ZHENGDATIANQING AISUPING Esomeprazole Magnesium Enteric-coated Capsules For Peptic Ulcer 20mg*30

[Drug Name]
Generic Name: Esomeprazole Magnesium Enteric-Coated Capsules
Trade Name: AiSuPing Esomeprazole Magnesium Enteric-Coated Capsules 20mg x 30 capsules
Pinyin Full Code: AiSuPing AiSiAoMeiLaZuoMeiChangRongJiaoNang 20mg x 30Li

[Main Ingredients]
The main ingredient of this product is esomeprazole magnesium. Chemical Name: Bis[5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl]-1H-benzimidazole] magnesium salt trihydrate. Molecular Formula: C34H36MgN6O6S2·3H2O Molecular Weight: 767.17

[Properties]
This product consists of white or off-white pellets.

[Indications/Main Functions]
Gastroesophageal Reflux Disease (GERD) - Treatment of reflux esophagitis - Long-term treatment to prevent relapses in patients with resolved esophagitis - Symptomatic control of GERD in combination with appropriate antimicrobial therapy to eradicate Helicobacter pylori. Furthermore: - Healing of duodenal ulcers associated with H. pylori infection - Prevention of relapses of H. pylori-related peptic ulcers requiring ongoing NSAID therapy - Treatment of gastric ulcers associated with NSAID therapy

[Specifications]
20mg x 30 capsules

[Dosage and Administration]
Gastroesophageal Reflux Disease (GERD) - Treatment of reflux esophagitis: 40 mg, once daily for four weeks. For patients with unresolved esophagitis or persistent symptoms, an additional four weeks of treatment is recommended. - Long-term maintenance treatment to prevent relapses in patients with resolved esophagitis: 20 mg, once daily. - Symptomatic control of GERD in patients without esophagitis: 20 mg, once daily. If symptoms are not controlled after 4 weeks of medication, the patient should undergo further evaluation. Once symptoms resolve, subsequent symptom control can be achieved with on-demand treatment: 20 mg taken orally once daily as needed. For patients at risk of developing gastric and duodenal ulcers while taking NSAIDs, on-demand treatment is not recommended. Esomeprazole magnesium enteric-coated capsules 20 mg + amoxicillin 1 g + clarithromycin 500 mg are used in combination with appropriate antimicrobial therapy to eradicate Helicobacter pylori and heal H. pylori-associated duodenal ulcers and prevent recurrence of H. pylori-associated peptic ulcers. For patients requiring continued NSAID therapy: For the treatment of gastric ulcers associated with NSAID therapy: the usual dose is 20 mg once daily for 4 to 8 weeks. This product is available as an enteric-coated capsule for oral administration. This product should be swallowed whole and taken at least one hour before a meal. For patients who have difficulty swallowing capsules, add one tablespoon of applesauce to an empty bowl, open the capsule, and carefully pour the granules onto the applesauce. The granules should be mixed with the applesauce and swallowed immediately; do not store for future use. The applesauce should not be overheated and should be soft enough to chew before swallowing. The granules should not be chewed or crushed. If the granule/applesauce mixture is not completely consumed, the remaining mixture should be discarded immediately. For patients with a nasogastric tube, the capsule can be opened, the intact granules poured into a 60mL catheter-tipped syringe, and mixed with 50mL of water.
When administering this product via a nasogastric tube, only a catheter-tipped syringe should be used. Replace the plunger and shake the syringe vigorously for 15 seconds. Lift the syringe and inspect for granules remaining at the tip. Connect the syringe to the nasogastric tube and pass the contents of the syringe into the stomach through the nasogastric tube. After administering the granules, the nasogastric tube should be flushed with additional water. If the granules dissolve or break down, do not use. The mixture must be used immediately after preparation.

