Omeprazole magnesium enteric-coated tablets

Omeprazole is a substituted benzimidazole compound and a racemate of a pair of active optical enantiomers. Omeprazole acts on the proton pump in the parietal cells through a special mechanism to reduce gastric acid secretion, and this effect is reversible. Omeprazole is a weak base that is concentrated and converted into an active form in the acidic environment of the parietal cells, inhibiting the last link in the production of hydrochloric acid in gastric juice: H. K-ATPase. This inhibition is dose-dependent and has an effect on both basal and stimulated gastric acid secretion, regardless of the type of stimulus. Omeprazole has no effect on cholinergic and histamine receptors. Similar to H2 receptor blockers, omeprazole reduces gastric acidity, thereby increasing gastrin in proportion to the decrease in acidity, and the increase in gastrin is reversible. It has been reported that the incidence of gastric glandular cysts increases during long-term treatment. These changes are physiological results of suppressed gastric acid secretion, which are benign and reversible. The reduction in gastric acid caused by proton pump inhibitors or other acid inhibitors will increase the number of normal bacteria in the gastrointestinal tract, so the risk of gastrointestinal infections (such as Salmonella and Campylobacter) caused by treatment is slightly increased. In addition to the effect on gastric acid secretion, no other clinically significant pharmacodynamic effects of omeprazole have been observed. The effect on gastric acid secretion is directly related to the area under the plasma concentration-time curve (AUC), but is not related to the actual plasma concentration at a given time. Oral administration of 20 mg of this product will reduce gastric acid secretion within 2 hours. Once a day, take it for three to five consecutive days to achieve the maximum effect. For patients with duodenal ulcers, the average 24-hour gastric acidity is reduced by about 80%; 24 hours after administration, the gastric acid production stimulated by pentagastrin is reduced by about 70%. Omeprazole inhibits gastric acid secretion for a long time, and gastric acid secretion can return to normal 5 days after stopping the drug. One tablet (20 mg) a day can relieve symptoms on the first day and cure most duodenal ulcers within two weeks, while patients with gastric ulcers and reflux esophagitis need four weeks to cure. Omeprazole can increase the antibacterial effect of some antibiotics against Helicobacter pylori.

The main ingredient of this product is omeprazole magnesium.

This product is a biconvex oval enteric-coated tablet with "" engraved on one side and "10mG" or "20mG" engraved on the other side. Each tablet contains 10.3 mg and 20.6 mg of omeprazole magnesium enteric-coated micropellets, equivalent to 10 mg and 20 mg of omeprazole. The 10 mg tablet is light pink and the 20 mg tablet is pink. Dosage form characteristics: Omeprazole is unstable in an acidic environment, so the oral dosage form consists of enteric-coated micropellets. The enteric-coated micropellets are very small, and each 20 mg oral tablet contains approximately 1,000 enteric-coated micropellets.

Treatment of duodenal ulcer, gastric ulcer and reflux esophagitis; (Reflux esophagitis is caused by the reflux of gastric contents into the esophagus, commonly known as "heartburn", because gastric acid normally only exists in the stomach, when it refluxes into the esophagus, it burns or irritates the esophagus and produces a "heartburn feeling". It often occurs after meals because the esophageal sphincter is weakened or the pressure in the stomach is higher than that in the esophagus. Long-term and repeated irritation of the esophageal mucosa by gastric contents, especially the mucosa of the lower esophagus, causes inflammation. This disease often coexists with chronic gastritis, peptic ulcer or hiatal hernia, but can also exist alone. Depending on the symptoms, they belong to the TCM diseases of "swallowing acid", "vomiting acid", "choking", "chest pain" and other diseases.) Combined with antibiotics to treat duodenal ulcers infected with Helicobacter pylori; treatment of non-steroidal anti-

The tablet must be swallowed whole, with at least half a cup of liquid. The tablet cannot be chewed or crushed, but can be dispersed in water or slightly acidic liquid (such as juice), and the dispersion must be taken within 30 minutes. Duodenal ulcer: The normal dose is 20 mg of this product, once a day, and the ulcer usually heals within two weeks.

Clinical trials have shown that the most common symptoms are headaches and gastrointestinal symptoms such as diarrhea, nausea, and constipation (constipation is a symptom of many diseases, not a disease. Common symptoms are a significant decrease in the number of bowel movements, once every 2 to 3 days or longer, irregular, and dry and hard feces. Long-term constipation will affect the functioning of the spleen and stomach, causing abnormal conduction of the large intestine, a large amount of toxin accumulation, and secondary gastrointestinal discomfort, bad breath, pigmentation and other symptoms. Traditional Chinese medicine believes that constipation is mostly caused by internal heat and qi stagnation, and the heat should be relieved and the stagnation should be eliminated. Therefore, to eliminate constipation, the body needs to be fundamentally adjusted to eliminate it. Do not rush to use some drugs that are more irritating to the gastrointestinal tract.), the incidence rate is 1-3%.

It is contraindicated for those who are allergic to Losec.

Precautions for children: There is no experience of using this product for children in China. Precautions for pregnancy and lactation: Use with caution for pregnant and lactating women. Precautions for the elderly: No dosage adjustment is required for elderly patients.

1. This product may affect the absorption of other drugs due to its effect on gastric pH. Therefore, the absorption of ketoconazole and itraconazole will decrease when treated with omeprazole or other acid inhibitors or antacids. 2. This product is metabolized by CYP2C19 enzyme in the liver, so it will increase the plasma concentration of other drugs metabolized by this enzyme, such as diazepam, phenytoin, and warfarin (R-warfarin, low activity). Patients who are receiving phenytoin, warfarin or other vitamin K-antagonists should be monitored when starting or stopping omeprazole. 3. This product (40 mg per day) increases the Cmax and AUC of voriconazole (CYP2C19 substrate) by 15% and 41%, respectively. Voriconazole increases the AUCt of omeprazole by 280%. When used in combination and long-term treatment, the dose of omeprazole should be adjusted for patients with severe liver damage. 4. When this product is used in combination with clarithromycin or erythromycin, the blood concentration of omeprazole will increase. However, there is no interaction when used in combination with metronidazole or amoxicillin. 5. The combination of this product with drugs that inhibit CYP2C19 or CYP3A4 enzymes (HIV protease inhibitors, ketoconazole, itraconazole) may increase the plasma concentration of omeprazole. 6. Studies have shown that daily oral administration of 20-40 mg of this product does not affect other related CYP isoenzymes, and has no metabolic interaction with the following enzyme substrates, CYPIA2 (caffeine, phenacetin, theophylline), CYP2C9 (S-warfarin, piroxicam, diclofenac and naproxen), CYP2D6 (metoprolol, propranolol), CYP2E1 (ethanol) and CYP3A (cyclosporine, lidocaine, quinidine, estradiol, erythromycin, budesonide). 7. Proton pump inhibitors including omeprazole should not be used in combination with atazanavir. The co-administration of omeprazole (40 mg, once daily) with atazanavir 300 mg/ritonavir 100 mg reduces the exposure of atazanavir in healthy subjects (AUC, Cmax and Cmin are reduced by approximately 75%). Increasing the atazanavir dose to 400 mg does not compensate for the effect of omeprazole on atazanavir exposure. 8. The co-administration of omeprazole and tacrolimus increases the serum concentration of the latter. It is recommended to monitor the plasma concentration of tacrolimus when co-administration and discontinuation of omeprazole.

Seal tightly and store below 25℃.

20 mg

36 months.