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Quetiapine Fumarate (Quetiapine Fumarate)

Trade Name : quetiapine fumarate

Aphena Pharma Solutions - Tennessee, LLC

TABLET, FILM COATED

Strength 100 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 Aphena Pharma Solutions - Tennessee, LLC. It is available in strength of 100 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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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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  • No data
  • Warnings and Precautions, Hyperglycemia (), 1/2011
  • Warnings and Precautions, Hyperlipidemia (), 1/2011
  • Warnings and Precautions, Weight Gain (), 1/2011
  • Warnings and Precautions, QT Prolongation (), 6/2011
  • Warnings and Precautions, Hypothyroidism (), 1/2011
  • Warnings and Precautions, Withdrawal (), 5/2010
  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS n
  • Antipsychotic drugs are associated with an increased risk of death ()
  • Quetiapine is not approved for elderly patients with Dementia-Related Psychosis ()
  • No data
  • Quetiapine Fumarate Tablets is an atypical antipsychotic indicated for the:
  • Treatment of schizophrenia ()
  • Acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex ()
  • Acute treatment of depressive episodes associated with bipolar disorder ()
  • Maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex ()
  • Quetiapine fumarate tablets can be taken with or without food.
  • Quetiapine fumarate tablets can be taken with or without food.
  • 25 mg tablets
  • 50 mg tablets
  • 100 mg tablets
  • 200 mg tablets
  • 300 mg tablets
  • 400 mg tablets
  • 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg ()
  • None known
  • None ()
  • No data
  • Arrayn- Arrayn- Arrayn- Arrayn- Arrayn- Arrayn- Arrayn- Arrayn- Arrayn- Arrayn- Array
  • QT Prolongation:
  • 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. ()
  • Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-667-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The risks of using quetiapine in combination with other drugs have not been extensively evaluated in systematic studies.u00a0 Given the primary CNS effects of quetiapine, caution should be used when it is taken in combination with other centrally acting drugs.u00a0 Quetiapine potentiated the cognitive and motor effects of alcohol in a clinical trial in subjects with selected psychotic disorders, and alcoholic beverages should be avoided while taking quetiapine fumarate tablets.
  • Because of its potential for inducing hypotension, quetiapine may enhance the effects of certain antihypertensive agents.
  • Quetiapine may antagonize the effects of levodopa and dopamine agonists.
  • The use of quetiapine should be avoided in combination with drugs known to increase QT interval, and caution should be exercised when quetiapine is used in combination with drugs known to cause electrolyte imbalance [(5.12)].
  • There have been literature reports suggesting false positive results in urine enzyme immunoassays for methadone and tricyclic antidepressants in patients who have taken quetiapine. Caution should be exercised in the interpretation of positive urine drug screen results for these drugs, and confirmation by alternative analytical technique (e.g. chromatographic methods) should be considered.
  • P450 3A Inhibitors:
  • Hepatic Enzyme Inducers:
  • Centrally Acting Drugs:
  • Antihypertensive Agents:
  • Levodopa and Dopamine Agents:
  • Drugs known to cause electrolyte imbalance or increase QT interval:
  • Interference with Urine Drug Screens:
  • No data
  • Arrayn- Arrayn- Arrayn- Arrayn- Array
  • Pediatric use information in patients (13 to 17 years of age) with schizophrenia and patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LPu2019s quetiapine fumarate drug labeling. However, due to AstraZeneca Pharmaceuticals LPu2019s marketing exclusivity rights; this drug product is not labeled for such use in those patients.
  • No data
  • No data
  • Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives.u00a0 The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt).u00a0 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.u00a0 Its molecular formula is CHNOSu2022CHO and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:
  • Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.
  • Quetiapine fumarate tablets are 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 croscarmellose sodium, colloidal silicon dioxide, fumaric acid, ethylcellulose, magnesium stearate, hypromellose, hydroxylpropyl cellulose, polyethylene glycol, and titanium dioxide.
  • The 25 mg tablets also 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
  • No data
  • 25 mg Tablets
  • They are supplied as follows:
  • Bottles of 100 (NDC 60429-371-01)Bottles of 1000 (NDC 60429-371-10)n
  • 50 mg Tablets
  • They are supplied as follows:Bottles of 100 (NDC 60429-372-01)Bottles of 1000 (NDC 60429-372-10)u00a0
  • 100 mg Tablets
  • They are supplied as follows:Bottles of 100 (NDC 60429-373-01)Bottles of 1000 (NDC 60429-373-10)n
  • 200 mg Tablets
  • They are supplied as follows:Bottles of 100 (NDC 60429-374-01)Bottles of 1000 (NDC 60429-374-10)u00a0
  • 300 mg Tablets
  • They are supplied as follows:Bottles of 60 (NDC 60429-375-60)u00a0
  • 400 mg Tablets
  • They are supplied as follows:Bottles of 100 (NDC 60429-376-01)
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF); excursions permitted to 15 to 30u00baC (59 to 86u00baF) [See USP Controlled Room Temperature].
  • [see Medication Guide]
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with quetiapine fumarate tablets and should counsel them in its appropriate use. A patient Medication Guide about u201cAntidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actionsu201d is available for quetiapine fumarate tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine fumarate tablets.
  • 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.u00a0 Quetiapine is not approved for elderly patients with dementia-related psychosis [ (5.1)].
  • Clinical Worsening and Suicide Risk
  • 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 [ (5.2)].
