Clozaril, Versacloz Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 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 its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1) Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2)
What should I know before taking it?
Clozapine ODT is contraindicated in patients with a history of hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson Syndrome) or any other component of Clozapine ODT [see Adverse Reactions (6.2)].
What important warnings are listed?
Severe Neutropenia Clozapine Orally Disintegrating Tablets (Clozapine ODT) have caused severe neutropenia which is associated with an increased risk of serious and fatal infections. Prior to initiating Clozapine ODT treatment, obtain baseline ANC(s). Clozapine ODT initiation is not recommended in patients with a baseline ANC less than 1500/µL (less than 1000/µL for those with Benign Ethnic Neutropenia (also known as Duffy-null associated neutrophil count)). See recommendations for dosage modifications based on ANC levels during Clozapine ODT treatment [see Dosage and Administration (2.4, 2.5)]. Consider a hematology consultation before initiating Clozapine ODT or during Clozapine ODT.
How is this medication usually taken?
Clozapine Orally Disintegrating Tablets are available containing 25 mg, 100 mg, 150 mg or 200 mg of clozapine, USP. •The 25 mg tablets are peach, round, unscored tablets debossed with C over 25 on one side of the tablet and blank on the other side. •The 100 mg tablets are peach, round, unscored tablets debossed with C over 100 on one side of the tablet and blank on the other side. •The 150 mg tablets are peach, round, unscored tablets debossed with C150 on one side of the tablet and blank on the other side. •The 200 mg tablets are peach, round, unscored tablets debossed with C200 on one side of the tablet and blank on the other side.
What side effects are listed?
The following adverse reactions are discussed in more detail in other sections of the labeling: •Severe Neutropenia [see Warnings and Precautions (5.1)] •Orthostatic Hypotension, Bradycardia, and Syncope [see Warnings and Precautions (5.2)] •Falls [see Warnings and Precautions (5.3)] •Seizures [see Warnings and Precautions (5.4)] •Myocarditis, Pericarditis, Cardiomyopathy, and Mitral Valve Incompetence [see Warnings and Precautions (5.5)] •Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.6)] •Gastrointestinal Hypomotility with Severe Complications [see Warnings and Precautions (5.7)] •Eosinophilia [see Warnings and Precautions (5.8)].
What interactions are listed?
See Table 3 for recommended dosage modifications to reduce the risk of Clozapine ODT-associated adverse reactions or reduce the risk of lower effectiveness [see Drug Interactions (7)]. Table 3: Clozapine ODT Dosage Modifications for Drug Interactions Strong CYP1A2 Inhibitors Administer one third of the Clozapine ODT dosage. Moderate or Weak CYP1A2 Inhibitors Consider reducing the Clozapine ODT dosage if necessary. CYP2D6 or CYP3A4 Inhibitors Strong CYP3A4 Inducers Concomitant use is not recommended. However, if concomitant use is necessary, it may be necessary to increase the Clozapine ODT dosage. Monitor for decreased effectiveness. Moderate or weak CYP1A2 or CYP3A4 Inducers Consider.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.