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Quetiapine Fumarate (Quetiapine Fumarate)

Trade Name : QUETIAPINE FUMARATE

Akron Pharma Inc

TABLET, FILM COATED, EXTENDED RELEASE

Strength 150 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 Akron Pharma Inc. It is available in strength of 150 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, Falls n
  • 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 extended-release tablets are not approved for the treatment of patients with dementia-related psychosis .
  • Arrayn- Suicidal Thoughts and Behavior
  • 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 . 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 extended-release tablets are not approved for use in pediatric patients under ten years of age .
  • 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 extended-release tablets are an atypical antipsychotic indicated for the treatment of:
  • u2022Schizophrenia (1.1)u2022Bipolar I disorder, manic or mixed episodes (1.2)u2022Bipolar disorder, depressive episodes (1.2)u2022Major depressive disorder, adjunctive therapy with antidepressants (1.3)
  • u2022Swallow tablets whole and do not split, chew or crush (2.1)u2022Take without food or with a light meal (approx. 300 calories) (2.1)u2022Administer once daily, preferably in the evening (2.1) u2022 Consider a lower starting dose (50 mg/day), slower titration, and careful monitoring during the initial dosing period in the elderly. (2.3, 8.5)u2022 Lower starting dose (50 mg/day) and slower titration may be needed (2.4, 8.7, 12.3)
  • Extended-Release Tablets: 150 mg, 200 mg, 300 mg, and 400 mg (3)
  • 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. (4)
  • u2022 Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs (5.3)u2022 Manage with immediate discontinuation and close monitoring (5.4)u2022 Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain (5.5)u2022 Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetesu2022 Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatmentu2022 Gain in body weight has been observed; clinical monitoring of weight is recommendedu2022 Discontinue if clinically appropriate (5.6)u2022 Use with caution in patients with known cardiovascular or cerebrovascular disease (5.7)u2022Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents (5.9)u2022 Monitor 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 (5.10)u2022 Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment (5.11)
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • u2022Increased mortality in elderly patients with dementia-related psychosis u2022Suicidal thoughts and behaviors in adolescents and young adults u2022Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis u2022Neuroleptic Malignant Syndrome (NMS) u2022Metabolic changes (hyperglycemia, dyslipidemia, weight gain) u2022Tardive dyskinesia u2022Hypotension u2022Falls u2022Increases in blood pressure (children and adolescents) u2022Leukopenia, neutropenia and agranulocytosis u2022Cataracts u2022QT Prolongation u2022Seizures u2022Hypothyroidism u2022Hyperprolactinemia u2022Potential for cognitive and motor impairment u2022Body temperature regulation u2022Dysphagia u2022Discontinuation Syndrome n
  • Most common adverse reactions (incidence u22655% and twice placebo): Adults: somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, and nasal congestion (6.1)
  • Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased (6.1)
  • To report SUSPECTED ADVERSE REACTIONS, contact ScieGen at (855) 724-3436- or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • u2022 Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) (2.5, 7.1, 12.3)u2022 Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7 to 14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. Johnu2019s wort) (2.6, 7.1, 12.3)u2022 Reduce quetiapine dose by 5 fold within 7 to 14 days of discontinuation of CYP3A4 inducers (2.6, 7.1, 12.3)
  • u2022 Limited human data. Based on animal data, may cause fetal harm. Quetiapine should be used only if the potential benefit justifies the potential risk (8.1)u2022 Discontinue drug or nursing, taking into consideration importance of drug to motheru2019s health (8.3)
  • No data
  • No data
  • Quetiapine extended-release tablets are 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 883.11 (fumarate salt). The structural formula is:
  • Quetiapine fumarate, USP is a white to off-white crystalline powder which is soluble in 0.1N hydrochloric acid, slightly soluble in water, in alcohol, and in methanol.
  • Quetiapine extended-release tablets,USP are supplied for oral administration as 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated.
  • Inactive ingredients for quetiapine extended-release tablets are lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, hypromellose, and magnesium stearate. The film coating for all quetiapine extended-release tablets, USP contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (200 mg and 300 mg tablets) are included in the film coating of specific strengths.
  • Each 150 mg tablet contains 172.7 mg of quetiapine fumarate equivalent to 150 mg quetiapine.
  • Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine.
  • Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine.
  • Each 400 mg tablet contains 460.5 mg of quetiapine fumarate equivalent to 400 mg quetiapine.
