Medication info
MD Esopark Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

MD Esopark Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›21.69mg / 1 tablet
Manufacturer / importer
(주)아리제약
Appearance
Pale pink rectangular film-coated tablets
Packaging
28T/Alu-Alu (14T/Alu-Alu*2)
Approval status
Active

MFDS item code 201604558 · Approved 2016.07.22 · Insurance code 058200060

Summary

Main use
Treatment of gastroesophageal reflux disease (erosive reflux esophagitis, symptoms) and treatment of peptic ulcer associated with Helicobacter pylori, relief of gastrointestinal symptoms related to NSAIDs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and prevention of rebleeding.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If symptoms persist or treatment is ineffective, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Symptomatic treatment regimen for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical advice is needed. · Once symptoms have improved, any following symptoms can be controlled with 20 mg once daily. · In adults, 20 mg once daily may be administered as needed. Patients at high risk of developing gastric and duodenal ulcers due to NSAID administration are not recommended for as-needed use to control ongoing symptoms. 2) Combination therapy for the eradication of Helicobacter pylori Administer 20 mg of this medication in conjunction with 1 g of amoxicillin and 500 mg of clarithromycin twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning) related to NSAID use (both non-selective and selective COX-2 NSAIDs) - 20 mg once daily. Additional medical advice is required if symptoms are not controlled after 4 weeks. Clinical trials beyond 4 weeks have not been conducted. 4) Patients requiring ongoing NSAID treatment - Treatment of gastric ulcers related to NSAID use: 20 mg once daily for 4 to 8 weeks. - Prevention of gastric ulcers and duodenal ulcers related to NSAID use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted based on the patient, and treatment should continue as long as clinical symptoms are present. According to clinical data, most patients are manageable at doses of 80 to 160 mg per day. Doses exceeding 80 mg per day should be divided into two administrations. 6) Maintenance therapy after inducing prevention of rebleeding due to gastric ulcers or duodenal ulcers through intravenous administration Administer 40 mg once daily for 4 weeks following the induction of prevention of rebleeding through intravenous administration.
Children's dosage
Adolescents over 12 years old 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If symptoms persist or treatment is ineffective, continue for an additional 4 weeks.

Ingredients

Manufacturer
(주)아리제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (erosive reflux esophagitis, symptoms) and treatment of peptic ulcer associated with Helicobacter pylori, relief of gastrointestinal symptoms related to NSAIDs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and prevention of rebleeding.

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • peptic ulcers positive for Helicobacter pylori
  • gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcers and duodenal ulcers associated with NSAID administration
  • Zollinger-Ellison syndrome
  • rebleeding due to gastric ulcer and duodenal ulcer.
View approved original text

This medication is used to treat gastroesophageal reflux disease and erosive reflux esophagitis, and is effective for long-term maintenance therapy to prevent recurrence in patients with esophagitis. In addition, it helps relieve symptoms of gastroesophageal reflux disease without esophagitis. It is used in combination with antibiotics for the treatment of duodenal ulcers and peptic ulcers associated with Helicobacter pylori infection, and is crucial for preventing recurrence. It is used short-term to treat upper gastrointestinal symptoms related to NSAID use and helps treat and prevent gastric ulcers and duodenal ulcers that may occur due to such therapy. It is also used for treating Zollinger-Ellison syndrome and for maintenance therapy to prevent rebleeding after intravenous administration. Thus, it is widely used for the treatment and prevention of various gastrointestinal disorders.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If symptoms persist or treatment is ineffective, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Symptomatic treatment regimen for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical advice is needed. · Once symptoms have improved, any following symptoms can be controlled with 20 mg once daily. · In adults, 20 mg once daily may be administered as needed. Patients at high risk of developing gastric and duodenal ulcers due to NSAID administration are not recommended for as-needed use to control ongoing symptoms. 2) Combination therapy for the eradication of Helicobacter pylori Administer 20 mg of this medication in conjunction with 1 g of amoxicillin and 500 mg of clarithromycin twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning) related to NSAID use (both non-selective and selective COX-2 NSAIDs) - 20 mg once daily. Additional medical advice is required if symptoms are not controlled after 4 weeks. Clinical trials beyond 4 weeks have not been conducted. 4) Patients requiring ongoing NSAID treatment - Treatment of gastric ulcers related to NSAID use: 20 mg once daily for 4 to 8 weeks. - Prevention of gastric ulcers and duodenal ulcers related to NSAID use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted based on the patient, and treatment should continue as long as clinical symptoms are present. According to clinical data, most patients are manageable at doses of 80 to 160 mg per day. Doses exceeding 80 mg per day should be divided into two administrations. 6) Maintenance therapy after inducing prevention of rebleeding due to gastric ulcers or duodenal ulcers through intravenous administration Administer 40 mg once daily for 4 weeks following the induction of prevention of rebleeding through intravenous administration.

Children's dosage

Adolescents over 12 years old 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If symptoms persist or treatment is ineffective, continue for an additional 4 weeks.

Precautions

This medication should not be used in certain patients. For instance, it should not be administered to patients who are allergic to this drug or its components, those with hypersensitivity to penicillin and macrolide antibiotics, patients taking certain heart-related medications, nursing women, or those with a history of myocardial infarction. This medication contains the dye Yellow No. 5, so caution should be exercised if there is a history of allergy or hypersensitivity to this dye. Various adverse reactions may occur with this medication, including headaches, dizziness, abdominal pain, diarrhea, skin rashes, muscle pain, and liver function abnormalities. Rarely, serious blood disorders or allergic reactions, hepatitis, and severe skin reactions may occur, and if any unusual symptoms occur, medical consultation should be sought immediately. Due to its acid-suppressive action, this medication can affect the normal bacterial balance in the stomach, increasing the risk of intestinal infections. Patients in a hospital setting should be especially cautious of Clostridium difficile infections. Prolonged use may lead to increased fracture risk and side effects such as hypomagnesemia, so regular monitoring is necessary. Hypomagnesemia can lead to cardiac arrhythmias or muscle symptoms, requiring caution. This medication may interact with various medicines, particularly those affecting blood coagulation such as warfarin, antiviral agents, certain antibiotics, and anticonvulsants. Therefore, medical guidance should be followed. The safety of this medication during pregnancy has not been sufficiently established, so pregnant women should use it cautiously after consulting their physician. Nursing women are advised to avoid this medication. In the event of overdose, specific antidotes are not available, and appropriate treatment should be administered according to symptoms. This medication is not removed through dialysis. Finally, this medication should be kept out of reach of children, and it is important not to transfer it to another container to ensure safety and quality.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reactions/shock, severe eruptions with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthmatic attacks, respiratory disturbances accompanied by cough and fever, jaundice, yellowing of skin or eyes, extreme lethargy, hepatic abnormalities, sudden severe headaches, lightning-like headaches, seizures, confusion, visual disturbances, paralysis.

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disorders, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal fullness, nausea, vomiting, dry mouth, stomatitis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, nephritis, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, chest pain, facial swelling, facial flushing, fatigue, fever, influenza.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius. This helps to safely maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pale pink rectangular film-coated tablets

Package unit

28T/Alu-Alu (14T/Alu-Alu*2)

Same-ingredient medicines

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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.