Skizoril 200 Mg Tablet (10 Tab)

SKIZORIL 200 MG TABLET (10 TAB) by INTAS PHARMACEUTICALS LTD.

• Name:

  • Brand Name: Skizoril 200 MG Tablet
  • Common Name: Clozapine (active ingredient)

• Composition:

  • Active Ingredient: Clozapine 200 mg

• Uses: Skizoril 200 MG Tablet is an antipsychotic medication primarily used for the treatment of schizophrenia, especially in patients who have not responded well to or cannot tolerate other antipsychotic drugs. It is also prescribed to reduce the risk of suicidal behavior in individuals with schizophrenia or similar disorders, and in managing psychotic disorders in people with Parkinson's disease when standard treatments are ineffective.

• Dosage and Administration:

  • Typically taken orally once or twice daily, with or without food.
  • It is advisable to take the tablet at the same time each day to maintain consistent medicine levels.
  • Initial doses may start at 12.5 mg, gradually increasing by 25-50 mg/day over two weeks to a target of 300-450 mg/day. The maximum recommended adult dosage can be up to 900 mg daily.
  • Do not discontinue the medicine suddenly, as this may lead to withdrawal symptoms or a relapse of symptoms.

• Side Effects:

  • Common: Tachycardia (rapid heartbeat), dizziness, headache, tremors, sweating, dry mouth, nausea, constipation, visual disturbances, drowsiness, weight gain, excessive salivation, muscle pain, and sore throat.
  • Serious: Agranulocytosis (a severe decrease in white blood cells), increased risk of infection, seizures, myocarditis, and cardiomyopathy. Regular blood tests are required to monitor white blood cell counts.

• Precautions:

  • Avoid consuming alcohol, as it can increase drowsiness and dizziness.
  • Use with caution during pregnancy; consult a doctor as benefits should outweigh risks. It is generally not recommended during breastfeeding.
  • Exercise caution when driving or operating machinery due to potential dizziness and drowsiness.
  • Contraindicated in patients with a history of clozapine allergy, low white blood cell count, bone marrow disorders, uncontrolled epilepsy, or severe liver, heart, or kidney disease.
  • Regular monitoring of blood sugar, cholesterol, and blood pressure is recommended, as the medication can cause increases in weight, blood sugar, and cholesterol.
  • Inform your doctor about all medications you are taking to prevent potential drug interactions.

• Storage: Store below 30°C in a cool, dry place, away from direct sunlight and moisture. Keep out of reach and sight of children.

SKIZORIL 200 MG TABLET (Clozapine) FAQs

SKIZORIL 200 MG Tablet contains Clozapine, an atypical antipsychotic medication. It is used to manage certain mental health conditions and carries specific considerations due to its potent effects.

What is SKIZORIL 200 MG Tablet used for?

SKIZORIL 200 MG Tablet is primarily used to treat severely ill patients with schizophrenia who have not responded well to other antipsychotic medications or who could not tolerate other treatments due to severe side effects. It is also prescribed to reduce the risk of recurrent suicidal behavior in individuals with schizophrenia or schizoaffective disorder. In some cases, it may also be used for psychosis in Parkinson's disease when standard treatments are ineffective.

How does SKIZORIL 200 MG Tablet work?

SKIZORIL 200 MG Tablet, with its active ingredient Clozapine, is an atypical antipsychotic. It works by balancing the levels of certain natural chemicals in the brain, such as dopamine and serotonin, which are thought to be involved in schizophrenia. Specifically, it blocks dopamine D2 and serotonin 5-HT2A receptors, among others, to help improve mood, behavior, and thoughts. This action helps to alleviate symptoms like hallucinations and delusions.

What is the usual dosage for SKIZORIL 200 MG Tablet?

The dosage of SKIZORIL 200 MG Tablet is highly individualized and determined by your doctor. Typically, treatment starts with a low dose, such as 12.5 mg once or twice daily. This dose is then gradually increased, often in increments of 25 mg to 50 mg per day, over several weeks to reach a target dose, usually between 300 mg to 450 mg per day, divided into doses. The maximum recommended daily dose can go up to 900 mg. It is crucial to follow your doctor's instructions precisely.

What are the possible side effects of SKIZORIL 200 MG Tablet?

SKIZORIL 200 MG Tablet can cause several side effects, some of which can be serious. A significant concern is a potentially life-threatening decrease in white blood cells (agranulocytosis), which requires regular blood tests. Other serious side effects include heart muscle inflammation (myocarditis), seizures, dangerously low blood pressure (orthostatic hypotension), and severe constipation.

