Lansoprazole enteric-coated capsules

After the drug is transferred to the acid secretion tubules of the gastric mucosal parietal cells, it is transformed into an active body structure under acidic conditions. This active substance combines with the SH group of the proton pump ((HK)-ATPase), thereby inhibiting the activity of the enzyme, and thus inhibiting the secretion of gastric acid. 1. Inhibition of (HK)-ATPase activity. Lansoprazole can inhibit the (HK)-ATPase activity of microsomes in dog gastric mucosa (in vitro experiment). 2. Inhibition of parietal cell acid production. Lansoprazole has an inhibitory effect on the acid secretion of isolated parietal cells of dog gastric mucosa stimulated by histamine, acetylcholine and gastrin (in vitro experiment). 3. Inhibition of gastric acid secretion. 1) Acid secretion caused by gastrin stimulation: In healthy adults, oral administration of 30 mg of lansoprazole once a day for 7 consecutive days can significantly inhibit the acid secretion caused by gastrin, and this effect can last for 24 hours. 2) Acid secretion caused by insulin stimulation: In healthy adults, oral administration of 30 mg of lansoprazole once a day for 7 consecutive days can significantly inhibit acid secretion caused by insulin. 3) Acid secretion at night: In healthy adults, oral administration of 30 mg of lansoprazole once a day for 7 consecutive days has a significant effect of inhibiting gastric acid secretion at night. 4) Acid secretion over 24 hours: In the 24-hour gastric juice sampling test of healthy adults, oral administration of 30 mg of lansoprazole once a day for 7 consecutive days significantly inhibited 24-hour gastric acid secretion. 5) Monitoring of 24-hour gastric pH value: In healthy adults and patients with duodenal ulcers, oral administration of 30 mg of lansoprazole once a day for 7 consecutive days significantly inhibited 24-hour gastric acid secretion. 6) Monitoring of 24-hour lower esophageal pH value: In patients with reflux esophagitis, oral administration of 30 mg of lansoprazole once a day for 7 to 9 consecutive days has a significant inhibitory effect on gastroesophageal reflux. 7) Gastric acid secretion in rats and gastric pouch dogs: This drug can significantly and continuously inhibit the basic acid secretion of rats and the acid secretion caused by histamine, gastrin, carbamoylcholine, 2-deoxy-D-glucose or water immersion stress test (in the duodenum). This drug also has a significant and continuous inhibitory effect on the acid secretion caused by various stimuli in gastric pouch dogs, and can show a stable acid secretion inhibitory effect during repeated administration (oral administration). 4. Promoting the healing of chronic ulcers. In experiments on rats, lansoprazole can significantly promote the healing of chronic gastric and duodenal ulcers caused by acetic acid (oral administration). 5. Inhibitory effect on ulcer formation. In experiments on rats, it has a significant inhibitory effect on gastric ulcers caused by water immersion stress test, aspirin or ethanol, duodenal ulcers caused by mepirisol or hemiamine, and reflux esophagitis (oral or intraduodenal administration).

The main ingredient of this product is lansoprazole. Its chemical name is (plusmn;)-2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole.

This product is a white capsule, and the contents are white or off-white enteric-coated spherical granules.

Used to treat gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome, and anastomotic ulcer.

Duodenal ulcer, usually adults take lansoprazole 15mg-30mg orally once a day for 4-6 weeks; gastric ulcer, reflux esophagitis, Zollinger-Ellison syndrome, anastomotic ulcer, usually adults take lansoprazole 30mg orally once a day for 6-8 weeks. However, for maintenance treatment, elderly patients, patients with liver dysfunction, and patients with renal impairment, lansoprazole 15mg can be taken orally once a day.

Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, Zollinger-Ellison syndrome: Among the 2,214 cases in the pre-approval clinical trial of this product, 342 cases (15.4%) had adverse reactions, including abnormal laboratory tests. Among the 6,260 cases in the post-marketing drug use survey (before the end of the review), 138 cases (2.2%) had adverse reactions. The following adverse reactions come from investigator reports and spontaneous reports. 1. Clinically important adverse reactions 1) Allergic reactions (rash, facial edema, dyspnea, etc.) (0.1%), occasionally shock (0.1%). Therefore, close observation is required. If abnormalities occur, the drug should be discontinued and appropriate treatment should be carried out. 2. Pancytopenia, agranulocytosis, hemolytic anemia (0.1%), or granulocytopenia, thrombocytopenia or anemia may occur (0.1%-5%). Therefore, close observation is required. If abnormalities occur, the drug should be discontinued and appropriate treatment should be carried out. 3. Jaundice, severe liver dysfunction accompanied by elevated AST (GOT), ALT (GPT), etc. (0.1%). If any abnormality occurs, the drug should be discontinued. 4. Lyell syndrome (toxic epidermal necrosis) and Stevens-Johnson syndrome (mucocutaneous eye syndrome) (0.1%). Therefore, close observation is required. If any abnormality occurs, the drug should be discontinued and appropriate treatment should be given. 5. Interstitial pneumonia (0.1%). If fever, cough, dyspnea, abnormal lung sounds (crepitus), etc. occur, a chest X-ray examination should be performed and the drug should be discontinued, and corticosteroids should be given for treatment. 6. Other adverse reactions. Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis and eye-mucosal-skin syndrome (Stevens-Johnson syndrome).

1. This product is contraindicated for those who are allergic to it; 2. This product is not suitable for breastfeeding women. If you have to take the medicine, you should avoid breastfeeding.

Precautions for children: The safety of the drug for children has not been established (due to very little clinical experience in children). Precautions for pregnancy and lactation: 1. It has been confirmed that the plasma concentration of lansoprazole in rat fetuses is higher than that in mother rats, and experiments in rabbits (oral administration of 30 mg/kg) have found that the fetal mortality rate increased. Therefore, for pregnant women or women who may become pregnant, it is necessary to determine in advance that the benefits of treatment outweigh the risks before using the drug. 2. It has been reported that in animal experiments (rat), this product will be transferred into breast milk. Therefore, this drug is not suitable for women who are breastfeeding. If you have to take the drug, you should avoid breastfeeding. Precautions for the elderly: Generally speaking, the gastric acid secretion capacity and other physiological functions of elderly patients will be reduced, so it should be used with caution, such as starting with a lower dose.

It may delay the metabolism and excretion of diazepam and phenytoin, data that have been published in reports of similar drugs such as omeprazole.

Sealed, store in a dry place.

30mg

60 months.

Beijing Honglin Pharmaceutical Co., Ltd.

• Founded in:

  1993-12-07

• Address:

  Yanqi Industrial Development Zone, Huairou District, Beijing

• Tax NO.:

  91110000621702873B

• Registered Funds:

  $15.8 million

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