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Quetiapine Fumarate (Quetiapine Fumarate)

Trade Name : Quetiapine fumarate

Jubilant Cadista Pharmaceuticals Inc.

TABLET

Strength 25 mg/1

QUETIAPINE FUMARATE Atypical Antipsychotic [EPC]

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

Quetiapine Fumarate (Quetiapine Fumarate) 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.

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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  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Suicidal Thoughts and Behaviors
  • Quetiapine tablets are atypical antipsychotic indicated for the treatment of:
  • Schizophrenia n
  • Bipolar I disorder manic episodes n
  • Bipolar disorder, depressive episodesn
  • Warnings and Precautions, Tardive Dyskinesia u00a0 u00a0 u00a008/2019 n
  • u25cfu00a0u00a0u00a0u00a0u00a0u00a0Quetiapine tabletsu00a0can be taken with or without food n
  • u25cfu00a0u00a0u00a0u00a0u00a0u00a0 Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly , n u25cfu00a0u00a0u00a0u00a0u00a0u00a0 Lower starting dose (25 mg/day) and slower titration may be needed (, , )
  • Quetiapine tablets, USP 25 mg are peach colored, round, biconvex, film coated tablets, debossed with u2018A5u2019 on one side and u2018Cu2019 on the other side.
  • Tablets: 25 mg n
  • Hypersensitivity to quetiapine or to any excipients in the quetiapine formulation. Anaphylactic reactions have been reported in patients treated with quetiapine.n
  • Known hypersensitivity to quetiapine or any components in the formulation. n
  • No data
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • Most common adverse reactions (incidence u22655% and twice placebo):Adults: somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, lethargy, ALT increased, dyspepsia n Children and Adolescents:u00a0somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased n n n
  • To report SUSPECTED ADVERSE REACTIONS, contactu00a0Jubilant Cadista Pharmaceuticals Inc.u00a0at 1-800-313-4623 or FDA at 1-800-FDA-1088 or .
  • No data
  • Concomitant use of strong CYP3A4 inhibitors:
  • Concomitant use of strong CYP3A4 inducers:
  • Discontinuation of strong CYP3A4 inducers:
  • No data
  • Pregnancy:
  • (8.1)
  • No data
  • No data
  • Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo n [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt.u00a0 All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt.u00a0u00a0 Its molecular formula is CHNOSu2022CHO and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:n
  • Quetiapine fumarate, USP is a off-white to creamy white powder which is soluble in dimethyl sulphoxide and dimethyl formamide.n Quetiapine tablets, USP are supplied for oral administration as 25 mg peach colored, round, biconvex, film coated tablets, debossed with u2018A5u2019 on one side and u2018Cu2019 on the other side.n Inactive ingredients are dibasic calcium phosphate dihydrate, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide. n Each 25 mg tablet contains 28.78 mg of quetiapine fumarate, USP equivalent to 25 mg quetiapine.n USP dissolution test is pending.n n
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  • Quetiapine tablets, USP 25 mg are peach colored, round, biconvex, film coated tablets, debossed with u2018A5u2019 on one side and u2018Cu2019 on the other side.n They are supplied as follows:Bottles of 60 with child-resistant closureu00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0NDC 59746-348-60Bottles of 100 with child-resistant closureu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 59746-348-01Bottles of 1000u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 NDC 59746-348-10Blister pack of 10 x 10u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0NDC 59746-348-03n Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [See USP Controlled Room Temperature].n
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).n
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine.
  • Increased Mortality in Elderly Patients with Dementia-Related PsychosisPatients and caregivers should be advised that elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Quetiapine is not approved for elderly patients with dementia-related psychosis .
  • Suicidal Thoughts and BehaviorsPatients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication n .
  • Neuroleptic Malignant Syndrome (NMS)Patients should be advised to report to their physician any signs or symptoms that may be related to NMS. These may include muscle stiffness and high fever n .
  • Hyperglycemia and Diabetes MellitusPatients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment n .
  • HyperlipidemiaPatients should be advised that elevations in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol may occur. Patients should have their lipid profile monitored at the beginning of and periodically during treatment n n
  • Weight GainPatients should be advised that they may experience weight gain. Patients should have their weight monitored regularly n n
  • Orthostatic HypotensionPatients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing, which may lead to falls), especially during the period of initial dose titration, and also at times of re-initiating treatment or increases in dose n n
  • Increased Blood Pressure in Children and AdolescentsChildren and adolescent patients should have their blood pressure measured at the beginning of, and periodically during, treatment n n n
