Quetiapine

What is Quetiapine?

• Quetiapine (Seroquel) is an atypical antipsychotic used for the treatment of schizophrenia, bipolar disorder, and major depressive disorder.

Quetiapine

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What are the uses of this medicine?

Quetiapine (Seroquel) is 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.

How does this medicine work?

• Quetiapine (kwe tye' a peen) is an atypical antipsychotic and dibenzodiazepine derivative which appears to act as a dopamine (D1-4) and serotonin (5-HT2) receptor antagonist.
• It also may have activity against histamine and alpha adrenergic receptors.
• Quetiapine is indicated for the treatment of schizophrenia and as either monotherapy or adjunctive therapy for acute manic episodes or as maintenance therapy in bipolar I disorder.
• It is also used in treatment of depressive episodes associated with bipolar I or II disorder and for major depressive disorders in combination with antidepressants.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have hypersensitivity to quetiapine or to any excipients in the quetiapine formulation.

What drug interactions can this medicine cause?

• Quetiapine and other medicines may affect each other causing serious side effects. Quetiapine may affect the way other medicines work, and other medicines may affect how quetiapine works.
• Quetiapine potentiated the cognitive and motor effects of alcohol in a clinical trial in subjects with selected psychotic disorders, and alcoholic beverages should be limited while taking quetiapine.
• Dose adjustment of quetiapine will be necessary if it is co-administered with potent CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.) or inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.).
• Because of its potential for inducing hypotension, Quetiapine may enhance the effects of certain antihypertensive agents.
• Quetiapine may antagonize the effects of levodopa and dopamine agonists.

Is this medicine FDA approved?

• Quetiapine was approved for use in the United States in 1997 and is still widely used.

How should this medicine be used?

Recommended dosage:

Indication	Initial Dose	Recommended Dose	Maximum Dose
Schizophrenia-Adults	25 mg twice daily	150 to 750 mg/day	750 mg/day
Schizophrenia-Adolescents (13 to 17 years)	25 mg twice daily	400 to 800 mg/day	800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex	50 mg twice daily	400 to 800 mg/day	800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy	25 mg twice daily	400 to 600 mg/day	600 mg/day
Bipolar Depression-Adults	50 mg once daily at bedtime	300 mg/day	300 mg/day

Geriatric Use:

• Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly.

Hepatic Impairment:

• Lower starting dose (25 mg/day) and slower titration may be needed.

• Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir).
• Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7-14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. John’s wort).
• Reduce quetiapine dose by 5 fold within 7-14 days of discontinuation of CYP3A4 inducers.

Administration:

• Take quetiapine exactly as your healthcare provider tells you to take it. Do not change the dose yourself.
• Take quetiapine by mouth, with or without food.
• If you feel you need to stop quetiapine, talk with your healthcare provider first. If you suddenly stop taking quetiapine, you may have side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.
• If you miss a dose of quetiapine, 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 25 mg, 50 mg, 100 mg,150mg, 200 mg, 300 mg, and 400 mg

This medicine is available in fallowing brand namesː

• Seroquel; Seroquel xr

What side effects can this medication cause?

The most common side effects of this medicine include: In Adults:

• dry mouth
• dizziness
• weakness
• abdominal pain
• constipation
• sore throat
• difficulty moving

In Children and Adolescents:

• Nausea
• Dry mouth
• Weight gain
• Increase appetite
• Vomiting
• Rapid heart beat

Quetiapine can cause serious side effects, including:

• risk of death in the elderly with dementia
• risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions)
• Depression
• stroke
• neuroleptic malignant syndrome
• hyperglycemia
• increased cholesterol and triglycerides
• weight gain
• tardive dyskinesia
• orthostatic hypotension
• increases in blood pressure in children and teenagers
• low white blood cell count
• cataracts
• seizures
• abnormal thyroid tests
• 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

What special precautions should I follow?

• Do not drive, operate machinery, or do other dangerous activities until you know how quetiapine affects you. Quetiapine 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. It may make some side effects of quetiapine worse.
• 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
• A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs, including quetiapine. Discontinue if clinically appropriate.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including quetiapine. Manage with immediate discontinuation and close monitoring.
• Atypical antipsychotics have been associated with metabolic changes like Hyperglycemia and Diabetes Mellitus, Dyslipidemia, Weight Gain, Hypotension , Increased Blood Pressure in Children and Adolescents,.
• Events of leukopenia/neutropenia have been reported temporally related to atypical antipsychotic agents, including quetiapine. 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 at the first sign of a decline in WBC in absence of other causative factors.
• The development of cataracts was observed in association with quetiapine treatment. 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.
• Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.
• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. quetiapine is not approved for the treatment of patients with dementia-related psychosis.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• drowsiness
• sedation
• tachycardia
• hypotension
• hypokalemia
• heart block
• QT prolongation

Management of overdosage:

• In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation.
• Gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered.
• Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
• There is no specific antidote to quetiapine.
• Therefore, appropriate supportive measures should be instituted.
• The possibility of multiple drug involvement should be considered.
• Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulation may worsen hypotension in the setting of quetiapine-induced alpha blockade). In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered.
• Close medical supervision and monitoring should continue until the patient recovers.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of quetiapine use in pregnant women.
• Quetiapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness of quetiapine in pediatric patients less than 13 years of age with schizophrenia have not been established.
• The safety and effectiveness of quetiapine in the maintenance treatment of bipolar disorder has not been established in pediatric patients less than 18 years of age.
• Safety and effectiveness of quetiapine in pediatric patients less than 10 years of age with bipolar mania have not been established.
• Safety and effectiveness of Quetiapine in pediatric patients less than 18 years of age with bipolar depression have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: quetiapine fumarate
• Inactive ingredients: povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide.The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide.

Who manufactures and distributes this medicine?

Manufactured for:

• AvKARE, Inc.
• Pulaski, TN

What should I know about storage and disposal of this medication?

• Store quetiapine at room temperature, between 68°F to 77°F (20°C to 25°C).

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Quetiapine
• FDA Quetiapine

Quetiapine Resources
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