Aripiprazole tablets

Aripiprazole has a high affinity for dopamine D2, D3, 5-HT1A and 5-HT2A receptors, and a moderate affinity for D4, 5-HT2c, 5-HT7, a1, H1 receptors and 5-HT reabsorption sites. Aripiprazole produces its anti-schizophrenia effect through partial agonism of D2 and 5-HT1A receptors and antagonism of 5-HT2A receptors.

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; after removing the film coating, it is white or off-white.

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.

Although the following adverse events were reported to have occurred during clinical studies, they were not necessarily caused by aripiprazole. 1 Adverse Events Related to Discontinuation in Short-Term Placebo-Controlled Trials The rate of discontinuation due to adverse events did not differ between aripiprazole-treated patients (7%) and placebo-treated patients (9%), and the types of adverse events leading to discontinuation were the same for aripiprazole and placebo-treated patients. 2 Dose-Related Adverse Events The dose-response relationship for the incidence of treatment-emergent adverse events was evaluated in four controlled trials of aripiprazole and placebo at different fixed doses (2, 10, 15, 20, and 30 mg/d). This analysis, stratified by study, indicated that the only adverse event that was likely to have a dose-response relationship and was most pronounced only at 30 mg was somnolence (7.7% for placebo, 8.7% for 15 mg, 7.5% for 20 mg, and 15.3% for 30 mg). 3 Extrapyramidal symptoms In short-term placebo-controlled trials, EPS were reported in 6% of aripiprazole-treated patients and 6% of placebo-treated patients, with no difference between aripiprazole and placebo, except for the Barnes Akathisia Rating Scale (0.08 for aripiprazole and -0.05 for placebo). Similarly, no difference was shown between aripiprazole and placebo in long-term (26-week) placebo-controlled trials. 4 Laboratory abnormalities Between-group comparisons of 4- to 6-week placebo-controlled trials showed no clinically significant differences between aripiprazole and placebo in the proportion of subjects with changes in routine blood chemistry, blood routine, or urine routine parameters. Similarly, there was no difference between aripiprazole/placebo in the rate of discontinuation due to these changes. In long-term (26-week) placebo-controlled trials, there were no clinically significant differences between aripiprazole and placebo-treated patients in mean changes from baseline in prolactin, fasting glucose, triglycerides, HDL, LDL, and total cholesterol. 5Weight Gain In short-term trials, there was a slight difference in mean weight gain between aripiprazole and placebo (0.7 kg and -0.05 kg, respectively), and there was also a difference in the percentage of patients who met the weight gain criteria (weight gain >7%): 8% for aripiprazole and 3% for placebo. 6ECG Changes Pooled between-group comparisons of placebo-controlled trials showed no significant differences between aripiprazole and placebo in the proportion of patients who experienced important changes in ECG parameters; in fact, aripiprazole slightly shortened the QTc interval over the dose range of 10 to 30 mg/d. The mean increase in heart rate was 4 beats/minute for aripiprazole and 1 beat/minute for placebo.

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. Given the effects of this product on the central nervous system, caution should be exercised when used in combination with other drugs and alcohol that act on the central nervous system. 2 Because it antagonizes alpha 1-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 12 months

5mg

24 months

Chengdu Kanghong Pharmaceutical Group Co., Ltd.

• Founded in:

  1996-10-03

• Address:

  No. 108, Shuxi Road, Jinniu District, Chengdu, Sichuan

• Tax NO.:

  91510100633116839D

• Registered Funds:

  919.463954 million yuan

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