Ziprasidone Hydrochloride Tablets

Ziprasidone is an atypical antipsychotic with a structure different from that of phenothiazine or butyrophenone antipsychotics. In vitro studies have shown that ziprasidone has high affinity for dopamine D2, D3, serotonin 5HT2A, 5HT2C, 5HT1A, 5HT1D, and a1-adrenergic receptors, moderate affinity for histamine H1 receptors, and no affinity for other tested receptors/binding sites including M cholinergic receptors. Ziprasidone has antagonistic effects on D2, 5HT2A, and 5HT1D receptors and agonistic effects on 5HT1A receptors. Ziprasidone can inhibit synaptic reuptake of serotonin and norepinephrine. Consistent with other antipsychotic drugs for schizophrenia, the mechanism of action of ziprasidone is unclear. Research

The main ingredient of this product is: Ziprasidone hydrochloride. Chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2(1H)-indol-2-one hydrochloride monohydrate.

This product is a hard capsule, and the contents are off-white to slightly pink powder.

This product is suitable for the treatment of schizophrenia.

Initial treatment: 20 mg once, twice a day, orally during meals. Depending on the condition, it can be gradually increased to 80 mg once, twice a day. In order to ensure the lowest effective dose, the patient's reaction after taking the drug should be carefully observed before adjusting the dose. The interval between dose adjustments should generally be no less than 2 days, because the blood concentration of this product reaches a stable state within 1-3 days after oral administration. Maintenance treatment: Regular evaluation should be conducted to determine whether the patient needs maintenance treatment. Although the length of maintenance treatment with ziprasidone has not yet been determined, in a 52-week clinical trial, the effective dose of ziprasidone for continuous use in patients with schizophrenia was: 20-80 mg once, twice a day. During maintenance treatment, the lowest effective dose should be used. In most cases, 20 mg of ziprasidone twice a day is sufficient.

The following adverse reactions were reported in overseas pre-marketing clinical trials: Patients with schizophrenia: The discontinuation rates due to adverse reactions in the ziprasidone group and the placebo group were 4.1% (29/702) and 2.2% (6/273), respectively. The main adverse reaction was rash. Seven patients in the ziprasidone group discontinued the drug due to rash (1%), and 0 patients in the placebo group. Extrapyramidal symptoms include the following adverse reactions: extrapyramidal symptoms, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis, and convulsions. In clinical trials for schizophrenia, these adverse reactions did not occur alone and the incidence was ≥5%. Dizziness includes vertigo and dizziness. In short-term, fixed-dose, placebo-controlled trials, there is no dose-dependency.

1QT interval prolongation Ziprasidone prolongs the QT interval in a dose-dependent manner, and some drugs that prolong the QT interval have been shown to be associated with fatal arrhythmias. Ziprasidone is contraindicated in patients with a history of QT interval prolongation (including congenital long QT interval syndrome), patients with recent acute myocardial infarction, and patients with uncompensated heart failure. Ziprasidone is contraindicated in combination with drugs that can prolong the QT interval pharmacodynamically, or drugs that are contraindicated in the prescribing information for patients with a prolonged QTc interval, and drugs that have a black box warning for cautious use in patients with a prolonged QTc interval. Ziprasidone should not be used with dofetilide, sotalol, quinidine, other Class Ia and III antiarrhythmic drugs, mesoridazine, thioridazine, chlorpromazine, fluphenazine, and chlorpromazine.

Precautions for children: The safety and efficacy of ziprasidone in pediatric patients have not been evaluated. Precautions for pregnancy and lactation: Ziprasidone should be used in pregnant women only when the benefits of taking the drug outweigh the potential risks of the drug to the fetus. It is not clear whether ziprasidone is secreted into breast milk, and women taking ziprasidone should not breastfeed. Precautions for the elderly: The starting dose should be lowered, the dose should be adjusted slowly, and the patient should be monitored closely.

1 Ziprasidone should not be used in combination with drugs that prolong the QT interval. 2 Ziprasidone mainly acts on the central nervous system and should be used with caution in combination with other centrally acting drugs. 3 Ziprasidone may induce hypotension and therefore may enhance the efficacy of certain antihypertensive drugs. 4 Ziprasidone may antagonize the effects of levodopamine and dopamine agonists. Effects of other drugs on ziprasidone Carbamazepine: Carbamazepine is a CYP3A4 inducer. When patients take 200 mg of carbamazepine twice a day for 21 consecutive days, the AUC of ziprasidone decreases by approximately 35%. The higher the dose of carbamazepine, the greater the decrease in the AUC of ziprasidone.

Store in sealed container. Valid for 24 months

20mg

24 months

Chongqing Shenghuaxi Pharmaceutical. Co., Ltd.

• Founded in:

  1999-09-28

• Address:

  No. 8 Jiangqiao Road, Nan'an District, Chongqing

• Tax NO.:

  915001082031990050

• Registered Funds:

  112 million yuan

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