SEROQUEL XR 150 mg/1

quetiapine · TABLET, EXTENDED RELEASE · H2-Pharma, LLC

No Recall History

Plain English

SEROQUEL XR is a tablet, extended release containing quetiapine at 150 mg/1, taken oral. Manufactured by H2-Pharma, LLC.

Key Facts

Brand Name: SEROQUEL XR
Generic Name: quetiapine
NDC Code (Product): 61269-271
Manufacturer: H2-Pharma, LLC
Strength: 150 mg/1
Dosage Form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA022047
Marketing Start: 02/01/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective9,588 reports

off label use9,588 reports

insomnia8,231 reports

diabetes mellitus8,085 reports

toxicity to various agents8,040 reports

somnolence7,121 reports

fatigue6,825 reports

weight increased6,616 reports

anxiety6,576 reports

drug interaction6,566 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE SEROQUEL XR is an atypical antipsychotic indicated for the treatment of: • Schizophrenia (1.1) • Bipolar I disorder, manic, or mixed episodes (1.2) • Bipolar disorder, depressive episodes (1.2) • Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia SEROQUEL XR is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL XR in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with SEROQUEL [see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder SEROQUEL XR is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of SEROQUEL XR in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic epis…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Swallow tablets whole and do not split, chew or crush (2.1) • Take without food or with a light meal (approx. 300 calories) (2.1) • Administer once daily, preferably in the evening (2.1) • Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration, and careful monitoring during the initial dosing period in the elderly ( 2.3 , 8.5 ) • Hepatic Impairment: Lower starting dose (50 mg/day) and slower titration may be needed ( 2.4 , 8.7 , 12.3 ) Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia - Adults (2.2) 300 mg/day 400-800 mg/day 800 mg/day Schizophrenia - Adolescents (13 to 17 years) (2.2) 50 mg/day 400-800 mg/day 800 mg/day Bipolar I Disorder manic or mixed - Acute monotherapy or adjunct to lithium or divalproex - Adults (2.2) 300 mg/day 400-800 mg/day 800 mg/day Bipolar I Disorder, manic Acute monotherapy - Children and Adolescents (10 to 17 years) (2.2) 50 mg/day 400-600 mg/day 600 mg/day Bipolar Disorder, Depressive Episodes - Adults (2.2) 50 mg/day 300 mg/day 300 mg/day Major Depressive Disorder, Adjunctive Therapy with Antidepressants - Adults (2.2) 50 mg/day 150-300 mg/day 300 mg/day 2.1 Important Administratio…

Contraindications

4 CONTRAINDICATIONS Hypersensitivity to quetiapine or to any excipients in the SEROQUEL XR formulation. Anaphylactic reactions have been reported in patients treated with SEROQUEL XR. Known hypersensitivity to SEROQUEL XR or any components in the formulation. (4)

Drug Interactions

7 DRUG INTERACTIONS • Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one‑sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) ( 2.5 , 7.1 , 12.3 ) • Concomitant use of strong CYP3A4 inducers: 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) ( 2.6 , 7.1 , 12.3 ) • Discontinuation of strong CYP3A4 inducers: Reduce quetiapine dose by 5‑fold within 7-14 days of discontinuation of CYP3A4 inducers ( 2.6 , 7.1 , 12.3 ) 7.1 Effect of Other Drugs on Quetiapine The risks of using SEROQUEL XR in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of SEROQUEL XR, caution should be used when it is taken in combination with other centrally acting drugs. 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. Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraco…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] • Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2) ] • Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.3) ] • Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] • Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see Warnings and Precautions (5.5) ] • Tardive dyskinesia [see Warnings and Precautions (5.6) ] • Hypotension [see Warnings and Precautions (5.7) ] • Falls [see Warnings and Precautions (5.8) ] • Increases in blood pressure (children and adolescents) [see Warnings and Precautions (5.9) ] • Leukopenia, neutropenia and agranulocytosis [see Warnings and Precautions (5.10) ] • Cataracts [see Warnings and Precautions (5.11) ] • QT Prolongation [see Warnings and Precautions (5.12) ] • Seizures [see Warnings and Precautions (5.13) ] • Hypothyroidism [see Warnings and Precautions (5.1…

Frequently Asked Questions

What is SEROQUEL XR used for?

SEROQUEL XR contains quetiapine. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is SEROQUEL XR a controlled substance?

SEROQUEL XR is not classified as a controlled substance by the DEA.

What is the generic name for SEROQUEL XR?

The generic name for SEROQUEL XR is quetiapine. There are 12 other brand versions of quetiapine.

What is the NDC code for SEROQUEL XR 150 mg/1?

The NDC (National Drug Code) for SEROQUEL XR 150 mg/1 is 61269-271, listed by H2-Pharma, LLC.

Product NDC

61269-271

Package NDC

61269-271-60

Other Quetiapine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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