  • No data
  • No data
  • No data
  • Store quetiapine extended-release tablets at 25u00baC (77u00baF); excursions permitted to15 to 30u00baC (59 to 86u00baF) [See USP Controlled Room Temperature].
  • See FDA-approved patient labeling ()
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with quetiapine extended-release 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 extended-release 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 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 is not approved for elderly patients with dementia-related psychosis 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
  • 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
  • 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 extended-release tablets 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
  • Heat Exposure and Dehydration
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration 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
  • Pregnancy and Nursing
  • Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with quetiapine extended-release tablets n
  • Need for Comprehensive Treatment Program
  • Quetiapine extended-release tablets 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 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
  • Manufactured for:
  • Akron Pharma, Inc.,
  • Fairfield, NJ 07004
  • Rev: 03/18
  • Read this Medication Guide before you start taking quetiapine extended-release 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 extended-release tablets?
  • Quetiapine extended-release tablets 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:
  • u00a0u00a0u00a0u2022 thoughts about suicide or dying
  • u00a0u00a0u00a0u2022 attempts to commit suicide
  • u00a0u00a0u00a0u2022 new or worse depression
  • u00a0u00a0u00a0u2022 new or worse anxiety
  • u00a0u00a0u00a0u2022 feeling very agitated or restless
  • u00a0u00a0u00a0u2022 panic attacks
  • u00a0u00a0u00a0u2022 trouble sleeping (insomnia)
  • u00a0u00a0u00a0u2022 new or worse irritability
  • u00a0u00a0u00a0u2022 acting aggressive, being angry, or violent
  • u00a0u00a0u00a0u2022 acting on dangerous impulses
  • u00a0u00a0u00a0u2022 an extreme increase in activity and talking (mania)
  • u00a0u00a0u00a0u2022 other unusual changes in behavior or mood
  • What else do I need to know about antidepressant medicines?
  • u00a0u00a0u00a0u2022 Never stop an antidepressant medicine without first talking to your healthcare provider. Stopping an antidepressant medicine suddenly can cause
  • u00a0u00a0u00a0u00a0u00a0u00a0other symptoms.
  • u00a0u00a0u00a0u2022 Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also
  • u00a0u00a0u00a0u00a0u00a0u00a0the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not u00a0u00a0u00a0u00a0u00a0u00a0just the use of antidepressants.
  • u00a0u00a0u00a0u2022 Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or u00a0u00a0u00a0u00a0u00a0u00a0your family member.
  • u00a0u00a0u00a0u2022 Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member take. Keep a list of all u00a0u00a0u00a0u00a0u00a0u00a0medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • u00a0u00a0u00a0u2022 Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your childu2019s healthcare provider for more u00a0u00a0u00a0u00a0u00a0u00a0information.
  • What is quetiapine extended-release tablet?
  • Quetiapine extended-release tablet is a prescription medicine used to treat:
  • u00a0u00a0u00a0u2022 schizophrenia in people 13 years of age or older
  • u00a0u00a0u00a0u2022 bipolar disorder in adults, including:
  • u00a0u00a0u00a0u00a0u00a0u00a0u25cb depressive episodes associated with bipolar disorder
  • u00a0u00a0u00a0u00a0u00a0u00a0u25cb manic episodes associated with bipolar I disorder alone or with lithium or divalproex
  • u00a0u00a0u00a0u00a0u00a0u00a0u25cb long-term treatment of bipolar I disorder with lithium or divalproex
  • u00a0u00a0u00a0u2022 manic episodes associated with bipolar I disorder in children ages 10 to 17 years old
  • u00a0u00a0u00a0u2022 major depressive disorder as add-on treatment with antidepressant medicines when your healthcare provider determines that 1 antidepressant u00a0u00a0u00a0u00a0u00a0u00a0alone is not enough to treat your depression.
  • It is not known if quetiapine extended-release tablet is safe and effective in children under 10 years of age.
  • Who should not take quetiapine extended-release tablets?
  • Do not take quetiapine extended-release tablets if you are allergic to quetiapine or any of the ingredients in quetiapine extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in quetiapine extended-release tablets.
  • What should I tell my healthcare provider before taking quetiapine extended-release tablets?
