Esomeprazole magnesium enteric-coated tablets

Based on conventional multiple-dose toxicity, genotoxicity, and reproductive toxicity studies, preclinical studies have not shown that esomeprazole is particularly harmful to humans. Carcinogenicity studies in rats using a racemic mixture have found ECL cell hyperplasia and carcinoid in the stomach. These effects on the stomach in rats are the result of persistent, significant hypergastrinemia. The latter is secondary to a decrease in gastric acid production, which is seen in rats after long-term use of gastric acid secretion inhibitors.

The active ingredient of this product is esomeprazole magnesium

This medicine is enteric-coated tablets. 20mg is light pink, 40mg is pink, both are oblong biconvex.

1. Gastroesophageal reflux disease (GERD). 2. Treatment of erosive reflux esophagitis. 3. Long-term maintenance treatment to prevent relapse in patients with cured esophagitis. 4. Combination of symptom control of gastroesophageal reflux disease (GERD) with appropriate antimicrobial therapy to eradicate Helicobacter pylori. 5. Healing of duodenal ulcers associated with Helicobacter pylori infection. 6. Preventing relapse of peptic ulcers associated with Helicobacter pylori.

The tablets should be swallowed whole with liquid and should not be chewed or crushed. 1. For the treatment of erosive reflux esophagitis, 40 mg once a day for four consecutive weeks. 2. For patients with uncured esophagitis or persistent symptoms, it is recommended to take the drug for another four weeks. For long-term maintenance treatment to prevent recurrence in patients with cured esophagitis, 20 mg once a day. 3. Symptom control of gastroesophageal reflux disease (GERD) 20 mg once a day for patients without esophagitis. If symptoms are not controlled after 4 weeks of medication, the patient should be further examined. Once the symptoms are eliminated, subsequent symptom control can be achieved with immediate therapy, that is, 20 mg orally once a day when needed. 4. Combined with appropriate antibacterial therapy to eradicate Helicobacter pylori, heal Helicobacter pylori-related duodenal ulcers, and prevent recurrence of Helicobacter pylori-related peptic ulcers: Esomeprazole magnesium enteric-coated tablets 20 mg + amoxicillin 1g + clarithromycin 500 mg, twice a day for 7 days.

The following adverse reactions have been identified or suspected in clinical trials of esomeprazole, and none of these reactions are dose-related. Common reactions 1. (1/100, 1/10): headache, abdominal pain, diarrhea, abdominal distension, nausea/vomiting, constipation; Uncommon reactions 2. (1/1000, 1/100): dermatitis, itching, urticaria, dizziness, dry mouth. Rare reactions 3. (1/10000, 1/1000): Allergic reactions, such as angioedema, allergic reactions, and elevated liver transaminases. The following adverse reactions have been observed in the use of the racemate (omeprazole), and therefore may also occur in the use of esomeprazole. 4. Central and peripheral nervous systems: paresthesia, drowsiness, insomnia, dizziness. Reversible delirium, excitement

This product is contraindicated in patients with known hypersensitivity to esomeprazole, other benzimidazole compounds, or any other ingredient of this product.

Precautions for children: Children should not use. Precautions for pregnancy and lactation: Use with caution in pregnant women. Women who are lactating should not use. Precautions for the elderly: No dosage adjustment is required for elderly patients.

The absorption of ketoconazole and itraconazole will be reduced during esomeprazole treatment. When used in combination with diazepam, citalopram, imipramine, clomipramine, phenytoin, etc., these drugs may need to be reduced in dose. Therefore, during phenytoin treatment, when esomeprazole is used in combination or discontinued, it is recommended to monitor the blood concentration of phenytoin. There is no incompatibility.

Seal and store below 30℃

20mg (calculated as C17H19N3O3S)

36 months

AstraZeneca Pharmaceutical Co., Ltd.

• Founded in:

  1993-10-26

• Address:

  No. 2 Huangshan Road, New District, Wuxi

• Tax NO.:

  91320214607915071G

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  $191.2 million

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