Quetiapine Fumarate Tablets

1. Quetiapine is a new antipsychotic drug that is an antagonist of multiple neurotransmitter receptors in the brain. The mechanism of action of quetiapine is not yet clear, but it may exert its anti-schizophrenia effect by antagonizing central D2 receptors and 5-HT2 receptors. 2. Antagonism of other receptors mediates other pharmacological effects of quetiapine; for example, antagonism of histamine H1 receptors and adrenergic a1 receptors can lead to drowsiness and orthostatic hypotension. Quetiapine has almost no affinity for cholinergic M receptors and benzodiazepine receptors (JC50% 5000nM).

The main ingredient is quetiapine fumarate.

This product is round white tablets.

Schizophrenia.

1. Common adverse reactions include dry mouth, tachycardia, constipation, dizziness or fainting, abnormal liver function, weight gain, drowsiness, akathisia, insomnia, excitement or agitation, blurred vision, decreased blood pressure, muscle tension, tremor, decreased activity, fatigue, headache, nasal congestion, and skin symptoms (arranged in order of incidence in clinical studies). 2. Foreign literature reports that dose-dependent adverse reactions to quetiapine fumarate are indigestion, abdominal pain, and weight gain. Laboratory tests found that asymptomatic ALT increases were related to the use of quetiapine. The following adverse events were also observed in placebo-controlled clinical trials. Although these adverse events occurred during treatment with quetiapine fumarate, they were not necessarily caused by the drug. 3. Systemic: headache, weakness, abdominal pain, back pain, fever

Contraindicated in patients who are allergic to any of the components of this product.

Precautions for children: The safety and efficacy of this product for children and adolescents have not been evaluated. Precautions for pregnancy and lactation: 1. The efficacy and safety of this product in human pregnancy have not been determined. Therefore, quetiapine can only be used in pregnant patients when the benefits outweigh the potential risks. 2. The excretion of this product in human milk is unclear. If lactating women use quetiapine, they should be advised to discontinue breastfeeding during medication. Precautions for the elderly: Because the oral clearance of quetiapine in elderly patients is 40% lower than that in adult patients, the oral dose needs to be adjusted (see Dosage and Administration).

1. Since this product mainly has central nervous system effects, caution should be exercised when it is used in combination with drugs that act on the central nervous system. 2. The combination of this product and lithium will not affect the pharmacokinetics of lithium. 3. This product will not induce the liver enzyme system related to the metabolism of antipyrine. The combination of this product and phenytoin (a microsomal enzyme inducer) can increase the clearance rate of quetiapine. If this product is used in combination with phenytoin or other liver enzyme inducers (such as carbamazepine, barbiturates, rifampicin), in order to maintain the effect of antipsychotic symptoms, the dose of this product should be increased. If phenytoin is discontinued and replaced with a non-inducing agent (such as sodium valproate), the dose of this product needs to be reduced. The combination of antipsychotic drugs risperidone or haloperidol will not significantly change the pharmacokinetics of quetiapine. However, the clearance rate of quetiapine will be increased when this product is used in combination with thioridazine. 4. Co-administration with the antidepressant imipramine (a known CYP2D6 inhibitor) or fluoxetine (a known CYP3A4 and CYP2D6 depressant) will not significantly change the pharmacokinetics of quetiapine. 5. Among cytochrome P450 enzymes, the main enzyme mediating quetiapine metabolism is CYP3A4. Co-administration with cimetidine (CIMETIDINE) or fluoxetine (both drugs are known P450 enzyme inhibitors) will not change the pharmacokinetics of quetiapine. However, caution should be exercised if quetiapine is co-administered with strong inhibitors of CYP3A4 (such as systemic ketoconazole or erythromycin).

Keep tightly closed.

25mg (calculated as C21H25N3O2S)

36 months

Hunan Dongting Pharmaceutical Co., Ltd.

• Founded in:

  1997-03-26

• Address:

  No. 16 Dongyan Road, Chenjiagang Community, Deshan Subdistrict Office, Changde Economic and Technological Development Zone, Hunan Province (No. 16 Dongyan Road, Deshan District, Changde City)

• Tax NO.:

  914307001838043692

• Registered Funds:

  309.624852 million yuan

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