  • Before you take quetiapine extended-release tablets, tell your healthcare provider if you have or have had:
  • u00a0u00a0u00a0u2022 diabetes or high blood sugar in you or your family. Your healthcare provider should check your blood sugar before you start quetiapine extendedu00a0 u00a0u00a0u00a0u00a0u00a0u00a0release tablets and also during therapy.
  • u00a0u00a0u00a0u2022 high levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL-cholesterol
  • u00a0u00a0u00a0u2022 low or high blood pressure
  • u00a0u00a0u00a0u2022 low white blood cell count
  • u00a0u00a0u00a0u2022 cataracts
  • u00a0u00a0u00a0u2022 seizures
  • u00a0u00a0u00a0u2022 abnormal thyroid tests
  • u00a0u00a0u00a0u2022 high prolactin levels
  • u00a0u00a0u00a0u2022 heart problems
  • u00a0u00a0u00a0u2022 liver problems
  • u00a0u00a0u00a0u2022 any other medical condition
  • u00a0u00a0u00a0u2022 pregnancy or plans to become pregnant. It is not known if quetiapine extended-release tablets will harm your unborn baby
  • u00a0u00a0 u2022 breast-feeding or plans to breast-feed. Quetiapine can pass into your breast milk. You and your healthcare provider should decide if you will take u00a0u00a0u00a0quetiapine extended-release tablets or breast-feed. You should not do both.
  • Tell the healthcare provider about all the medicines that you take or recently have taken including prescription medicines, over-the-counter medicines, herbal supplements and vitamins. 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 works.
  • 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?
  • u00a0u00a0u00a0u2022 Take quetiapine extended-release tablets exactly as your healthcare provider tells you to take it. Do not change the dose yourself.
  • u00a0u00a0u00a0u2022 Take quetiapine extended-release tablets by mouth, with a light meal or without food.
  • u00a0u00a0u00a0u2022 Quetiapine extended-release tablets should be swallowed whole and not split, chewed or crushed.
  • u00a0u00a0u00a0u2022 If you feel you need to stop quetiapine extended-release tablets, talk with your healthcare provider first. If you suddenly stop takingu00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0quetiapine extended-release tablets, you may have side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and u00a0u00a0u00a0u00a0u00a0u00a0vomiting.
  • u00a0u00a0u00a0u2022 If you miss a dose of quetiapine extended-release tablets, take it as soon as you remember. If you are close to your next dose, skip the missed u00a0u00a0u00a0u00a0u00a0u00a0dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you u00a0u00a0u00a0u00a0u00a0u00a0are not sure about your dosing, call your healthcare provider.
  • What should I avoid while taking quetiapine extended-release tablets?
  • u00a0u00a0u00a0u2022 Do not drive, operate machinery, or do other dangerous activities until you know how quetiapine extended-release tablets affects you.u00a0 u00a0u00a0u00a0u00a0u00a0u00a0Quetiapine extended-release tablets may make you drowsy.
  • u00a0u00a0u00a0u2022 Avoid getting overheated or dehydrated.
  • u00a0u00a0u00a0u00a0u00a0u00a0u25cb Do not over-exercise.
  • u00a0u00a0u00a0u00a0u00a0u00a0u25cb In hot weather, stay inside in a cool place if possible.
  • u00a0u00a0u00a0u00a0u00a0u00a0u25cb Stay out of the sun. Do not wear too much or heavy clothing.
  • u00a0u00a0u00a0u00a0u00a0u00a0u25cb Drink plenty of water.
  • u00a0u00a0u00a0u2022 Do not drink alcohol while taking quetiapine extended-release tablets. It may make some side effects of quetiapine extended-release tablets
  • u00a0u00a0u00a0u00a0u00a0u00a0worse.
  • What are possible side effects of quetiapine extended-release tablets?
  • Quetiapine extended-release tablets can cause serious side effects, including:
  • See u201cWhat is the most important information I should know about
  • quetiapine extended-release tablets?u201d
  • u2022 stroke that can lead to death can happen in elderly people with dementia who take medicines like quetiapine tablets
  • u2022 neuroleptic malignant syndrome (NMS). NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines,
  • including quetiapine extended-release tablets. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you
  • become severely ill and have some or all of these symptoms:
  • u25cb high fever
  • u25cb excessive sweating
  • u25cb rigid muscles
  • u25cb confusion
  • u25cb changes in your breathing, heartbeat, and blood pressure
  • u2022 falls can happen in some people who take quetiapine extended-release tablets. These falls may cause serious injuries.
