Product Overview
[Drug Name]
Generic Name: Rebamipide Capsules
Trade Name: Ruibo/Shenghuaxi
English Name: Rebamipide Capsules
Chinese Pinyin: Rebamipide Capsules
[Ingredients]
Chemical Name: (±)-2-(4-chlorobenzamido)-3-[2(1H)-quinolinone-4]-propionic acid. Molecular Weight: C19H15CLN2O4
[Properties]
This product is a luminal capsule containing white granules or powder.
[Indications]
Improvement of gastric mucosal lesions (erosion, bleeding, congestion, edema) in gastric ulcers, acute gastritis, and acute exacerbations of chronic gastritis.
[Dosage and Administration]
1. Improvement of gastric mucosal lesions (erosion, bleeding, congestion, edema) in acute exacerbations of chronic gastritis and acute exacerbations of acute gastritis: Generally, adults take 0.1g (one capsule) orally three times a day. 2. Gastric Ulcer: Generally, for adults, take 0.1g (1 tablet) orally three times a day, morning, evening, and before bed.
[Adverse Reactions]
According to a Japanese study, adverse reactions, including abnormal clinical test values, occurred in 54 of 10,047 patients (0.54%). Among these patients, 18 of 3,035 (0.59%) patients aged 65 and over experienced adverse reactions. There was no difference in the type or incidence of adverse reactions between the elderly and younger patients. Serious Adverse Reactions: 1) Shock and Allergic Symptoms (Incidence Unknown*): This product may cause anaphylactic shock. Careful observation is recommended. If any abnormalities are detected, discontinue use and take appropriate measures. 2) Leukopenia (less than 0.1%) and Thrombocytopenia (Incidence Unknown*): This product may cause leukopenia and thrombocytopenia. Careful observation is recommended. If any abnormalities are detected, the patient should be treated.
[Contraindications]
This product should not be used by patients with a history of allergic reactions to any of its ingredients.
[Precautions]
1. Patients with a history of allergy to the ingredients of this product are prohibited from taking it; 2. Lactating women should avoid breastfeeding when taking this product; 3. The safety of this product for children has not been confirmed (little experience in use). 【Special population use】 Precautions for children: The safety of this product for children has not been confirmed (little experience in use). Precautions for pregnancy and lactation: (1) Since the safety of administration during pregnancy has not been confirmed, this product should only be used by pregnant women or women who may become pregnant when the benefits of treatment outweigh the risks. (2) According to animal experiments (rat studies), this product can be secreted through breast milk, so lactating women should avoid breastfeeding when taking this product. Precautions for the elderly: Since the physiological functions of elderly patients are generally low, attention should be paid to adverse reactions of the digestive system. 【Drug interactions】 This study has not been conducted yet and there are no reliable references. 【Pharmacological effects】 I. Pharmacological effects According to foreign literature reports: This product is a gastric mucosal protective drug that has the effect of protecting the gastric mucosa and promoting ulcer healing. (1) Inhibitory effect on experimental gastric ulcer and its effect on promoting healing This product can inhibit water immersion ulcer, aspirin ulcer, indomethacin ulcer, serum-based ulcer, pyloric ligation ulcer and gastric mucosal damage caused by ischemia-reperfusion related to active oxygen, platelet activating factor (PAF), diethyldithiocarbamate (DDC), stress response, indomethacin, etc. in rats. It can also promote the healing of acetic acid ulcer in rats and inhibit the recurrence of ulcer 120-140 days after formation. (2) Inhibitory effect on experimental gastritis and its effect on promoting healing This product not only inhibits the occurrence of experimental gastritis induced by taurocholic acid in rats, but also has the effect of promoting healing. (3) Effect of increasing prostaglandins in gastric mucosa This product increases the content of prostaglandin E2 in the gastric mucosa of rats, and increases prostaglandin E2 and prostaglandin I2 in gastric juice. It also increases the metabolite of prostaglandin E2, 15-keto-13,14-dihydroprostaglandin E2. This product increases the content of prostaglandin E2 in the gastric mucosa of healthy adult men and shows that it has an inhibitory