Mellaril: Advanced Antipsychotic Therapy for Schizophrenia Management
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Mellaril (thioridazine hydrochloride) represents a significant therapeutic option within the phenothiazine class of antipsychotic medications. It is primarily indicated for the management of manifestations of schizophrenia in patients who have not responded adequately to treatment with other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those medications. This agent functions as a dopamine receptor antagonist, exerting its effects primarily within the mesolimbic system of the brain. Its development marked an important advancement in psychopharmacology, offering clinicians an alternative mechanism for addressing the complex positive and negative symptoms associated with psychotic disorders. The following comprehensive product card provides detailed information for healthcare professionals regarding the appropriate use, pharmacological profile, and clinical considerations of Mellaril.
Features
- Active ingredient: Thioridazine hydrochloride
- Drug class: Piperidine phenothiazine antipsychotic
- Available formulations: Oral tablets (10 mg, 25 mg, 50 mg, 100 mg)
- Mechanism of action: Dopamine D2 receptor antagonism
- Bioavailability: Approximately 30-50% following oral administration
- Protein binding: Extensive (≥90%)
- Metabolism: Hepatic, primarily via CYP2D6 isoenzyme
- Elimination half-life: Approximately 21-24 hours
- Excretion: Primarily renal (as metabolites)
Benefits
- Effectively reduces positive symptoms of schizophrenia, including hallucinations, delusions, and thought disorders
- Demonstrates particular utility in managing agitation and aggressive behaviors associated with psychotic conditions
- May exhibit a lower incidence of extrapyramidal symptoms compared to some other typical antipsychotics
- Provides an alternative treatment pathway for patients refractory to other antipsychotic medications
- Established clinical profile with extensive historical use data in psychiatric practice
- Offers multiple dosage strengths to facilitate precise titration and individualized treatment regimens
Common use
Mellaril is principally employed in the management of schizophrenia in adult patients who have demonstrated inadequate response to other antipsychotic agents. Its use is typically reserved for cases where first-line antipsychotics have proven ineffective or intolerable due to adverse effects. Clinicians may consider Mellaril for patients who experience significant extrapyramidal symptoms with other typical antipsychotics, as its piperidine structure may confer a relatively lower propensity for these particular adverse effects compared to piperazine phenothiazines. The medication has also been used historically in the management of severe behavioral problems in children, though this application has become substantially limited due to safety concerns. Additionally, it has been utilized in the treatment of organic brain syndrome with associated psychotic features, though contemporary practice generally favors newer antipsychotic agents with improved safety profiles for such indications.
Dosage and direction
Initial dosage for adults with schizophrenia typically begins at 50-100 mg administered three times daily, with gradual titration based on therapeutic response and tolerability. The target maintenance dosage generally ranges from 200-800 mg per day divided into two to four doses, though some patients may require up to 800 mg daily in divided doses. Dosage adjustments should be implemented cautiously, with increments of 50-100 mg every several days as needed. The maximum recommended dosage is 800 mg per day. For elderly or debilitated patients, initial dosage should be lower, typically starting at 25-50 mg two to three times daily, with careful monitoring for adverse effects. Administration with food may minimize potential gastrointestinal upset. Regular assessment of therapeutic response and adverse effects is essential throughout treatment, with dosage adjustments made accordingly. Abrupt discontinuation should be avoided; instead, gradual tapering is recommended to prevent withdrawal symptoms or recurrence of psychotic symptoms.
Precautions
Mellaril carries a boxed warning regarding increased mortality in elderly patients with dementia-related psychosis. It is not approved for use in patients with dementia-related psychosis. Significant precautions include the risk of QTc prolongation and potentially fatal cardiac arrhythmias, particularly torsades de pointes. Baseline and periodic electrocardiograms are recommended, especially in patients with cardiac risk factors. Neuroleptic malignant syndrome, characterized by hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability, represents a rare but potentially fatal adverse effect requiring immediate discontinuation and intensive medical treatment. Tardive dyskinesia may develop with chronic use and is often irreversible. Other precautions include the potential for seizures, particularly in patients with seizure disorders; cognitive and motor impairment that may affect driving or operating machinery; orthostatic hypotension; and elevated prolactin levels. Patients should be monitored for signs of agranulocytosis, particularly during the initial months of therapy. Caution is advised in patients with hepatic impairment, renal impairment, or Parkinson’s disease.
Contraindications
Mellaril is contraindicated in patients with known hypersensitivity to thioridazine or any component of the formulation. It must not be used in patients with severe central nervous system depression or comatose states from any cause. Contraindications include significant cardiac abnormalities, including congenital long QT syndrome, history of cardiac arrhythmias, and recent myocardial infarction. Concomitant use with other drugs that prolong the QTc interval is absolutely contraindicated. The medication is contraindicated in patients with severe hepatic impairment or severe renal impairment. It should not be administered concurrently with cytochrome P450 2D6 inhibitors or other drugs that may significantly inhibit its metabolism. Mellaril is contraindicated in patients with blood dyscrasias or bone marrow suppression.
