CLOZARIL Tablet (2020)
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HLS Therapeutics (USA), Inc.
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BOXED WARNING SECTION
<b>WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS</b> ...
1. Indications and Usage
1.1 Treatment-Resistant Schizophrenia CLOZARIL is indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of ...
2. Dosage and Administration
2.1 Required Laboratory Testing Prior to Initiation and During Therapy Prior to initiating treatment with CLOZARIL, a baseline ANC must be obtained. The baseline ANC must be at least 1500/µL for the general ...
3. Dosage Forms and Strengths
CLOZARIL (clozapine) is available as 25 mg, 50 mg and 100 mg round, pale-yellow, uncoated tablets with a facilitated score on one side. Clozaril (clozapine) 200 mg tablets are capsule-shaped, pale-yellow, ...
4. Contraindications
CLOZARIL is contraindicated in patients with a history of serious hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson Syndrome) or any other component ...
5. Warnings and Precautions
5.1 Severe Neutropenia Background CLOZARIL can cause neutropenia (a low absolute neutrophil count (ANC)), defined as a reduction below pre-treatment normal levels of blood neutrophils. The ANC is usually ...
6. Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Severe Neutropenia <em>[see Warnings and Precautions (5.1)]</em> Orthostatic Hypotension, Bradycardia, and ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of clozapine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Potential for Other Drugs to Affect CLOZARIL Clozapine is a substrate for many cytochrome P450 isozymes, in particular CYP1A2, CYP3A4, and CYP2D6. Use caution when administering CLOZARIL concomitantly ...
8. Use in Specific Populations
8.6 Patients with Renal or Hepatic Impairment Dose reduction may be necessary in patients with significant impairment of renal or hepatic function. Clozapine concentrations may be increased in these patients, ...
8.1. Pregnancy
Pregnancy Category B. Risk Summary There are no adequate or well-controlled studies of clozapine in pregnant women. Reproduction studies have been performed in rats and rabbits at doses up to 0.4 and 0.9 ...
8.3. Nursing Mothers
CLOZARIL is present in human milk. Because of the potential for serious adverse reactions in nursing infants from CLOZARIL, a decision should be made whether to discontinue nursing or to discontinue the ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
There have not been sufficient numbers of geriatric patients in clinical studies utilizing CLOZARIL to determine whether those over 65 years of age differ from younger subjects in their response to CLOZARIL. ...
10. Overdosage
10.1 Overdosage Experience The most commonly reported signs and symptoms associated with clozapine overdose are: sedation, delirium, coma, tachycardia, hypotension, respiratory depression or failure; and ...
11. Description
CLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5<em>H</em>-dibenzo [<em>b,e</em>] [1,4] diazepine. The structural ...
12.1. Mechanism of Action
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<sub> ...
12.2. Pharmacodynamics
Clozapine demonstrated binding affinity to the following receptors: histamine H<sub>1</sub> (K<sub>i</sub> 1.1 nM), adrenergic α<sub>1A</sub> (K<sub>i</sub> 1.6 nM), serotonin 5-HT<sub>6</sub> (K<sub> ...
12.3. Pharmacokinetics
Absorption In humans, CLOZARIL tablets (25 mg and 100 mg) are equally bioavailable relative to a CLOZARIL solution. Following oral administration of CLOZARIL 100 mg twice daily, the average steady-state ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis No carcinogenic potential was demonstrated in long-term studies in mice and rats at doses up to 0.3 times and 0.4 times, respectively, the maximum recommended human dose (MRHD) of 900 mg/day ...
14. Clinical Studies
14.1 Treatment-Resistant Schizophrenia The efficacy of CLOZARIL in treatment-resistant schizophrenia was established in a multicenter, randomized, double-blind, active-controlled (chlorpromazine) study ...
16.1. How Supplied
CLOZARIL (clozapine) Tablets. <u>25 mg:</u> Round, pale-yellow, uncoated tablet. Debossed with CLOZARIL once on the periphery of one side. Debossed with a facilitated score and 25 once on the other side. ...
16.2. Storage and Handling
Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.
17. Patient Counseling Information
Discuss the following issues with patients and caregivers: <u>Severe Neutropenia:</u>Instruct patients (and caregivers) beginning treatment with CLOZARIL about the risk of developing severe neutropenia ...