Product Overview
[Drug Name]
Generic Name: Esomeprazole Magnesium Enteric-Coated Capsules
Trade Name: Dongyangguang Esomeprazole Magnesium Enteric-Coated Capsules 20mg*14 Capsules
Pinyin Code: DongYangGuang AiSiAoMeiLaZuoMeiChangRongJiaoNang 20mg*14 Tablets
[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.
[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 - Symptom control of GERD in combination with appropriate antimicrobial therapy to eradicate Helicobacter pylori. Furthermore, it can be used to heal duodenal ulcers associated with Helicobacter pylori infection - Prevention of relapses of peptic ulcers associated with H. pylori requiring continued NSAID therapy - Treatment of gastric ulcers associated with NSAID therapy (nonsteroidal anti-inflammatory drugs).
[Specifications]
20mg x 14 Capsules
[Dosage and Administration]
Gastroesophageal Reflux Disease (GERD) - Treatment of reflux esophagitis: 40mg, 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: 20mg, once daily. - Symptom control of GERD: 20mg, once daily in patients without esophagitis. If symptoms are not controlled after four weeks, the patient should undergo further evaluation. Once symptoms resolve, subsequent symptom control can be achieved with on-demand treatment: 20 mg orally once daily as needed. For patients at risk for developing gastric or 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 ongoing NSAID therapy, the usual dose for the treatment of gastric ulcers associated with NSAID use is 20 mg once daily for 4-8 weeks. This product is available as enteric-coated capsules for oral administration. The capsule should be swallowed whole, 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 capsule contents onto the applesauce. The granules should be mixed with applesauce and swallowed immediately; do not store for future use. The applesauce used 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 used, the remaining mixture should be discarded immediately. For patients with a nasogastric tube, the tablet 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 deliver 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 disintegrate, do not use. The mixture must be used immediately after preparation.
[Adverse Reactions]
See package insert for details.
[Contraindications]
This product is contraindicated in patients with a known hypersensitivity to esomeprazole, other benzimidazole compounds, or any other ingredient in this product. Hypersensitivity reactions, such as anaphylaxis, 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 of antibacterial drugs (clarithromycin and amoxicillin) used in combination with esomeprazole magnesium, please refer to the contraindications section of the respective package inserts.
[Precautions]
See package insert for details.
