Quetiapine (Page 13 of 13)
16 HOW SUPPLIED/STORAGE AND HANDLING
- 50 mg Tablets (NDC 16729-146) white to off white, round, biconvex, film coated tablet, debossed ‘50’ on one side and plain on other side, are supplied as follow:
Bottles of 30 tablets NDC #68788-7186-3
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP].
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.
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 [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 . 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 [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. 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 [see Use in Specific Populations (8.1)].
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 [see Use in Specific Populations (8.3)].
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 physician’s assessment of the chronicity and severity of the patient’s symptoms [see Indications and Usage (1.3)]
- Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.
Manufactured By:
- Intas Pharmaceuticals Limited,
Ahmedabad -380 054, India.
10 0210 8 6006164
Issued May 2022
Repackaged By: Preferred Pharmaceuticals Inc.
Medication Guide
Quetiapine Tablets
(kwe-TYE-a-peen)
Read this Medication Guide before you start taking quetiapine tablets 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 tablets?
Quetiapine tablets may cause serious side effects, including:
1. risk of death in the elderly with dementia: Medicines like quetiapine tablets can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine tablet is 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:
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- all risks and benefits of treatment with antidepressant medicines.
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- all treatment choices for depression or other serious mental illness.
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- Antidepressant medications may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
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:
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- thoughts about suicide or dying
What else do I need to know about antidepressant medicines?
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- Never stop an antidepressant medicine without first talking to your healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
What is a quetiapine tablet?
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- Quetiapine tablet is a prescription medicine used to treat.
It is not known if quetiapine tablet is safe and effective in children under 10 years of age.
What should I tell my healthcare provider before taking quetiapine tablets?
Before you take quetiapine tablets, tell your healthcare provider if you have or have had:
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- diabetes or high blood sugar in you or your family. Your healthcare provider should check your blood sugar before you start quetiapine tablets and also during therapy
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 tablets and other medicines may affect each other causing serious side effects. Quetiapine tablets may affect the way other medicines work, and other medicines may affect how quetiapine tablets works.
Tell your healthcare provider if you are having a urine drug screen because quetiapine tablets may affect your test results. Tell those giving the test that you are taking quetiapine tablets.
How should I take quetiapine tablets?
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- Take quetiapine tablets exactly as your healthcare provider tells you to take it. Do not change the dose yourself.
– If you feel you need to stop quetiapine tablets, talk with your healthcare provider first. If you suddenly stop taking quetiapine 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 tablets, take it 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 tablets?
– Do not drive, operate machinery, or do other dangerous activities until you know how quetiapine tablets affects you. Quetiapine tablets may make you drowsy.
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- Avoid getting overheated or dehydrated.
What are possible side effects of quetiapine tablets?
Quetiapine tablets can cause serious side effects, including:
• See “What is the most important information I should know about quetiapine tablets?”
• stroke that can lead to death can happen in elderly people with dementia who take medicines like quetiapine tablets
• neuroleptic malignant syndrome (NMS). NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including quetiapine 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:
o high fever
o excessive sweating
o rigid muscles
o confusion
o changes in your breathing, heartbeat, and blood pressure
• falls can happen in some people who take quetiapine 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:
o build-up of acid in your blood due to ketones (ketoacidosis)
o coma
o death
Increases in blood sugar can happen in some people who take quetiapine 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 tablets and during therapy.
Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine tablets:
o feel very thirsty
o need to urinate more than usual
o feel very hungry
o feel weak or tired
o feel sick to your stomach
o 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 tablets. You may not have any symptoms, so your healthcare provider may decide to check your cholesterol and triglycerides during your treatment with quetiapine tablets.
• increase in weight (weight gain). Weight gain is common in people who take quetiapine 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 tablets. Tardive dyskinesia may also start after you stop taking quetiapine 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 tablets and during therapy.
• 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
• 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 tablets. These symptoms usually get better 1 week after you start having them.
The most common side effects of quetiapine tablets include:
In Adults:
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- drowsiness
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- sudden drop in blood pressure upon standing
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- weight gain
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- sluggishness
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- abnormal liver tests
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- upset stomach
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- dry mouth
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- dizziness
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- weakness
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- abdominal pain
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- constipation
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- sore throat
In Children and Adolescents:
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- drowsiness
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- dizziness
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- fatigue
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- nausea
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- dry mouth
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- weight gain
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- increased appetite
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- vomiting
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- rapid heart beat
These are not all the possible side effects of quetiapine 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 tablets?
• Store quetiapine tablets at room temperature, between 68°F to 77°F (20°C to 25°C).
• Bottles of 30’s,60’s and 100’s count comes in a child-resistant package.
• Keep quetiapine tablets and all medicines out of the reach of children.
General information about the safe and effective use of quetiapine tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine tablets for a condition for which it was not prescribed. Do not give quetiapine 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 tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine tablets that is written for health professionals.
For more information, go to www.accordhealthcare.us or call Accord Healthcare Inc. at 1-866-941-7875.
What are the ingredients in quetiapine tablets?
Active ingredient: quetiapine
Inactive ingredients: povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. The 25 mg tablets contain iron oxide red and yellow. The 100 mg and 400 mg tablets contain only iron oxide yellow.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Medication guide available at www.accordhealthcare.us/products
- Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.
Manufactured By:
- Intas Pharmaceuticals Limited,
Ahmedabad -380 054, India.
10 0210 8 6006164
Issued May 2022
Repackaged By: Preferred Pharmaceuticals Inc.
Quetiapine
Tablets, USP
50 mg
Rx Only
Attention Pharmacist: Dispense the enclosed Medication Guide to each patient.
Repackaged By: Preferred Pharmaceuticals Inc.
| QUETIAPINE quetiapine tablet, film coated | |||||||||||||||||||||||||||||
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| Labeler — Preferred Pharmaceuticals Inc. (791119022) |
| Registrant — Preferred Pharmaceuticals Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Preferred Pharmaceuticals Inc. | 791119022 | REPACK (68788-7186) | |
Revised: 09/2023 Preferred Pharmaceuticals Inc.
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