Quetiapine

Quetiapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). It is also used with other medications to treat depression. Quetiapine is known as an anti-psychotic drug (atypical type). It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain.

• Quetiapine can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. It may also improve your mood, sleep, appetite, and energy level. Quetiapine can help prevent severe mood swings or decrease how often mood swings occur.
• Quetiapine is available under the following different brand names: Seroquel and Seroquel XR.

Dosages of Quetiapine:

Adult and Pediatric Dosage Forms and Strengths

Tablet, immediate release

• 25 mg
• 50 mg
• 100 mg
• 200 mg
• 300 mg
• 400 mg

Tablet, extended-release

• 50 mg
• 150 mg
• 100 mg
• 200 mg
• 300 mg
• 400 mg

Dosage Considerations – Should be Given as Follows:

Schizophrenia

Adult

Immediate release

• Day 1: 50 mg/day orally divided every 12 hours
• Days 2-3: Dose increased daily in increments of 25-50 mg every 8-12 hours to 300-400 mg by day 4; further adjustments can be made in increments of 25-50 mg every 12 hours at intervals 2 days or more
• Dosage range: 150-750 mg/day

Extended-release

• Day 1: 300 mg/day orally; subsequently, may be increased by up to 300 mg/day at intervals 1 day or more
• Maintenance (monotherapy): 400-800 mg/day
• Patients who have discontinued therapy for more than 1 week should have their dose re-titrated following initiation of therapy; patients may reinitiate at their previous maintenance dose if discontinued therapy less than 1 week

Pediatric

Children under 12 years

• Safety and efficacy not established

Children over 12 years (monotherapy, immediate-release)

• Day 1: 50 mg/day orally divided every 12 hours
• Day 2: 100 mg/day orally divided every 12 hours
• Day 3: 200 mg/day orally divided every 12 hours
• Day 4: 300 mg/day orally divided every 12 hours
• Day 5: 400 mg/day orally divided every 12 hours; further adjustments should be in increments up to 100 mg/day
• Dosage range: 400-800 mg/day
• Depending on response and tolerance, the daily dose may be divided every 8 hours

Children over 12 years (monotherapy, extended-release)

• Day 1: 50 mg/day orally once daily
• Day 2: 100 mg/day orally once daily
• Day 3: 200 mg/day orally once daily
• Day 4: 300 mg/day orally once daily
• Day 5: 400 mg/day orally once daily; further adjustments should be in increments up to 100 mg/day

Bipolar I Disorder, Mania

Adult

Administered as monotherapy or as an adjunct to lithium or Divalproex

Immediate release

• Day 1: 100 mg/day orally divided every 12 hours
• Day 2: 200 mg/day orally divided every 12 hours
• Day 3: 300 mg/day orally divided every 12 hours
• Day 4: 400 mg/day orally divided every 12 hours
• Further dosage adjustments, up to 800 mg/day by day 6, should be in increments up to 200 mg/day
• Dosage range: 400-800 mg/day; not to exceed 800 mg/day

Extended-release

• Day 1: 300 mg orally once daily
• Day 2: 600 mg orally once daily
• Maintenance (day 3 onward): 400-800 mg/day orally

Pediatric

Children under 10 years

• Safety and efficacy not established

Children over 10 years (monotherapy, immediate-release)

• Day 1: 50 mg/day orally divided every 12 hours
• Day 2: 100 mg/day orally divided every 12 hours
• Day 3: 200 mg/day orally divided every 12 hours
• Day 4: 300 mg/day orally divided every 12 hours
• Day 5: 400 mg/day orally divided every 12 hours; further adjustments should be in increments up to 100 mg/day
• Dosage range: 400-600 mg/day
• Depending on response and tolerance, the daily dose may be divided every 8 hours

Children over 10 years (monotherapy, extended-release)

• Day 1: 50 mg/day orally once daily
• Day 2: 100 mg/day orally once daily
• Day 3: 200 mg/day orally once daily
• Day 4: 300 mg/day orally once daily
• Day 5: 400 mg/day orally once daily; further adjustments should be in increments up to 100 mg/day
• Dosage range: 400-600 mg once daily

Bipolar Disorder, Depressive Episodes

• Either immediate-release or extended-release tablets may be given; dosage titrated upward over 4 days
• Day 1: 50 mg orally at bedtime
• Day 2: 100 mg orally at bedtime
• Day 3: 200 mg orally at bedtime
• Maintenance (day 4 onward): 300 mg orally at bedtime

Bipolar I Disorder, Maintenance

• Administered as an adjunct to lithium or Divalproex
• Immediate release: 400-800 mg/day orally divided every 12 hours
• Extended-release: 400-800 mg/day orally in a single dose
• Generally, in the maintenance phase, patients continue to receive the same dosage on which they were stabilized

Major Depressive Disorder

• Extended-release formulation administered as an adjunct to antidepressants
• Days 1 and 2: 50 mg orally in the evening
• Day 3: May be increased to 150 mg orally in the evening
• Dosage range: 150-300 mg/day

Alcohol Dependence (Off-label)

• 25-50 mg orally at bedtime; may be titrated; not to exceed 300 mg

Insomnia (Off-label)