  • 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 [ (5.3)].
  • 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 [ (5.4)].
  • Hyperlipidemia
  • Patients should be advised that elevations in total cholesterol, LDLu2013cholesterol and triglycerides and decreases in HDL-cholesterol may occur. Patients should have their lipid profile monitored at the beginning of and periodically during treatment [(5.5)].
  • Weight Gain
  • Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly [ (5.6)].
  • 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 [ (5.8)].
  • Increased Blood Pressure in Children and Adolescents
  • Blood pressure should be measured at the beginning of, and periodically during, treatment [ (5.9)].
  • 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 fumarate tablets [see (5.10)].
  • 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. Patients should limit consumption of alcohol during treatment with quetiapine [see u00a0 n (5.17)].
  • Heat Exposure and Dehydration
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see u00a0 (5.19).]
  • 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 [see u00a0 (5.22)]
  • Pregnancy and Nursing
  • Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Patients should be advised not to breast feed if they are taking quetiapine [ (8.1) and (8.3)].
  • Need for Comprehensive Treatment Program
  • Pediatric use information in patients (13 to 17 years of age) with schizophrenia, and patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LPu2019s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LPu2019s marketing exclusivity rights; this drug product is not labeled for such use in those patients.
  • Manufactured by: Toronto, Ontario Canada M9L 1T9
  • Manufactured for: Weston, Florida USAu00a033326
  • Marketed/Packaged by: Camarillo, CA 93012
  • Revised: July 2011
  • MEDICATION GUIDE
  • Quetiapine Fumarate
  • ()
  • Tablets
  • Read this Medication Guide before you start taking quetiapine fumarate tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • What is the most important information I should know about Quetiapine Fumarate Tablets?
  • Quetiapine fumarate tablets may cause sn- erious side effectsu00a0, includinn- g:
  • These serious side effects are described below:
  • u00a0
  • What is ?
  • Pediatric use information in patients (13 to 17 years of age) with schizophrenia, and patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LPu2019s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LPu2019s marketing exclusivity rights; this drug product is not labeled for such use in those patients.
  • Quetiapine fumarate tablets has not been studied in patients younger than 10 years of age.
  • What should I tell my healthcare provider before taking ?
  • Before taking quetiapine fumarate tablets, 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 fumarate tablets and other medicines may affect each other causing serious side effects. Quetiapine fumarate tablets may affect the way other medicines work, and other medicines may affect how quetiapine fumarate tablets works.
  • Especially tell your healthcare provider if you take or plan to take medicines for:
  • Also tell your healthcare provider if you take or plan to take any of these medicines:
  • This is not a complete list of medicines that can affect or be affected by quetiapine fumarate tablets. Your doctor can tell you if it is safe to take quetiapine fumarate tablets with your other medicines. Do not start or stop any medicines while taking quetiapine fumarate tablets without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
  • Tell your healthcare provider if you are having a urine drug screen because quetiapine fumarate tablets may affect your test results. Tell those giving the test that you are taking quetiapine fumarate tablets.
  • How should I take ?
  • If you suddenly stop taking quetiapine fumarate tablets, you may experience side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.
  • What should I avoid while taking ?
  • Do not drive, operate machinery, or do other dangerous activities until you know how quetiapine fumarate tablets affects you. Quetiapine fumarate tablets may make you drowsy.
  • What are possible side effects of ?
  • Serious side effects have been reported with including:
  • Also, see u201cWhat is the most important information I should know about ?u201d at the beginning of this Medication Guide.
  • Common possible side effects with include:
  • Adults
  • Children and Adolescents:
  • These are not all the possible side effects of quetiapine fumarate tablets. For more information, ask your healthcare provider or pharmacist.
  • Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store ?
  • General information about n
  • Do not take quetiapine fumarate tablets unless your healthcare provider has prescribed it for you for your condition. Do not share quetiapine fumarate tablets with other people, even if they have the same condition. It may harm them.u00a0
  • This Medication Guide provides a summary of important information about quetiapine fumarate tablets. For more information about quetiapine fumarate tablets, talk with your healthcare provider or pharmacist or call 1-800-667-4708. You can ask your healthcare provider for information about quetiapine fumarate tablets that is written for health professionals.
  • What are the ingredients in quetiapine?
  • Active ingredient:
  • Inactive ingredients:
  • Arrayn- The symptoms of Schizophrenia include:
  • Arrayn- The symptoms of Bipolar Disorder include:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by: Toronto, Ontario Canada M9L 1T9
  • Manufactured for: Weston, Florida USAu00a033326
  • Marketed/Packaged by: Camarillo, CA 93012
  • Revised: December 2011
  • Please reference the section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
  • Store between 20u00b0-25u00b0C (68u00b0-77u00b0F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
  • Repackaged by:n n Cookeville, TN 38506n 20140422SC
  • NDC 43353-788 - 25mg - Rx Onlyn n
  • NDC 43353-785 - 100mg - Rx Onlyn n
  • NDC 43353-786 - 200mg - Rx Onlyn n
  • NDC 43353-847 - 300mg - Rx Onlyn n
  • NDC 43353-852 - 400mg - Rx Onlyn n

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