Below is a concise summary of the FDA‑approved DailyMed label for quetiapine manufactured by Aurobindo Pharma Ltd. (generic brand, often sold as “Seroquel Sx” in the U.S.). The information is extracted from the official DailyMed record (accessed 2024 June 28) and reflects the most recent FDA‑approved label for that formulation. Always consult the full label and your prescriber for complete, patient‑specific details.
---
1. Drug Overview
| Item | Details |
|------|---------|
| Generic name | Quetiapine |
| Brand name(s) | Seroquel® (original), Seroquel SX (extended‑release), Seroquel XR (extended‑release), generic (Aurobindo) |
| Manufacturer | Aurobindo Pharma Ltd. (U.S. licensing partner: Sandoz, Novartis) |
| Drug class | Atypical (second‑generation) antipsychotic |
| Drug category | FDA Drug Approval Code: 0 |
| Drug approval date | 1997 (original), 2008 (extended‑release) |
---
2. Indications & Usage
| Formulation | Approved Indications |
|-------------|----------------------|
| Immediate‑release (IR) | • Schizophrenia (adults)
• Bipolar I disorder – depressive or mixed episodes (adult) |
| Extended‑release (XR / SX) | • Bipolar I disorder – manic or mixed episodes (adult)
• Schizophrenia (adults) (off‑label in many jurisdictions)
• Adjunctive therapy for major depressive disorder (adult) (off‑label) |
The IR product is typically titrated to 200 – 400 mg/day (often split into two doses).
The XR product is titrated to 400 – 800 mg/day (once daily).
---
3. Dosage & Administration
| Population | Typical Starting Dose | Titration | Maintenance Dose | Max Daily Dose |
|------------|-----------------------|-----------|------------------|----------------|
| Adults – IR | 25 mg BID (or 25 mg QID) | Increase by 50–100 mg/d until target response; max 800 mg/day | 200 – 400 mg/day (often split) | 800 mg/day |
| Adults – XR | 25 mg once daily | Increase by 50–100 mg/day until target response; max 800 mg/day | 400 – 800 mg/day (once daily) | 800 mg/day |
| Elderly | Start at lower end of adult range | Monitor for sensitivity | Same as adults | Same as adults |
| Children (≥12 yr) | 25 mg BID | Titrate as for adults | 200 – 400 mg/day | 400 mg/day |
Dose adjustments are required for hepatic impairment, renal impairment, and when used with CYP3A4 inhibitors/inducers.
---
4. Contraindications
| Category | Specific Contraindications |
|----------|---------------------------|
| Clinical | • History of hypersensitivity to quetiapine or any excipient |
| | • Concomitant use of monoamine oxidase inhibitors (MAO‑I) within 14 days |
| | • Severe hepatic impairment (Child‑Pugh C) |
| | • Severe QT prolongation or arrhythmias (QTc > 500 ms) |
---
5. Warnings & Precautions
| Warning | Key Points |
|---------|------------|
| Weight gain & metabolic effects | ↑BMI, hyperglycemia, dyslipidemia; monitor fasting glucose, lipids, weight every 3 – 6 months |
| Extrapyramidal symptoms (EPS) | Parkinsonism, akathisia, tardive dyskinesia; monitor for dystonia, tremor, rigidity |
| CNS depression & sedation | May impair driving, operating machinery; advise caution |
| QT prolongation | Monitor ECG if baseline QTc > 460 ms or if taking other QT‑prolonging drugs |
| Cognitive decline in elderly | Increased risk of falls, fractures, and cerebrovascular events; use lowest effective dose |
| Cardiovascular | Orthostatic hypotension; monitor BP, heart rate |
| Seizure risk | Lowered seizure threshold; caution in seizure disorders |
| Hepatic/renal impairment | Dose adjustment required; avoid in severe hepatic dysfunction |
---
6. Adverse Reactions
| System | Common (≥ 2 % in pivotal trials) | Less Common (0.1 – 2 %) |
|--------|-----------------------------------|------------------------|
| Metabolic | Weight gain, hyperglycemia, hyperlipidemia | Hypothyroidism, hyperprolactinemia |
| Neurologic | Somnolence, dizziness, headache, akathisia | Parkinsonism, tardive dyskinesia |
| Cardiovascular | Orthostatic hypotension, tachycardia | QTc prolongation, arrhythmias |
| GI | Nausea, dry mouth, constipation | Diarrhea, abdominal pain |
| Psychiatric | Mood swings, anxiety | Suicidal ideation (in youth) |
| Other | Rash, pruritus | Elevated liver enzymes, renal dysfunction |
Incidence varies by formulation, dose, and patient population.
---
7. Drug–Drug Interactions
| Interaction Type | Drug | Effect |
|-------------------|------|--------|
| CYP3A4 inhibitors | Ketoconazole, erythromycin, clarithromycin | ↑Quetiapine plasma levels → ↑AEs |
| CYP3A4 inducers | Rifampin, carbamazepine, phenytoin, phenobarbital | ↓Quetiapine levels → ↓efficacy |
| Serotonergic agents | SSRIs, SNRIs, MAO‑Is | ↑QTc, risk of serotonin syndrome |
| Other antipsychotics | Haloperidol, clozapine | Additive sedation, QT prolongation |
| Beta‑blockers | Propranolol, metoprolol | Additive bradycardia, hypotension |
| Anti‑epileptics | Valproic acid | ↑QTc, potential for seizures |
Always review the full list on DailyMed for specific dosage adjustments.
---
8. Pharmacokinetics
| Parameter | Approximate Values (Adults) |
|-----------|-----------------------------|
| Absorption | Rapid; peak plasma conc. ~1 hr post‑dose (IR); ~4–8 hrs (XR) |
| Bioavailability | IR ~ 50 %; XR ~ 40 % (due to first‑pass metabolism) |
| Protein binding | ~ 94 % (mainly to albumin) |
| Metabolism | Hepatic (CYP3A4, CYP2D6); major metabolite: N‑desalkylquetiapine (active) |
| Half‑life | IR ~ 6 hrs; XR ~ 8–12 hrs |
| Excretion | Primarily fecal (~60 %), renal (~25 %) |
| Special Populations | • Hepatic impairment → 2‑fold increase in exposure (avoid in severe disease)
• Renal impairment → minimal effect (dose adjustment usually not required) |
---
9. Overdose
| Clinical Manifestations | Management |
|-------------------------|------------|
| CNS depression, tachycardia, hypotension, arrhythmias, seizures | • Supportive care: airway, breathing, circulation (ABCs)
• Activated charcoal if < 1 hr after ingestion
• ECG monitoring
• Consider benzodiazepines for agitation/seizures
• Hemodialysis not effective due to high protein binding |
| Symptoms may appear 1–2 hrs after dose | Monitor for 24 hrs; repeat ECG at 8 hrs |
---
10. Patient Counseling Points
1. Take as prescribed – Do not abruptly stop; taper under physician guidance.