Quetiapine Fumarate (Quetiapine Fumarate)

Trade Name : Quetiapine Fumarate

West-Ward Pharmaceuticals Corp

TABLET

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 (Quetiapine Fumarate) which is also known as Quetiapine Fumarate and Manufactured by West-Ward Pharmaceuticals Corp. 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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  • 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 Quetiapine tablets are not approved for the treatment of patients with dementia-related psychosis 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
  • 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
  • Quetiapine tablets are not approved for use in pediatric patients under ten years of age 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
  • Quetiapine is an atypical antipsychotic indicated for the treatment of:
  • No data
  • Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg ()
  • Hypersensitivity to quetiapine or to any excipients in the quetiapine tablet formulation. Anaphylactic reactions have been reported in patients treated with quetiapine.
  • Known hypersensitivity to quetiapine or any components in the formulation. ()
  • 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 West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Concomitant use of strong CYP3A4 inhibitors:
  • Concomitant use of strong CYP3A4 inducers:
  • Discontinuation of strong CYP3A4 inducers
  • No data
  • u2022
  • Pregnancy:
  • 8.1
  • No data
  • No data
  • Quetiapine fumarate 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-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 CHNOSu2022CHO and it has a molecular weight of 883.10 (fumarate salt). The structural formula is:
  • Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water.
  • Quetiapine Tablets USP are available for oral administration containing either 25 mg, 50 mg, 100 mg, 200 mg, 300 mg or 400 mg of quetiapine fumarate. Each 25 mg tablet contains the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate.
  • The 50 mg, 100 mg, 200 mg, 300 mg and 400 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate.
  • Each tablet meets the requirements of the Test 3 Dissolution in the USP monograph for Quetiapine Tablets USP.
  • No data
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  • Quetiapine Tablets USP
  • 25 mg tablets are supplied as a round, white to off-white, standard biconvex tablet debossed with product identification u201c54u201d over u201c137u201d on one side and plain on the other side.
  • NDC 0054-0220-25: Bottle of 100 Tablets
  • NDC 0054-0220-31: Bottle of 1,000 Tablets
  • NDC 0054-0220-20: 2 x 5 x 10 Unit-Dose Tablets
  • 50 mg tablets are supplied as a white to off-white, oval, standard biconvex tablet debossed with product identification u201c54u201d on one side and u201c377u201d on the other side.
  • NDC 0054-0229-25: Bottle of 100 Tablets
  • NDC 0054-0229-31: Bottle of 1,000 Tablets
  • NDC 0054-0229-20: 2 x 5 x 10 Unit-Dose Tablets
  • 100 mg tablets are supplied as a round, white to off-white, standard biconvex tablet debossed with product identification u201c54u201d over u201c373u201d on one side and plain on the other side.
  • NDC 0054-0221-25: Bottle of 100 Tablets
  • NDC 0054-0221-20: 2 x 5 x 10 Unit-Dose Tablets
  • 200 mg tablets are supplied as a round, white to off-white, standard biconvex tablet debossed with product identification u201c54u201d over u201c527u201d on one side and plain on the other side.
  • NDC 0054-0222-25: Bottle of 100 Tablets
  • 300 mg tablets are supplied as a white to off-white, oval, standard biconvex tablet debossed with product identification u201c54 531u201d on one side and plain on the other side.
  • NDC 0054-0223-21: Bottle of 60 Tablets
  • NDC 0054-0223-20: 2 x 5 x 10 Unit-Dose Tablets
  • 400 mg tablets are supplied as a white to off-white, oval, standard biconvex tablet debossed with product identification u201c54 735u201d on one side and plain on the other side.
  • NDC 0054-0230-25: Bottle of 100 Tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • 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.
  • 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
  • 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
  • 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 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
  • 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
  • Weight Gain:
  • Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly 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
  • 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. 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
  • 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
  • Heat Exposure and Dehydration:
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration 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 .
  • Pregnancy:
  • Advise 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 .
  • Infertility:
  • Advise females of reproductive potential that quetiapine may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible 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 physicianu2019s assessment of the chronicity and severity of the patientu2019s symptoms n
  • Distr. by: n Eatontown, NJ 07724
  • 10004966/08
  • Revised February 2020
  • Quetiapine Tablets USP
  • (kwe tyeu2032 a peen)
  • Rx only
  • Read this Medication Guide before you start taking quetiapine 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 quetiapine?
  • Quetiapine may cause serious side effects, including:
  • What else do I need to know about antidepressant medicines?
  • What is quetiapine?
  • Quetiapine is a prescription medicine used to treat:
  • It is not known if quetiapine is safe and effective in children under 10 years of age.
  • What should I tell my healthcare provider before taking quetiapine?
  • Before you take quetiapine, 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 and other medicines may affect each other causing serious side effects. Quetiapine may affect the way other medicines work, and other medicines may affect how quetiapine works.
  • Tell your healthcare provider if you are having a urine drug screen because quetiapine may affect your test results. Tell those giving the test that you are taking quetiapine.
  • How should I take quetiapine?
  • What should I avoid while taking quetiapine?
  • What are possible side effects of quetiapine?
  • Quetiapine can cause serious side effects, including:
  • The most common side effects of quetiapine include:
  • In Adults:
  • In Children and Adolescents:
  • These are not all the possible side effects of quetiapine. 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?
  • General information about the safe and effective use of quetiapine.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine for a condition for which it was not prescribed. Do not give quetiapine to other people, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes the most important information about quetiapine. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine that is written for health professionals.
  • For more information, please call 1-800-962-8364.
  • What are the ingredients in Quetiapine Tablets USP?
  • Active ingredient:
  • Inactive ingredients:
  • The 50 mg, 100 mg, 200 mg, 300 mg and 400 mg tablets contain colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, purified water and sodium starch glycolate.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Distr. by: n Eatontown, NJ 07724
  • 10004966/08
  • Revised February 2020
  • Quetiapine Tablets USP, 25 mg
  • NDC: 0054-0220-25
  • Quetiapine Tablets USP, 25 mg
  • NDC: 0054-0220-20
  • Quetiapine Tablets USP, 50 mg
  • NDC: 0054-0229-25
  • Quetiapine Tablets USP, 50 mg
  • NDC: 0054-0229-20
  • Quetiapine Tablets USP, 100 mg
  • NDC: 0054-0221-25
  • Quetiapine Tablets USP, 100 mg
  • NDC: 0054-0221-20
  • Quetiapine Tablets USP, 200 mg
  • NDC: 0054-0222-25
  • Quetiapine Tablets USP, 300 mg
  • NDC: 0054-0223-21
  • Quetiapine Tablets USP, 300 mg
  • NDC: 0054-0223-20
  • Quetiapine Tablets USP, 400 mg
  • NDC: 0054-0230-25

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