  • Leukopenia/NeutropeniaPatients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking quetiapine. Patients should be advised to talk to their doctor as soon as possible if they have a fever, flu-like symptoms, sore throat, or any other infection as this could be a result of a very low WBC, which may require quetiapine to be stopped and/or treatment to be given [].n n
  • Interference with Cognitive and Motor PerformancePatients should be advised of the risk of somnolence or sedation (which may lead to falls), especially during the period of initial dose titration. Patients should be cautioned about performing any activity requiring mental alertness, such as operating a motor vehicle (including automobiles) or operating machinery, until they are reasonably certain quetiapine therapy does not affect them adversely n n
  • Heat Exposure and DehydrationPatients should be advised regarding appropriate care in avoiding overheating and dehydration n n
  • Concomitant MedicationAs with other medications, patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs.
  • PregnancyAdvise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with quetiapine. Advise patients that quetiapine may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to quetiapine during pregnancy [].n InfertilityAdvise females of reproductive potential that quetiapine may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible n n
  • Need for Comprehensive Treatment Program Quetiapine is indicated as an integral part of a total treatment program for adolescents with schizophrenia and pediatric bipolar disorder that may include other measures (psychological, educational, and social). Effectiveness and safety of quetiapine have not been established in pediatric patients less than 13 years of age for schizophrenia or less than 10 years of age for bipolar mania. Appropriate educational placement is essential and psychosocial intervention is often helpful. The decision to prescribe atypical antipsychotic medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms n n
  • Rx Only
  • Manufactured by:n
  • Marketed by:n
  • Revised: 04/2020
  • u00a0
  • u00a0
  • Quetiapine Tabletsn- (kwe-TYE-a-peen FUE-ma-rate)
  • Read this Medication Guide before you start taking quetiapine tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • What is the most important information I should know about n- quetiapine tablets?
  • Quetiapineu00a0tablets may cause serious side effects, including:
  • Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
  • What else do I need to know about antidepressant medicines?
  • Whatu00a0are quetiapineu00a0tablets?n n- u00a0n- u00a0
  • It is not known if quetiapinetabletsare safe and effective in children under 10 years of age.
  • What should I tell my healthcare provider before taking n- quetiapineu00a0tablets?n n n- Before you take n- quetiapineu00a0tablets, tell your healthcare provider if you have or have had:
  • Tell the healthcare provider about all the medicines that you take or recently have taken
  • Quetiapine tablets and other medicines may affect each other causing serious side effects. Quetiapine tablets may affect the way other medicines work, and other medicines may affect how quetiapine tablet works.
  • Tell your healthcare provider if you are having a urine drug screen because quetiapine tablets may affect your test results. Tell those giving the test that you are taking quetiapinetablets.
  • How should I take quetiapineu00a0tablets?
  • What should I avoid while taking n- quetiapineu00a0tablets?
  • What are possible side effects of qn- uetiapineu00a0tablets? n n n- Quetiapineu00a0tablets can cause serious side effects, including:
  • Increases in blood sugar can happen in some people who take quetiapine tablets. Extremely high blood sugar can lead to coma or death.u00a0 If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes) your healthcare provider should check your blood sugar before you start quetiapine tablets and during therapy.u00a0u00a0 n Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine tablets:
  • The most common side effects of n- quetiapine tablets include:n n- In Adults:
  • In Children and Adolescents:
  • These are not all the possible side effects of quetiapine tablets. For more information, ask your healthcare provider or pharmacist. n Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store quetiapine tablets?
  • General information about the safe and effective use of quetiapineu00a0tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine tablets for a condition for which it was not prescribed. Do not give quetiapine tabletsu00a0to other people, even if they have the same symptoms you have. It may harm them.n This Medication Guide summarizes the most important information about quetiapine tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine tabletsu00a0that is written for health professionals.
  • For more information, about quetiapine tablets call 1-800-313-4623.
  • What are the ingredients in quetiapine tablets?
  • Active ingredient: n- Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Rx Only
  • Manufactured by:
  • Marketed by:
  • Revised: 04/2020
  • NDC 59746-348-60n CADISTAn Quetiapine Tablets, USPn 25 mgn 60 Tabletsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Rx Onlyn Pharmacist: Dispense the medication guide provided separately to each patient.
  • NDC 59746-348-03n CADISTAn
  • Quetiapine Tablets, USP
  • 25 mg
  • 100 Tabletsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Rx Only(10x10 unit-dose)n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Pharmacist: Dispense the medication guide provided separately to each patient.

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