Generic Clozapine ( Clozapine )

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Clozapine is an atypical antipsychotic reserved for people with treatment-resistant schizophrenia, meaning at least two other antipsychotics have not worked well enough or caused unbearable side effects. It is also used to reduce the risk of recurrent suicidal behaviour in people with schizophrenia or schizoaffective disorder. The medication works by binding to several dopamine and serotonin receptors in the brain, though its exact mechanism is still being studied.
Clozapine is not started at a fixed dose. Treatment begins at 12.5 mg once or twice daily, then the dose is raised by 25 mg to 50 mg per day over the first two weeks, as tolerated. Most people respond to a daily dose between 300 mg and 600 mg, divided into two or three doses. The maximum daily dose is 900 mg.
The administration form is tablets in 25 mg, 50 mg, 100 mg, and 200 mg strengths. Orally disintegrating tablets are also available in 12.5 mg, 25 mg, 50 mg, 100 mg, and 200 mg.
Clozapine does not work overnight. Some calming effects may appear within the first week or two, but the full benefit for schizophrenia usually takes several weeks to a few months of steady dosing and careful titration.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that clozapine can cause, and it can also increase the risk of seizures and low blood pressure.
The most common side effects are drowsiness, dizziness, increased salivation (especially at night), weight gain, and constipation. Clozapine also carries serious risks that require regular blood monitoring, including a severe drop in white blood cells called agranulocytosis and inflammation of the heart muscle called myocarditis.
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Common Use Clozapine

Clozapine is a dibenzodiazepine antipsychotic. It blocks dopamine D2 receptors less tightly than older antipsychotics, which is part of why it causes fewer movement side effects. It also blocks serotonin 5-HT2A receptors, muscarinic receptors, histamine H1 receptors, and alpha-1 adrenergic receptors. This broad receptor profile explains both its effectiveness and its side effect burden. Health Canada has approved clozapine for the management of symptoms of treatment-resistant schizophrenia in adults over 18 years old. In controlled trials, it improved both positive symptoms (hallucinations, delusions) and negative symptoms (social withdrawal, flat affect). It is also approved for reducing the risk of recurrent suicidal behaviour in patients with schizophrenia or schizoaffective disorder who are at chronic risk for suicide. Clozapine is not approved for use in children and adolescents, and it is not indicated for dementia-related psychosis in elderly patients.

Basic Clozapine Information

• INN (International Nonproprietary Name): Clozapine
• Brand names available in Canada: Clozaril® (original brand, marketed by HLS Therapeutics Inc.); generics include AA-Clozapine (AA Pharma Inc.), Auro-Clozapine (Auro Pharma Inc.), Gen-Clozapine (Mylan Pharmaceuticals ULC), Jamp Clozapine (Jamp Pharma Corporation), and Sandoz Clozapine (Sandoz Canada Incorporated). PMS-Clozapine (Pharmascience Inc.) is listed as cancelled after market.
• ATC Code: N05AH02
• Forms and dosages: Tablets – 25 mg, 50 mg, 100 mg, and 200 mg. Orally disintegrating tablets – 12.5 mg, 25 mg, 50 mg, 100 mg, and 200 mg.
• Manufacturers in Canada: HLS Therapeutics Inc. (Clozaril), AA Pharma Inc. (AA-Clozapine), Auro Pharma Inc. (Auro-Clozapine), Mylan Pharmaceuticals ULC (Gen-Clozapine), Jamp Pharma Corporation (Jamp Clozapine), Sandoz Canada Incorporated (Sandoz Clozapine), and Innomar Strategies Inc. (Clozapine Tablets).
• Registration status in Canada: Approved by Health Canada. Multiple DINs exist, including 02248034 (AA-Clozapine 25 mg), 02458748 (AA-Clozapine 50 mg), 02248035 (AA-Clozapine 100 mg), 02458756 (AA-Clozapine 200 mg), 02455161 (Auro-Clozapine 25 mg), 02247243 (Gen-Clozapine 25 mg), 02554658 and 02554666 and 02554674 (Gen-Clozapine ODT 50 mg, 100 mg, 200 mg), 02561611 (Jamp Clozapine 25 mg), 00894737 (Clozaril 25 mg), 02240668 (PMS-Clozapine 25 mg, cancelled after market), 02247798 (Sandoz Clozapine 25 mg, cancelled before market), and 02470020 (Clozapine Tablets 25 mg, Innomar).
• OTC / Rx classification: Prescription only (Rx). Clozapine is subject to a controlled distribution program in Canada that requires regular blood monitoring. It is not legally sold over-the-counter.