[Adverse Reactions]
1. Clinical Trial Experience: Adverse Reactions with a Frequency of >1%: The safety of curative therapy for erosive esophagitis was evaluated in four randomized controlled clinical trials, including 1,240 patients in the esomeprazole magnesium 20 mg group, 2.44 patients in the esomeprazole magnesium 40 mg group, and 3,008 patients in the omeprazole 20 mg group, all administered once daily. The most frequent adverse reactions (21%) in all three treatment groups were: Nervous system: headache Gastrointestinal: diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. Adverse reactions possibly or probably related to esomeprazole magnesium, reported at a frequency of <1%, were listed by system organ class as follows: General system: abdominal distension, allergic reaction, fatigue, back pain, chest pain, substernal pain, facial edema, peripheral edema, hot flush, fatigue, fever, flu-like symptoms, generalized edema, leg edema, malaise, pain, chills, Cardiovascular: flushing, hypertension, tachycardia, Endocrine: goiter Gastrointestinal: bowel dysfunction, constipation aggravated, dyspepsia, dysphagia, gastrointestinal abnormalities Hyperplasia, epigastric pain, flatulence, esophageal disorders, frequent bowel movements, gastroenteritis, gastrointestinal bleeding, gastrointestinal symptoms (nonspecific), hiccups, melena, oral disorders, pharyngeal disorders, rectal disorders, increased serum gastrin, tongue disorders, tongue edema, ulcerative stomatitis, vomiting. Hearing: earache, tinnitus. Hematology: anemia, hemoglobinopenic anemia, cervical lymphadenopathy, rhinitis, leukocytosis, leukopenia, thrombocytopenia. Liver: bilirubinemia, abnormal liver function, increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Metabolism/Nutrition: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight gain, weight loss. Musculoskeletal: arthralgia, arthritis exacerbation, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica. Nervous/Psychiatric System: Anorexia, apathy, increased appetite, confusion, severe depression, dizziness, hypertonia, tension, decreased sensation, impotence, insomnia, migraine, exacerbated migraine, paresthesia, sleep disturbance, somnolence, tremor, vertigo, visual field loss. Reproductive System: Dysmenorrhea, menstrual disorders, vaginitis. Respiratory System: Exacerbated asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis. Skin and Appendages: Acne, angioedema, dermatitis, pruritus, pruritus anus, rash, erythematous rash, maculopapular rash, skin inflammation, increased sweating, urticaria. Special Senses: Otitis media, parosmia, anorexia, taste perversion. Urogenital System: Abnormal urine flow, albuminuria, cystitis, dysuria, fungal infection, hematuria, frequent urination, candidiasis, genital candidiasis, polyuria. Visual System: Conjunctivitis, visual disturbances. In clinical trials, potentially clinically significant changes of ≤1% in laboratory values ​​(regardless of whether they were related to esomeprazole magnesium) included: increases in creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell count, platelets, serum gastrin, serum potassium concentration, serum sodium concentration, thyroxine, and thyroid-stimulating hormone; and decreases in hemoglobin, white blood cell count, platelets, serum potassium concentration, serum sodium concentration, and thyroxine. Endoscopically detected adverse reactions included duodenitis, esophagitis, esophageal stricture, esophageal ulcer, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett's esophagus, and mucosal discoloration. During the 6-month maintenance treatment period, the incidence of treatment-related adverse reactions in the treatment group was comparable to that in the placebo group. There were no differences in the types of treatment-related adverse reactions between maintenance therapy for up to 12 months and short-term treatment. In two placebo-controlled studies of 710 patients with symptomatic gastroesophageal reflux disease, the most common adverse reactions possibly or probably related to this product were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%). In clinical trials of esomeprazole magnesium combined with amoxicillin and clarithromycin, adverse reactions associated with the combination were all those that occurred in studies of esomeprazole magnesium, amoxicillin, or clarithromycin monotherapy; no other adverse reactions related to these combination therapies were identified. For patients receiving triple therapy for 10 consecutive days, the most frequently reported drug-related adverse reactions were diarrhea (9.2%), taste perversion (6.6%), and abdominal pain (3.7%). The frequency of adverse reactions in the triple therapy group was no greater than that in the esomeprazole magnesium monotherapy group. In clinical trials of esomeprazole magnesium combined with amoxicillin and clarithromycin, no increase in other laboratory abnormalities associated with these combined drugs was observed. For more information on adverse reactions and laboratory changes with amoxicillin or clarithromycin, please refer to the respective product labels. 3. Postmarketing Experience: The following adverse reactions have been identified during postmarketing use of esomeprazole magnesium. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are listed by body system as follows: Blood and Lymphatic System: Agranulocytosis, Pancytopenia. Eye: Blurred vision. Gastrointestinal System: Pancreatitis, stomatitis, microscopic colitis, fundic gland polyps. Hepatobiliary System: Liver failure, icteric or non-icteric hepatitis. Immune System: Hypersensitivity reaction/shock. Infections and Infectious Diseases: Gastrointestinal candidiasis, Clostridium difficile-associated diarrhea. Metabolic Disorders and Malnutrition: Hypomagnesemia, with or without hypocalcemia or hypokalemia. Musculoskeletal and Connective Tissue: Muscle weakness, myalgia, fractures. Nervous System: Hepatic encephalopathy, taste disturbances. Psychiatric Disorders: Aggression, agitation, depression, hallucinations. Renal and Urinary System Disorders: Interstitial nephritis. Reproductive System and Breast Disorders: Gynecomastia. Respiratory System, Thoracic Cage, and Mediastinum: Bronchospasm. Skin and Subcutaneous Tissue: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Ohnson syndrome, toxic epidermal necrolysis (some cases can be fatal), cutaneous lupus erythematosus.

