Pronunciation:

kwe-TYE-a-peen

Brand Names:

• Seroquel
• Seroquel XR

Dosage Forms:

• Tablet
• Tablet, Extended Release

Warnings:

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 times to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Quetiapine fumarate tablets are not approved for the treatment of patients with dementia-related psychosis.
• Suicidality and Antidepressant Drugs
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of quetiapine fumarate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Quetiapine fumarate tablets are not approved for use in pediatric patients .

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death were varied in clinical trials, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

• Increased Mortality in Elderly Patients with Dementia-related Psychosis
  • Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 times to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Quetiapine fumarate extended-release tablets are not approved for the treatment of patients with dementia-related psychosis .
• Suicidality and Antidepressant Drugs
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of quetiapine fumarate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Quetiapine fumarate extended-release tablets are not approved for use in pediatric patients. Quetiapine fumarate extended-release tablets are not approved for use in the treatment of depression, however, an immediate release form of quetiapine fumarate is approved for the treatment of bipolar depression .

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death were varied in clinical trials, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Extended-release formulation not approved for use in pediatric patients nor for the treatment of depression .

Classifications:

Therapeutic—

Antipsychotic

Chemical—

Dibenzothiazepine

Uses of This Medicine:

Quetiapine is used to treat psychotic disorders, such as schizophrenia. It is also used to treat symptoms of bipolar disorder (manic-depressive illness). This medicine has NOT been approved to treat behavioral problems in older adult patients who have dementia .

Quetiapine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of quetiapine in the pediatric population. Safety and efficacy have not been established .

Older adults—

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, quetiapine may be removed from the body more slowly in older adults, so an older adult may receive a lower dose than a younger adult. This medicine has NOT been approved to treat behavioral problems in older adults with dementia .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Mesoridazine
• Terfenadine
• Thioridazine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alzheimer's disease—Quetiapine may cause problems with swallowing, which may increase the chance of pneumonia; also, the chance of seizures may be increased .

• Breast cancer, or history of or
• Underactive thyroid—Quetiapine may make these conditions worse .

• Dehydration—Decreased blood pressure caused by quetiapine may be more severe; chance of developing heatstroke may be increased .

• Heart disease or
• Stroke, or history of—Decreased blood pressure caused by quetiapine may be more severe or may make these conditions worse .

• Kidney disease (severe) or
• Liver disease—Higher blood levels of quetiapine may occur, increasing the chance of side effects; the dose may need to be changed .

• Seizures, or history of—Chance of seizures may be increased .

Proper Use of This Medicine:

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more or less of it and do not take it more or less often than your doctor ordered .

Quetiapine may be taken with or without food on a full or empty stomach. However, if your doctor tells you to take it a certain way, take it as directed .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For depressive episodes associated with bipolar disorder:
    • Adults—At first, 50 milligrams (mg) once a day at bedtime. The dose usually is increased daily to reach 300 mg per day on the fourth day. Your doctor may increase your dose further, if needed. However, the dose usually is not more than 600 mg a day.
    • Children—Use and dose must be determined by the doctor .
  • For manic episodes associated with bipolar disorder:
    • Adults—At first, 100 milligrams (mg) per day, given in two equally divided doses. The dose usually is increased to 400 mg a day, which is divided and given in two doses a day. Your doctor may increase your dose further, if needed. However, the dose usually is not more than 800 mg a day.
    • Children—Use and dose must be determined by the doctor .
  • For schizophrenia:
    • Adults—At first, 25 milligrams (mg) two times a day. The dose usually is increased to 300 to 400 mg a day, which is divided and given in two or three doses a day. Your doctor may increase your dose further, if needed. However, the dose usually is not more than 800 mg a day.
    • Children—Use and dose must be determined by the doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

Your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow your dosage to be changed if necessary to meet your needs .

This medicine may add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using quetiapine .

Quetiapine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away .

Quetiapine may cause drowsiness, especially during the first week of use. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor .

Quetiapine may make it more difficult for your body to cool down. Use extra care not to become overheated and to drink plenty of fluids during exercise or hot weather while you are taking this medicine. Overheating may result in heatstroke .

Side Effects of This Medicine:

Along with its needed effects, quetiapine can sometimes cause serious side effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others, such as changes in the lenses of the eyes, by doing certain tests. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Another serious but rare side effect that may occur is the neuroleptic malignant syndrome (NMS). You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

(Symptoms of NMS; two or more occur together; most of these effects do not require emergency medical attention if they occur alone)

Convulsions (seizures)

difficult or unusually fast breathing

fast heartbeat or irregular pulse

high fever

high or low (irregular) blood pressure

increased sweating

loss of bladder control

severe muscle stiffness

unusually pale skin

unusual tiredness or weakness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Dizziness, lightheadedness, or fainting, especially when getting up from a lying or sitting position

fever, chills, muscle aches, or sore throat

loss of balance control

mask-like face

shuffling walk

skin rash

slowed movements

stiffness of arms or legs

swelling of feet or lower legs

trembling and shaking of hands and fingers

trouble in breathing, speaking, or swallowing

Rare

Fainting

fast, pounding, or irregular heartbeat

menstrual changes

unusual secretion of milk (in females)

Rare

(Symptoms of underactive thyroid; usually two or more occur together; these effects do not require medical attention if they occur alone unless they continue or are bothersome)

Dry, puffy skin

loss of appetite

tiredness

weight gain

Symptoms of overdose

(May be similar to side effects seen at normal doses, but may be more severe or two or more may occur together)

Drowsiness

fast, slow, or irregular heartbeat

low blood pressure

weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

drowsiness

dry mouth

increased weight

indigestion

Less common

Abdominal pain

abnormal vision

decreased appetite

decreased strength and energy

feeling of fast or irregular heartbeat

headache

increased muscle tone

increased sweating

stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.