Quetiapine

QUETIAPINE EXTENDED-RELEASE

Manufacturer: Amneal Pharmaceuticals LLC

Score: 148.0

Quick Summary

Quetiapine is an atypical antipsychotic used for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. It has a boxed warning for increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors in children, adolescents, and young adults. The recommended initial dose and titration schedule vary depending on the indication and patient population. Quetiapine is contraindicated in patients with a known hypersensitivity to the drug or its ingredients. Special considerations are needed for use in pregnancy, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

Treatment of schizophrenia
Treatment of bipolar disorder (manic or mixed episodes)
Treatment of bipolar disorder (depressive episodes)
Adjunctive treatment of major depressive disorder

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors in children, adolescents, and young adults

Contraindications

Hypersensitivity to quetiapine or its ingredients

Adverse Reactions

Somnolence
Dry mouth
Constipation
Dizziness
Increased appetite
Dyspepsia
Weight gain
Fatigue
Dysarthria
Nasal congestion

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with hepatic impairment, elderly patients, and patients taking CYP3A4 inhibitors or inducers

Schizophrenia

Adult Dose

300 mg/day on Day 1, with increases up to 400-800 mg/day

Pediatric Dose

50 mg/day on Day 1, with increases up to 400-800 mg/day (for adolescents 13-17 years old)

Bipolar disorder (manic or mixed episodes)

Adult Dose

300 mg/day on Day 1, with increases up to 400-800 mg/day

Pediatric Dose

50 mg/day on Day 1, with increases up to 400-600 mg/day (for children and adolescents 10-17 years old)

Bipolar disorder (depressive episodes)

Adult Dose

50 mg/day on Day 1, with increases up to 300 mg/day

Pediatric Dose

Not established

Major depressive disorder (adjunctive therapy)

Adult Dose

50 mg/day on Day 1, with increases up to 150-300 mg/day

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine, during pregnancy
Neonates exposed to quetiapine during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery

Nursing Mothers

Quetiapine is excreted in human milk, and caution should be exercised when administering quetiapine to a nursing woman

Pediatric Use

Safety and effectiveness of quetiapine extended-release in pediatric patients less than 10 years of age have not been established
The efficacy and safety of quetiapine extended-release in the treatment of schizophrenia in adolescents aged 13 to 17 years is supported by one 6-week, double-blind, placebo-controlled trial with SEROQUEL

Geriatric Use

The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions

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