effect on gastric mucosal damage caused by ethanol load. (4) Effect of protecting gastric mucosa This product can inhibit gastric mucosal damage in rats caused by ethanol, strong acid and strong alkali, and can also inhibit the damage of aspirin and taurocholic acid to gastric mucosal epithelial cells of rabbit fetuses, and inhibit the damage of aspirin, ethanol, and hydrochloric acid-ethanol load to the gastric mucosa of healthy adult men. (5) Effect of increasing gastric mucosal fluid volume This product can increase the activity of biosynthetic enzymes of high molecular weight glycoproteins in rat mucus, and increase the surface viscosity and soluble mucus of gastric mucosa. The effect of increasing soluble mucus is related to endogenous prostaglandins. (6) Effect of increasing gastric mucosal blood flow This product increases the blood flow of the rat mucosa and can improve blood circulation disorders caused by blood loss. (7) Effect on gastric mucosal barrier This product has almost no effect on the gastric mucosal potential difference of rats, but it can inhibit the decrease in gastric mucosal potential difference caused by ethanol. (8) Effect on hypersecretion of gastric alkaline substances This product hypersecretion of gastric alkaline substances in rats. (9) Effect on promoting gastric mucosal cell regeneration This product enhances the regeneration ability of gastric mucosal cells in rats and increases the number of surface epithelial cells. (10) Effect on repairing damaged gastric mucosa This product can normalize the repair process of rabbit cultured gastric mucosal epithelial cell wound repair model that was delayed by bile acid and hydrogen peroxide. (11) Effect on gastric acid secretion This product has almost no effect on the basal gastric juice secretion of rats and does not show an inhibitory effect on stimulated gastric acid secretion. (12) Effect on reactive oxygen species This product has the effect of eliminating hydroxyl free radicals and inhibiting the production of superoxides by polymorphonuclear leukocytes. In vitro, it inhibits gastric mucosal damage caused by reactive oxygen species produced by neutrophils caused by Helicobacter pylori. This product reduces the content of lipid peroxides in the gastric mucosa while inhibiting the gastric mucosal damage of stress-induced indomethacin-loaded rabbits. (13) Effect on gastric mucosal inflammatory cell infiltration Through studies on the taurocholic acid-induced gastritis model, NSAIDs gastric mucosal injury model, and ischemia-reperfusion model in rats, it was found that this product can inhibit inflammatory cell infiltration. (14) Effect on gastric mucosal inflammatory cytokine (interleukin-8) This product can inhibit the increase in interleukin-8 (IL-8) production in human gastric mucosal epithelial cells caused by Helicobacter pylori, and can also inhibit the activation of NF-KB in epithelial cells and the appearance of IL-8 mmRNA (in vitro). II. Toxicological studies According to foreign literature reports: (1) Single-dose toxicity [LD50 (mg/kg)]: (2) Repeated-dose toxicity: No drug-induced changes were observed in 52-week oral administration studies in SD rats and Beagle dogs, and the estimated no-toxic dose was 1000 mg/kg/day. (3) Genotoxicity: Negative results were obtained in microbial DNA damage repair tests, microbial or mouse cell gene mutation tests. The results of the Chinese hamster ovary cell chromosome aberration test were positive, and the rat micronucleus test was negative. (4) Reproductive toxicity: No significant drug-induced changes were observed in the pre-pregnancy and early pregnancy administration studies (SD rats: 30-1000 mg/kg/day; NZW strain rabbits: 10-300 mg/kg/day) and the perinatal and lactation administration studies (SD rats: 10-1000 mg/kg/day). (5) Carcinogenicity: In mice and rats, the drug was administered at doses of up to 1500 mg/kg/day and 2000 mg/kg/day, respectively, for up to 2 years in mixed feed. No changes in carcinogenicity were observed in either animal. (6) Antigenicity: No antigenicity was observed in systemic anaphylaxis, Schultz-Dyer reaction, passive skin allergy test, and agar gel immunodiffusion test.
[Storage]
Store in sealed containers.
[Specification]
0.1 g*30 capsules
[Packaging Specification]
Box
[Validity Period]
24 months
[Approval Number]
National Medicine Standard H20110123
[Manufacturer]
Company Name: Chongqing Shenghuaxi Pharmaceutical Co., Ltd.
