Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
Clozaril
Overview
What is Clozaril?
CLOZARIL (clozapine), an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5-dibenzo [] [1,4] diazepine. The structural formula is:
CLOZARIL is available in pale yellow tablets of 25 mg and 100 mg for oral administration.
Active Ingredient: clozapine
Inactive Ingredients are colloidal silicon dioxide, lactose, magnesium stearate, povidone, starch (corn), and talc.
What does Clozaril look like?
What are the available doses of Clozaril?
25 mg and 100 mg tablets with a facilitated score on one side ()
What should I talk to my health care provider before I take Clozaril?
How should I use Clozaril?
CLOZARIL is 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 its use, CLOZARIL should be used only in patients who have failed to respond adequately to standard antipsychotic treatment .
The effectiveness of CLOZARIL in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing CLOZARIL and chlorpromazine in patients who had failed other antipsychotics .
Prior to initiating treatment with CLOZARIL, 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 Clozaril?
Sorry No Records found
What are the warnings of Clozaril?
Sorry No Records found
What are the precautions of Clozaril?
Sorry No Records found
What are the side effects of Clozaril?
Sorry No records found
What should I look out for while using Clozaril?
Known serious hypersensitivity to clozapine or any other component of CLOZARIL (
What might happen if I take too much Clozaril?
How should I store and handle Clozaril?
Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.Metformin hydrochloride extended-release tablets USP, 500 mg are available as blue, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ ” on the top and “ ” on the bottom of one side, and plain on the other. They are supplied as follows: Bottles of 90 NDC 42291-558-90 Metformin hydrochloride extended-release tablets USP, 1,000 mg are available as white to off-white, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ ” on the top and “ ” on the bottom of one side, and plain on the other. They are supplied as follows: Bottles of 90 NDC 42291-559-90 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Metformin hydrochloride extended-release tablets USP, 500 mg are available as blue, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ ” on the top and “ ” on the bottom of one side, and plain on the other. They are supplied as follows: Bottles of 90 NDC 42291-558-90 Metformin hydrochloride extended-release tablets USP, 1,000 mg are available as white to off-white, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ ” on the top and “ ” on the bottom of one side, and plain on the other. They are supplied as follows: Bottles of 90 NDC 42291-559-90 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Metformin hydrochloride extended-release tablets USP, 500 mg are available as blue, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ ” on the top and “ ” on the bottom of one side, and plain on the other. They are supplied as follows: Bottles of 90 NDC 42291-558-90 Metformin hydrochloride extended-release tablets USP, 1,000 mg are available as white to off-white, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ ” on the top and “ ” on the bottom of one side, and plain on the other. They are supplied as follows: Bottles of 90 NDC 42291-559-90 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Metformin hydrochloride extended-release tablets USP, 500 mg are available as blue, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ ” on the top and “ ” on the bottom of one side, and plain on the other. They are supplied as follows: Bottles of 90 NDC 42291-558-90 Metformin hydrochloride extended-release tablets USP, 1,000 mg are available as white to off-white, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ ” on the top and “ ” on the bottom of one side, and plain on the other. They are supplied as follows: Bottles of 90 NDC 42291-559-90 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
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. CLOZARIL also acts 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 CLOZARIL (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 available as a component of the complete blood count (CBC), including differential, and is more relevant to drug-induced neutropenia than is the white blood cell (WBC) count. The ANC may also be calculated using the following formula: . Other granulocytes (basophils and eosinophils) contribute minimally to neutropenia and their measurement is not necessary . Neutropenia may be mild, moderate, or severe (see and ). To improve and standardize understanding, “severe neutropenia” replaces the previous terms severe leukopenia, severe granulocytopenia, or agranulocytosis.
Severe neutropenia, ANC less than (<) 500/µL, occurs in a small percentage of patients taking CLOZARIL and is associated with an increase in the risk of serious and potentially fatal infections. Risk of neutropenia appears greatest during the first 18 weeks on treatment and then declines. The mechanism by which CLOZARIL causes neutropenia is unknown and is not dose-dependent.
Two separate management algorithms are provided below, the first for patients in the general population, and the second for patients identified to have baseline neutropenia.
CLOZARIL Treatment and Monitoring in the General Patient Population (see )
Obtain a CBC, including the ANC value, prior to initiating treatment with CLOZARIL to ensure the presence of a normal baseline neutrophil count (equal to or greater than 1500/µL) and to permit later comparisons. Patients in the general population with an ANC equal to or greater than (≥)1500/µL are considered within normal range () and are eligible to initiate treatment. Weekly ANC monitoring is required for all patients during the first 6 months of treatment. If a patient’s ANC remains equal to or greater than 1500/µL for the first 6 months of treatment, monitoring frequency may be reduced to every 2 weeks for the next 6 months. If the ANC remains equal to or greater than 1500/µL for the second 6 months of continuous therapy, ANC monitoring frequency may be reduced to once every 4 weeks thereafter.
* Confirm all reports of ANC less than 1500/ µL with a repeat ANC measurement within 24 hours
** If clinically appropriate
CLOZARIL Treatment and Monitoring in Patients with Benign Ethnic Neutropenia (see )
Benign ethnic neutropenia (BEN) is a condition observed in certain ethnic groups whose average ANC values are lower than “standard” laboratory ranges for neutrophils. It is most commonly observed in individuals of African descent (approximate prevalence of 25-50%), some Middle Eastern ethnic groups, and in other non-Caucasian ethnic groups with darker skin. BEN is more common in men. Patients with BEN have normal hematopoietic stem-cell number and myeloid maturation, are healthy, and do not suffer from repeated or severe infections. They are not at increased risk for developing CLOZARIL-induced neutropenia. Additional evaluation may be needed to determine if baseline neutropenia is due to BEN. Consider hematology consultation before initiating or during CLOZARIL treatment as necessary.
Patients with BEN require a different ANC algorithm for CLOZARIL management due to their lower baseline ANC levels. provides guidelines for managing CLOZARIL treatment and ANC monitoring in patients with BEN.
General Guidelines for Management of All Patients with Fever or with Neutropenia
Rechallenge after an ANC less than 500/µL (severe neutropenia)
For some patients who experience severe CLOZARIL-related neutropenia, the risk of serious psychiatric illness from discontinuing CLOZARIL treatment may be greater than the risk of rechallenge (e.g., patients with severe schizophrenic illness who have no treatment options other than CLOZARIL). A hematology consultation may be useful in deciding to rechallenge a patient. In general, however, do not rechallenge patients who develop severe neutropenia with CLOZARIL or a clozapine product.
If a patient will be rechallenged, the clinician should consider thresholds provided in and , the patient’s medical and psychiatric history, a discussion with the patient and his/her caregiver about the benefits and risks of CLOZARIL rechallenge, and the severity and characteristics of the neutropenic episode.
Using CLOZARIL with Other Drugs Associated with Neutropenia
It is unclear if concurrent use of other drugs known to cause neutropenia increases the risk or severity of CLOZARIL-induced neutropenia. There is no strong scientific rationale to avoid CLOZARIL treatment in patients concurrently treated with these drugs. If CLOZARIL is used concurrently with an agent known to cause neutropenia (e.g., some chemotherapeutic agents), consider monitoring patients more closely than the treatment guidelines provided in and . Consult with the treating oncologist in patients receiving concomitant chemotherapy.
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.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
516Total User Reviews
User Reviews
Learn about
User Reviews
Professional
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
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).