Seroquel Quetiapine Fumarate Tablets

Brand Name:思瑞康®( Seroquel®)
Generic Name: Quetiapine Fumarate
Strength: 0.2 g (200 mg) per tablet, 20 tablets per box
Manufacturer: AstraZeneca UK Limited
Marketing Authorization Holder: AstraZeneca AB
Approval Date in China: 2004
Registration Number: 国药准字H20040720
Storage: Store tightly sealed in a cool dry place, protected from light; keep out of reach of children, follow complete storage specifications in the package insert

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1. Indications and Usage
Schizophrenia: Treatment of schizophrenia.
Bipolar Disorder: Treatment of acute manic episodes associated with bipolar disorder.
2. Dosage and Administration
Adults:
Schizophrenia: The recommended initial dose is 25 mg twice daily. This can be increased on the first and second days to 100 mg and 200 mg, respectively. The total daily dose should be titrated to an effective range of 300-450 mg.
Bipolar Mania: The initial dose is 100 mg once daily. The dose can be titrated up by 100 mg daily on days 2, 3, and 4 to reach 400 mg by day 4. The effective dose range is generally 400-800 mg daily.
Special Populations: For elderly patients or those with hepatic or renal impairment, the starting dose should be 25 mg daily, with gradual titration based on tolerance.
Administration: Can be taken with or without food.
3. Mechanism of Action
Receptor Antagonism: Quetiapine acts primarily as an antagonist at serotonin 5-HT2A and dopamine D2 receptors.
Additional Effects: It also exhibits affinity for histamine H1 and adrenergic α1 and α2 receptors, contributing to its therapeutic efficacy and side effect profile.
4. Safety and Warnings
Elderly Patients with Dementia: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Suicidal Ideation: Antipsychotics increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.
Metabolic Changes: Can cause hyperglycemia, dyslipidemia, and weight gain.
Neuroleptic Malignant Syndrome: A potentially fatal syndrome requiring immediate discontinuation and intensive care.
Tardive Dyskinesia: May cause irreversible, involuntary dyskinetic movements.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Somnolence, dizziness, constipation, dry mouth, and orthostatic hypotension.
Clinical Research: Clinical trials have demonstrated efficacy in reducing positive and negative symptoms of schizophrenia and manic episodes in bipolar disorder.
6. Drug Interactions
CYP3A4 Inhibitors: Strong inhibitors (e.g., ketoconazole, clarithromycin) increase quetiapine exposure.
CYP3A4 Inducers: Strong inducers (e.g., carbamazepine, rifampin) decrease quetiapine exposure, potentially reducing efficacy.
CNS Depressants: Concomitant use with alcohol or other CNS depressants may potentiate sedation.
Antihypertensives: May potentiate the antihypertensive effect.
7. Pharmaceutical Information
Active Ingredient: Quetiapine Fumarate.
Appearance: Film-coated tablets.
Storage: Store at controlled room temperature, protected from moisture.

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