Thioril 50

THIORIL 50 by TORRENT PHARMACEUTICALS LTD

Name

• Brand Name: THIORIL 50
• Common Name: Thioridazine
• Previous Brand Names: Mellaril, Melleril (globally withdrawn in 2005 due to severe cardiac arrhythmias, though generic versions of Thioridazine are still available)

Composition

• Active Ingredient: Thioridazine (50 mg)

Uses

THIORIL 50 (Thioridazine) is a first-generation (typical) antipsychotic medication. It works by decreasing abnormal excitement in the brain and blocking dopamine receptors. It is primarily used for:

• Schizophrenia: Management of symptoms such as hallucinations, delusions, and disorganized thinking, particularly in patients who have not responded well to other antipsychotic medications. It is not a first-line treatment due to potential severe side effects.
• Bipolar Disorder (Manic Depression): To control symptoms by stabilizing mood and reducing episodes of mania.
• Severe Behavioural Problems in Children: Including combativeness or explosive hyper-excitable behavior, especially when other treatments have failed.
• Depression: Short-term management of moderate to marked depression with varying degrees of anxiety in adults.
• Psychoneurotic Conditions: In older adults, managing symptoms like agitation, anxiety, depressed mood, tension, sleep disturbances, and fears.
• Nausea and Vomiting: May help prevent by blocking histamine H1 and muscarinic M1 receptors.

Dosage and Administration

• THIORIL 50 should be taken with food, preferably at the same time each day to maintain consistent medication levels.
• It is crucial to follow the doctor's prescribed dose and duration; do not skip doses or stop the medication suddenly, as this may worsen symptoms or cause withdrawal effects.
• Typical adult dosage for Schizophrenia: May range from 50 mg to 100 mg, taken three times daily (TID).
• Pediatric Dosage (example): For children 7-12 years, 25-500 mg/day; for children 3-6 years, 10-100 mg/day. Specific dosages should be determined by a healthcare professional.

Side Effects

Common Side Effects:

• Drowsiness, sleepiness
• Dry mouth
• Constipation
• Blurred vision
• Weight gain
• Orthostatic hypotension (sudden lowering of blood pressure on standing)
• Abnormality of voluntary movements (e.g., muscle stiffness, tremors, pseudoparkinsonism)
• Urinary retention
• Increased prolactin level in blood
• Nasal congestion

Serious Side Effects:

• Irregular heartbeat and heart rhythm (QTc prolongation): Can lead to sudden death. This is a life-threatening side effect, and the medicine is used only when other options have failed.
• Neuroleptic Malignant Syndrome (NMS): A rare but potentially fatal condition characterized by high fever, muscle stiffness, altered mental status, and irregular vital signs.
• Tardive Dyskinesia (TD): Irreversible and involuntary body movements, particularly of the face, lips, jaw, and tongue.
• Blood Disorders: Such as agranulocytosis, low neutrophil levels (neutropenia), and low white blood cell levels (leukopenia).
• Seizures.

Precautions

• Contraindications: Do not take if allergic to Thioridazine, have a history of heart rhythm disorders, are pregnant or planning pregnancy, are an older adult with dementia-related psychosis, have nervous system disorders (like seizures), are taking Levodopa for Parkinson's disease, have Tardive Dyskinesia or Neuroleptic Malignant Syndrome, have a pheochromocytoma, or have low potassium or other electrolyte imbalances.
• Cardiac Monitoring: Regular heart function monitoring is crucial due to the risk of QTc prolongation.
• Interactions: Avoid alcohol due to increased drowsiness and side effects. Use caution with other CNS depressants, certain antidepressants (e.g., fluoxetine, paroxetine), heart medications (e.g., propranolol, pindolol, and those causing QT prolongation), diuretics, laxatives, and antimalarial medicines.
• Pregnancy and Breastfeeding: Not recommended during pregnancy as it may harm the fetus, especially in the third trimester. Consult a doctor if pregnant or breastfeeding.
• Driving and Machinery: Avoid driving or operating heavy machinery as it can cause dizziness, drowsiness, and blurred vision.
• Sunlight Exposure: May cause increased sensitivity to sunlight; use sunscreen.
• Other Conditions: Use with caution in patients with liver or kidney disease, glaucoma, or myasthenia gravis.
• Blood Sugar and Cholesterol: May increase weight, blood sugar, and cholesterol levels; monitor regularly.
• Children: Not recommended for children under 2 years of age.

