Quetiapine 100 mg Immediate Release Tablets — Generic For Seroquel — Lupin

These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS.QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine is not approved for elderly patients with dementia-related psychosis (5.1)

Suicidal Thoughts and Behaviors

Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants (5.2)

Monitor for worsening and emergence of suicidal thoughts and behaviors (5.2)

Recent Major Changes

Warnings and Precautions (5.15) 1/2025

Indications And Usage

Quetiapine tablet is an atypical antipsychotic indicated for the treatment of:

Schizophrenia (1.1)

Bipolar I disorder manic episodes (1.2)

Bipolar disorder, depressive episodes (1.2)

Dosage And Administration

Quetiapine tablets can be taken with or without food (2.1).

Indication

Initial Dose

Recommended Dose

Maximum Dose

Schizophrenia-Adults (2.2)

25 mg twice daily

150 to 750 mg/day

750 mg/day

Schizophrenia-Adolescents

(13 to 17 years) (2.2)

25 mg twice daily

400 to 800 mg/day

800 mg/day

Bipolar Mania- Adults Monotherapy

or as an adjunct to lithium or

divalproex (2.2)

50 mg twice daily

400 to 800 mg/day

800 mg/day

Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2)

25 mg twice daily

400 to 600 mg/day

600 mg/day

Bipolar Depression-Adults (2.2)

50 mg once daily at bedtime

300 mg/day

300 mg/day

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 (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3)

Dosage Forms And Strengths

Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3)

Contraindications

Known hypersensitivity to quetiapine or any components in the formulation. (4)

Warnings And Precautions

• (5.15) 1/2025 INDICATIONS AND USAGE Quetiapine tablet is an atypical antipsychotic indicated for the treatment of:
• Schizophrenia (1.1)
• Bipolar I disorder manic episodes (1.2)
• Bipolar disorder, depressive episodes (1.2) DOSAGE AND ADMINISTRATION
• Quetiapine tablets can be taken with or without food (2.1). Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia-Adults (2.2) 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily 400 to 600 mg/day 600 mg/day Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime 300 mg/day 300 mg/day
• 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 (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3) DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3) CONTRAINDICATIONS Known hypersensitivity to quetiapine or any components in the formulation. (4) WARNINGS AND PRECAUTIONS
• Cerebrovascular

• (5.15) 1/2025 INDICATIONS AND USAGE Quetiapine tablet is an atypical antipsychotic indicated for the treatment of:
• Schizophrenia (1.1)
• Bipolar I disorder manic episodes (1.2)
• Bipolar disorder, depressive episodes (1.2) DOSAGE AND ADMINISTRATION
• Quetiapine tablets can be taken with or without food (2.1). Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia-Adults (2.2) 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily 400 to 600 mg/day 600 mg/day Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime 300 mg/day 300 mg/day
• 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 (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3) DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3) CONTRAINDICATIONS Known hypersensitivity to quetiapine or any components in the formulation. (4) WARNINGS AND PRECAUTIONS
• Cerebrovascular

Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs (5.3)

Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring (5.4)

Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain (5.5)

Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes

Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment

Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended

Tardive Dyskinesia: Discontinue if clinically appropriate (5.6)

Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease (5.7)

Increased Blood Pressure in Children and Adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents (5.9)

Leukopenia, Neutropenia and Agranulocytosis: Monitor complete blood count frequently during the first few months of treatment in patients with a pre-existing low white cell count or a history of leukopenia/neutropenia and discontinue quetiapine at the first sign of a decline in WBC in absence of other causative factors (5.10)

Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment (5.11)

Anticholinergic(antimuscarinic) Effects : Use with caution with other anticholinergic drugs and in patients with urinary retention, prostatic hypertrophy or constipation (5.20).

Adverse Reactions

Most common adverse reactions (incidence ≥5% and twice placebo):

Adults: somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, lethargy, ALT increased, dyspepsia. (6.1)

Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Concomitant Use of Strong CYP3A4 Inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) (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)

Use In Specific Populations

Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. (8.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 6/2026