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Clozapine (Clozapine)

Trade Name : Clozapine

Teva Pharmaceuticals USA Inc

TABLET, ORALLY DISINTEGRATING

Strength 100 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 100 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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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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  • u2022
  • Arrayn- 5.4
  • Arrayn- 5.12
  • Arrayn- Severe Neutropenia
  • Clozapine treatment has caused severe neutropenia, defined as an absolute neutrophil count (ANC) less than 500/u00b5L. Severe neutropenia can lead to serious infection and death. Prior to initiating treatment with Clozapine ODT a baseline ANC must be at least 1500/u00b5L for the general population, and must be at least 1000/u00b5L 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 ODT 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 n n- Arrayn- Array
  • Arrayn- 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 n n- Arrayn- Array
  • 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 ODT is not approved for use in patients with dementia-related psychosisn n- Arrayn- Array
  • 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 ODT must have a baseline blood absolute neutrophil count (ANC) measured before treatment initiation and regular ANC monitoring during treatment (, ).
  • Clozapine ODT is available only through a restricted program called the Clozapine REMS ().
  • Orthostatic Hypotension, Bradycardia, and Syncope: Risk is dose-related. Starting dose is 12.5 mg. Titrate gradually and use divided dosages (, , ).
  • 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 (, n- Arrayn- ).
  • Myocarditis and Cardiomyopathy: Can be fatal. Discontinue and obtain cardiac evaluation if findings suggest these cardiac reactions (n- Arrayn- ).
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Clozapine ODT is not approved for this condition (n- Arrayn- ).
  • Clozapine ODT is an atypical antipsychotic indicated for:
  • Arrayn- Array
  • Arrayn- Array
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  • Arrayn- 2.3
  • Arrayn- Array
  • Arrayn- 2.3
  • Arrayn- 2.3
  • Arrayn- 2.3
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  • Arrayn- 2.3
  • Clozapine ODT is available as 12.5 mg, 25 mg, 100 mg, 150 mg and 200 mg round, yellow, orally disintegrating tablets.
  • Orally disintegrating tablets: 12.5 mg, 25 mg, 100 mg, 150 mg and 200 mg ().
  • Clozapine ODT 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 of Clozapine ODT .
  • u2022
  • underline
  • No data
  • Eosinophilian- Array
  • QT Interval Prolongationn- Array
  • Metabolic Changes
  • Neuroleptic Malignant Syndrome (NMS)n- Array
  • Hepatotoxicity:n- Array
  • Fevern- Array
  • Pulmonary Embolism (PE)n- Array
  • Anticholinergic Toxicityn- Array
  • Interference with Cognitive and Motor Performancen- Array
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • Most common adverse reactions (u22655%) 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 ().n
  • No data
  • Strong CYP1A2 Inhibitorsn- Arrayn- Array
  • Strong CYP3A4 Inducersn- Arrayn- Array
  • Discontinuation of CYP1A2 or CYP3A4 Inducersn- Arrayn- Array
  • No data
  • u2022
  • Arrayn- 8.3
  • No data
  • Clozapine ODT, 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:
  • CHClNu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Mol. Wt. 326.83
  • Clozapine ODT is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg and 200u00a0mg for oral administration without water. Clozapine ODT may be chewed.
  • Each orally disintegrating tablet contains clozapine equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg and 200 mg.
