Thioril 25mg Tab

THIORIL 25MG TAB by TORRENT PHARMACEUTICALS LTD

Name:

• Brand Name: THIORIL 25MG TAB
• Common Name: Thioridazine

Composition: Each tablet contains Thioridazine 25 mg as the active ingredient.

Uses: THIORIL 25MG TAB is an antipsychotic medication primarily used for the management of psychotic disorders, particularly schizophrenia. It helps to alleviate symptoms such as hallucinations, delusions, and disorganized thinking by rebalancing dopamine levels in the brain. It is also prescribed for bipolar disorder (manic depression). In some cases, it may be used for short-term treatment of moderate to marked depression with anxiety in adults, severe behavioral problems in children, or acute agitation in the elderly.

Dosage and Administration: Take THIORIL 25MG TAB with food, preferably at the same time each day, as advised by your doctor. Swallow the tablet whole; do not chew, crush, or break it. The dosage varies based on the medical condition and patient's age. For adults, typical daily doses range from 200–800 mg in divided doses, not exceeding 800 mg/day. Do not stop taking this medication abruptly, as it may lead to withdrawal symptoms.

Side Effects:

• Common Side Effects: Orthostatic hypotension (sudden drop in blood pressure upon standing), sleepiness, dry mouth, abnormal voluntary movements (such as tremors or muscle stiffness), weight gain, urinary retention, and constipation.
• Serious Side Effects: Include heart rhythm problems, fainting, seizures, tardive dyskinesia (involuntary movements of the face, lips, jaw, and tongue), and neuroleptic malignant syndrome (NMS), characterized by high fever, muscle stiffness, and confusion. Seek immediate medical attention if any serious side effects occur.

Precautions: Inform your doctor if you have thyroid, kidney, or heart problems, epilepsy, Parkinson's disease, glaucoma, bone marrow depression, or liver damage. Avoid alcohol and other CNS depressants while on this medication. THIORIL may cause drowsiness and dizziness, so caution is advised when driving or operating machinery. Regular monitoring of heart function (ECG), liver function, and complete blood count is recommended. Use caution in elderly patients, especially those with dementia-related psychosis, due to increased risks. Protect yourself from sun exposure as this medicine can cause photosensitivity.

Storage: Store THIORIL 25MG TAB in a tight, light-resistant container at room temperature (20-25°C). Protect it from light and moisture, and keep it out of the sight and reach of children. Do not use the medicine past its expiry date.

THIORIL 25MG TAB contains Thioridazine, an antipsychotic medication manufactured by Torrent Pharmaceuticals Ltd..

What is THIORIL 25MG TAB used for?

THIORIL 25MG TAB is primarily used to treat schizophrenia, especially when other treatments have not been effective or tolerated. It helps manage symptoms such as hallucinations, delusions, and disorganized thinking. It may also be prescribed for psychotic disorders and bipolar disorder (manic depression), as well as for the short-term treatment of moderate to marked depression with associated anxiety, and for managing agitation, anxiety, depressed mood, tension, sleep disturbances, and fears in geriatric patients.

How does THIORIL 25MG TAB work?

THIORIL 25MG TAB is a typical antipsychotic that works by blocking the action of dopamine, a chemical messenger in the brain that affects thoughts, mood, and behavior. By rebalancing dopamine levels, it helps improve thinking, mood, and behavior. It also affects other neurotransmitter receptors, including serotonin, alpha-adrenergic, and histamine receptors, which contribute to its overall effects, including sedative properties.

What is the usual dosage of THIORIL 25MG TAB?

The dosage of THIORIL 25MG TAB is determined by your doctor and depends on the condition being treated and your response to the medication. For schizophrenia, initial adult doses typically range from 50 mg to 100 mg three times a day, which may be gradually increased to a maintenance dose of 200 mg to 800 mg per day, divided into 2 to 4 doses. For depressive disorders with anxiety in adults, the usual initial dosage is 25 mg three times daily, with a dosage range of 20 mg to 200 mg per day. It is crucial to start with a low dose and gradually increase it due to the risk of dose-dependent QT prolongation.

What are the possible side effects of THIORIL 25MG TAB?

Common side effects can include drowsiness, blurred vision, dry mouth, nausea, vomiting, diarrhea, constipation, changes in appetite, weight gain, stuffed nose, pale skin, dizziness, and difficulty urinating.

