Clozapine (Clozapine)

Trade Name : Clozapine

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 25 mg/1

CLOZAPINE Atypical Antipsychotic [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Clozapine (Clozapine) which is also known as Clozapine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 25 mg/1 per ml. Read more

Clozapine (Clozapine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Warnings and Precautions, Myocarditis, Cardiomyopathy and Mitral Valve Incompetence () 12/2016
  • Warnings and Precautions, Falls (), Hepatotoxicity () 02/2017
  • Arrayn- Severe Neutropenia
  • Clozapine treatment has caused severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/u03bcL. Severe neutropenia can lead to serious infection and death. Prior to initiating treatment with clozapine, a baseline ANC must be at least 1500/u03bcL for the general population; and must be at least 1000/u03bcL 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 .
  • Arrayn- 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) .
  • Arrayn- 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 .
  • Arrayn- Myocarditis, Cardiomyopathy and Mitral Valve Incompetence
  • 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 n
  • Arrayn- 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 .
  • WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
  • See full prescribing information for complete boxed warning.
  • Severe Neutropenia: Clozapine can cause severe neutropenia, which can lead to serious and fatal infections. Patients initiating and continuing treatment with clozapine must have a baseline blood absolute neutrophil count (ANC) measured before treatment initiation and regular ANC monitoring during treatment (2.1, 5.1).
  • Clozapine is available only through a restricted program called the Clozapine REMS (5.2).
  • Orthostatic Hypotension, Bradycardia, and Syncope: Risk is dose-related. Starting dose is 12.5 mg. Titrate gradually and use divided dosages (2.2, 2.5, 5.3).
  • Seizure: Risk is dose-related. Titrate gradually and use divided doses. Use with caution in patients with history of seizure or risk factors for seizure (2.2, ).
  • Myocarditis, Cardiomyopathy and Mitral Valve Incompetence: Can be fatal. Discontinue and obtain cardiac evaluation if findings suggest these cardiac reactions ().
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Clozapine is not approved for this condition ().
  • Clozapine tablets are an atypical antipsychotic indicated for:
  • Treatment-resistant schizophrenia. Efficacy was established in an active-controlled study (, ).
  • Reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Efficacy was established in an active-controlled study (, ).
  • No data
  • Starting Dose: 12.5 mg once daily or twice daily (2.2).
  • Use cautious titration and divided dosage schedule (2.2, ).
  • Titration: increase the total daily dosage in increments of 25 mg to 50 mg per day, if well-tolerated (2.2).
  • Target dose: 300 mg to 450 mg per day, in divided doses, by the end of 2 weeks (2.2).
  • Subsequent increases: increase in increments of 100 mg or less, once or twice weekly (2.2).
  • Maximum daily dose: 900 mg (2.2).
  • Clozapine tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg pale-yellow tablets with a score on one side.
  • 25 mg, 50 mg, 100 mg, and 200 mg tablets ()
  • Clozapine tablets are 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 of clozapine tablets .
  • Known serious hypersensitivity to clozapine or any other component of clozapine tablets ()
  • No data
  • 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:
  • Most common adverse reactions (u2265 5%) were: CNS reactions (sedation, dizziness/vertigo, headache, and tremor); cardiovascular reactions (tachycardia, hypotension, and syncope); autonomic nervous system reactions (hypersalivation, sweating, dry mouth, and visual disturbances); gastrointestinal reactions (constipation and nausea); and fever ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-866-832-8537 oru00a0 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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  • Concomitant use of: Reduce clozapine dose to one-third when coadministered with strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin) (, ).
  • Concomitant use of is not recommended (, ).
  • Discontinuation of CYP1A2 or CYP3A4 Inducers
  • No data
  • Nursing Mothers
  • 8.3
  • No data
  • Clozapine tablets USP, an atypical antipsychotic drug, are a tricyclic dibenzodiazepine derivative. The chemical name of clozapine, USP is 8-chloro-11-(4-methyl-1-piperazinyl)-5-dibenzo [] [1,4] diazepine and it has the following structural formula:
  • Clozapine, USP is a yellow, crystalline powder, very slightly soluble in water. Each tablet, for oral administration, contains 25 mg, 50 mg, 100 mg, or 200 mg clozapine, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, pregelatinized corn starch, and talc. Additionally, the 25 mg and 100 mg tablets contain lactose monohydrate and the 50 mg and 200 mg tablets contain anhydrous lactose and crospovidone.
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  • Discuss the following issues with patients and caregivers:
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. S 3/2017
  • No data
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