Dosage & Direction

Clozapine is started slowly to reduce the risk of sedation, low blood pressure, and seizures. The first dose is 12.5 mg once or twice daily. The dose is then increased by 25 mg to 50 mg per day over the first two weeks, as tolerated, until it reaches a therapeutic level. Most people respond to a daily dose between 300 mg and 600 mg, divided into two or three doses. The maximum daily dose is 900 mg. If your dose is above 500 mg per day, it is usually split into twice-daily dosing to lower the risk of seizures. Take clozapine with or without food. If it upsets your stomach, take it with a meal. Swallow the tablet whole. If you have an orally disintegrating tablet, peel back the foil and place it on your tongue; it will dissolve within seconds. Do not push it through the foil, because the tablet is fragile. If you have liver or kidney problems, your doctor will start you on a lower dose and raise it more slowly. If you smoke, you may need a higher dose, because smoking speeds up the breakdown of clozapine. If you stop smoking while taking clozapine, your levels can rise and cause side effects. Tell your doctor if you start or stop smoking. If you miss more than three days of clozapine treatment, do not restart at your previous dose. You must start again at 12.5 mg once or twice daily and be re-titrated under medical supervision, because restarting at a full dose after a break can cause severe low blood pressure, sedation, and cardiac arrest. Never stop clozapine suddenly on your own.

Precautions

Agranulocytosis is the most serious risk with clozapine. It is a severe drop in white blood cells that leaves you vulnerable to life-threatening infections. The risk is highest during the first year of treatment and drops after that, but it never goes away. In Canada, clozapine is only available through a controlled distribution program that requires regular blood tests. Before you start, you must have a normal white blood cell count. During treatment, you need weekly blood tests for the first 18 weeks, then at least every four weeks as long as you take the medication. If your neutrophil count drops below a certain level, your doctor will interrupt treatment and may need to stop it permanently. Contact your doctor immediately if you develop fever, sore throat, mouth ulcers, or other signs of infection. Myocarditis is another serious risk. It is inflammation of the heart muscle that can occur early in treatment, sometimes within the first two weeks. Symptoms include chest pain, shortness of breath, fatigue, palpitations, and flu-like symptoms. In Canada, cases have been reported in patients aged 19 to 37, and some have been fatal. If you develop any of these symptoms, go to an emergency department right away. Seizures are a dose-related risk with clozapine. They are more common at doses above 500 mg per day and in people with a history of seizures or other risk factors. Your doctor will raise your dose slowly and may split it into two doses to reduce this risk. Clozapine can cause severe constipation, which in rare cases can progress to a bowel obstruction or a condition called toxic megacolon. If you go several days without a bowel movement, or if you develop severe stomach pain, vomiting, or a swollen abdomen, contact your doctor. Tell your doctor if you have a history of constipation or bowel problems. Clozapine can lower blood pressure when you stand up, causing dizziness and falls. This is more common early in treatment. Move slowly when getting up from a sitting or lying position. The medication can cause drowsiness, so do not drive or operate machinery until you know how it affects you. Clozapine can cause metabolic changes, including weight gain, high blood sugar, and high cholesterol. Your doctor should check your weight, blood sugar, and lipid levels before you start and periodically during treatment. Clozapine is not recommended during pregnancy unless the benefit clearly outweighs the risk. It passes into breast milk, and breastfeeding is not recommended during treatment. Women who could become pregnant should use effective contraception. Clozapine is not approved for use in children and adolescents under 18 years of age. It should not be used to treat dementia-related psychosis in elderly patients, because studies show an increased risk of death in that population.

