Quetiapine Fumarate: Package Insert and Label Information (Page 8 of 9)

14.3 Major Depressive Disorder, Adjunctive Therapy to Antidepressants

The efficacy of quetiapine extended-release tablets as adjunctive therapy to antidepressants in the treatment of MDD was demonstrated in two 6-week placebo-controlled, fixed-dose trials (n=936). Quetiapine extended-release tablets 150 mg/day or 300 mg/day was given as adjunctive therapy to existing antidepressant therapy in patients who had previously shown an inadequate response to at least one antidepressant. Quetiapine extended-release tablets were administered as 50 mg/day on Days 1 and 2, and increased to 150 mg/day on Day 3 for both dose groups. On Day 5, the dose was increased to 300 mg/day in the 300 mg/day fixed-dose group. Inadequate response was defined as having continued depressive symptoms for the current episode [Hamilton Depression Rating Scale (HAM-D) total score of ≥20] despite using an antidepressant for 6 weeks at or above the minimally effective labelled dose. The mean HAM-D total score at entry was 24, and 17% of patients scored 28 or greater. Patients were on various antidepressants prior to study entry including SSRI’s (paroxetine, fluoxetine, sertraline, escitalopram, or citalopram), SNRI’s, (duloxetine and venlafaxine), TCA (amitriptyline), and other (bupropion). The primary endpoint in these trials was change from baseline to week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS.), quetiapine extended-release tablets 300 mg once daily as adjunctive treatment to other antidepressant therapy was superior to antidepressant alone in reduction of MADRS total score in both trials. Quetiapine extended-release tablets 150 mg once daily as adjunctive treatment was superior to antidepressant therapy alone in reduction of MADRS total score in one trial (studies 1 and 2 in Table 29).

Table 29: Major Depressive Disorder, Adjunctive Therapy to Antidepressants
AD: Antidepressant; SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: unadjusted confidence interval. 1. Doses that are statistically significantly superior to placebo.2. Difference (drug minus placebo) in least-squares mean change from baseline.
Study Number Treatment Group Primary Efficacy Measure: MADRS Total
Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Placebo-subtracted Difference 2 (95% CI)
Study 1 QuetiapineExtended-Release Tablets (150 mg/day) + AD 27.2 (5.2) -13.6 (0.8) -1.9 (-3.9, 0.1)
Quetiapine Extended-Release Tablets (300 mg/day)1 + AD 27.6 (5) -14.7 (0.8) -3 (-5, -1)
Placebo + AD 27.6 (5.5) -11.7 (0.8)
Study 2 Quetiapine Extended-Release Tablets (150 mg/day) + AD 28.6 (5.4) -15.3 (0.7) -3.1 (-4.9, -1.2)
Quetiapine Extended-Release Tablets (300 mg/day) + AD 28.4 (5.5) -14.9 (0.7) -2.7 (-4.6, -0.8)
Placebo 28.2 (5.6) -12.2 (0.7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Quetiapine Extended-Release Tablets USP 50 mg are peach, film-coated, capsule shaped, biconvex, tablet debossed with “Z45” on one side and plain on the other side.
Bottles of 60 NDC 65862-873-60
Bottles of 100 NDC 65862-873-01
Bottles of 500 NDC 65862-873-05

Quetiapine Extended-Release Tablets USP 150 mg are white, film-coated, capsule shaped, biconvex, tablet debossed with “Z46” on one side and plain on the other side.
Bottles of 60 NDC 65862-874-60
Bottles of 100 NDC 65862-874-01
Bottles of 500 NDC 65862-874-05

Quetiapine Extended-Release Tablets USP 200 mg are yellow, film-coated, capsule shaped, biconvex, tablet debossed with “Z47” on one side and plain on the other side.
Bottles of 60 NDC 65862-875-60
Bottles of 100 NDC 65862-875-01
Bottles of 500 NDC 65862-875-05

Quetiapine Extended-Release Tablets USP 300 mg are pale yellow, film-coated, capsule shaped, biconvex, tablet debossed with “Z48” on one side and plain on the other side.
Bottles of 60 NDC 65862-876-60
Bottles of 100 NDC 65862-876-01
Bottles of 500 NDC 65862-876-05

Quetiapine Extended-Release Tablets USP 400 mg are white, film-coated, capsule shaped, biconvex, tablet debossed with “Z49” on one side and plain on the other side.
Bottles of 60 NDC 65862-877-60
Bottles of 100 NDC 65862-877-01
Bottles of 500 NDC 65862-877-05
Store quetiapine extended-release tablets USP at 20o to 25ºC (68o to 77ºF) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

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 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 [see Warnings and Precautions (5.1)].

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 [see Warnings and Precautions (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 [see Warnings and Precautions (5.4)].

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 [see Warnings and Precautions (5.5)].

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 [see Warnings and Precautions (5.5)].

Weight Gain

Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly [see Warnings and Precautions (5.5)].

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 [see Warnings and Precautions (5.7)].

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 [ see Warnings and Precautions (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 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 [see Warnings and Precautions (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 [see Warnings and Precautions (5.16)].

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.17)].

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 Drug Interactions (7.1)].

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 [see Use in Specific Populations (8.1)].

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 [see Use in Specific Populations (8.3)].

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 physician’s assessment of the chronicity and severity of the patient’s symptoms [see Indications and Usage (1.4)].

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

Medication Guide

Quetiapine Extended-Release Tablets USP
(kwe tye’ a peen)

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:

1. risk of death in the elderly with dementia: Medicines like quetiapine extended-release tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine extended-release tablets are not for treating psychosis in the elderly with dementia.

2. risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions).

Talk to your or your family member’s, healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness
  • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or suicidal thoughts or actions.

  • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

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:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to your healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression, and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member take. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

What are quetiapine extended-release tablets?

Quetiapine extended-release tablets are a prescription medicine used to treat:

  • schizophrenia in people 13 years of age or older
  • bipolar disorder in adults, including:
    • depressive episodes associated with bipolar disorder
    • manic episodes associated with bipolar I disorder alone or with lithium or divalproex
    • long-term treatment of bipolar I disorder with lithium or divalproex
  • manic episodes associated with bipolar I disorder in children ages 10 to 17 years old
  • major depressive disorder as add-on treatment with antidepressant medicines when your healthcare provider determines that 1 antidepressant alone is not enough to treat your depression.

It is not known if quetiapine extended-release tablets are 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 fumarate 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:

  • diabetes or high blood sugar in you or your family. Your healthcare provider should check your blood sugar before you start quetiapine extended-release tablets and also during therapy.
  • high levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL-cholesterol
  • low or high blood pressure
  • low white blood cell count
  • cataracts
  • seizures
  • abnormal thyroid tests
  • high prolactin levels
  • heart problems
  • liver problems
  • any other medical condition
  • pregnancy or plans to become pregnant. It is not known if quetiapine extended-release tablets will harm your unborn baby.
  • If you become pregnant while receiving quetiapine extended-release tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
  • breast-feeding or plans to breast-feed. Quetiapine can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive quetiapine extended-release tablets.
  • if you have or have had a condition where you cannot completely empty your bladder (urinary retention), have an enlarged prostate, or constipation, or increased pressure inside your eyes.

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 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?

  • Take quetiapine extended-release tablets exactly as your healthcare provider tells you to take them. Do not change the dose yourself.
  • Take quetiapine extended-release tablets by mouth, with a light meal or without food.
  • Quetiapine extended-release tablets should be swallowed whole and not split, chewed or crushed.
  • If you feel you need to stop quetiapine extended-release tablets, talk with your healthcare provider first. If you suddenly stop taking quetiapine extended-release tablets, you may have side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.
  • If you miss a dose of quetiapine extended-release tablets, take them as soon as you remember. If you are close to your next dose, skip the missed dose. 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 are not sure about your dosing, call your healthcare provider.

What should I avoid while taking quetiapine extended-release tablets?

  • Do not drive, operate machinery, or do other dangerous activities until you know how quetiapine extended-release tablets affect you. Quetiapine extended-release tablets may make you drowsy.
  • Avoid getting overheated or dehydrated.
    • Do not over-exercise.
    • In hot weather, stay inside in a cool place if possible.
    • Stay out of the sun. Do not wear too much or heavy clothing.
    • Drink plenty of water.
  • Do not drink alcohol while taking quetiapine extended-release tablets. They may make some side effects of quetiapine extended-release tablets worse.

What are possible side effects of quetiapine extended-release tablets?

Quetiapine extended-release tablets can cause serious side effects, including:

See “What is the most important information I should know about quetiapine extended-release tablets?”

  • stroke that can lead to death can happen in elderly people with dementia who take medicines like quetiapine extended-release tablets
  • 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:
    • high fever
    • excessive sweating
    • rigid muscles
    • confusion
    • changes in your breathing, heartbeat, and blood pressure

  • falls can happen in some people who take quetiapine extended-release tablets. These falls may cause serious injuries.
  • 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:
    • build up of acid in your blood due to ketones (ketoacidosis)
    • coma
    • 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:

  • feel very thirsty
  • need to urinate more than usual
  • feel very hungry
  • feel weak or tired
  • feel sick to your stomach
  • feel confused, or your breath smells fruity

  • high fat levels in your blood (increased cholesterol and triglycerides). High fat levels may happen in people treated with quetiapine extended-release 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.
  • 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.
  • 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.
  • decreased blood pressure (orthostatic hypotension), including lightheadedness or fainting caused by a sudden change in heart rate and blood pressure when rising too quickly from a sitting or lying position.
  • 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 are not approved for patients under 10 years of age.
  • low white blood cell count. Tell your healthcare provider as soon as possible if you have a fever, flu-like symptoms, or any other infection, as this could be a result of a very low white blood cell count. Your healthcare provider may check your white blood cell level to determine if further treatment or other action is needed
  • cataracts
  • seizures
  • abnormal thyroid tests: Your healthcare provider may do blood tests to check your thyroid hormone level.
  • increases in prolactin levels: Your healthcare provider may do blood tests to check your prolactin levels.
  • sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities
  • increased body temperature
  • difficulty swallowing
  • 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:

  • dry mouth
  • constipation
  • dizziness
  • increased appetite
  • upset stomach
  • fatigue
  • stuffy nose
  • difficulty moving
  • disturbance in speech or language

Children and Adolescents:

  • drowsiness
  • dizziness
  • fatigue
  • stuffy nose
  • increased appetite
  • upset stomach
  • vomiting
  • dry mouth
  • tachycardia
  • weight increased

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?

  • Store quetiapine extended-release tablets at room temperature, between 20o to 25ºC (68o to 77ºF).
  • 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. They 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876.
What are the ingredients in quetiapine extended-release tablets?

Active ingredient: quetiapine

Inactive ingredients: 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.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 038, India
Revised: 10/2020

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.