• Usually, 25 mg/day orally at bedtime initially

Administration

• Preferably, take in the evening without food or with a light meal
• Switching from immediate-release to extended-release
  • Convert to extended-release tablets at equivalent immediate release total daily dose; administer once daily; individual adjustments may be necessary

Common side effects or health problems may include:

• Dizziness
• Fatigue
• Extrapyramidal symptoms (muscle spasms, restlessness, muscle rigidity, slowness of movement, tremor, and jerky movements)
• Increased diastolic blood pressure
• Increased triglycerides
• Increased total cholesterol
• Increased appetite
• Constipation
• Dry mouth
• Headache
• Drowsiness
• Abdominal pain (dose-related)
• Indigestion (dose-related)
• Tremor
• Back pain
• Dizziness upon standing
• Fast heart rate
• Sore throat
• Runny or stuffy nose
• Rash
• Blurred vision
• Joint pain
• Muscle pain
• Neck pain
• Abnormal involuntary movements
• Low white blood cell count (neutropenia)
• Hemorrhage

Less common side effects of quetiapine include:

• Prolonged erection
• Heart disease
• Inflammation of the heart muscle (myocarditis)
• QTc prolongation
• Nightmares
• Pancreatitis
• Muscle wasting (rhabdomyolysis)
• Palpitations
• Leukocytosis
• Nosebleed
• Red and peeling skin (exfoliative dermatitis)

Postmarketing side effects of quetiapine reported include:

• Drug reaction with eosinophilia and systemic symptoms (DRESS)

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any drug before seeking medical advice from your doctor, healthcare provider, or pharmacist first. To do so may result in serious consequences or side effects.

• Severe Interactions of quetiapine include:
  • goserelin
  • leuprolide
• Quetiapine has serious interactions with at least 43 different drugs.
• Quetiapine has moderate interactions with at least 384 different drugs.
• Mild Interactions of quetiapine include:
  • brimonidine
  • chasteberry
  • ethanol
  • eucalyptus
  • sage

This document does not contain all possible interactions from the use of this medication. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• Not approved for dementia-related psychosis; elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
• Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders; prescriptions should be written for the smallest therapeutically effective quantity, and caregivers should monitor and report to healthcare professionals incidence of suicidality and associated behaviors.
• Not approved for children under 10 years.
• This medication contains quetiapine. Do not take Seroquel or Seroquel XR if you are allergic to quetiapine or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Documented hypersensitivity

Effects of Drug Abuse

• Potential for withdrawal symptoms after abrupt discontinuance.

Short-Term Effects

• Increased blood pressure in children and adolescents reported; monitor blood pressure at the beginning of, and periodically during treatment.
• See "What Are Side Effects Associated with Using Quetiapine?"

Long-Term Effects

• Hyperlipidemia may occur; appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment.
• Weight gain may occur; monitoring of weight is recommended.
• Increased blood pressure in children and adolescents reported; monitor blood pressure at the beginning of, and periodically during treatment.
• See "What Are Side Effects Associated with Using Quetiapine?"

Cautions

• Use caution in cardiovascular and cerebrovascular disease.
• May worsen hypotensive conditions.
• Use with caution in breast cancer and history of seizure.
• Increased risk of hyperglycemia and diabetes; in some cases, hyperglycemia concomitant with the use of atypical antipsychotics have been associated with ketoacidosis, hyperosmolar coma, or death; monitor blood glucose of high-risk patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness; monitor glucose regularly in patients with diabetes or at risk for diabetes.
• Increased incidence of cerebrovascular adverse effects, including stroke and TIAs, in elderly with dementia (not approved for the treatment of patients with dementia-related psychosis).
• Neuroleptic malignant syndrome (NMS) was reported with use.
• Tardive dyskinesia is possible after discontinuance.
• Clinical worsening of depression and suicide ideation may occur despite treatment.
• Hyperlipidemia may occur; appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment.
• Weight gain may occur; monitoring of weight is recommended.
• Orthostatic hypotension associated with use.
• Monitor for cataracts.
• Increased blood pressure in children and adolescents reported; monitor blood pressure at the beginning of, and periodically during treatment.
• Leukopenia, neutropenia, and agranulocytosis may occur.
• Somnolence may occur (especially with the extended-release product).
• Potential for withdrawal symptoms after abrupt discontinuance.
• False-positive urine drug screens were reported when immunoassays for methadone or tricyclic antidepressants were used.
• FDA warning regarding off-label use for dementia in elderly.
• QT interval prolongation:
  • Not associated with a persistent increase in QT interval in trials, but QT effect was not systematically evaluated in a thorough study
  • QT prolongation reported with acute overdose during postmarketing experience
  • Avoid using in combination with other drugs known to prolong QTc or in patients with increased risk of QT prolongation

Pregnancy and Lactation

• Use quetiapine with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• Neonates exposed to antipsychotic drugs such as quetiapine during the 3rd trimester of pregnancy are at risk for extrapyramidal symptoms (EPS) or withdrawal symptoms after delivery; these complications vary in severity, with some
• being self-limited and others requiring ICU support and prolonged hospitalization.
• Quetiapine is excreted in breast milk; breastfeeding is not recommended.