Aripiprazole tablets

Aripiprazole has high affinity for D2, D3, 5-HT1A, and 5-HT2A receptors, and moderate affinity for D4, 5-HT2c, 5-HT7, alpha 1, H1 receptors, and 5-HT reabsorption sites. Aripiprazole is a partial agonist of D2 and 5-HT1A receptors, and an antagonist of 5-HT2A receptors. Like other drugs with anti-schizophrenia effects, the mechanism of action of aripiprazole is still unclear. However, it is believed that it is mediated by partial agonism of D2 and 5-HT1A receptors and antagonism of 5-HT2A receptors. The effects on other receptors may produce some other clinical effects of aripiprazole, such as the antagonism of alpha 1 receptors, which can explain the phenomenon of postural hypotension.

The main ingredient of this product is aripiprazole. Chemical name: 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)quinolinone

This product is a film-coated tablet; pink tablet.

1. For the treatment of schizophrenia. 2. The efficacy of aripiprazole in the treatment of schizophrenia has been established in short-term (4-week and 6-week) controlled trials in patients with schizophrenia. Physicians who choose aripiprazole for long-term treatment should regularly re-evaluate the long-term efficacy of the drug for individual patients.

Adults: Oral, once a day. The initial dose is 10 mg. After 2 weeks of medication, the dose can be gradually increased according to the individual's efficacy and tolerance, up to 30 mg. After that, this dose can be maintained unchanged. The maximum daily dose should not exceed 30 mg. For patients who switch from other antipsychotics to this product: some patients can stop the antipsychotic they were using immediately; while other patients should gradually stop the antipsychotic they were using when they start using it. The time for taking antipsychotics at the same time should be minimized.

The safety of aripiprazole was evaluated in multiple-dose, premarketing studies involving 5592 patients with schizophrenia, mania in bipolar disorder, and dementia due to Alzheimer's disease; exposure was approximately 3639 case-years. A total of 1887 patients were treated with aripiprazole for at least 180 days, and 1251 were treated for at least 1 year. Because the characteristics of the patients and other factors vary from those in clinical trials, the data in the following tables cannot be used to predict the incidence of adverse reactions in ordinary medical practice. Likewise, the frequencies cited cannot be compared with data obtained from other clinical investigations involving different treatments, uses, and investigators. However, the data cited do provide some basis for the physician to evaluate the effects of drug and nondrug factors on the study subjects.

Patients with known hypersensitivity to this product are contraindicated.

Precautions for children: There is currently a lack of sufficient clinical experience in children. Precautions for pregnancy and lactation: It is not clear whether this product is safe for pregnant women to take. For pregnant women, the pros and cons should be weighed to decide whether to take this product. It can only be used when the potential benefits outweigh the risks, otherwise it should not be taken during pregnancy and lactation. Precautions for the elderly: Aripiprazole is well tolerated by the elderly at the recommended dose and no dose adjustment is required.

1 The risk of using this product in combination with other drugs has not been systematically evaluated. In view of the effects of this product on the central nervous system, caution should be exercised when it is used in combination with other drugs and alcohol that act on the central nervous system. 2 Because it antagonizes α1-adrenergic receptors, aripiprazole has the potential to enhance the effects of certain antihypertensive drugs. 3 Aripiprazole is not a substrate for CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2E1 enzymes, and does not undergo direct glucuronidation. This indicates that there is no possibility of interaction between aripiprazole and inhibitors or inducers of these enzymes, or other factors (such as smoking). 4n

Store in sealed container. Valid for 24 months

10mg

24 months

ZheJiang Otsuka Pharmaceutical Co., Ltd.

• Founded in:

  1991-10-12

• Address:

  No. 1 Shangguafan, Jinnan Street, Lin'an District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100609129453D

• Registered Funds:

  $54,333,333

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