Serious side effects that require immediate medical attention include:

• Heart rhythm changes: Fast or irregular heartbeat, dizziness, lightheadedness, chest pain, or fainting, as thioridazine can cause a serious type of irregular heartbeat (QT prolongation) that may lead to sudden death.
• Neuroleptic Malignant Syndrome (NMS): Characterized by very high fever, muscle stiffness, confusion, sweating, and an abnormal pulse or fast heartbeat.
• Tardive Dyskinesia: Uncontrolled and repetitive body movements, particularly of the face, mouth, or jaw, which can become permanent.
• Vision changes: Vision loss, especially at night, or seeing everything with a brown tint, due to the risk of pigmentary retinopathy.
• Other serious effects: Seizures, yellowing of the skin and eyes (jaundice), rash, hives, or an erection lasting for hours.

Is THIORIL 25MG TAB safe during pregnancy or breastfeeding?

Thioridazine is generally not recommended during the third trimester of pregnancy because it may cause problems in newborns after delivery, such as abnormal muscle movements and withdrawal symptoms.

For breastfeeding, an alternative drug may be preferred, especially when nursing a newborn or preterm infant, as there is no published data on thioridazine during breastfeeding in humans to assess the risk in breast milk. Phenothiazines, including thioridazine, can be excreted into breast milk and may cause drowsiness, lethargy, and developmental delays in the nursing infant. Thioridazine can also increase prolactin levels, which may lead to breast enlargement or milk production.

Can THIORIL 25MG TAB be taken with other medications?

No, THIORIL 25MG TAB can interact with many other medications, potentially changing how they work or increasing the risk of serious side effects. It is contraindicated or should be used with extreme caution with:

• Drugs that prolong the QT interval: This includes many antiarrhythmic medications (e.g., amiodarone, dofetilide, procainamide, quinidine, sotalol), certain antibiotics (e.g., erythromycin, clarithromycin), other antipsychotics (e.g., pimozide, ziprasidone, chlorpromazine), and some antidepressants (e.g., citalopram, fluoxetine).
• CYP2D6 inhibitors: Medications that block the CYP2D6 enzyme can increase thioridazine levels, leading to a higher risk of cardiac arrhythmias. Examples include fluoxetine, paroxetine, duloxetine, and bupropion.
• CNS depressants: Alcohol, opioids, anesthetics, barbiturates, and other psychoactive drugs can increase central nervous system depression and may worsen side effects like drowsiness.
• Anticholinergics: May reduce the therapeutic effects of thioridazine and worsen anticholinergic side effects (like dry mouth, blurred vision, constipation).
• Lithium: May cause disorientation, unconsciousness, and extrapyramidal effects.
• Hormonal birth control: Thioridazine may decrease the effectiveness of hormonal birth control.

Always inform your doctor or pharmacist about all prescription, non-prescription, and herbal products you are using before starting any new medication.

What precautions should be taken while taking THIORIL 25MG TAB?

• Cardiac Monitoring: Your doctor will likely order electrocardiograms (ECGs) before and during treatment, especially when doses are changed, due to the risk of serious heart rhythm problems.
• Avoid Alcohol: Alcohol can worsen the side effects of thioridazine, especially drowsiness.
• Driving and Operating Machinery: This medication can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how it affects you.
• Temperature Regulation: Avoid becoming overheated in hot weather, as thioridazine can depress the body's temperature-regulating mechanism, potentially causing heatstroke.
• Medical History: Inform your doctor about your medical history, especially if you have heart problems, high or low blood pressure, liver or kidney problems, epilepsy, Parkinson's disease, glaucoma, an enlarged prostate, or a history of blood clots or stroke.
• Elderly Patients: Older adults, especially those with dementia, should generally not take thioridazine due to increased risks of serious side effects and death.

What happens if a dose is missed?

If you miss a dose of THIORIL 25MG TAB, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not double the dose to catch up.

How should THIORIL 25MG TAB be stored?

THIORIL 25MG TAB should be stored at room temperature, away from light and moisture. Keep the container tightly closed and protect it from moisture. Do not store it in the bathroom. It is important to keep all medications away from children and pets to prevent accidental ingestion.