Storage

• Store in dry conditions at room temperature, ideally between 10ºC to 25ºC or below 30°C.
• Keep away from wet surfaces, direct sunlight, and humidity.
• Store in a tight, light-resistant container.
• Keep out of sight and reach of children and pets.

THIORIL 50 (Thioridazine) is an antipsychotic medication primarily used to manage certain mental health conditions. Below are frequently asked questions about this medicine.

What is THIORIL 50 used for?

THIORIL 50 (Thioridazine) is used to treat schizophrenia, particularly in patients who have not responded well to other antipsychotic medications. It also helps manage bipolar disorder (manic depression), depression with psychotic features, and severe behavioral problems in children, especially when other treatments have failed.

How does THIORIL 50 work?

THIORIL 50 contains Thioridazine, an antipsychotic drug that primarily works by blocking dopamine receptors (D2) in the brain, helping to rebalance dopamine levels. This action decreases abnormal excitement and helps improve thinking, mood, and behavior. It also blocks histamine H1 and muscarinic M1 receptors in the brain, which can help prevent nausea and vomiting.

What is the usual dosage for THIORIL 50?

For adults, the typical starting dose is 50 mg to 100 mg taken two to three times a day. The dosage may be gradually increased by your doctor up to a maximum of 800 mg per day, divided into 2 to 4 doses. It should be taken with food, preferably at the same time each day.

What are the possible side effects of THIORIL 50?

Common side effects include sleepiness, dry mouth, orthostatic hypotension (a sudden drop in blood pressure upon standing), weight gain, urinary retention, constipation, muscle stiffness, and tremor. More serious side effects can include heart rhythm problems (QT prolongation), neuroleptic malignant syndrome (NMS), seizures, and tardive dyskinesia (involuntary movements, especially of the face, lips, jaw, and tongue).

Is THIORIL 50 safe during pregnancy or breastfeeding?

THIORIL 50 is generally not recommended during pregnancy as it may harm the unborn baby, especially if used in the third trimester, and can cause withdrawal symptoms in newborns. It is also known to pass into breast milk and is considered probably unsafe for nursing mothers. Always consult your doctor before taking this medication if you are pregnant, planning to conceive, or breastfeeding.

Can THIORIL 50 be taken with other medications?

THIORIL 50 can interact with many medications. It should not be taken with drugs that cause a slow or irregular heartbeat or prolong the QT interval, as this can lead to severe and potentially fatal heart rhythm disorders. Avoid consuming alcohol and other CNS depressants, as this can increase drowsiness and other side effects. Discuss all other medications, including over-the-counter drugs and supplements, with your doctor.

What precautions should be taken while on THIORIL 50?

It's important to avoid alcohol while taking THIORIL 50. Due to potential dizziness and sleepiness, do not drive or operate heavy machinery until you know how the medicine affects you. Patients with existing heart conditions, liver or kidney disease, a history of blood clots, glaucoma, Parkinson's disease, or epilepsy should use it with caution. Regular monitoring of heart function (ECG), blood levels, and eye examinations may be recommended. Do not stop taking THIORIL 50 abruptly, as it can worsen symptoms and cause withdrawal effects. Elderly patients with dementia-related psychosis should avoid this medication due to an increased risk of death.

What happens if a dose of THIORIL 50 is missed?

If you miss a dose of THIORIL 50, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose or extra doses to make up for the missed one.

How should THIORIL 50 be stored?

THIORIL 50 tablets should be stored in a cool and dry place, away from direct sunlight. Keep it out of the sight and reach of children. The recommended storage temperature is between 10ºC to 25ºC (room temperature) or below 30°C, in a tight, light-resistant container.