Quetiapine Extended-Release 200 mg/1

Quetiapine · TABLET, FILM COATED, EXTENDED RELEASE · AlignScience Pharma Inc.

No Recall History

Plain English

Quetiapine Extended-Release is a tablet, film coated, extended release containing quetiapine at 200 mg/1, taken oral. Manufactured by AlignScience Pharma Inc..

Key Facts

Brand Name: Quetiapine Extended-Release
Generic Name: Quetiapine
NDC Code (Product): 69948-003
Manufacturer: AlignScience Pharma Inc.
Strength: 200 mg/1
Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: ANDA209497
Marketing Start: 12/31/2020

Recall History

No Recall History

Side Effects Reported to FDA

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

toxicity to various agents7,375 reports

drug ineffective5,392 reports

completed suicide5,118 reports

off label use5,034 reports

drug interaction4,928 reports

somnolence3,491 reports

drug abuse3,424 reports

fatigue3,327 reports

intentional overdose3,276 reports

suicide attempt3,016 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Quetiapine extended-release tablets are 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 Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets 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 to 17 years) treated with SEROQUEL [see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder Quetiapine extended-release tablets are 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 quetiapine extended-release tablets 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 disorde…

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 to 800 mg/day 800 mg/day Schizophrenia-Adolescents (13 to 17 years) (2.2) 50 mg/day 400 to 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 to 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 to 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 to 300 mg/day 300 mg/day 2.1 Important Administration Instru…

Contraindications

4 CONTRAINDICATIONS Hypersensitivity to quetiapine or to any excipients in the quetiapine extended-release tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine extended-release tablets. Known hypersensitivity to quetiapine extended-release tablets 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 to 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 to 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 quetiapine extended-release tablets in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of quetiapine extended-release tablets, 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 p…

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 (5.14) ] Hyperprolactinemia [see…

Frequently Asked Questions

What is Quetiapine Extended-Release used for?

Quetiapine Extended-Release contains Quetiapine. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Quetiapine Extended-Release a controlled substance?

Quetiapine Extended-Release is not classified as a controlled substance by the DEA.

What is the generic name for Quetiapine Extended-Release?

The generic name for Quetiapine Extended-Release is Quetiapine. There are 12 other brand versions of Quetiapine.

What is the NDC code for Quetiapine Extended-Release 200 mg/1?

The NDC (National Drug Code) for Quetiapine Extended-Release 200 mg/1 is 69948-003, listed by AlignScience Pharma Inc..

Product NDC

69948-003

Package NDC

69948-003-03

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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