- Indications and Usage Quetiapine Fumarate Extended-Release Tablets are indicated for the treatment of schizophrenia and bipolar depressive episodes.
- Dosage and Administration Recommended Dosage: For schizophrenia, the recommended starting dose is 300 mg once daily at night. The dose can be titrated to 400-800 mg/day based on clinical response. Bipolar Depression Dosage: The recommended starting dose is 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. Administration: Tablets must be swallowed whole and cannot be divided, chewed, or crushed. They can be taken with or without food.
- Mechanism of Action Quetiapine is an atypical antipsychotic that acts as an antagonist at multiple neurotransmitter receptors, including serotonin 5-HT2A and dopamine D2 receptors, which helps modulate psychotic and mood symptoms.
- Safety and Warnings Elderly with Dementia-Related Psychosis: Antipsychotic drugs increase the risk of mortality in elderly patients with dementia-related psychosis. Suicidal Thoughts and Behaviors: Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults. Metabolic Changes: The use of atypical antipsychotics may cause hyperglycemia, dyslipidemia, and weight gain. Neuroleptic Malignant Syndrome (NMS): A potentially fatal syndrome characterized by hyperthermia, muscle rigidity, and autonomic instability. Tardive Dyskinesia: A syndrome of involuntary movements that may become irreversible.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common adverse reactions include somnolence, dry mouth, constipation, dizziness, weight gain, and dyspepsia. Clinical Research: Clinical trials have demonstrated the efficacy and safety of quetiapine extended-release tablets in reducing psychotic symptoms and improving depressive episodes compared to placebo.
- Drug Interactions CYP3A4 Inhibitors: Ketoconazole and other strong CYP3A4 inhibitors significantly increase quetiapine plasma concentrations. CYP3A4 Inducers: Rifampin and other strong CYP3A4 inducers decrease quetiapine plasma concentrations. CNS Depressants: Caution is advised when used with alcohol or other sedative drugs. Antihypertensives: Quetiapine may enhance the hypotensive effect of antihypertensive agents.
- Pharmaceutical Information Composition: The active ingredient is quetiapine fumarate. Appearance: Extended-release tablets are available in various strengths (e.g., 50mg, 150mg, 200mg, 300mg), typically oval and film-coated. Storage: Store at controlled room temperature, protected from moisture.
Quetiapine Fumarate Extended-Release Tablets
Brand Name: No proprietary Chinese brand name (Pharmathen generic)
Generic Name: Quetiapine Fumarate
Strength: 300 mg per tablet (calculated as quetiapine base), 30 tablets per box
Manufacturer: Pharmathen International S.A. (Greece)
Marketing Authorization Holder: PHARMATHEN INVESTMENTS GROUP LIMITED
Approval Date in China: March 08, 2021
Registration Number:国药准字 HJ20210058
Storage: Store sealed at 15°C–30°C, protect from light and moisture. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.
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