Common side effects can include:

• Drowsiness or sedation
• Dizziness or feeling unsteady
• Increased salivation (hypersalivation) or dry mouth
• Weight gain
• Headache
• Constipation
• Tremors
• Increased sweating
• Tachycardia (fast heartbeat)

Always report any unusual or severe symptoms to your doctor immediately.

Is SKIZORIL 200 MG Tablet safe during pregnancy or breastfeeding?

Pregnancy: Limited data on clozapine use during pregnancy do not conclusively show an increased risk of birth defects. However, there might be a higher risk of gestational diabetes in pregnant women taking clozapine, and newborns may experience temporary symptoms like changes in muscle tone, breathing problems, or feeding difficulties if exposed late in pregnancy. Discuss the benefits and risks with your healthcare provider if you are pregnant or planning to become pregnant.

Breastfeeding: Clozapine passes into breast milk, and there are reports of side effects in breastfed infants, including drowsiness and, rarely, a serious blood disorder called agranulocytosis. Due to these potential risks, many medical guidelines recommend avoiding breastfeeding while taking clozapine, or at least close monitoring of the infant for sedation and white blood cell count.

Can SKIZORIL 200 MG Tablet be taken with other medications?

SKIZORIL 200 MG Tablet can interact with many other medications and substances, potentially affecting its efficacy or increasing the risk of side effects. It's crucial to inform your doctor about all medications, supplements, and herbal products you are taking.

Some notable interactions include:

• Drugs that can increase clozapine levels: Certain antidepressants (e.g., fluvoxamine, fluoxetine, paroxetine), some antibiotics (e.g., ciprofloxacin, erythromycin), caffeine (in large amounts), cimetidine, and oral contraceptives. This can increase the risk of clozapine side effects.
• Drugs that can decrease clozapine levels: Tobacco smoking, omeprazole, rifampicin, and phenytoin. This can make clozapine less effective.
• Drugs that depress bone marrow function: Co-administration with drugs like carbamazepine or trimethoprim/sulfamethoxazole is generally avoided due to increased risk of agranulocytosis.
• Drugs that can cause hypotension: Antihypertensives and other antipsychotics can increase the risk of low blood pressure.
• Benzodiazepines: Concomitant use with benzodiazepines should be approached with caution due to the risk of profound collapse and respiratory/cardiac arrest.

What precautions should be taken while taking SKIZORIL 200 MG Tablet?

Several important precautions are necessary when taking SKIZORIL 200 MG Tablet:

• Blood Monitoring: Regular blood tests to monitor your white blood cell count (Absolute Neutrophil Count - ANC) are mandatory before and throughout treatment, and for at least four weeks after discontinuation, due to the risk of agranulocytosis.
• Cardiovascular Health: Clozapine can affect the heart. Your doctor will monitor for signs of heart inflammation (myocarditis) or other cardiac issues. Report chest pain, shortness of breath, or a fast/irregular heartbeat immediately.
• Seizures: Clozapine can lower the seizure threshold. Use with caution if you have a history of seizures, head injury, or consume large amounts of alcohol. Avoid activities where a sudden loss of consciousness could be dangerous.
• Constipation: This medicine can cause severe constipation, which should be managed promptly.
• Diabetes and Weight Gain: Clozapine can increase blood sugar levels and cause significant weight gain. Regular monitoring of blood sugar and weight is advised.
• Drowsiness/Impaired Alertness: This medication can cause drowsiness, dizziness, and problems with thinking or controlling body movements. Do not drive or operate machinery until you know how it affects you.
• Alcohol and Smoking: Avoid alcohol as it can worsen side effects. Smoking can decrease clozapine effectiveness, while sudden smoking cessation can increase levels, requiring dose adjustment.
• Missed Doses: If you miss doses for more than 2 days (48 hours), contact your doctor before restarting, as re-titration at a lower dose may be required to minimize serious side effects.

What happens if a dose is missed?

If you miss a dose of SKIZORIL 200 MG Tablet, 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 double doses to make up for a missed one. If you miss taking clozapine for two or more days, it is very important to contact your doctor before restarting the medication, as you may need to restart at a lower dose to avoid serious side effects like sudden drops in blood pressure or seizures.

How should SKIZORIL 200 MG Tablet be stored?

SKIZORIL 200 MG Tablets should be stored in a closed container at room temperature, typically between 68°F to 77°F (20°C to 25°C). Keep the medicine away from excessive heat, moisture, and direct light. Do not refrigerate or freeze it. Always keep this medication, and all medicines, out of the reach of children.