: Periodic blood counts are advised; leukopenia and agranulocytosis have been reported.
- Seizures: May lower seizure threshold; use with caution in patients with a history of seizure disorders.
- Temperature Regulation: Impaired thermoregulation; caution in patients exposed to extreme heat.
- Pregnancy and Lactation: Use during pregnancy only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding.
Contraindications
- Hypersensitivity to thioridazine, any phenothiazine, or any component of the formulation.
- Severe central nervous system depression or comatose states.
- History of cardiac arrhythmias, including significant QTc prolongation (typically >450 msec in males, >470 msec in females).
- Concomitant use with other drugs known to prolong the QTc interval (e.g., certain antiarrhythmics, macrolide antibiotics, fluoroquinolones) or potent CYP2D6 inhibitors (e.g., fluoxetine, paroxetine).
- Pre-existing severe cardiovascular disease.
- History of hepatic impairment severe enough to compromise metabolic clearance.
- Pheochromocytoma.
Possible side effect
- Common: Drowsiness, dry mouth, blurred vision, constipation, orthostatic hypotension, weight gain.
- Neurological: Extrapyramidal symptoms (though less frequent than with high-potency antipsychotics), akathisia, tardive dyskinesia, dizziness.
- Cardiac: QTc prolongation, tachycardia, hypotension (especially orthostatic).
- Endocrine: Galactorrhea, amenorrhea, gynecomastia, impotence.
- Dermatological: Photosensitivity, skin rashes.
- Ophthalmic: Pigmentary retinopathy (particularly at doses exceeding recommended limits), corneal opacities.
- Other: Nasal congestion, urinary retention.
Drug interaction
- CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine): May significantly increase thioridazine levels and risk of QTc prolongation; contraindicated.
- Other QTc-Prolonging Agents (e.g., Class IA/III antiarrhythmics, certain antibiotics, antipsychotics): Additive risk of life-threatening arrhythmias; avoid concomitant use.
- Central Nervous System Depressants (e.g., alcohol, benzodiazepines, opioids): Enhanced sedative effects.
- Antihypertensives: May potentiate hypotensive effects.
- Levodopa and Dopamine Agonists: Thioridazine may antagonize their effects.
- Anticholinergic Agents: Additive anticholinergic side effects (e.g., dry mouth, constipation, urinary retention).
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, skip the missed dose and resume the usual dosing schedule. Do not double the dose to make up for a missed one. Maintaining a consistent dosing schedule is important for therapeutic efficacy.
Overdose
Symptoms of overdose may include severe sedation, coma, hypotension, tachycardia, arrhythmias (including QTc prolongation and torsades de pointes), extrapyramidal symptoms, agitation, restlessness, convulsions, and hypothermia. Cardiac arrhythmias and profound hypotension are medical emergencies. There is no specific antidote. Management is supportive and symptomatic, including gastric lavage (if presented early) and activated charcoal. Cardiovascular monitoring (continuous ECG) is essential. Avoid epinephrine in treating hypotension due to potential paradoxical further lowering of blood pressure; use norepinephrine or phenylephrine if necessary. Forced diuresis is not effective.
Storage
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (59°F and 86°F). Keep in a tightly closed container, protected from light and moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.
Disclaimer
This information is for educational purposes and does not constitute medical advice. The prescribing of Mellaril (thioridazine) requires careful clinical judgment and is typically reserved for specialists familiar with its risks and benefits, particularly its cardiac safety profile. It is not a first-line treatment. Always consult a qualified healthcare professional for diagnosis and treatment decisions. Do not initiate, discontinue, or alter the dosage of this medication without direct medical supervision. The full prescribing information should be reviewed prior to administration.
Reviews
Clinical experience with Mellaril is extensive but dated, as its use has diminished in favor of newer atypical antipsychotics with better safety profiles regarding QTc prolongation. In historical contexts, it was noted by some clinicians for its efficacy in certain treatment-resistant psychotic patients and for its lower incidence of acute extrapyramidal symptoms compared to other typical antipsychotics like haloperidol. However, contemporary reviews emphasize its significant risks, particularly cardiotoxicity, which severely limit its utility. It is generally viewed as a niche agent, to be used with extreme caution and rigorous monitoring when other options have failed. Patient experiences, where documented from past use, often mention its sedating effects and anticholinergic side effects as prominent.