[Contraindications]
This product is contraindicated in patients with a known hypersensitivity to esomeprazole, other benzimidazole compounds, or any other component of this product. Hypersensitivity reactions, such as anaphylactic reactions, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria, have been reported following the use of esomeprazole magnesium. Esomeprazole should not be used concomitantly with nelfinavir (see [Drug Interactions]). For information on contraindications to antibacterial drugs (clarithromycin and amoxicillin) used in combination with esomeprazole magnesium, please refer to the contraindications section of their package inserts.

[Precautions]
Warnings and Precautions 1. Concurrent Gastric Malignancy: Malignancy should be excluded first when any alarm symptoms occur (such as significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis, or melena), or when gastric ulcer is suspected or present, as treatment with this product may alleviate symptoms and delay diagnosis. 2. Acute Interstitial Nephritis: Acute interstitial nephritis has been observed in patients taking PPIs, including esomeprazole magnesium. Acute interstitial nephritis may occur at any time during PPI treatment and is usually attributed to an idiopathic hypersensitivity reaction. If acute interstitial nephritis develops, discontinue this product (see [Contraindications]). 3. Atrophic Gastritis: Atrophic gastritis has occasionally been found in gastric corpus biopsies of patients receiving long-term omeprazole (esomeprazole as its enantiomer). 4. Clostridium difficile (C. difficile)-Associated Diarrhea: Published observational studies suggest that treatment with proton pump inhibitors (PPs), such as esomeprazole magnesium, may increase the risk of Clostridium difficile-associated diarrhea (CDAD), particularly in hospitalized patients. This diagnosis should be considered if diarrhea does not improve (see [Adverse Reactions]). Patients should be treated with the lowest dose and shortest duration of PPI appropriate for the treatment condition. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial drugs. For more information, particularly regarding the combined use of this product with antibacterial drugs (such as clarithromycin and amoxicillin), please refer to the "Warnings and Precautions" in the package insert for the relevant antibacterial drug. 5. Interactions with Clopidogrel: Avoid co-administration of this product with clopidogrel. Clopidogrel is a prodrug. The platelet aggregation inhibitory effect of clopidogrel is entirely attributable to its active metabolite. Concomitant use of drugs that inhibit CYP2C19 activity (such as esomeprazole) can affect the metabolism of clopidogrel to its active metabolite. Co-administration of clopidogrel and 40 mg of esomeprazole reduces the pharmacological activity of clopidogrel. Therefore, alternative antiplatelet therapy should be considered when using this product (see [Drug Interactions]). 6. Fractures: Several published observational studies have shown that treatment with proton pump inhibitors (PPIs) may increase the risk of osteoporotic fractures in areas such as the hip, wrist, or spine. The risk of fracture is also increased in patients receiving high-dose (defined as multiple daily doses) and long-term (1 year or longer) PPI therapy. Patients should receive the lowest dose and shortest duration of PPI therapy appropriate for their condition. Patients at risk for osteoporosis-related fractures should be treated according to existing guidelines. 7. When this product is used for Helicobacter pylori eradication, potential drug interactions between all components of triple therapy should be considered. 8. Hypomagnesemia: Rare cases of asymptomatic and symptomatic hypomagnesemia have been reported in patients who have received PPI therapy for at least 3 months and in the vast majority of patients who have received PPI therapy for 1 year. Serious adverse reactions include tetany, arrhythmia, and seizures. For most patients, correction of hypomagnesemia requires magnesium supplementation and discontinuation of PPI therapy. If prolonged PPI therapy is anticipated or concomitant medications such as digoxin or drugs that can cause hypomagnesemia (e.g., diuretics) are used, healthcare professionals should consider monitoring blood magnesium levels before initiating PPI therapy and periodically. 