Contraindications

Do not take clozapine if you have had an allergic reaction to clozapine or any of the inactive ingredients in the tablet. Clozapine is contraindicated if you are unable to undergo regular blood tests, because the risk of agranulocytosis cannot be managed without monitoring. Do not take it if you have ever been diagnosed with a low white blood cell count, except if that was from cancer treatment. It is contraindicated if you have bone marrow disease or any disease that affects blood cell formation. Clozapine should not be used if you have severe liver, kidney, or heart problems, including myocarditis, cardiomyopathy, or heart failure. Do not take it if you have uncontrolled seizures. It is also contraindicated in patients with a history of alcohol or drug abuse, because of the increased risk of seizures and other complications. Do not take clozapine if you have severe constipation, bowel obstruction, or any other condition that has affected your large bowel. Clozapine is contraindicated with other drugs that are known to cause agranulocytosis or bone marrow suppression. Do not take it with monoamine oxidase inhibitors. Clozapine should not be used during pregnancy or breastfeeding unless specifically directed by a doctor.

Possible Side Effects

More than 1 in 10 people experience drowsiness, dizziness, increased salivation, weight gain, and constipation. Drowsiness is often most noticeable when starting treatment or increasing the dose. Increased salivation, especially at night, is a common complaint and can be distressing. Constipation is common and can become serious if not managed. Other common side effects include nausea, vomiting, dry mouth, blurred vision, headache, and increased sweating. Low blood pressure when standing up causes lightheadedness and falls. Some people experience tremors, muscle stiffness, or restlessness, though these movement side effects are less common with clozapine than with older antipsychotics. Serious side effects require immediate medical attention. Agranulocytosis presents with fever, sore throat, mouth ulcers, or other signs of infection. Myocarditis causes chest pain, shortness of breath, fatigue, or palpitations. Seizures can occur, especially at higher doses. Severe constipation or bowel obstruction causes severe stomach pain, vomiting, or a swollen abdomen. Neuroleptic malignant syndrome is a rare but life-threatening reaction marked by high fever, muscle rigidity, confusion, and unstable blood pressure. Tardive dyskinesia causes involuntary movements of the face, tongue, or limbs. Metabolic changes such as high blood sugar and high cholesterol can develop gradually. Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), can cause fever, rash, swollen lymph nodes, and organ inflammation. If you develop any of these, stop the medication and seek help right away. Weight gain is common and can be significant. Clozapine can also cause a condition called priapism, a prolonged and painful erection that requires emergency medical attention. Antidepressants, including clozapine, can increase suicidal thoughts and behaviours in some people, especially young adults. If you notice worsening mood or new thoughts of self-harm, contact your doctor immediately.

Drug Interaction

Clozapine is metabolized by several liver enzymes, including CYP1A2, CYP2D6, and CYP3A4. Drugs that affect these enzymes can change clozapine levels. Fluvoxamine, a strong CYP1A2 inhibitor, significantly increases clozapine levels and should be avoided or used with caution and close monitoring. Ciprofloxacin, another CYP1A2 inhibitor, also raises clozapine levels. Caffeine can increase clozapine levels, so a sudden change in coffee or energy drink intake can affect you. Smoking and carbamazepine induce CYP1A2, which lowers clozapine levels and may require a higher dose. If you start or stop smoking while taking clozapine, tell your doctor. Cimetidine, erythromycin, and azole antifungals such as ketoconazole and itraconazole can raise clozapine levels. Rifampin and phenytoin can lower clozapine levels. Clozapine can add to the sedative effects of alcohol, benzodiazepines, opioids, and other central nervous system depressants. It can also add to the blood pressure-lowering effects of antihypertensive medications. Do not take clozapine with other drugs that can cause agranulocytosis or bone marrow suppression, such as carbamazepine or phenylbutazone. Avoid St. John's wort, because it can reduce clozapine levels. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of clozapine, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss more than three days of treatment, do not restart at your previous dose. You must start again at 12.5 mg once or twice daily and be re-titrated under medical supervision. Restarting at a full dose after a break can cause severe low blood pressure, sedation, and cardiac arrest. Contact your doctor before restarting clozapine after any gap in treatment.

Overdose

Clozapine overdose is a medical emergency. Symptoms include severe drowsiness, confusion, agitation, hallucinations, fast or irregular heartbeat, low blood pressure, seizures, and coma. The risk of seizures and cardiac complications is high. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and medications to control seizures and support blood pressure. Close monitoring of heart rhythm and vital signs is necessary. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store clozapine tablets and orally disintegrating tablets at room temperature between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. For orally disintegrating tablets, keep them in the original blister pack until use. Peel back the foil and place the tablet on your tongue; it will dissolve within seconds. Do not push it through the foil. Keep all forms of clozapine out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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