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Quetiapine (Quetiapine Fumarate)

Trade Name : Quetiapine Fumarate

Aurobindo Pharma Limited

TABLET, FILM COATED, EXTENDED RELEASE

Strength 150 mg/1

QUETIAPINE FUMARATE 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 Quetiapine (Quetiapine Fumarate) which is also known as Quetiapine Fumarate and Manufactured by Aurobindo Pharma Limited. It is available in strength of 150 mg/1 per ml. Read more

Quetiapine (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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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 ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a09/2020
  • 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
  • u00a0
  • u00a0
  • Suicidal Thoughts and Behaviors
  • u00a0
  • Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of:
  • Schizophrenia n
  • Bipolar I disorder, manic, or mixed episodes n
  • Bipolar disorder, depressive episodesu00a0n
  • Major depressive disorder, adjunctive therapy with antidepressantsu00a0n n
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  • Swallow tablets whole and do not split, chew or crushu00a0n
  • Take without food or with a light meal (approx. 300 calories)u00a0n
  • Administer once daily, preferably in the eveningu00a0n
  • Geriatric Use:
  • Hepatic Impairment:
  • Extended-Release Tablets: 50 mg, 150 mg, 200 mg, 300 mg, and 400 mgu00a0n
  • Hypersensitivity to quetiapine or to any excipients in the quetiapine extended-release tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine extended-release tablets.
  • Known hypersensitivity to quetiapine extended-release tablets or any components in the formulation. n
  • No data
  • Cerebrovascular Adverse Reactions:
  • Neurolepticn- Malignant Syndrome (NMS):
  • Metabolicn- Changes:
  • Arrayn- Array
  • Tardiven- Dyskinesia:
  • Hypotension:
  • Increased Blood Pressure in Children and Adolescents:
  • u00a0Monitor complete blood count frequently during the first few months of treatment in patients with a pre-existing low white cell count or a history of leukopenia/neutropenia and discontinue quetiapine extended-release tablets at the first sign of a decline in WBC in absence of other causative factors ()
  • Cataracts:u00a0
  • Anticholinergic(antimuscarinic) Effects:
  • 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, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, and nasal congestionu00a0n Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increasedu00a0n n n n n n
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  • Concomitant use of strong CYP3A4 inhibitors:
  • Concomitant use of strong CYP3A4 inducers:
  • Discontinuation of strong CYP3A4 inducers:u00a0
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  • Array
  • 8.1
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  • Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [][1,4] thiazepin-11-yl-1u00ad-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is CHNOSu2022CHO and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: n n n n Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water.n Quetiapine extended-release tablets USP are supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film-coated.n Inactive ingredients for quetiapine extended-release tablets USP are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, sodium citrate, titanium dioxide. In addition, the 50 mg contains iron oxide red and iron oxide yellow, the 200 mg, and 300 mg contains iron oxide yellow.n Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.n USP dissolution test is pending.
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  • Advise the patient to read the FDA-approved patient labeling ().
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine extended-release tablets.
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Quetiapine extended-release tablets are not approved for elderly patients with dementia-related psychosis .
  • Suicidal Thoughts and Behaviors
  • Patients, 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 .
  • 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 .
  • Hyperglycemia and Diabetes Mellitus
  • Patients 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 .
  • Hyperlipidemia
  • Patients 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 .
  • Weight Gain
  • Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly .
  • Orthostatic Hypotension
  • Patients 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 .
  • Increased Blood Pressure in Children and Adolescents
  • Children and adolescent patients should have their blood pressure measured at the beginning of, and periodically during, treatment n .
  • Leukopenia/Neutropenia
  • Patients 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 extended-release tablets. 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 extended-release tablets to be stopped and/or treatment to be given .
  • Interference with Cognitive and Motor Performance
  • Patients 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 .
  • Heat Exposure and Dehydration
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration .
  • Concomitant Medication
  • As with other medications, patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-theu00ad-counter drugs.
  • Pregnancy
  • Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with quetiapine extended-release tablets. Advise patients that quetiapine extended-release tablets 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 extended-release tablets during pregnancy .
  • Infertility
  • Advise females of reproductive potential that quetiapine extended-release tablets may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible n
  • Need for Comprehensive Treatment Program
  • Quetiapine extended-release tablets are 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 extended-release tablets 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 physicianu2019s assessment of the chronicity and severity of the patientu2019s symptoms n n
  • Dispense with Medication Guide available at: n
  • Quetiapine Extended-Release Tablets USP (kwe tye' a peen)n n- Arrayn- Arrayn- Arrayn- Array
  • Talk to your or your family memberu2019s, healthcare provider about:
  • 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?
  • What are quetiapine extended-release tablets?n
  • It is not known if quetiapine extended-release tablets are safe and effective in children under 10 years of age.n n n n n n See the end of this Medication Guide for a complete list of ingredients in quetiapine extended-release tablets.n n n
  • Tell the healthcare provider about all the medicines that you take or recently have taken
  • Quetiapine extended-release tablets and other medicines may affect each other causing serious side effects. Quetiapine extended-release tablets may affect the way other medicines work, and other medicines may affect how quetiapine extended-release tablets work.
  • Tell your healthcare provider if you are having a urine drug screen because quetiapine extended-release tablets may affect your test results. Tell those giving the test that you are taking quetiapine extended-release tablets.
  • How should I take quetiapine extended-release tablets?n
  • What should I avoid while taking quetiapine extended-release tablets?
  • What are possible side effects of quetiapine extended-release tablets?n n- Array
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0See u201cWhat is the most important information I should know about quetiapine extended-release tablets?u201d
  • Increases in blood sugar can happen in some people who take quetiapine extended-release tablets. Extremely high blood sugar can lead to coma or death. 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 extended-release tablets and during therapy.
  • Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine extended-release tablets:
  • The most common side effects of quetiapine extended-release tablets include:
  • Children and Adolescents:
  • These are not all the possible side effects of quetiapine extended-release tablets. For more information, ask your healthcare provider or pharmacist.
  • 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 extended-release tablets?
  • General information about the safe and effective use of quetiapine extended-release tablets.u00a0n n- What are the ingredients in quetiapine extended-release tablets?n n- Arrayn- Arrayn- Arrayn- Dispense with Medication Guide available at: n n- Aurobindo Pharma USA, Inc.n n- Aurobindo Pharma Limitedn
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