Medication info
Anaprazole 20 mg Tablets (Esomeprazole Magnesium Trihydrate)

Anaprazole 20 mg Tablets (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›21.69mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
Pale pink round film-coated tablet
Packaging
Box - 28 tablets/box [14 tablets/PTP x 2]
Approval status
Active

MFDS item code 201507644 · Approved 2015.11.10 · Insurance code 654004700

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and recurrence prevention of Helicobacter pylori positive peptic ulcers, alleviation of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, preventive maintenance therapy for rebleeding from gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquids like water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - For the treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms continue, take for an additional 4 weeks. - Long-term maintenance therapy for preventing recurrence in patients with esophagitis: 20 mg once daily. - For the symptom treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is needed. · Once symptoms alleviate, subsequent symptoms should be controlled with 20 mg once daily. · In adults, it is possible to take 20 mg once daily as needed. Patients at high risk for gastric ulcers and duodenal ulcers due to non-steroidal anti-inflammatory drug use are not recommended to take it as needed for continuous symptom control. 2) Combination therapy with antibiotics for the eradication of Helicobacter Pylori: 20 mg of this medication with 1 g of amoxicillin and 500 mg of clarithromycin, administered twice daily for 7 days. 3) Short-term therapy for treating upper gastrointestinal symptoms (pain, discomfort, burning) related to the use of non-steroidal anti-inflammatory drugs (non-selective and selective COX-2): 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. Clinical trials beyond 4 weeks have not been conducted. 4) For patients requiring continuous non-steroidal anti-inflammatory drug use - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drugs: 20 mg once daily. The treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drugs: 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 individual patient's needs, and treatment should continue as long as clinical symptoms are present. According to clinical data, the majority of patients can be managed on doses of 80 to 160 mg daily. Doses exceeding 80 mg should be divided into two daily doses. 6) Maintenance therapy after intravenous induction of prevention for rebleeding due to gastric or duodenal ulcers 40 mg once daily for 4 weeks after intravenous induction for the prevention of rebleeding due to gastric or duodenal ulcers. 2. Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - For the treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, an additional 4 weeks of use is required.
Children's dosage
Adolescents aged 12 and older: - For the treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, an additional 4 weeks of use is required.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and recurrence prevention of Helicobacter pylori positive peptic ulcers, alleviation of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, preventive maintenance therapy for rebleeding from gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal pain
  • upper gastrointestinal discomfort
  • upper gastrointestinal burning sensation
  • gastric ulcers
  • duodenal ulcers
  • Zollinger-Ellison syndrome
  • rebleeding.
View approved original text

This medication is used to treat gastroesophageal reflux disease and erosive reflux esophagitis, as well as for long-term maintenance therapy to prevent recurrence of esophagitis. It is used as part of a combination therapy with effective antibiotics for the treatment of duodenal ulcers and peptic ulcers in patients with Helicobacter pylori infection and to prevent recurrence. Additionally, it is used to treat upper gastrointestinal symptoms related to the use of non-steroidal anti-inflammatory drugs and in the treatment of gastric ulcers, as well as for prevention of gastric and duodenal ulcers. It also applies to the treatment of Zollinger-Ellison syndrome and for the prevention and maintenance therapy of rebleeding due to gastric ulcers or duodenal ulcers. Overall, it is widely used in the treatment and prevention of gastrointestinal-related diseases to improve symptoms and help maintain health.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquids like water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - For the treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms continue, take for an additional 4 weeks. - Long-term maintenance therapy for preventing recurrence in patients with esophagitis: 20 mg once daily. - For the symptom treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is needed. · Once symptoms alleviate, subsequent symptoms should be controlled with 20 mg once daily. · In adults, it is possible to take 20 mg once daily as needed. Patients at high risk for gastric ulcers and duodenal ulcers due to non-steroidal anti-inflammatory drug use are not recommended to take it as needed for continuous symptom control. 2) Combination therapy with antibiotics for the eradication of Helicobacter Pylori: 20 mg of this medication with 1 g of amoxicillin and 500 mg of clarithromycin, administered twice daily for 7 days. 3) Short-term therapy for treating upper gastrointestinal symptoms (pain, discomfort, burning) related to the use of non-steroidal anti-inflammatory drugs (non-selective and selective COX-2): 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. Clinical trials beyond 4 weeks have not been conducted. 4) For patients requiring continuous non-steroidal anti-inflammatory drug use - Treatment of gastric ulcers related to non-steroidal anti-inflammatory drugs: 20 mg once daily. The treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drugs: 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 individual patient's needs, and treatment should continue as long as clinical symptoms are present. According to clinical data, the majority of patients can be managed on doses of 80 to 160 mg daily. Doses exceeding 80 mg should be divided into two daily doses. 6) Maintenance therapy after intravenous induction of prevention for rebleeding due to gastric or duodenal ulcers 40 mg once daily for 4 weeks after intravenous induction for the prevention of rebleeding due to gastric or duodenal ulcers. 2. Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - For the treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, an additional 4 weeks of use is required.

Children's dosage

Adolescents aged 12 and older: - For the treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, an additional 4 weeks of use is required.

Precautions

This medication should not be used in individuals with allergies or a history of hypersensitivity to certain ingredients or benzimidazole derivatives. Patients taking some antibiotics or antivirals used in the eradication of Helicobacter pylori should also avoid this medication, as well as those with a history of myocardial infarction or those who are breastfeeding. This medication contains a dye called Yellow No. 5, so people with allergy reactions to this ingredient should use it with caution. Rarely, the use of this medication may result in various side effects such as blood abnormalities, allergic reactions, electrolyte imbalances, neurological symptoms, gastrointestinal disturbances, liver dysfunction, skin rashes, and more. If any symptoms arise, immediate consultation with a physician is required. Long-term use of this medication may lead to electrolyte imbalances such as hypomagnesemia, necessitating regular testing. Moreover, since this medication suppresses gastric acid secretion, there is a slightly increased risk of bacterial infections in the gastrointestinal tract, so if abnormal symptoms such as diarrhea persist, the healthcare provider should be informed. Patients at risk of osteoporosis or fractures should be cautious, as the long-term use of this medication may increase the risk of fractures. This medication can interact with various drugs, so if other medications are being taken, individuals must inform their healthcare provider, particularly when used alongside anticoagulants, antibiotics, antivirals, and anticonvulsants. Women who are pregnant or breastfeeding must consult with a physician before using this medication, and it is safest for breastfeeding mothers not to use this medication. In the case of overdose, there is no specific antidote available, so appropriate treatment should be provided according to symptoms, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis reaction/shock, severe allergic reactions, severe edema, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, eosinophilia with systemic symptoms drug reaction (DRESS syndrome), jaundice, liver failure, liver abnormalities, sudden and severe headache, seizures, altered consciousness, vision changes, paralysis, breathing problems, bronchospasm.

Mild side effects

  • Leukopenia
  • thrombocytopenia
  • agranulocytosis
  • pancytopenia
  • fever
  • peripheral edema
  • hyponatremia
  • hypomagnesemia
  • insomnia
  • anxiety
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  • confusion
  • depression
  • aggression
  • hallucinations
  • headache
  • dizziness
  • paresthesia
  • drowsiness
  • taste disturbances
  • blurred vision
  • bronchospasm
  • pancreatitis
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • microscopic colitis
  • increased liver enzymes
  • hepatitis
  • liver.

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

Storage

This medication can be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

Pale pink round film-coated tablet

Package unit

Box - 28 tablets/box [14 tablets/PTP x 2]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.