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Clozapine
Overview
What is Clozapine?
Clozapine Orally Disintegrating Tablets, an atypical antipsychotic drug, are a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5-dibenzo [,] [1,4] diazepine. The structural formula is:
CHCIN M.W. 326.82
Clozapine, USP is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg and 100 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed.
Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg and 100 mg.
The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. The remaining components are aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol.
THIS PRODUCT CONTAINS ASPARTAME AND IS NOT INTENDED FOR USE BY INFANTS. PHENYLKETONURICS: CONTAINS PHENYLALANINE [. Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. The allowable daily intake of aspartame is 50 mg per kilogram of body weight per day.
What does Clozapine look like?
What are the available doses of Clozapine?
Orally disintegrating tablets: 12.5 mg, 25 mg and 100 mg ()
What should I talk to my health care provider before I take Clozapine?
How should I use Clozapine?
Clozapine orally disintegrating tablets are indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with their use, clozapine orally disintegrating tablets should be used only in patients who have failed to respond adequately to standard antipsychotic treatment
The effectiveness of clozapine orally disintegrating tablets in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing clozapine orally disintegrating tablets and chlorpromazine in patients who had failed other antipsychotics
Prior to initiating treatment with clozapine orally disintegrating tablets, a baseline ANC must be obtained. The baseline ANC must be at least 1500/μL for the general population, and at least 1000/μL for patients with documented Benign Ethnic Neutropenia (BEN). To continue treatment, the ANC must be monitored regularly
What interacts with Clozapine?
Sorry No Records found
What are the warnings of Clozapine?
Sorry No Records found
What are the precautions of Clozapine?
Sorry No Records found
What are the side effects of Clozapine?
Sorry No records found
What should I look out for while using Clozapine?
Known serious hypersensitivity to clozapine or any other component of clozapine orally disintegrating tablets ()
Severe Neutropenia
Clozapine treatment has caused severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/μL. Severe neutropenia can lead to serious infection and death. Prior to initiating treatment with clozapine,
a baseline ANC must be at least 1500/μL for the general population; and must be at least 1000/μL for patients with documented Benign Ethnic Neutropenia (BEN). During treatment, patients must have regular ANC monitoring. Advise patients to immediately report symptoms consistent with severe neutropenia or infection (e.g., fever, weakness, lethargy, or sore throat) .
Because of the risk of severe neutropenia, clozapine is available only through a restricted program under a Risk Evaluation Mitigation Strategy (REMS) called the Clozapine REMS Program .
Orthostatic Hypotension, Bradycardia, Syncope
Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with clozapine treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day. Initiate treatment at 12.5 mg once or twice daily; titrate slowly; and use divided dosages. Use clozapine cautiously in patients with cardiovascular or cerebrovascular disease or conditions predisposing to hypotension (e.g., dehydration, use of antihypertensive medications) .
Seizures
Seizures have occurred with clozapine treatment. The risk is dose-related. Initiate treatment at 12.5 mg, titrate gradually, and use divided dosing. Use caution when administering clozapine to patients with a history of seizures or other predisposing risk factors for seizure (CNS pathology, medications that lower the seizure threshold, alcohol abuse). Caution patients about engaging in any activity where sudden loss of consciousness could cause serious risk to themselves or others .
Myocarditis and Cardiomyopathy
Fatal myocarditis and cardiomyopathy have occurred with clozapine treatment. Discontinue clozapine and obtain a cardiac evaluation upon suspicion of these reactions. Generally, patients with clozapine-related myocarditis or cardiomyopathy should not be rechallenged with clozapine. Consider the possibility of myocarditis or cardiomyopathy if chest pain, tachycardia, palpitations, dyspnea, fever, flu-like symptoms, hypotension, or ECG changes occur .
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Clozapine is not approved for use in patients with dementia-related psychosis .
What might happen if I take too much Clozapine?
How should I store and handle Clozapine?
Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Store Clozapine Orally Disintegrating Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from moisture. Keep in a sealed blister until time of use. This unit-dose package is non child-resistant.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Clozapine Orally Disintegrating Tablets must remain in the original package until used by the patient. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Drug dispensing should not ordinarily exceed a weekly supply. If a patient is eligible for ANC testing every 2 weeks, then a 2-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. If a patient is eligible for ANC testing every 4 weeks, then a 4-week supply of Clozapine Orally Disintegrating Tablets can be dispensed. Dispensing should be contingent upon the ANC testing results. Product: 63629-5094NDC: 63629-5094-1 1 g in a POUCH / 30 in a CARTON Product: 63629-5094NDC: 63629-5094-1 1 g in a POUCH / 30 in a CARTON
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of clozapine is unknown. However, it has been proposed that the therapeutic efficacy of clozapine in schizophrenia is mediated through antagonism of the dopamine type 2 (D) and the serotonin type 2A (5-HT) receptors. Clozapine orally disintegrating tablets also act as an antagonist at adrenergic, cholinergic, histaminergic and other dopaminergic and serotonergic receptors.
Non-Clinical Toxicology
Known serious hypersensitivity to clozapine or any other component of clozapine orally disintegrating tablets ()Severe Neutropenia
Clozapine treatment has caused severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/μL. Severe neutropenia can lead to serious infection and death. Prior to initiating treatment with clozapine,
a baseline ANC must be at least 1500/μL for the general population; and must be at least 1000/μL for patients with documented Benign Ethnic Neutropenia (BEN). During treatment, patients must have regular ANC monitoring. Advise patients to immediately report symptoms consistent with severe neutropenia or infection (e.g., fever, weakness, lethargy, or sore throat) .
Because of the risk of severe neutropenia, clozapine is available only through a restricted program under a Risk Evaluation Mitigation Strategy (REMS) called the Clozapine REMS Program .
Orthostatic Hypotension, Bradycardia, Syncope
Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with clozapine treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day. Initiate treatment at 12.5 mg once or twice daily; titrate slowly; and use divided dosages. Use clozapine cautiously in patients with cardiovascular or cerebrovascular disease or conditions predisposing to hypotension (e.g., dehydration, use of antihypertensive medications) .
Seizures
Seizures have occurred with clozapine treatment. The risk is dose-related. Initiate treatment at 12.5 mg, titrate gradually, and use divided dosing. Use caution when administering clozapine to patients with a history of seizures or other predisposing risk factors for seizure (CNS pathology, medications that lower the seizure threshold, alcohol abuse). Caution patients about engaging in any activity where sudden loss of consciousness could cause serious risk to themselves or others .
Myocarditis and Cardiomyopathy
Fatal myocarditis and cardiomyopathy have occurred with clozapine treatment. Discontinue clozapine and obtain a cardiac evaluation upon suspicion of these reactions. Generally, patients with clozapine-related myocarditis or cardiomyopathy should not be rechallenged with clozapine. Consider the possibility of myocarditis or cardiomyopathy if chest pain, tachycardia, palpitations, dyspnea, fever, flu-like symptoms, hypotension, or ECG changes occur .
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Clozapine is not approved for use in patients with dementia-related psychosis .
Eosinophilia
QT Interval Prolongation
Metabolic Changes
Neuroleptic Malignant Syndrome (NMS)
Hepatotoxicity:
Fever
Pulmonary Embolism (PE)
Anticholinergic Toxicity
Interference with Cognitive and Motor Performance
The following adverse reactions are discussed in more detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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