  • u2022 high blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes.
  • High blood sugar could lead to:
  • u25cb build up of acid in your blood due to ketones (ketoacidosis)
  • u25cb coma
  • u25cb death
  • 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:
  • u25cb feel very thirsty
  • u25cb need to urinate more than usual
  • u25cb feel very hungry
  • u25cb feel weak or tired
  • u25cb feel sick to your stomach
  • u25cb feel confused, or your breath smells fruity
  • u2022 high fat levels in your blood (increased cholesterol and triglycerides). High fat levels may happen in people treated with quetiapine extendedrelease
  • tablets. You may not have any symptoms, so your healthcare provider may decide to check your cholesterol and triglycerides during your treatment with quetiapine extended-release tablets.
  • u2022 increase in weight (weight gain). Weight gain is common in people who take quetiapine extended-release tablets so you and your healthcare
  • provider should check your weight regularly. Talk to your healthcare provider about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.
  • u2022 movements you cannot control in your face, tongue, or other body parts (tardive dyskinesia). These may be signs of a serious condition. Tardive
  • dyskinesia may not go away, even if you stop taking quetiapine extended-release tablets. Tardive dyskinesia may also start after you stop
  • taking quetiapine extended-release tablets.
  • u2022 decreased blood pressure (orthostatic hypotension), including light headedness or fainting caused by a sudden change in heart rate and blood
  • pressure when rising too quickly from a sitting or lying position.
  • u2022 increases in blood pressure in children and teenagers. Your healthcare provider should check blood pressure in children and adolescents before
  • starting quetiapine extended-release tablets and during therapy. Quetiapine extended-release tablets is not approved for patients under
  • 10 years of age.
  • u2022 low white blood cell count
  • u2022 cataracts
  • u2022 seizures
  • u2022 abnormal thyroid tests: Your healthcare provider may do blood tests to check your thyroid hormone level.
  • u2022 increases in prolactin levels: Your healthcare provider may do blood tests to check your prolactin levels.
  • u2022 sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities
  • u2022 increased body temperature
  • u2022 difficulty swallowing
  • u2022 trouble sleeping or trouble staying asleep (insomnia), nausea, or vomiting if you suddenly stop taking quetiapine extended-release tablets.
  • These symptoms usually get better 1 week after you start having them.
  • The most common side effects of quetiapine extended-release tablets
  • include:
  • u2022 dry mouth
  • u2022 constipation
  • u2022 dizziness
  • u2022 increased appetite
  • u2022 upset stomach
  • u2022 fatigue
  • u2022 stuffy nose
  • u2022 difficulty moving
  • 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?
  • u2022 Store quetiapine extended-release tablets at room temperature, between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
  • u2022 Keep quetiapine extended-release tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of quetiapine extended-release tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine extended-release tablets for a condition for which it was not prescribed. Do not give quetiapine extended-release tablets 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 extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine extended-release tablets that is written for health professionals.
  • For more information, call 1-877-225-6999.
  • What are the ingredients in quetiapine extended-release tablets?
  • Active ingredient: quetiapine
  • Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, hypromellose, and magnesium stearate. The film coating for all quetiapine extended-release tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (200 mg and 300 mg tablets) are included in the film coating of specific strengths.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:
  • Akron Pharma, Inc.,
  • Fairfield, NJ 07004
  • Rev: 03/18
  • NDC: 71399-1500-6
  • Quetiapine Extended-Release Tablets, USP
  • 150 mg Once Daily
  • Dispense the accompanying Medication Guide to each patient.
  • 60 Tablets
  • Rx Only
  • Akron Pharma
  • NDC: 71399-2000-6
  • Quetiapine Extended-Release Tablets, USP
  • 200 mg Once Daily
  • Dispense the accompanying Medication Guide to each patient.
  • 60 Tablets
  • Rx Only
  • Akron Pharma
  • NDC: 71399-3000-6
  • Quetiapine Extended-Release Tablets, USP
  • 300 mg Once Daily
  • Dispense the accompanying Medication Guide to each patient.
  • 60 Tablets
  • Rx Only
  • Akron Pharma
  • NDC: 71399-4000-6
  • Quetiapine Extended-Release Tablets, USP
  • 400 mg Once Daily
  • Dispense the accompanying Medication Guide to each patient.
  • 60 Tablets
  • Rx Only
  • Akron Pharma

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