Quetiapine Fumarate ER 200 mg/1
Quetiapine Fumarate ER · TABLET, EXTENDED RELEASE · Direct_Rx
Quetiapine Fumarate ER is a tablet, extended release containing quetiapine fumarate er at 200 mg/1, taken oral. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Quetiapine Fumarate ER
- Generic Name
- Quetiapine Fumarate ER
- NDC Code (Product)
72189-482- Manufacturer
- Direct_Rx
- Strength
- 200 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090681
- Marketing Start
- 06/01/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 quetiapine tablets [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 disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as well as one 3-week monotherapy trial in children and adolescents (10 to 17 years) with manic episodes associated with bipolar I disorder tre…
Dosage & Administration
2.1 Important Administration Instructions Quetiapine extended-release tablets should be swallowed whole and not split, chewed or crushed. It is recommended that quetiapine extended-release tablets be taken without food or with a light meal (approximately 300 calories) [see CLINICAL PHARMACOLOGY (12.3)]. Quetiapine extended-release tablets should be administered once daily, preferably in the evening. 2.2 Recommended Dosing The recommended initial dose, titration, dose range and maximum quetiapine extended-release tablets dose for each approved indication is displayed in Table 1 below. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies ( 14.1, 14.2 and 14.3)]. Table 1: Recommended Dosing for quetiapine extended-release tablets Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia- Adults Day 1: 300 mg/day Dose increases can be made at intervals as short as 1 day and in increments of up to 300 mg/day 400 to 800 mg/day 800 mg/day Schizophrenia-Adolescents (13 to 17 years) Day 1: 50 mg/day Day 2: 100 mg/day Day 3: 200 mg/day Day 4: 300 mg/…
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.
Drug Interactions
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 prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype of CYP3A4 inducers (e.g, phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). Dose adjustment of quetiapine will be necessary if it is co-administered with potent CYP3A4 inducers or inhibitors. CYP3A4 inhibitors: Coadministration of ketoconazole, a potent inhibitor of cytochrome CYP3A4, resulted in significant increase in quetiapine exposure. The dose should be reduced to one sixth of the original dose in patients coadministered with a strong CYP3A4 inhibitor…
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 WARNINGS AND PRECAUTIONS (5.15)] …
Frequently Asked Questions
What is Quetiapine Fumarate ER used for?
Quetiapine Fumarate ER contains Quetiapine Fumarate ER. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Quetiapine Fumarate ER a controlled substance?
Quetiapine Fumarate ER is not classified as a controlled substance by the DEA.
What is the generic name for Quetiapine Fumarate ER?
The generic name for Quetiapine Fumarate ER is Quetiapine Fumarate ER. There are no other listed brand versions of Quetiapine Fumarate ER.
What is the NDC code for Quetiapine Fumarate ER 200 mg/1?
The NDC (National Drug Code) for Quetiapine Fumarate ER 200 mg/1 is 72189-482, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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