Bupropion Hydrochloride Tablets

Bupropion has a weak inhibitory effect on norepinephrine, 5-HT, and dopamine reuptake, but has no such effect on monoamine oxidase. The antidepressant mechanism of this product is still unclear, and it may be related to norepinephrine and/or dopamine effects.

Bupropion, chemical name: (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride.

This product is a film-coated tablet, which appears white or off-white after removing the coating.

Used to treat depression.

Oral administration. Start with a low dose, with a starting dose of 100 mg (1 tablet) twice a day (morning and evening); after taking for at least 3 days, the dose can be gradually increased to 100 mg (1 tablet) 3 times a day (morning, noon and evening) based on clinical efficacy and tolerance. As an antidepressant, this product usually takes 4 weeks to show obvious effects. If there is no obvious effect after several weeks of continuous use, you can consider gradually increasing to a maximum daily dose of 450 mg, but the maximum dose each time should not exceed 150 mg, and the interval between two doses should not be less than 6 hours.

According to foreign literature reports, common clinical adverse events of bupropion include agitation, dry mouth, insomnia, headache/migraine, nausea/vomiting, constipation and tremor. About 10% of the 2,400 subjects (including patients and healthy volunteers) discontinued the medication due to adverse events. The most common causes were neuropsychiatric disorders (3.0%), mainly agitation and mental disorders; gastrointestinal dysfunction (2.1%), mainly nausea and vomiting; nervous system dysfunction (1.7%), mainly epilepsy, headache and sleep disorders; skin discomfort (1.4%). It is worth noting that some adverse events were caused by dosages above the recommended daily dose. In other open, uncontrolled clinical studies, the following adverse events were also observed:

1. Patients with a history of epilepsy are prohibited from taking this product. 2. Patients who are taking other drugs containing bupropion are prohibited from taking this product. 3. Patients with bulimia or anorexia are prohibited from taking this product. 4. Patients who are allergic to bupropion or any of the ingredients in this product are prohibited from taking this product. 5. Patients who suddenly stop drinking or stop taking sedatives are prohibited from taking this product. 6. Do not use it in combination with monoamine oxidase (MAO) inhibitors. The interval between taking monoamine oxidase inhibitors and this product should be at least 14 days.

Drugs metabolized by cytochrome P450IIB6: In vitro tests have shown that bupropion is mainly metabolized by the P450IIB6 isoenzyme, so there is a potential interaction with other drugs that affect the P450IIB6 isoenzyme. Bupropion can be extensively metabolized, so the combination with other drugs will affect its clinical efficacy. For example, some drugs can induce the metabolism of bupropion (carbamazepine, phenobarbital, phenytoin), and some drugs can inhibit the metabolism of bupropion (such as cimetidine). A clinical trial involving 24 healthy volunteers has shown that concomitant use of cimetidine can affect the pharmacokinetics of bupropion and its active metabolites. After oral administration of 300 mg of this product, whether or not to co-administer 800 mg of cimetidine has no effect on the pharmacokinetics of the original and hydrogenated metabolites.

Keep in a light-proof and airtight container. The validity period is tentatively set at two years.

0.1g

Nanjing Sike Medicine Industry Co., Ltd.

• Founded in:

  2002-02-22

• Address:

  No. 28, Gaoxin Road, Nanjing High-tech Development Zone

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  91320100745351171H

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