9. Concomitant use of Hypericum perforatum or rifampicin with drugs that induce CYP2C19 or CYP3A4 (e.g., Hypericum perforatum or rifampicin) can significantly reduce esomeprazole blood concentrations. This product should be avoided in combination with Hypericum perforatum or rifampicin. 10. Interactions between this product and neuroendocrine tumor testing drugs: Increased serum chromogranin A levels can secondary to reduced drug-induced gastric neuroendocrine tumors. Providers should suspend esomeprazole for at least 14 days before assessing serum chromogranin A levels and consider rechecking this level if the initial serum chromogranin A level remains elevated. Because normal reference values ​​may vary between laboratories, serial testing (e.g., monitoring) should be performed within the same commercial laboratory. 11. Concomitant Use of Methotrexate: Literature suggests that concomitant use of PPls and methotrexate (primarily high-dose; see methotrexate prescribing information) may increase serum concentrations of methotrexate and/or its metabolites, prolong elevated serum concentrations, and potentially lead to methotrexate toxicity. Temporary discontinuation of PPls may be considered in some patients taking high-dose methotrexate (see [Drug Interactions]). 12. Patients receiving treatment should contact their physician if their symptoms or signs change significantly. When using on-demand medication, potential drug interactions due to fluctuations in esomeprazole blood concentrations should be considered (see [Drug Interactions]). 13. This product contains sucrose. Patients with rare hereditary disorders such as glucose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this product. 14. Treatment with proton pump inhibitors may result in a slightly increased risk of gastrointestinal infections, such as Salmonella and Campylobacter (see [Pharmacology and Toxicology]). 15. Concomitant use of esomeprazole and atazanavir is not recommended (see [Drug Interactions]). If it is determined that combination therapy with atazanavir and a proton pump inhibitor is necessary, close clinical monitoring should be considered. For example, if the atazanavir dose is increased to 400 mg or ritonavir (often used in combination with atazanavir) to 100 mg, the esomeprazole dose should not exceed 20 mg. 16. Patients receiving long-term treatment with this drug (especially those receiving treatment for more than one year) should be monitored regularly. 17. Like all gastric acid suppressants, esomeprazole can reduce vitamin B12 (vitamin B12) absorption due to decreased or deficient gastric acid. Therefore, this risk should be considered during long-term treatment in patients with reduced body stores or risk factors for decreased vitamin B12 absorption. 18. Cutaneous and Systemic Lupus Erythematosus: Cases of cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including esomeprazole. These events include new onset and exacerbation of existing autoimmune diseases. The majority of lupus cases caused by PPIs are CLE, with SLE being less common. Avoid off-label, long-term use of PPIs. If symptoms or signs of CLE or SLE develop, discontinue the drug and consult a specialist. Most patients improve within 4 to 12 weeks after stopping the PPI. 19. Gastric Fundic Polyps: Long-term use of PPIs increases the risk of gastric fundic polyps, especially for use for more than one year. Most PP users who develop gastric fundic polyps are asymptomatic and are only discovered incidentally during endoscopy. PP treatment should be used for the shortest duration appropriate for the disease being treated. Renal Impairment: No dose adjustment is required for patients with renal impairment. Due to limited experience with this medication, treatment should be approached with caution in patients with severe renal impairment (see [Pharmacokinetics]). No dose adjustment is required for patients with mild to moderate hepatic impairment. For patients with severe hepatic impairment, the dose should not exceed 20 mg (see [Pharmacokinetics]). Effects on the ability to drive or use machines have not been observed.