SEROQUEL 100/MG TAB 60/TAB

Indications

Approved Uses

Schizophrenia; Bipolar I disorder (acute manic episodes and depressive episodes; maintenance as adjunct to lithium/valproate); Major depressive disorder (adjunctive therapy) - noting that some indications/age ranges depend on local labeling.

Off-Label Uses

Common off‑label uses include insomnia (not recommended as first‑line), generalized anxiety symptoms, PTSD-related symptoms, and delirium/agitation in select settings; use in dementia-related psychosis/agitation carries increased mortality risk and is generally discouraged unless benefits outweigh risks.

Dosage & Administration

Dosing by Condition

Immediate‑release (this SFDA film‑coated tablet): Schizophrenia adults: start 25 mg twice daily, titrate to ~300-450 mg/day by day 4; usual range 150-750 mg/day. Bipolar mania adults: start 50 mg twice daily (day 1), titrate to 400 mg/day by day 4; range 400-800 mg/day (max 800 mg/day). Bipolar depression adults: 50 mg at bedtime day 1, then 100 mg day 2, 200 mg day 3, 300 mg day 4; target 300 mg nightly. MDD adjunctive: typically uses XR formulations in many labels; if used, start low (e.g., 50 mg nightly) and titrate per local labeling.

Initial Dose

Schizophrenia: 25 mg twice daily (immediate-release); Bipolar mania: 100 mg twice daily (immediate-release) on day 1, titrate as indicated

Maintenance Dose

300-800 mg/day (immediate-release, divided dosing) depending on indication and response

Maximum Dose

800 mg/day

Children's Dosage

Schizophrenia (13-17 years): Initial 25 mg twice daily, titrate to 400-800 mg/day. Bipolar mania (10-17 years): Initial 25 mg twice daily, titrate to 400-600 mg/day. Not approved under 10 years.

Dose Adjustment Notes

Hepatic impairment: start 25 mg/day and titrate slowly; elderly/debilitated: slower titration and lower target doses. CYP3A4 inhibitors: reduce quetiapine dose substantially; strong CYP3A4 inducers: may require higher quetiapine doses and reassessment when inducer is stopped. Renal impairment: no routine adjustment.

Side Effects

Common Side Effects

Somnolence/drowsiness, dizziness, dry mouth, constipation, orthostatic hypotension, weight gain/increased appetite, fatigue; nasal congestion can occur.

Side Effect Frequency

Very common (>10%): somnolence/sedation, dizziness, dry mouth, headache, weight gain. Common (1-10%): constipation, orthostatic hypotension, tachycardia, fatigue/asthenia, increased appetite, peripheral edema, dyspepsia, blurred vision, elevated liver enzymes, metabolic changes (e.g., increased glucose and lipids). Uncommon/rare (<1%): QT prolongation, seizures, neuroleptic malignant syndrome, tardive dyskinesia, agranulocytosis/severe neutropenia, hyponatremia, priapism.

Safety & Warnings

Contraindications

Contraindication: known hypersensitivity to quetiapine or any component of the formulation.

Warnings & Precautions

Key warnings/precautions: increased mortality in elderly with dementia-related psychosis (not approved); suicidality risk in children/adolescents/young adults; metabolic monitoring (weight, glucose, lipids); orthostatic hypotension/syncope and somnolence; QT prolongation risk in susceptible patients/drug combinations; NMS; tardive dyskinesia; seizure risk; leukopenia/neutropenia; cataracts (eye exam consideration per labeling); caution in hepatic impairment.

Age Restriction

Not approved for schizophrenia in children <13 years; not approved for bipolar mania in children <10 years.

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Major interactions: strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) markedly increase quetiapine exposure-avoid/major dose adjustment; strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort) markedly decrease exposure-avoid; additive CNS depression with alcohol/benzodiazepines; additive hypotension with antihypertensives; additive QT-prolongation risk with QT-prolonging drugs.

Interaction Severity

MAJOR: strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin); other QT‑prolonging drugs in high‑risk patients. MODERATE: CNS depressants (alcohol, opioids, benzodiazepines), antihypertensives (additive hypotension).

Food Interaction

Immediate‑release (this SFDA product): may be taken with or without food. Extended‑release: take without food or with a light meal (avoid high‑fat meals). Avoid grapefruit juice.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Schizophrenia (13-17 years): Initial 25 mg twice daily, titrate to 400-800 mg/day. Bipolar mania (10-17 years): Initial 25 mg twice daily, titrate to 400-600 mg/day. Not approved under 10 years.

Elderly

Start at a lower dose (e.g., 25-50 mg/day) and titrate more slowly due to reduced clearance.

Liver Impairment

Hepatic impairment: start 25 mg/day and increase by 25-50 mg/day to effective dose; titrate cautiously (applies broadly, including severe impairment).

Storage & Patient Advice

Overdose

Overdose: commonly causes marked sedation/somnolence, tachycardia, hypotension; may cause QT prolongation/arrhythmias, seizures, coma (rare). Management is supportive (airway/ventilation, IV fluids/vasopressors as needed, ECG/cardiac monitoring; consider activated charcoal if appropriate); no specific antidote-seek emergency care.

Patient Counseling

Take exactly as prescribed; do not stop abruptly without medical advice. May cause drowsiness/dizziness-avoid driving until effects are known and rise slowly to prevent falls. Avoid alcohol and grapefruit juice. Report symptoms of high blood sugar, severe muscle stiffness/fever (NMS), abnormal movements, fainting/palpitations, or infection signs (if low WBC risk). Keep follow‑ups for weight and metabolic labs; store below 25°C in original blister.

Monitoring Requirements

Baseline and periodic: weight/BMI and waist circumference, blood pressure, fasting glucose or HbA1c, fasting lipids; assess EPS/tardive dyskinesia, sedation/orthostasis, and suicidality (especially in younger patients). CBC if history of low WBC/neutropenia or symptoms. ECG if cardiac disease/QT risk or interacting QT‑prolongers. Eye exam for cataracts is not routinely required by many modern guidelines but may be considered if clinically indicated or per local labeling.

Pharmacology

Duration of Effect

Immediate-release: approximately 12-hour coverage (twice-daily dosing

Half-Life

Approximately 7 hours for quetiapine and 12 hours for its active metabolite, norquetiapine.

Bioavailability

Absolute oral bioavailability is low (approximately ~9%) due to first‑pass metabolism; food has minimal effect on IR but can increase exposure for XR (especially high‑fat meals).

Metabolism

Extensively hepatically metabolized, primarily by CYP3A4; minor contribution from CYP2D6 and other pathways; forms the active metabolite norquetiapine (N-desalkylquetiapine) plus other inactive metabolites.

Protein Binding

Approximately 83%.

Product Information

Available Dosage Forms

Film‑coated tablet (immediate‑release) for this SFDA product; quetiapine is also available in extended‑release tablets in some markets (Seroquel XR).

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.