  • The active component of Clozapine ODT is clozapine. The remaining components are aminoalkyl methacrylate copolymer E, mannitol, aspartame, microcrystalline cellulose*, silicified microcrystalline cellulose**, crospovidone, natural and artificial mint flavor, sodium bicarbonate, citric acid, ferric oxide (yellow), and magnesium stearate.
  • *12.5, 25, and 100 mg tablets
  • **150 and 200 mg tablets
  • THIS PRODUCT CONTAINS ASPARTAME AND IS NOT INTENDED FOR USE BY INFANTS. PHENYLKETONURICS: CONTAINS PHENYLALANINE n n . Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 1.6u00a0mg aspartame, thus, 0.87u00a0mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 3.1u00a0mg aspartame, thus, 1.74 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 12.4u00a0mg aspartame, thus, 6.96 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 18.6 mg aspartame, thus, 10.44 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 24.8 mg aspartame, thus, 13.92 mg phenylalanine. The allowable daily intake of aspartame is 50u00a0mg per kilogram of body weight per day.
  • No data
  • 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 on a mg/m body surface area basis.
  • Mutagenesis
  • Clozapine was not genotoxic when tested in the following gene mutation and chromosomal aberration tests: the bacterial Ames test, the mammalian V79 in Chinese hamster cells, the unscheduled DNA synthesis in rat hepatocytes or the micronucleus assay in mice.
  • Impairment of Fertility
  • Clozapine had no effect on any parameters of fertility, pregnancy, fetal weight or postnatal development when administered orally to male rats 70 days before mating and to female rats for 14 days before mating at doses up to 0.4 times the MRHD of 900 mg/day on a mg/m body surface area basis.
  • No data
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  • Discuss the following issues with patients and caregivers:
  • Manufactured by:Cephalon, Inc. Salt Lake City, UT 84116
  • Manufactured for:Teva Select Brands, Horsham, PAu00a0 19044Division of Teva Pharmaceuticals USA
  • *FazaClo is a registered trademark of Jazz Pharmaceuticals plc or its subsidiaries.
  • Revised: February 2017
  • 12.5 mg (Bottle)
  • NDCn- 3011n- Rx only
  • CLOZAPINE
  • Orally Disintegrating Tablets
  • 12.5 mg
  • Phenylketonurics:
  • 100 TABLETS
  • Usual Adult Dosage:
  • Storage Conditions:
  • Dispense:
  • Manufactured by:Cephalon, Inc.Salt Lake City, UT 84116
  • Manufactured For:Teva Select Brands, Horsham, PA 19044Division of Teva Pharmaceuticals USA
  • 25 mg (Bottle)
  • NDCn- 3012n- Rx only
  • CLOZAPINE
  • Orally Disintegrating Tablets
  • 25 mg
  • Phenylketonurics:
  • 100 TABLETS
  • Usual Adult Dosage:
  • Storage Conditions:
  • Dispense:
  • Manufactured by:Cephalon, Inc.Salt Lake City, UT 84116
  • Manufactured for:Teva Select Brands, Horsham, PA 19044Division of Teva Pharmaceuticals USA
  • 100 mg (Bottle)
  • NDCn- 3010
  • CLOZAPINE
  • Orally Disintegrating Tablets
  • 100 mg
  • Rx only
  • Phenylketonurics:
  • 100 TABLETS
  • Usual Adult Dosage:
  • Storage Conditions:
  • Dispense:
  • Manufactured by:Cephalon, Inc.Salt Lake City, UT 84116
  • Manufactured for:Teva Select Brands, Horsham, PA 19044Division of Teva Pharmaceuticals USA
  • 150 mg (Bottle)
  • NDCn- 3086
  • CLOZAPINE
  • Orally Disintegrating Tablets
  • 150 mg
  • Rx only
  • Phenylketonurics:
  • 100 TABLETS
  • Usual Adult Dosage:
  • Storage Conditions:
  • Dispense:
  • Manufactured by:Cephalon, Inc.Salt Lake City, UT 84116
  • Manufactured for:Teva Select Brands, Horsham, PA 19044Division of Teva Pharmaceuticals USA
  • 200 mg (Bottle)
  • NDCn- 3087
  • CLOZAPINE
  • Orally Disintegrating Tablets
  • 200 mg
  • Rx only
  • Phenylketonurics:
  • 100 TABLETS
  • Usual Adult Dosage:
  • Storage Conditions:
  • Dispense:
  • Manufactured by:Cephalon, Inc.Salt Lake City, UT 84116
  • Manufactured for:Teva Select Brands, Horsham, PA 19044Division of Teva Pharmaceuticals USA

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