Possible side effect
Common adverse effects include drowsiness (particularly during initial therapy), orthostatic hypotension, dizziness, dry mouth, blurred vision, nasal congestion, constipation, and weight gain. Extrapyramidal symptoms may occur, though typically less frequently than with other typical antipsychotics, and can include parkinsonism, dystonia, akathisia, and tardive dyskinesia. Cardiovascular effects may include QTc prolongation, tachycardia, and electrocardiographic changes. Endocrine effects can manifest as galactorrhea, amenorrhea, gynecomastia, and impotence. Dermatological reactions may include photosensitivity, skin pigmentation changes, and allergic skin reactions. Ocular changes, particularly retinopathy, may occur with prolonged use at higher doses. Other potential adverse effects include urinary retention, seizures, hyperprolactinemia, and neuroleptic malignant syndrome. Hematological effects, though rare, may include agranulocytosis, leukopenia, and thrombocytopenia.
Drug interaction
Mellaril exhibits numerous clinically significant drug interactions. Concomitant use with other QTc-prolonging agents (including certain antiarrhythmics, antibiotics, and antidepressants) is contraindicated due to increased risk of torsades de pointes. CYP2D6 inhibitors (such as fluoxetine, paroxetine, and quinidine) may significantly increase thioridazine levels and are contraindicated. Concurrent use with central nervous system depressants (including alcohol, benzodiazepines, and opioids) may potentiate sedation and respiratory depression. Anticholinergic agents may enhance anticholinergic adverse effects. Mellaril may antagonize the effects of levodopa and dopamine agonists. It may enhance the hypotensive effects of antihypertensive medications. Lithium coadministration may increase the risk of extrapyramidal symptoms and possibly neurotoxicity. Barbiturates may decrease thioridazine levels through enzyme induction.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not double the next dose to make up for a missed dose, as this may increase the risk of adverse effects. Healthcare providers should educate patients about the importance of consistent dosing and develop strategies to improve adherence if missed doses become frequent. Abrupt discontinuation should be avoided due to potential withdrawal symptoms or recurrence of psychotic symptoms.
Overdose
Mellaril overdose represents a medical emergency that may be fatal. Symptoms may include severe central nervous system depression, hypotension, cardiac arrhythmias (including QTc prolongation and torsades de pointes), extrapyramidal symptoms, agitation, restlessness, seizures, and coma. Management involves immediate gastric lavage if presentation is early, followed by activated charcoal administration. Cardiovascular monitoring with continuous ECG is essential. Treatment is primarily supportive and symptomatic, with attention to maintaining airway, breathing, and circulation. Hypotension should be managed with intravenous fluids and vasopressors if necessary. Antiarrhythmic therapy may be required for significant cardiac arrhythmias, though drugs that prolong the QTc interval should be avoided. Forced diuresis, dialysis, and hemoperfusion are not effective due to extensive protein binding and large volume of distribution.
Storage
Mellaril tablets should be stored at controlled room temperature, between 20-25°C (68-77°F), with excursions permitted between 15-30°C (59-86°F). The medication must be kept in its original container, tightly closed, and protected from light and moisture. It should be stored out of reach of children and pets. Unused medication should be properly disposed of according to local regulations or medication take-back programs. Patients should be advised not to store medication in bathrooms or other areas susceptible to moisture and temperature fluctuations.
Disclaimer
This information is intended for healthcare professionals and should not replace professional medical advice, diagnosis, or treatment. The content provided represents summary information about Mellaril (thioridazine hydrochloride) and does not include all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The prescribing physician should be consulted for complete information regarding this medication and its appropriate use. Safety and efficacy in pediatric patients have not been established. This medication should be used only as directed by a qualified healthcare provider familiar with the patient’s medical history and current condition.
Reviews
Clinical experience with Mellaril spans several decades, with numerous studies documenting its efficacy in managing schizophrenia symptoms. Many clinicians report satisfactory responses in patients who have not tolerated or responded to other antipsychotic medications. However, contemporary psychiatric practice has largely shifted toward newer atypical antipsychotics due to their improved side effect profiles, particularly regarding extrapyramidal symptoms. The significant cardiac safety concerns associated with Mellaril, specifically QTc prolongation and risk of fatal arrhythmias, have substantially limited its use in modern practice. Most current reviews emphasize that Mellaril should be reserved for treatment-resistant cases where other options have failed and only with appropriate cardiac monitoring. The medication’s historical role in psychiatry is acknowledged, but its current positioning is as a second- or third-line option due to safety considerations.