Quetiapine Fumarate (Seroquel)

Trade Name : SEROQUEL

PD-Rx Pharmaceuticals, Inc.

TABLET, FILM COATED

Strength 25 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 Fumarate (Seroquel) which is also known as SEROQUEL and Manufactured by PD-Rx Pharmaceuticals, Inc.. It is available in strength of 25 mg/1 per ml. Read more

Quetiapine Fumarate (Seroquel) 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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  • No data
  • Warnings and Precautions, Tardive Dyskinesia n n n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a008/2019n nn
  • 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 n n n . SEROQUEL is not approved for the treatment of patients with dementia-related psychosis n n n .n n n
  • Arrayn- Suicidal Thoughts and Behaviors
  • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older n n n n
  • In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [n n n .n n n
  • SEROQUEL is not approved for use in pediatric patients under ten years of age n n n .n n n
  • 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
  • SEROQUEL is an atypical antipsychotic indicated for the treatment of:
  • Schizophrenia (n n n )n n n
  • Bipolar I disorder manic episodes n n n n
  • Bipolar disorder, depressive episodes n n n n
  • No data
  • Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg n n n n
  • Hypersensitivity to quetiapine or to any excipients in the SEROQUEL formulation. Anaphylactic reactions have been reported in patients treated with SEROQUEL.
  • Known hypersensitivity to SEROQUEL or any components in the formulation. n n n n
  • No data
  • Cerebrovascular Adverse Reactions:
  • Neuroleptic Malignant Syndrome (NMS):
  • Metabolic Changes:
  • Tardive Dyskinesia:
  • Hypotension:
  • Increased Blood Pressure in Children and Adolescents:
  • Leukopenia, Neutropenia and Agranulocytosis:
  • Cataracts:
  • Anticholinergic(antimuscarinic) Effects
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or
  • www.fda.gov/medwatch.
  • 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 n n )n n n
  • Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased (n n n )n n n
  • No data
  • Concomitant use of strong CYP3A4 inhibitors:
  • Concomitant use of strong CYP3A4 inducers:
  • Discontinuation of strong CYP3A4 inducers:
  • No data
  • Arrayn- (8.1)
  • No data
  • No data
  • SEROQUELn n n (quetiapine fumarate) is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [n n n ] [1,4]thiazepin-11-yl-1-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 Cn n n Hn n n Nn n n On n n Sn n n u2022Cn n n Hn n n On n n and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:n nn
  • Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.
  • SEROQUEL is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.
  • Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.
  • The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide.
  • No data
  • No data
  • No data
  • 25 mg Tablets peach, round, biconvex, film coated tablets, identified with u2018SEROQUELu2019 and u201825u2019 on one side and plain on the other side, are supplied in bottles of 30 tablets (NDC 55289-872-30) .
  • Store at 25u00baC (77u00baF); excursions permitted to 15-30u00baC (59-86u00baF) [See USP].
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking SEROQUEL.
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Patients 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 n n n n
  • 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 n n n 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 n n n
  • 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 n n n n n n
  • 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 n n n n n n
  • Weight Gain
  • Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly n n n n n n
  • 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 n n n n n n
  • 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 n n n n 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 SEROQUEL. 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 SEROQUEL to be stopped and/or treatment to be given n n n n n n
  • 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 n n n n n n
  • Heat Exposure and Dehydration
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration n n n n n n
  • 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-the-counter drugs n n n n
  • Pregnancy
  • Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with SEROQUEL. Advise patients that SEROQUEL 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 SEROQUEL during pregnancy n n n .n nn
  • Infertility
  • Advise females of reproductive potential that SEROQUEL may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible n n n .n nn
  • Need for Comprehensive Treatment Program
  • SEROQUEL 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 SEROQUEL 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 n .n nn
  • No data
  • SeroQUELn n n n
  • quetiapine fumarate
  • 25 mg tablets
  • Rx only

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