Lomerizine Hydrochloride Tablets

Pharmacological action: This product is a diphenylpiperazine calcium channel blocker with selective cerebral vasodilation. Toxicological study: Genetic toxicity: The results of microbial reverse mutation test, chromosome aberration test and mouse micronucleus test were all negative. Reproductive toxicity: The non-toxic dose for male rat fertility is 100 mg/kg/day, and that for female rats is 30 mg/kg/day. The rat fetal organogenesis toxicity test showed that in the female rats with a dose of more than 10 mg/kg/day, abnormal delivery and decreased birth rate of young rats were observed; in the 30 mg/kg/day dose group, maternal vaginal bleeding, weight gain inhibition and reduced food intake were observed, the number of fetal deaths increased, weight loss and abnormal appearance with finger loss as the main manifestation were observed. The non-toxic dose for mother rats, fetuses and postnatal rats was 3 mg/kg/day. The results of the rabbit fetal organogenesis toxicity test showed that the administration of 5, 15 and 45 mg/kg/day dose groups had no significant effect on maternal animals. In the 45mg/kg/day group, the fetal mortality rate increased, the survival rate decreased, and no teratogenic effect was observed. The safe dose for pregnant rabbits is 45mg/kg/day, and for rabbit fetuses it is 15mg/kg/day. The results of toxicity tests on rats during the perinatal and lactation periods showed that the 30mg/kg/day dose group showed inhibition of maternal weight gain and delivery disorders. At the same time, the pups in the same group showed deterioration of general condition, weight loss, and decreased survival rate due to poor lactation. During lactation, the pups given doses of 10mg/kg/day or more showed a tendency to have low body weight and a low completion rate of auricle separation. The safe dose for perinatal and lactation mothers is 10mg/kg/day, and for pups it is 3mg/kg/day.

Main ingredient: Lomerizine hydrochloride Chemical name: 1-[bis(4-fluorophenyl)methyl]-4-(2,3,4-trimethoxybenzyl)piperazine dihydrochloride Molecular formula: C27H30F2N2O32HCl Molecular weight: 541.46

This product is white or off-white tablets.

Preventive treatment of migraine.

Adults take 5 mg (1 tablet) twice a day, after breakfast and dinner or before sleep. The dosage can be increased or decreased according to symptoms, but the daily dose should not exceed 20 mg (4 tablets).

The main symptoms are drowsiness, dizziness, staggering (shaking), nausea, and fever (0.3%). In addition, changes in laboratory test values may also occur, including ALT increase of 2.2%, AST increase of 1.7%, GGT increase of 1.4%, LDH increase of 1.1%, and AL-P increase of 0.9%.

The following patients are contraindicated: 1. Patients with a history of allergy to the ingredients of this product. 2. Patients with intracranial hemorrhage or those who may have such a condition [the effect of increasing cerebral blood flow will worsen the symptoms] 3. Patients in the acute stage of cerebral infarction [the acute take-off and landing of the lesion is in a state of metabolic disorder, accompanied by the effect of increasing blood flow in the non-lesion area, which will lead to a decrease in blood flow in the lesion area] 4. Pregnant women or women who may become pregnant are contraindicated [see (Drug Use in Pregnant and Lactating Women)]

Precautions for children: There is no safety data for children. Precautions for pregnancy and lactation: Pregnant women or women who may become pregnant are prohibited. Precautions for the elderly: 1. The dose selection for elderly patients should be very cautious, mainly considering that most elderly patients may have impaired liver function, which will lead to persistent high blood drug concentrations or higher potential safety risks. 2. Similar compounds (such as flunarizine hydrochloride) can easily cause extrapyramidal symptoms and depression in elderly patients after administration, so during the medication process of elderly patients, the reaction needs to be closely monitored. Once abnormal conditions are found, the administration should be stopped and appropriate treatment methods should be taken.

Concomitant use of antihypertensive drugs can cause an enhanced interaction, leading to lower blood pressure.

Keep away from light and store in sealed container.

5mg

24 months

Nanjing CHANG AO Pharmaceutical Co., Ltd.

• Founded in:

  1997-08-13

• Address:

  No. 63, Kexin Road, Jiangbei New District, Nanjing

• Tax NO.:

  91320100634081762H

• Registered Funds:

  $46.83 million

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