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Levetiracetam tablets (kaipulan)

It is used for the treatment of partial seizures in adults and children over 4 years old. More role
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Common name:
Levetiracetam tablets
Product No.:
B14202068231
Approval No.:
Gyzz hj20160254 (former gyzz j20160085) (inquired by the State Drug Administration)
Jianke price:
¥299.00
Product specification:
0.5g*30s 0.25g*30s
Manufacturer:
Youshibi (Zhuhai) Pharmaceutical Co., Ltd
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Product name Levetiracetam tablets (kaipulan)
Main raw materials Each tablet contains 0.5g levetiracetam.
Main role It is used for the treatment of partial seizures in adults and children over 4 years old.
Product specification 0.5g*30s
Usage and dosage (1) Administration route: oral. It should be swallowed with an appropriate amount of water. It will not be affected by eating. (2) Administration method and dose: the body weight of adults (> 18 years old) and adolescents (12-17 years old) is ≥ 50kg, and the initial treatment dose is 500mg each time, twice a day. According to the clinical effect and tolerance, the daily dose can be increased to 1500 mg twice a day. For others, please refer to the manual.
manufacturing enterprise Youshibi (Zhuhai) Pharmaceutical Co., Ltd
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[drug name] Levetiracetam tablets (kaipulan)

[common name] Levetiracetam tablets

[specification and model] 0.5g*30s

[manufacturer] Youshibi (Zhuhai) Pharmaceutical Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz hj20160254 (former gyzz j20160085)

[validity period] 36 months

[functional indications] It is used for the treatment of partial seizures in adults and children over 4 years old.

[usage and dosage] (1) Administration route: oral. It should be swallowed with an appropriate amount of water. It will not be affected by eating. (2) Administration method and dose: the body weight of adults (> 18 years old) and adolescents (12-17 years old) is ≥ 50kg, and the initial treatment dose is 500mg each time, twice a day. According to the clinical effect and tolerance, the daily dose can be increased to 1500 mg twice a day. For others, please refer to the manual.

[adverse reactions] 1. The safety data collected from adult clinical studies showed that the incidence of adverse reactions in the drug group and placebo group were similar, 46.4% and 42.2% respectively. Among them, the serious adverse reactions were 2.4% and 2.0% respectively. The most common adverse reactions were drowsiness, fatigue and dizziness, which often occurred at the beginning of treatment. Over time, the incidence and severity of adverse reactions related to the central nervous system will decrease. There was no significant dose correlation between the adverse reactions of levetiracetam. 2. The clinical study of children (aged 4-16 years) showed that the incidence of adverse reactions in the drug group and the placebo group were similar, 55.4% and 40.2% respectively, and there were no serious adverse reactions in the drug group (1.0% in the placebo group). The most common adverse reactions in children were drowsiness, hostility, neuroticism, emotional instability, irritability, anorexia, fatigue and headache. Except that the incidence of behavioral and mental adverse reactions was higher than that of adults (38.6% in children and 18.6% in adults), the overall safety was similar to that of adults. 3. The risk of adverse reactions in adults and children is comparable. The clinical research results and post marketing experience of adults and children were summarized, and the adverse reactions and frequency of each system were evaluated: very common > 10%; Common 1-10%; Rare 0.1-1%; Rare: 0.01-0.1%; Very rare < 0.01%, including separate reports. 4. The data of clinical application after marketing are not enough to estimate the incidence of adverse reactions in the treatment population. -General reaction and discomfort at the administration site: fatigue is very common. -Nervous system discomfort: sleepiness, amnesia, ataxia, convulsion, dizziness, headache, excessive exercise and tremor are common. -Mental and psychological changes: common excitability, depression, emotional instability, hostility, insomnia, neuroticism, personality change and abnormal thinking. (see the inner packaging manual for details)

[precautions] 1. According to the current clinical practice, if it is necessary to stop taking kaipulan, it is recommended to stop the drug gradually. (for example, adults should reduce 500 mg / kg every 2-4 weeks, twice a day; children should reduce 10 mg / kg every 2 weeks, twice a day). 2. For patients with renal impairment, the dosage of levetiracetam needs to be adjusted. For severe liver impairment, renal function test needs to be carried out before selecting the dosage, and the dosage of patients needs to refer to [usage and dosage] 3. There have been reports of suicide, attempted suicide, suicidal ideation and behavior in epileptic patients treated with antiepileptic drugs, including levetiracetam. A meta-analysis based on randomized placebo-controlled clinical studies of antiepileptic drugs showed a slight increase in the risk of suicidal ideation and behavior. The mechanism of this increased risk is unknown. (see the inner packaging instructions for details) please read the instructions carefully and follow the doctor's instructions.

[taboo] It is forbidden for patients allergic to levetiracetam or to pyrrolidone derivatives or any other ingredients.

[listing Permit Holder] Ucbpharmas. A. (Belgium)

[packaging unit] box

[main ingredients] Each tablet contains 0.5g levetiracetam.

[character] This product is a Yellow Oval film coated tablet. There are nicks on one side of the tablet. It turns white after removing the coating.

[applicable population] unlimited

[medication for pregnant and lactating women] At present, there is no data on pregnant women taking this product. Animal tests have proved that the drug has certain reproductive toxicity. The potential danger to humans is unclear. Do not apply levetiracetam to pregnant women unless necessary. Sudden interruption of antiepileptic treatment may worsen the condition and be equally harmful to the mother and fetus. Animal experiments show that levetiracetam can be excreted from milk. Therefore, it is not recommended that patients breastfeed while taking drugs. (see the inner packaging manual for details)

[medication for children] See [usage and dosage]

[medication for elderly patients] See [usage and dosage]

[storage] Store at or below 25 ℃.

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    Levetiracetam tablets (kaipulan)

    ¥299.00

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